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Cited by 316Diabetes, Cardiovascular Risks, and LipoproteinsPhysical Activity and HealthDiabetes Management and Research

Diet, physical activity or both for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus

Open access
Hemmingsen, Bianca, Gimenez-Perez, Gabriel, Mauricio, Didac, Roqué i Figuls, Marta, Metzendorf, Maria-Inti, Richter, Bernd·2017·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd003054.pub4PMC PMC6486271
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Abstract

BACKGROUND: The projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether diet, physical activity or both can prevent or delay T2DM and its associated complications in at-risk people is unknown. OBJECTIVES: To assess the effects of diet, physical activity or both on the prevention or delay of T2DM and its associated complications in people at increased risk of developing T2DM. SEARCH METHODS: This is an update of the Cochrane Review published in 2008. We searched the CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, ICTRP Search Portal and reference lists of systematic reviews, articles and health technology assessment reports. The date of the last search of all databases was January 2017. We continuously used a MEDLINE email alert service to identify newly published studies using the same search strategy as described for MEDLINE up to September 2017. SELECTION CRITERIA: We included randomised controlled trials (RCTs) with a duration of two years or more. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology for data collection and analysis. We assessed the overall quality of the evidence using GRADE. MAIN RESULTS: We included 12 RCTs randomising 5238 people. One trial contributed 41% of all participants. The duration of the interventions varied from two to six years. We judged none of the included trials at low risk of bias for all 'Risk of bias' domains.Eleven trials compared diet plus physical activity with standard or no treatment. Nine RCTs included participants with impaired glucose tolerance (IGT), one RCT included participants with IGT, impaired fasting blood glucose (IFG) or both, and one RCT included people with fasting glucose levels between 5.3 to 6.9 mmol/L. A total of 12 deaths occurred in 2049 participants in the diet plus physical activity groups compared with 10 in 2050 participants in the comparator groups (RR 1.12, 95% CI 0.50 to 2.50; 95% prediction interval 0.44 to 2.88; 4099 participants, 10 trials; very low-quality evidence). The definition of T2DM incidence varied among the included trials. Altogether 315 of 2122 diet plus physical activity participants (14.8%) developed T2DM compared with 614 of 2389 comparator participants (25.7%) (RR 0.57, 95% CI 0.50 to 0.64; 95% prediction interval 0.50 to 0.65; 4511 participants, 11 trials; moderate-quality evidence). Two trials reported serious adverse events. In one trial no adverse events occurred. In the other trial one of 51 diet plus physical activity participants compared with none of 51 comparator participants experienced a serious adverse event (low-quality evidence). Cardiovascular mortality was rarely reported (four of 1626 diet plus physical activity participants and four of 1637 comparator participants (the RR ranged between 0.94 and 3.16; 3263 participants, 7 trials; very low-quality evidence). Only one trial reported that no non-fatal myocardial infarction or non-fatal stroke had occurred (low-quality evidence). Two trials reported that none of the participants had experienced hypoglycaemia. One trial investigated health-related quality of life in 2144 participants and noted that a minimal important difference between intervention groups was not reached (very low-quality evidence). Three trials evaluated costs of the interventions in 2755 participants. The largest trial of these reported an analysis of costs from the health system perspective and society perspective reflecting USD 31,500 and USD 51,600 per quality-adjusted life year (QALY) with diet plus physical activity, respectively (low-quality evidence). There were no data on blindness or end-stage renal disease.One trial compared a diet-only intervention with a physical-activity intervention or standard treatment. The participants had IGT. Three of 130 participants in the diet group compared with none of the 141 participants in the physical activity group died (very low-quality evidence). None of the participants died because of cardiovascular disease (very low-quality evidence). Altogether 57 of 130 diet participants (43.8%) compared with 58 of 141 physical activity participants (41.1%) group developed T2DM (very low-quality evidence). No adverse events were recorded (very low-quality evidence). There were no data on non-fatal myocardial infarction, non-fatal stroke, blindness, end-stage renal disease, health-related quality of life or socioeconomic effects.Two trials compared physical activity with standard treatment in 397 participants. One trial included participants with IGT, the other trial included participants with IGT, IFG or both. One trial reported that none of the 141 physical activity participants compared with three of 133 control participants died. The other trial reported that three of 84 physical activity participants and one of 39 control participants died (very low-quality evidence). In one trial T2DM developed in 58 of 141 physical activity participants (41.1%) compared

AI snapshot

Written from a shortened version of the paper’s full text (it is longer than we read).

TL;DR

This Cochrane review update found moderate-quality evidence that diet plus physical activity reduces or delays type 2 diabetes in people with impaired glucose tolerance, but there is no firm evidence that diet alone or physical activity alone affects type 2 diabetes risk or its complications. Data on patient-important outcomes such as mortality, cardiovascular events, microvascular complications, and quality of life remain sparse.

Key findings

  • In 11 trials comparing diet plus physical activity with standard or no treatment, T2DM developed in 315 of 2122 intervention participants (14.8%) versus 614 of 2389 comparator participants (25.7%) (RR 0.57, 95% CI 0.50 to 0.64; 4511 participants; moderate-quality evidence).
  • All-cause mortality was 12 deaths in 2049 diet-plus-physical-activity participants versus 10 in 2050 comparator participants (RR 1.12, 95% CI 0.50 to 2.50; 4099 participants, 10 trials; very low-quality evidence). Cardiovascular mortality was 4 of 1626 versus 4 of 1637 (RR 0.94, 95% CI 0.24 to 3.65; 3263 participants, 7 trials; very low-quality evidence).
  • One trial compared diet only with physical activity only in participants with IGT: 57 of 130 diet participants (43.8%) versus 58 of 141 physical activity participants (41.1%) developed T2DM; 3 of 130 diet participants versus none of 141 physical activity participants died (very low-quality evidence).
  • Two trials compared physical activity with standard treatment in 397 participants: one reported T2DM in 58 of 141 physical activity participants (41.1%) versus 90 of 133 controls (67.7%); the other reported 10 of 84 (11.9%) versus 7 of 39 (18%) (very low-quality evidence).

Methods

  • Systematic review and meta-analysis; update of a Cochrane Review published in 2008. Searches included CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, ICTRP, and reference lists, with the last database search in January 2017 and MEDLINE alerts through September 2017.
  • Included 12 RCTs randomising 5238 people at increased risk of T2DM, defined by intermediate hyperglycaemia/prediabetes. Interventions were diet, physical activity, or both versus standard treatment or no intervention, with a minimum intervention duration of two years; pharmacological intervention trials were excluded.
  • Ten trials were parallel RCTs and two were cluster-randomised. Analyses used random-effects meta-analysis with risk ratios or mean differences, 95% prediction intervals, trial sequential analysis, and GRADE assessment.

Limitations

  • The paper states that none of the included trials was at low risk of bias for all domains; most outcomes were low- or very low-quality evidence, and reporting on patient-important outcomes was insufficient. It also states that the diagnosis of intermediate hyperglycaemia varied across trials, results may not apply to people defined by other glycaemic categories or to children/adolescents, and only four investigators provided additional data.
  • The paper states that many included trials were not designed or powered to detect the review’s predefined patient-important outcomes, individual participant data were unavailable, and funnel plots could not be drawn for most outcomes. Review authors were not blinded during data extraction.
  • Evident from the text: three trials contributed about 70% of all data, and one trial contributed 41% of all participants; most trials included people with IGT, with little evidence for IFG or elevated HbA1c; interventions and diagnostic criteria were heterogeneous; and complications such as blindness, end-stage renal disease, and non-fatal myocardial infarction/stroke were rarely or not reported.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1002/14651858.cd003054.pub4

Cites

231 of 231 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 245 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    In one trial T2DM developed in 58 of 141 physical activity participants (41.1%) compared with 90 of 133 control participants (67.7%).

    “In one trial T2DM developed in 58 of 141 physical activity participants (41.1%) compared with 90 of 133 control participants (67.7%).”
    • Also stated in: § Key results · plain
      “in one study 58 of 141 participants (41%) in the physical activity group compared with 90 of 133 participants (68%) in the control group developed type 2 diabetes”
    Quote in the paperSubstantial claim
  • Findingown data

    There were no data on non-fatal myocardial infarction, nonfatal stroke, blindness, end-stage renal disease, health-related quality of life or socioeconomic effects.

    “There were no data on non-fatal myocardial infarction, nonfatal stroke, blindness, end-stage renal disease, health-related quality of life or socioeconomic effects.”
    Quote in the paperNot a substantial claim
  • Findingnone given

    There were no data on blindness or end-stage renal disease.

    “There were no data on blindness or end-stage renal disease.”
    Quote in the paperNot a substantial claim
  • Findingown data

    The other trial reported that three of 84 physical activity participants and one of 39 control participants died (very low-quality evidence).

    “The other trial reported that three of 84 physical activity participants and one of 39 control participants died (very low-quality evidence).”
    Quote in the paperNot a substantial claim
  • Findingown data

    One trial investigating health-related quality of life in 123 participants showed no substantial differences between intervention groups (very low-quality evidence).

    “One trial investigating health-related quality of life in 123 participants showed no substantial differences between intervention groups (very low-quality evidence).”
    Quote in the paperNot a substantial claim
  • May combine two claims. 86
  • Classified as probably not a substantial claim. 243
  • The quote only partly states this claim. 3

  • May combine two claims.

    Findingown data

    The review included 12 randomised controlled trials randomising 5238 people.

    “We included 12 RCTs randomising 5238 people.”
    • Also stated in: § Study characteristics · plain
      “We found 12 randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 5238 participants.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingnone given

    There were no data on blindness or socioeconomic effects.

    “There were no data on blindness or socioeconomic effects.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    In one trial no adverse events occurred.

    “In one trial no adverse events occurred.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingnone given

    One trial included participants with IGT, the other trial included participants with IGT, IFG or both.

    “One trial included participants with IGT, the other trial included participants with IGT, IFG or both.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The duration of the interventions varied from two to six years.

    “The duration of the interventions varied from two to six years.”
    • Also stated in: § Study characteristics · plain
      “The duration of the treatments varied from two years to six years.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingnone given

    Very few participants died in the course of the studies and side-effects were also rare.

    “Very few participants died in the course of the studies and side-effects were also rare.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    One RCT included people with fasting glucose levels between 5.3 to 6.9 mmol/L.

    “one RCT included people with fasting glucose levels between 5.3 to 6.9 mmol/L”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The definition of T2DM incidence varied among the included trials.

    “The definition of T2DM incidence varied among the included trials.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    One RCT included participants with IGT, impaired fasting blood glucose (IFG) or both.

    “one RCT included participants with IGT, impaired fasting blood glucose (IFG) or both”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Findingown data

    In this update, two trials from the original review were excluded because they did not have intermediate hyperglycaemia as an inclusion criterion.

    “In this update we excluded two of these trials as they did not have intermediate hyperglycaemia as an inclusion criterion (Bo 2007; Wing 1998).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites Bo 2007

      Not checked in the free run.

    • cites Wing 1998

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The original Cochrane Review published in 2008 included eight RCTs.

    “The original Cochrane Review published in 2008 included eight RCTs.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    Thirteen percent of participants in the DPP had HbA1c ≥ 6.5% at baseline.

    “Thirteen percent of the participants included in the DPP had HbA1c ≥ 6.5% at baseline (DPP 2002).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    All participants in the included trials were treatment-naive with regard to pharmacological glucose-lowering interventions.

    “All the participants in the included trials were treatment-naive with regard to pharmacological glucose-lowering interventions.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Ten included trials were parallel RCTs and two had a cluster-randomised design.

    “Ten included trials were parallel RCTs and two trials had a clusterrandomised design (Da Qing 1997; PODOSA 2014).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    A total of 33 health care clinics were included in Da Qing.

    “A total of 33 health care clinics were included (Da Qing 1997).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    56 additional references were identified for four already included trials of the 2008 review.

    “In this updated search we identified a total of 56 additional references for four of the already included trials of the 2008 review (Da Qing 1997;DPP 2002;DPS 2001;IDPP 2006).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    All ongoing trials assessed one or more outcomes of interest for the review.

    “All the ongoing trials assessed one or more outcomes of interest for our review.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The updated search of the databases identified 2072 records after duplicates were removed.

    “The updated search of the databases identified 2072 records after duplicates were removed (Figure 1).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Three ongoing RCTs were found in nine references.

    “We found three ongoing randomised controlled trials (RCTs) in nine references (NCT01530165; PREVIEW; PROPELS).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    Twenty-two participants of the initially randomised 147 participants in SLIM had a two-hour glucose value above 11 mmol/L.

    “Twenty-two participants of the initially randomised 147 participants had a two-hour glucose value above 11 mmol/L in this trial (SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    As the treatment effect was almost identical in both groups, Hellgren 2016 analysed the two groups together and designated them as the combined intervention group.

    “As the treatment effect was almost identical in both groups, they analysed the two groups together and thereafter designated them as the combined intervention group.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    181 references were evaluated further.

    “We evaluated 181 references further.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    Ten trials aimed for weight reduction for all participants allocated to the intervention groups or only for participants with a BMI above a certain limit.

    “Ten trials aimed for weight reduction for all participants allocated to the intervention groups or only for participants with a BMI above a certain limit (this BMI limit varied among the included trials) (Da Qing 1997; DPP 2002; DPS 2001; EDIPS 2009; HELP PD 2011; JDPP 2013; Kosaka 2005; Oldroyd 2005; PODOSA 2014; SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingnone given

    Participants with BMI above 25 kg/m2 allocated to the diet-only group in Da Qing 1997 were encouraged to reduce their calorie intake, so they lost 0.5 kg to 1.0 kg per month until they achieved [cut off].

    “Participants with BMI above 25 kg/m 2 allocated to the diet-only group in Da Qing 1997 were encouraged to reduce their calorie intake, so they lost 0.5 kg to 1.0 kg per month until they achieved”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In PODOSA 2014, participants constituted 156 family clusters that were randomised.

    “In the PODOSA 2014 trial participants constituted 156 family clusters that were randomised (78 families with 85 participants were allocated to the intervention group and 78 families with 86 participants were allocated to the control group).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    One trial included people with IGT defined by FPG < 7.8 mmol/L and two-hour plasma glucose after 100 g OGTT between 8.9 and 13.3 mmol/L, roughly corresponding to 7.8 to 11 mmol/L after a 75 g OGTT.

    “One trial included people with IGT defined by FPG < 7.8 mmol/L and two-hour plasma glucose after 100 g OGTT between 8.9 mmol/L and 13.3 mmol/ L, which roughly corresponds to 7.8 mmol/L to 11 mmol/L after a 75 g OGTT (Kosaka 2005).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    62 references were excluded after full-text evaluation.

    “We excluded a total of 62 references from the updated search after full-text evaluation.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    One trial included people with fasting glucose levels between 5.3 and 6.9 mmol/L.

    “One trial included people with fasting glucose levels between 5.3 mmol/L and 6.9 mmol/L (HELP PD 2011).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingreasoning

    In addition to the six included trials of the 2008 review, six more trials were included.

    “Therefore, in addition to the six included trials of the Cochrane Review published in 2008 we included six more trials (EDIPS 2009; Hellgren 2016; HELP PD 2011; JDPP 2013; PODOSA 2014; SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Five trials in six references were classified as studies awaiting classification.

    “We classified five trials in six references as studies awaiting classification (see 'Characteristics of studies awaiting classification' table).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    Diet advice was identical in both intervention groups and the comparator group in Hellgren 2016.

    “Diet advice was identical in both intervention groups and the comparator group.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Findingnone given

    Da Qing 1997 had four intervention arms: physical activity only, diet only, physical activity plus diet, and control group.

    “Da Qing 1997 had four intervention arms: physical activity only, diet only, physical activity plus diet and control group.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    Both intervention arms in Hellgren 2016 had a more intense physical activity strategy than the comparator group.

    “Both the intervention arms in Hellgren 2016 had a more intense physical activity strategy than the comparator group.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    One trial applied the WHO 1999 criteria for IFG and/or IGT.

    “One trial applied the WHO 1999 criteria for the definition of IFG (FPG ≥ 6.1 and < 7.8 mmol/L and twohour glucose < 7.8 mmol/L) and/or IGT (FPG < 7.0 mmol/L and two-hour plasma glucose after OGTT between ≥ 7.8 mmol/L and < 11.1 mmol/L) (PODOSA 2014).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Two ongoing trials' predefined outcomes stated that they would assess incidence of T2DM.

    “Two of the ongoing trials' predefined outcomes stated that they would assess one of our primary outcomes (incidence of T2DM) (NCT01530165; PREVIEW).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingreasoning

    Six trials of the original review remained.

    “Thus, six trials of the original review remained (Da Qing 1997;DPP 2002;DPS 2001;IDPP 2006;Kosaka 2005;Oldroyd 2005).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Three trials applied the WHO 1985 diagnostic criteria for IGT.

    “Three trials applied the World Health Organization (WHO) 1985 diagnostic criteria for the definition of IGT (fasting plasma glucose (FPG) < 7.8 mmol/L and two-hour plasma glucose after oral glucose tolerance test (OGTT) between ≥ 7.8 mmol/L and < 11.1 mmol/L) (Da Qing 1997; DPS 2001; Oldroyd 2005).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The definition of intermediate hyperglycaemia varied among the ongoing trials.

    “The definition of intermediate hyperglycaemia varied among the ongoing trials; one trial included participants with impaired glucose tolerance (IGT) (NCT01530165), one trial included participants with IGT, impaired fasting glucose (IFG) or both (PREVIEW), and one trial included participants with IFG or moderately elevated glycosylated haemoglobin A1c (HbA1c) (PROPELS).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    One trial applied the ADA 1997 diagnostic criteria for impaired glucose.

    “One trial applied the diagnostic criteria for impaired glucose de-fined by ADA 1997 (FPG 5.3 mmol/L to 6.9 mmol/L and twohour plasma glucose after OGTT between 7.8 and 11.0 mmol/ L) (ADA 1997) (DPP 2002).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites ADA 1997

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    One trial defined IGT by FPG < 7.8 mmol/L and two-hour plasma glucose after OGTT between ≥ 7.8 and < 12.5 mmol/L.

    “One trial defined IGT by FPG < 7.8 mmol/L and two-hour plasma glucose after OGTT between ≥ 7.8 mmol/L and < 12.5 mmol/L (SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    The ongoing trials are estimated to include 23,808 participants.

    “We estimate the ongoing trials to include 23,808 participants.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Two included trials had more than one intervention group of relevance for the review.

    “Two of the included trials had more than one intervention group of relevance for this review (Da Qing 1997; Hellgren 2016).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    Hellgren 2016 initially analysed data from the two intervention groups separately.

    “Hellgren 2016 initially analysed data from the two intervention groups separately.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Three trials applied the WHO 1999 criteria for IGT.

    “Three trials applied the WHO 1999 criteria for the definition of IGT (fasting plasma glucose (FPG) < 7.0 mmol/L and two-hour plasma glucose after OGTT between ≥ 7.8 mmol/L and < 11.1 mmol/L) (EDIPS 2009; IDPP 2006; JDPP 2013).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    A total of 54 participants in the DPP had FPG above 7.0 mmol/L at baseline.

    “A total of 54 participants (total in all three intervention groups) included in the Diabetes Prevention Program (DPP) had FPG above 7.0 mmol/L at baseline (DPP 2002).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingcitation

    One trial defined IFG as FPG > 6.0 to < 7.0 mmol/L with two-hour plasma glucose after OGTT < 8.9 mmol/L, and IGT as two-hour plasma glucose after OGTT between 8.8 and < 12.2 mmol/L, and fasting glucose < 7.0 mmol/L.

    “One trial defined IFG as FPG > 6.0 mmol/L to < 7.0 mmol/L with two-hour plasma glucose after OGTT < 8.9 mmol/L, while IGT was defined as two-hour plasma glucose after OGTT between 8.8 mmol/L and < 12.2 mmol/L, and fasting glucose < 7.0 mmol/L (Hellgren 2016).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S4 (based).

    Findingnone given

    The intra-cluster correlation coefficient for Da Qing was estimated to be 0.05.

    “However, we estimated it to be 0.05.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Findingnone given

    Data for the physical activity only, diet only, and physical activity plus diet groups were combined as one intervention group in the post-intervention follow-up period.

    “We combined data for the physical activity only, diet only and physical activity plus diet group as one intervention group in the post-intervention followup period.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    No intra-cluster correlation coefficient was reported for Da Qing.

    “No intra-cluster correlation (ICC) coefficient was reported.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The cumulative incidence of T2DM at six years was 43.8% (95% CI 35.3 to 52.3) in the diet only group compared with 41.1% (95% CI 33.4 to 49.4) in the physical activity only group (not adjusted for clustering).

    “The cumulative incidence of T2DM at six years was 43.8% (95% CI 35.3 to 52.3) in the diet only group compared with 41.1% (95% CI 33.4 to 49.4) in the physical activity only group (not adjusted for clustering).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingcitation

    In the standard treatment group, 15 participants had IGT only, 21 had IFG only, and six had IGT and IFG combined.

    “In the standard treatment group 15 participants had IGT only; 21 had IFG only and six had IGT and IFG combined.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Most of the trials reporting death were from trials with low risk of selection bias.

    “Most of the trials reporting death were from trials with low risk of selection bias (DPP 2002; DPS 2001; EDIPS 2009; HELP PD 2011; JDPP 2013; Oldroyd 2005; PODOSA 2014).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    Of the 32 participants with IGT at baseline in the physical activity group, seven (22%) developed T2DM; of the 38 with IFG, three (7.8%) developed T2DM; of the 11 with combined IFG and IGT, two (18.2%) developed T2DM.

    “Of the 32 participants with IGT at baseline in the physical activity group, seven (22%) developed T2DM; of the 38 with IFG at baseline, three (7.8%)developed T2DM; of the 11 with combined IFG and IGT, two (18.2%)developed T2DM.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    In the physical activity group, 13 participants (27%) reported that health-related quality of life worsened, 21 (43%) were unchanged, and 14 (29%) increased; the total number included in analyses was 48.

    “The investigators reported that 13 participants (27%) in the physical activity group reported that HrQoL from baseline to end of follow-up worsened, in 21 participants (43%) it was unchanged and in 14 participants (29%) it increased -the total number of participants in the physical activity group included in the analyses was 48 participants.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    One trial reported that none of the participants in the trial experienced an amputation of the lower extremity.

    “One trial reported that none of the participants in the trial experienced an amputation of the lower extremity.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    One trial included people with IGT, IFG or both.

    “One trial included people with IGT, IFG or both (PODOSA 2014).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    Of the 15 participants with IGT at baseline in the standard treatment group, five (33%) developed T2DM; of the 21 with IFG, two (7.8%) developed T2DM; of the six with combined IFG and IGT, four (66.7%) developed T2DM.

    “Of the 15 participants with IGT at baseline in the standard treatment group five (33%) developed T2DM; of the 21 with IFG at baseline, two (7.8%) developed T2DM; of the six with combined IFG and IGT, four (66.7%) developed T2DM (Hellgren 2016).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    The other trial reported that four participants died; three out of 84 in the physical activity group and one out of 39 in the standard treatment group.

    “The other trial reported that four participants died; three out of 84 in the physical activity group and one out of 39 in the standard treatment group.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    Of the 263 diabetes diagnoses made in all intervention groups during the six years of intervention, 55 (21%) were initially made by local physicians and confirmed by the city hospital with an OGTT, and 208 (79%) were made as a result of the systematic OGTT during the trial.

    “Of the 263 diabetes diagnoses made in all the intervention groups during the six years of intervention, 55 (21%) diagnoses were initially made by local physicians and confirmed by the city hospital with an OGTT; 208 (79%) were made as a result of the systematic OGTT during the trial.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    The two-hour glucose after an oral glucose load in the physical activity group was 10.5 mmol/L (SD 3.9) based on 141 participants (81 when adjusting for clustering) compared with 12.4 mmol/L (SD 4.2) in 133 participants (76 when adjusting for clustering) in the standard treatment group.

    “The two-hour glucose after an oral glucose load in the physical activity group was 10.5 mmol/L (SD 3.9) based on 141 participants (81 participants when adjusting for clustering) compared with 12.4 mmol/L (SD 4.2) in 133 participants (76 participants when adjusting for clustering) in the standard treatment group (Da Qing 1997).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    One trial included people with FPG levels between 5.3 to 6.9 mmol/L.

    “One trial included people with FPG levels between 5.3 to 6.9 mmol/L (HELP PD 2011).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingcitation

    In the standard treatment group, eight participants (35%) rated themselves worsened, 10 (43%) remained unchanged, and five (22%) improved; the total number included in analyses was 23.

    “The investigators reported that eight participants (35%) in the standard treatment group rated themselves worsened, 10 participants (43%) remained unchanged and five participants (22%) improved -the total number of participants in the standard treatment group included in the analyses was 23 (Hellgren 2016).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    Da Qing 1997 reported the incidence of severe retinopathy among participants originally assigned to diet only (4.5/1000 person years, 95% CI 1.8 to 7.1) compared with physical activity only (5.3/1000 person years, 95% CI 2.5 to 8.0) after 20 years of follow-up, and this difference was not statistically significant.

    “Da Qing 1997 reported the incidence of severe retinopathy among the participants originally assigned to diet only (4.5/1000 person years (95% CI 1.8 to 7.1)) compared with physical activity only (5.3/1000 person years (95% CI 2.5 to 8.0)) after 20 years of follow-up (i.e. 14 years after the end of intervention).This difference was not statistically significant.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    In the physical activity group, 32 participants had IGT only, 38 had IFG only, and 11 had IGT and IFG combined.

    “In the physical activity group 32 participants had IGT only; 38 had IFG only and 11 had IGT and IFG combined.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    Subgroup analyses found that treatment effects did not differ substantially according to sex, race or ethnic group; however, the effect of the behaviour-changing intervention was greater among participants with lower baseline glucose concentrations two hours after a glucose load.

    “Subgroup analyses found that treatment effects did not differ substantially according to sex, race or ethnic group; however, the effect of the behaviour-changing intervention was greater among participants with lower baseline glucose concentrations two hours after a glucose load.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DPP 2002

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    The incidence of T2DM per 100 person years was 4.5 (95% CI 3.8 to 5.5) in the diet plus physical activity group versus 7.2 (95% CI 6.1 to 8.5) in the control group; the HR (adjusted for sex, age, BMI and two-hour glucose) was 0.61 (95% CI 0.48 to 0.79; P < 0.001) and the absolute risk reduction was 19%.

    “The incidence of T2DM per 100 person years was 4.5 (95% CI 3.8 to 5.5) in the diet plus physical activity group versus 7.2 (95% CI 6.1 to 8.5) in the control group; the HR (adjusted for sex, age, BMI and two-hour glucose) was 0.61 (95% CI 0.48 to 0.79; P < 0.001) and the absolute risk reduction was 19%.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites DPS 2001

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    A total of 749 participants were included in the composite analysis with a mean follow-up of 3.1 years.

    “A total of 749 participants were included in the analyses with a mean follow-up of 3.1 years (Penn 2013).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Penn 2013

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    There was a 32% relative risk reduction and a 15% absolute risk reduction during the post-intervention follow-up period in favour of the former diet plus physical activity group.

    “There was a 32% relative risk reduction and a 15% absolute risk reduction during the post-intervention follow-up period in favour of the former diet plus physical activity group (DPS 2001).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites DPS 2001

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    The incidence of T2DM in the former diet plus physical activity group was 4.9 (95% CI 3.8 to 6.3) compared with 7.0 (95% CI 5.5 to 8.9) in the control group; the HR (adjusted for sex, age, BMI and two-hour glucose) was 0.67 (95% CI 0.48 to 0.95; P = 0.023).

    “The incidence of T2DM in the former diet plus physical activity group was 4.9 (95% CI 3.8 to 6.3) compared with 7.0 (95% CI 5.5 to 8.9) in the control group (DPS 2001); the HR (adjusted for sex, age, BMI and two-hour glucose) was 0.67 (95% CI 0.48 to 0.95; P = 0.023).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites DPS 2001

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    On average 7.4 people had to undergo diet plus physical activity for a mean of 3.1 years to prevent one case of T2DM (number needed to treat for an additional beneficial outcome 22.9 for one year).

    “On average 7.4 people had to undergo diet plus physical activity for a mean of 3.1 years to prevent one case of T2DM (number needed to treat for an additional beneficial outcome 22.9 for one year).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Penn 2013

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    The cumulative incidence of all-cause mortality was 28.1% (95% CI 23.9 to 32.4) in the combined former intervention group and 38.4% (95% CI 30.3 to 46.5) in the former comparator group, with a HR (adjusted for cluster randomisation) of 0.71 (95% CI 0.51 to 0.99; P = 0.049).

    “The cumulative incidence of all-cause mortality was 28.1% (95% CI 23.9 to 32.4) in the combined former intervention group and 38.4% (95% CI 30.3 to 46.5) in the former comparator group, with a HR (adjusted for clusterrandomisation) of 0.71 (95% CI 0.51 to 0.99; P = 0.049).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Da Qing 1997

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    The cumulative incidence of T2DM was significantly lower in the diet plus physical activity group compared with controls among participants with baseline HbA1c levels of 5.7% or higher, while this was not found among participants with baseline HbA1c levels less than 5.7%.

    “The cumulative incidence of T2DM was significantly lower in the diet plus physical activity group compared with controls among participants with baseline HbA1c levels of 5.7% or higher, while this was not found among participants with baseline HbA1c levels less than 5.7% (JDPP 2013).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites JDPP 2013

      Not checked in the free run.

  • May combine two claims.

    Findingown data

    Analysing trials performed in Asia showed a RR of 0.67 (95% CI 0.56 to 0.82; P < 0.0001); for trials performed in Europe, the RR was 0.54 (95% CI 0.41 to 0.72; P < 0.0001).

    “Analysing trials performed in Asia showed a RR of 0.67 (95% CI 0.56 to 0.82; P <0.0001) (Da Qing 1997; IDPP 2006; JDPP 2013; Kosaka 2005); for trials performed in Europe, the RR was 0.54 (95% CI 0.41 to 0.72; P < 0.0001) (DPS 2001; EDIPS 2009; Oldroyd 2005; PODOSA 2014; SLIM 2003).”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites Da Qing 1997

      Not checked in the free run.

    • cites IDPP 2006

      Not checked in the free run.

    • cites JDPP 2013

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    Baseline glycaemic (fasting and two-hour glucose) status was directly associated with diabetes incidence in the diet plus physical activity group and the control group; however, the effect of intervention was independent of glycaemic status.

    “Baseline glycaemic (fasting and twohour glucose) status was directly associated with diabetes incidence in the diet plus physical activity group and the control group.However, the effect of intervention was independent of glycaemic status (Appendix 19).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DPS 2001

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    A total of 263 participants were diagnosed with T2DM during the six years of intervention; 55 diagnoses (21%) were initially made by local physicians and confirmed by the city hospital with an OGTT; 208 (79%) were made as a result of the systematic OGTTs during the trial.

    “A total of 263 participants were diagnosed with T2DM during the six years of intervention; 55 diagnoses (21%) were initially made by local physicians and confirmed by the city hospital with an OGTT; 208 (79%) were made as a result of the systematic OGTTs during the trial (Da Qing 1997).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Da Qing 1997

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    After 23 years of follow-up 312 out of 430 participants of the combined former intervention group versus 124 out of 138 participants in the former control group developed T2DM; the HR (adjusted for clustering) was 0.55 (95% CI 0.40 to 0.76; P = 0.001).

    “After 23 years of follow-up 312 out of 430 participants of the combined former intervention group versus 124 out of 138 participants in the former control group developed T2DM.The HR (adjusted for clustering) was 0.55 (95% CI 0.40 to 0.76; P = 0.001).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Da Qing 1997

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    The incidence rate of cardiovascular morbidity was 22.9 in the former diet plus physical activity group versus 22.0 per 1000 person years in the former control group; the HR was 1.04 (95% CI 0.72 to 1.51).

    “The incidence rate of cardiovascular morbidity was 22.9 in the former diet plus physical activity group versus 22.0 per 1000 person years in the former control group; the HR was 1.04( 95% CI 0.72 to 1.51).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DPS 2001

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    There were no substantial differences in the treatment effects on aggregate microvascular complications in subgroups defined by age or ethnicity, except that Hispanic Americans had a lower microvascular disease prevalence in the former diet plus physical activity group than in the former control group (RR 0.43, 95% CI 0.20 to 0.91).

    “There were no substantial differences in the treatment effects on aggregate microvascular complications in subgroups defined by age or ethnicity, except that Hispanic Americans had a lower microvascular disease prevalence in the former diet plus physical activity group than in the former control group (RR 0.43, 95% CI 0.20 to 0.91) (DPP 2002).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DPP 2002

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    Post hoc analysis defining T2DM by HbA1c at 6.5% or higher showed that the incidence rate was reduced with diet plus physical activity compared with control during the DPP (4.6 cases/100 person years versus 8.8 cases/100 person years) and at 10 years of follow-up (3.5 cases/100 person years versus 5.0 cases/100 person years).

    “Post hoc analysis defining T2DM by HbA1c at 6.5% or higher showed that the incidence rate was reduced with diet plus physical activity compared with control during the DPP (4.6 cases/100 person years versus 8.8 cases/100 person years) and at 10 years of follow-up (3.5 cases/100 person years versus 5.0 cases/100 person years) (DPP 2002).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites DPP 2002

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    MCS improved in the placebo group compared with the diet plus physical activity group during the intervention period with 0.28 (SD 0.32); no exact P-value was provided, the value was more than 5%; the MID was not achieved.

    “MCS improved in the placebo group compared with the diet plus physical activity group during the intervention period with 0.28 (SD 0.32).No exact Pvalue was provided, the value was more than 5%.The MID was not achieved (DPP 2002).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DPP 2002

      Not checked in the free run.

  • May combine two claims.

    Findingown data

    Subgroup analyses of HbA1c by duration of intervention (≥4 years vs <4 years) and by BMI (≥30 vs <30 kg/m2) showed no interaction between subgroups (P = 0.99 and P = 0.10, respectively).

    “analysing trials according to the duration of the intervention (≥ 4 years) versus trials with short duration (< 4 years) showed no interaction between subgroups (P = 0.99) ( Analysis 2.34; Appendix 18).Analysing trials according to the BMI ≥ 30 kg/m 2 versus < 30 kg/m 2 showed no interaction between subgroups (P = 0.10) (Analysis 2.35).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In the random-effects model, the mean difference in HbA1c was -0.11% (95% CI -0.23 to 0.02; P = 0.09; 4 trials; 2453 participants), and in the fixed-effect model it was -0.18% (95% CI -0.23 to -0.13; P < 0.00001).

    “In the random-effects model the MD was -0.11% (95% CI -0.23 to 0.02; P = 0.09; 4 trials; 2453 participants) (Analysis 2.31), in the fixed-effect model the MD was -0.18%, 95% CI -0.23 to -0.13; P < 0.00001).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    TSA showed that 36.5% diversity-adjusted information size was accrued to detect or reject a HbA1c difference of -0.11% between intervention groups; alfa-spending-adjusted 95% CI was -0.34 to 0.12; diversity was 86%.

    “TSA showed that 36.5% diversity-adjusted information size was accrued to detect or reject a HbA1c difference of -0.11% between the intervention groups.Alfa-spending-adjusted 95% CI was -0.34 to 0.12.Diversity was 86%.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingcitation

    In PODOSA 2014, primary-care visits and costs did not differ between groups, but there were more outpatient visits in the intervention group (costing GBP 327 more than in the control group).

    “Primary-care visits and costs did not differ between groups, but there were more outpatient visits in the intervention group (costing GBP 327 more than in the control group).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites PODOSA 2014

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    After a mean of 3.2 years of follow-up there were improvements in the SF-6D (0.008; P = 0.04) in the diet plus physical activity group compared with control, however, the MID of 3% between the intervention groups was not achieved.

    “After a mean of 3.2 years of follow-up there were improvements in the SF-6D (0.008; P = 0.04) in the diet plus physical activity group compared with control, however, the MID of 3% between the intervention groups was not achieved.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DPP 2002

      Not checked in the free run.

  • The quote only partly states this claim.

    Findingown data

    Subgroups of trials according to age (≥ 50 years versus < 50 years) showed a significant interaction for two-hour plasma glucose (P = 0.003).

    “The subgroups of trials according to age (≥ 50 years versus < 50 years) showed significant interaction between subgroups (P = 0.003).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingreasoning

    The diet plus physical activity intervention was estimated to be cost-effective due to the high direct medical costs of T2DM, with low quality of evidence.

    “However, due to the high direct medical costs of T2DM, the diet plus physical activity intervention was estimated to be cost-effective.The quality of evidence was low.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites DPP 2002

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    In both the diet plus physical activity arm as well as the control arm HrQoL summary scores worsened during the trial, but the decline for SF-6D (P < 0.05) and PCS (P < 0.01) was slower in diet plus physical activity participants compared to the changes in the control group; however, none reached the MID of 3%.

    “In both the diet plus physical activity arm as well as the control arm HrQoL summary scores worsened during the trial, but the decline for SF-6D (P < 0.05) and PCS (P < 0.01) was slower in diet plus physical activity participants compared to the changes in the control group; however, none reached the MID of 3%.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DPP 2002

      Not checked in the free run.

  • May combine two claims.

    Findingown data

    TSA showed that diversity-adjusted information size was accrued to detect or reject a difference in two-hour plasma glucose at -0.46 mmol/L in favour of the diet plus physical activity group, with diversity 82%.

    “TSA showed that diversity-adjusted information size was accrued to detect or reject a difference in two-hour plasma glucose at -0.46 mmol/L in favour of the diet plus physical activity group.Diversity was 82%.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    The PCS (1.57; P < 0.0001) also improved in the diet plus physical activity group compared with control; again, the MID between the intervention groups was not achieved.

    “The PCS (1.57; P < 0.0001) also improved in the diet plus physical activity group compared with control (DPP 2002).Again, the MID between the intervention groups was not achieved.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DPP 2002

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    PODOSA 2014 reported that the extra mean cost for the diet plus physical activity group was GBP 1126 (95% CI -2414 to 4666) after three years, with GBP 615 of the difference being dietitian costs.

    “PODOSA 2014 reported that the extra mean cost for the diet plus physical activity group was GBP 1126 (95% CI -2414 to 4666) after three years, with GBP 615 of the difference being dietitian costs.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites PODOSA 2014

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    All trials reporting HbA1c included people with IGT, all included participants aged 50 years or more, and all included only white or mainly white people.

    “All trials reporting HbA1c included people with IGT, all included participants aged 50 years or more, and all included only white or mainly white people (DPP 2002;DPS 2001;EDIPS 2009;SLIM 2003).”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites DPP 2002

      Not checked in the free run.

    • cites DPS 2001

      Not checked in the free run.

    • cites EDIPS 2009

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    In the comparison of physical activity versus standard treatment, 1 trial reported 58/141 participants in the physical activity group compared with 90/133 in the standard treatment group developed T2DM (Da Qing 1997), and 1 trial reported 10/84 in the physical activity group compared with 7/39 in the standard treatment group developed T2DM (Hellgren 2016).

    “1 trial reported that 58/ 141 participants in the physical activity group com pared with 90/ 133 participants in the standard treatm ent group developed T2DM (Da Qing 1997) 1 trial reported that 10/ 84 participants in the physical activity group com -m m ol/ L (Hellgren 2016) Follow-up: 3 and 6 years pared with 7/ 39 participants in the standard treatm ent group developed T2DM (Hellgren 2016)”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites Da Qing 1997

      Not checked in the free run.

    • cites Hellgren 2016

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    After 23 years of follow-up, all-cause mortality and cardiovascular mortality were reduced in one study (Da Qing 1997), and this effect was only found in women.

    “However, after 23 years of follow-up, all-cause mortality and cardiovascular mortality were reduced in one study (Da Qing 1997).This effect was only found in women.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Da Qing 1997

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    In the comparison of physical activity versus standard treatment, 1 trial reported no (serious) adverse events (Da Qing 1997), and 1 trial reported 3/66 participants in the physical activity group compared with 1/39 in the standard treatment group experienced a serious adverse event (Hellgren 2016).

    “1 trial reported no (serious) adverse events occurred (Da Qing 1997). 1 trial reported that 3/ 66 participants in the physical activity group compared with 1/ 39 participants in the standard treatm ent group experienced a serious adverse event (Hellgren 2016data provided by trial authors)”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites Da Qing 1997

      Not checked in the free run.

    • cites Hellgren 2016

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The included trials applied different intensities of diet and physical activity.

    “The included trials applied different intensities of diet and physical activity.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    One excluded trial included 379 overweight Japanese people with IFG only; the intervention and control groups received similar diet and physical activity advice but with less frequent visits in the control group, and it was consequently not included in this review.

    “One of the excluded trials included 379 overweight Japanese people with IFG only.However, the intervention group and the control group received similar diet and physical activity advice, but with less frequent visits in the control group, and was consequently not included in this review (Saito 2011).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Saito 2011 source

      Not checked in the free run.

  • May combine two claims.

    Findingnone given

    The diagnosis of intermediate hyperglycaemia varied among trials, and some trials used a definition that may have included participants judged to be euglycaemic or having T2DM.

    “The diagnosis of intermediate hyperglycaemia varied among trials and some trials used a definition that may have included participants judged to be euglycaemic or having T2DM.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    Most trials included participants aged above 50 years.

    “Most trials included participants aged above 50 years.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation

    In the comparison of physical activity versus standard treatment, 1 trial reported 0/141 participants in the physical activity group compared with 3/133 in the standard treatment group died (Da Qing 1997), and 1 trial reported 3/84 in the physical activity group and 1/39 in the standard treatment group died (Hellgren 2016).

    “1 trial reported that 0/ 141 participants in the physical activity group compared with 3/ 133 participants in the standard treatm ent group died (Da Qing 1997) 1 trial reported that 3/ 84 participants in the physical activity group and 1/ 39 participants in the standard treatm ent group died (Hellgren 2016 -data provided by trial authors)”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites Da Qing 1997

      Not checked in the free run.

    • cites Hellgren 2016

      Not checked in the free run.

  • May combine two claims.

    Findingnone given

    In general, adherence to diet and lifestyle advice was low in the included trials, and might even be lower in a non-trial setting.

    “In general, the adherence to diet and lifestyle advice was low in the included trials, and might even be lower in a non-trial setting.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingcitation

    Long-term follow-up data for DPP 2002 have not shown any substantial effect on mortality or diabetes-related complications after 15 years of follow-up, even though the incidence of T2DM was reduced with the diet plus physical activity intervention.

    “In addition, long-term follow-up data for DPP 2002 have not shown any substantial effect on mortality or diabetes-related complications after 15 years of follow-up, even though the incidence of T2DM was reduced with the diet plus physical activity intervention.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites DPP 2002

      Not checked in the free run.

  • May combine two claims.

    Findingreasoning

    The only trial reporting long-term benefits was Da Qing 1997, but few participants were included in the analyses.

    “The only trial reporting long-term benefits was Da Qing 1997, however, few participants were included in the analyses.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Da Qing 1997

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In the DPS trial, the P value for interaction for sex was 0.33.

    “P interaction 0.33”
    Quote in the paperNot a substantial claim

  • May combine two claims. The quote only partly states this claim.

    Findingown data

    In the DPP, at the end of intervention, incidence of type 2 diabetes was lower with diet plus physical activity than control in each ethnic subgroup (White 4.7 vs 8.5; African American 4.1 vs 8.0; Hispanic 3.6 vs 9.1; American Indian 3.9 vs 7.9; Asian American 3.7 vs 11.4 per 100 person years).

    “White participants; diet plus physical activity 4.7/100 person years (N = 539); control 8.5/100 person years (N = 534) African American; diet plus physical activity 4.1/100 person years (N = 161); control 8.0/100 person years (N = 147)”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    A total of 5238 participants were randomised.

    “A total of 5238 participants were randomised; 11 trials evaluated diet plus physical activity (Da Qing 1997; DPP 2002; DPS 2001; EDIPS 2009; HELP PD 2011; IDPP 2006; JDPP 2013; Kosaka 2005; Oldroyd 2005; PODOSA 2014; SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Eleven trials evaluated diet plus physical activity.

    “A total of 5238 participants were randomised; 11 trials evaluated diet plus physical activity (Da Qing 1997; DPP 2002; DPS 2001; EDIPS 2009; HELP PD 2011; IDPP 2006; JDPP 2013; Kosaka 2005; Oldroyd 2005; PODOSA 2014; SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In the meta-analysis, heterogeneity was Tau2 = 0.00, Chi2 = 10.65, df = 10 (P = 0.39), I2 = 6%.

    “Heterogeneity: Tau 2 = 0.00; Chi 2 = 10.65,df = 10 (P = 0.39); I 2 =6%”
    Quote in the paperNot a substantial claim

  • The quote only partly states this claim.

    Findingown data

    The effect of diet plus physical activity versus comparator on fasting plasma glucose does not differ by ethnicity (test for subgroup differences Chi2 = 0.14, df = 1, P = 0.71).

    “Test for subgroup differences: Chi 2 = 0.14, df = 1 (P = 0.71), I 2”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    In the meta-analysis, the test for subgroup differences was Chi2 = 0.64, df = 1 (P = 0.42).

    “Test for subgroup differences: Chi 2 = 0.64, df = 1 (P = 0.42), I 2”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The number of participants varied from 78 (Oldroyd 2005) to 2161 (DPP 2002).

    “The number of participants varied from 78 (Oldroyd 2005) to 2161 (DPP 2002).”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites Oldroyd 2005

      Not checked in the free run.

    • cites DPP 2002

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Findingown data

    In the meta-analysis, there were 315 events in the diet plus physical activity group and 614 in the comparator group.

    “Total events: 315 (Diet + physical activity), 614 (Comparator)”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    Nine trials reported glucose values two hours after an oral glucose load.

    “Nine trials reported glucose values two hours after an oral glucose load (Da Qing 1997; DPP 2002; DPS 2001; EDIPS 2009; IDPP 2006; JDPP 2013; Oldroyd 2005; PODOSA 2014; SLIM 2003).”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites Da Qing 1997

      Not checked in the free run.

    • cites DPP 2002

      Not checked in the free run.

    • cites DPS 2001

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Findingown data

    In the meta-analysis, the overall effect test was Z = 8.70 (P < 0.00001).

    “Test for overall effect: Z = 8.70 (P < 0.00001)”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    One trial contributed 41% of the total number of all randomised participants (DPP 2002).

    “One trial contributed 41% of the total number of all randomised participants (DPP 2002).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DPP 2002

      Not checked in the free run.

  • May combine two claims.

    Findingown data

    The reduction in incidence of type 2 diabetes with diet plus physical activity versus control is 76% (95% CI 58 to 86) in the 7.7-8.5 mmol/L fasting plasma glucose stratum, 60% (95% CI 41 to 72) in the 8.6-9.5 mmol/L stratum, and 50% (95% CI 33 to 63) in the 9.6-11.0 mmol/L stratum.

    “7.7-8.5 mmol/L; incidence (cases/100 person years); I: 1.8; C: 7.1; reduction in incidence diet plus physical activity versus control 76 (95% CI 58 to 86) 8.6-9.5 mmol/L; incidence (cases/100 person years); I: 4.4; C: 10.3; reduction in incidence diet plus physical activity versus control 60 (95% CI 41 to 72) 9.6-11.0mmol/L; incidence (cases/100 person years); I: 8.5; C: 16.1; reduction in incid”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    In 1997 the ADA and later on the WHO introduced the IFG concept to define 'prediabetes'.

    “In 1997 the ADA and later on the WHO introduced the IFG concept to define 'prediabetes' (ADA 1997; WHO 1999).”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites ADA 1997

      Not checked in the free run.

    • cites WHO 1999

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The first glycaemic measurement used to define the prediabetic stage by the US National Diabetes Data Group was IGT.

    “The first glycaemic measurement used to define the prediabetic stage by the US National Diabetes Data Group was IGT (NDDG 1979).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites NDDG 1979

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    This lower cut-off point for IFG to define 'prediabetes' was not endorsed by the WHO.

    “However, this lower cut-off point for IFG to define 'prediabetes' was not endorsed by the WHO (WHO/IDF 2006).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites WHO/IDF 2006

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    IGT is caused by insulin resistance and defective insulin secretion.

    “Studies have indicated that IGT is caused by insulin resistance and defective insulin secretion (Abdul-Ghani 2006).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Abdul-Ghani 2006

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Later on, the ADA reduced the lower threshold for defining IFG to 5.6 mmol/L (100 mg/dL).

    “Later on, the ADA reduced the lower threshold for defining IFG to 5.6 mmol/L (100 mg/dL) (ADA 2003).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites ADA 2003

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Two review authors independently assessed the risk of bias of each included trial.

    “Two review authors (BH and GG) independently assessed the risk of bias of each included trial.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The overall quality of evidence for each outcome was presented according to the GRADE approach.

    “We presented the overall quality of the evidence for each outcome according to the GRADE approach, which takes into account issues relating not only to internal validity (risk of bias, inconsistency, imprecision, publication bias) but also to external validity, such as directness of results.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    Trials with high risk of selection bias were excluded.

    “In case of high risk of selection bias, we excluded the trial.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Discrepancies were resolved through consensus or by recourse to a third review author.

    “We resolved discrepancies through consensus or by recourse to a third review author (MM).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Self-reported, investigator-assessed, and adjudicated outcome measures were distinguished.

    “We distinguished between self-reported, investigator-assessed and adjudicated outcome measures.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S4 (based).

    Study design and conductnone given

    Other concomitant interventions had to be the same in the intervention and comparator groups to establish fair comparisons.

    “Other concomitant interventions had to be the same in the intervention and comparator groups to establish fair comparisons.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    In 2009, the International Expert Committee (IEC) suggested the HbA1c to identify people with a high risk of T2DM.

    “In 2009, the International Expert Committee (IEC) suggested the HbA1c to identify people with a high risk of T2DM.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites IEC 2009

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    If adequate information was not available from the trial publication or protocol, trial authors were contacted for missing data on risk of bias items.

    “If adequate information was not available from the trial publication, trial protocol or both, we contacted trial authors for missing data on 'Risk of bias' items.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Diet plus physical activity reduces cardiovascular risk factors, thereby indicating a potential beneficial effect on mortality and cardiovascular outcomes.

    “It has been shown that diet plus physical activity reduces cardiovascular risk factors, thereby indicating a potential beneficial effect on mortality and cardiovascular outcomes (Balk 2015).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Balk 2015 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    'Summary of findings' tables were created on the basis of methods described in the Cochrane Handbook.

    “We created the 'Summary of findings' tables on the basis of methods described in the Cochrane Handbook for Systematic Reviews of Interventions (Schünemann 2011) by means of the table editor in Review Manager 5 (RevMan 2014)”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites Schünemann 2011

      Not checked in the free run.

    • cites RevMan 2014

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Risk of detection bias was evaluated separately for each outcome.

    “We evaluated the risk of detection bias separately for each outcome (Hróbjartsson 2013).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Hróbjartsson 2013 source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductown data

    Outcome reporting bias was assessed by integrating results of Appendix 6 and Appendix 7.

    “We assessed outcome reporting bias by integrating the results of Appendix 6, 'Matrix of trial endpoints (publications and trial documents)' (Mathieu 2009), with those of Appendix 7 'High risk of outcome reporting bias according to ORBIT classification' (Kirkham 2010).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites Mathieu 2009 source

      Not checked in the free run.

    • cites Kirkham 2010 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Currently, ADA recommends reduced calorie intake and increased physical activity for people with increased risk of T2DM.

    “Currently, ADA recommends reduced calorie intake and increased physical activity for people with increased risk of T2DM (ADA 2017).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites ADA 2017

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    One review author extracted key characteristics of participants and interventions and another checked them.

    “One review author (BH) extracted key characteristics of participants and interventions and another (GG) checked them.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    A 'Risk of bias' graph and a 'Risk of bias' summary figure were presented.

    “We presented a 'Risk of bias' graph and a 'Risk of bias' summary figure.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Two review authors rated the quality of evidence for each outcome.

    “Two review authors (BH and BR) rated the quality of evidence for each outcome.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Unlike IFG and IGT, HbA1c reflects longer-term glycaemic control, that is, how the blood glucose levels have been during the previous two to three months.

    “Unlike IFG and IGT, HbA1c reflects longer-term glycaemic control, that is, how the blood glucose levels have been during the previous two to three months (Inzucchi 2012).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Inzucchi 2012

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    The Cochrane 'Risk of bias' assessment tool was used to judge risk of bias criteria as low, high, or unclear.

    “We used the Cochrane 'Risk of bias' assessment tool (Higgins 2011a) and judged risk of bias criteria as either low, high, or unclear”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Higgins 2011a

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    'Prediabetes' is commonly an asymptomatic condition, and naturally often remains 'undiagnosed'.

    “Most importantly, 'prediabetes' is commonly an asymptomatic condition, and naturally often remains 'undiagnosed' (CDC 2015).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites CDC 2015

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Two review authors independently scanned the abstract or title, or both, of every record retrieved to determine which trials should be assessed further.

    “Two review authors (BH and BR) independently scanned the abstract or title, or both, of every record we retrieved, to determine which trials should be assessed further.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Shortly after, the ADA redefined this HbA1c level as 5.7% to 6.4% to identify people with a high risk of developing T2DM.

    “Shortly after, the ADA redefined this HbA1c level as 5.7% to 6.4% to identify people with a high risk of developing T2DM (ADA 2010).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites ADA 2010

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    All decisions to downgrade the quality of evidence were justified using footnotes.

    “We justified all decisions to downgrade the quality of the evidence using footnotes”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Diet plus physical activity is recommended as an initial intervention not only for people with intermediate hyperglycaemia but also for people with T2DM.

    “Diet plus physical activity is recommended as an initial intervention not only for people with intermediate hyperglycaemia but also for people with T2DM (ADA 2017).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites ADA 2017

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    People with HbA1c measurements between 6.0% to 6.4% fulfilled this criterion.

    “People with HbA1c measurements between 6.0% to 6.4% fulfilled this criterion (IEC 2009).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites IEC 2009

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    This evidence is up to date as of January 2017.

    “This evidence is up to date as of January 2017.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    IFG seems to be associated with ß-cell dysfunction (impaired insulin secretion) and an increase of the hepatic glucose output.

    “IFG seems to be associated with ß-cell dysfunction (impaired insulin secretion) and an increase of the hepatic glucose output (DeFronzo 1989).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites DeFronzo 1989 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Risk of performance bias was evaluated separately for each outcome.

    “We evaluated the risk of performance bias separately for each outcome (Hróbjartsson 2013).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Hróbjartsson 2013 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    IFG and HbA1c are both thought to predict a different risk spectrum for developing T2DM.

    “IFG and HbA1c are both thought to predict a different risk spectrum for developing T2DM (Cheng 2006; Morris 2013).”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites Cheng 2006

      Not checked in the free run.

    • cites Morris 2013

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    For trials that fulfilled the inclusion criteria, two review authors independently extracted outcome data and assessed the risk of bias.

    “For trials that fulfilled the inclusion criteria, two review authors (BH and GG) independently extracted outcome data and assessed the risk of bias.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Disagreements on risk of bias assessment were resolved by consensus or by consultation with a third review author.

    “We resolved any disagreements by consensus, or by consultation with a third review author (BR).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Low risk of bias data were primarily summarised using a random-effects model.

    “Unless good evidence showed homogeneous effects across trials of different methodological quality, we primarily summarised low risk of bias data using a random-effects model (Wood 2008).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Wood 2008 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The remaining trials reported that participants were randomised but provided no further description.

    “The remaining trials reported that the participants were randomised but provided no further description (Da Qing 1997; IDPP 2006; Kosaka 2005; SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Three trials had an unclear risk of other bias.

    “Three trials had an unclear risk of other bias (HELP PD 2011; Kosaka 2005; SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    One trial mentioned that an independent outcome committee evaluated the incidence of T2DM.

    “One trial mentioned that an independent outcome committee evaluated the incidence of T2DM (DPS 2001).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Six of the trials had a published protocol.

    “Six of the trials had a published protocol (DPP 2002; DPS 2001; EDIPS 2009; HELP PD 2011; JDPP 2013; PODOSA 2014).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    All included trials reported blood glucose measurements performed by the investigators, and these outcome measures were judged at low risk of performance and detection bias.

    “All the included trials reported blood glucose measurements performed by the investigators and we judged these outcomes measures to be at low risk of performance and detection bias.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Overall risk of attrition bias was considered unclear for most outcomes.

    “We considered overall risk of attrition bias to be unclear for most of our outcomes.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductreasoning

    Where measured, all primary outcomes of this review were investigator assessed and were judged at low risk of performance and detection bias.

    “Where measured, all primary outcomes of this review were investi-gator assessed and we judged these to be at low risk of performance and detection bias.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    Four included trials had received grants from a pharmaceutical company and were judged as unclear risk of other bias.

    “Four of the included trials had received grants from a pharmaceutical company and we judged these as unclear risk of other bias (DPP 2002; DPS 2001; HELP PD 2011; IDPP 2006).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Five trials were judged at low risk of other bias.

    “We judged five trials to be at low risk of other bias (EDIPS 2009; Hellgren 2016; JDPP 2013; Oldroyd 2005; PODOSA 2014).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    One trial did not report its funding source.

    “One trial did not report funding source (Kosaka 2005).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Three trials provided details on the participants not completing the trial.

    “Three trials provided details on the participants not completing the trial (DPS 2001; JDPP 2013; PODOSA 2014).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Eight trials were judged at low risk of selection bias with regard to the method of randomisation and allocation concealment.

    “We judged eight of the trials to be at low risk of selection bias with regard to the method of randomisation and allocation concealment (DPP 2002; DPS 2001; EDIPS 2009; Hellgren 2016; HELP PD 2011; JDPP 2013; Oldroyd 2005; PODOSA 2014).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Two trials did not describe how many participants were initially randomised to each intervention group but reported the number analysed.

    “Two trials did not describe how many participants were initially randomised to each intervention group but reported the number analysed (Da Qing 1997; Hellgren 2016).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Attrition rates were investigated and issues concerning missing data and imputation methods were critically appraised.

    “We investigated attrition rates (e.g.dropouts, losses to follow-up, withdrawals), and critically appraised issues concerning missing data and imputation methods (e.g. last observation carried forward).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    If 10 or more trials investigated a particular outcome, funnel plots were used to assess small-trial effects.

    “If we included 10 or more trials investigating a particular outcome, we used funnel plots to assess small-trial effects.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Two of the judgments of unclear risk of selective outcome reporting bias were based on lack of trial protocol, and one trial was judged unclear because the primary outcome was changed during the trial.

    “Two of the judgments of unclear risk of selective outcome reporting bias were based on lack of trial protocol (Oldroyd 2005; SLIM 2003) and one trial because the primary outcome was changed during the trial (PODOSA 2014).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Ten trials reported the number of participants randomised and finishing the trial for each intervention group.

    “Ten trials reported the number of participants randomised and finishing the trial for each intervention group (DPP 2002; DPS 2001; EDIPS 2009; HELP PD 2011; IDPP 2006; JDPP 2013; Kosaka 2005; Oldroyd 2005; PODOSA 2014; SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    One trial was judged at low risk of selective outcome reporting bias after the investigators provided additional information.

    “We judged one trial as low risk of selective outcome reporting bias after the investigators provided additional information (Hellgren 2016).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Missing data were sought from trial authors and important numerical data were carefully evaluated.

    “We tried to obtain missing data from trial authors and carefully evaluated important numerical data such as screened, randomly assigned participants as well as intention-to-treat, and as-treated and per-protocol populations.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Another trial reported that physical activity was significantly higher at baseline in the diet plus physical activity group than in the control group.

    “Another trial reported that physical activity was significantly higher at baseline in the diet plus physical activity group than in the control group (Da Qing 1997).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    One trial prolonged the intervention period without any explanation.

    “One trial prolonged the intervention period without any explanation (SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Receiving funding or provision of free drugs or devices from a pharmaceutical company leads to more favourable results and conclusions than sponsorship from other sources.

    “It is known that receiving funding or provision of free drugs or devices from a pharmaceutical company leads to more favourable results and conclusions than sponsorship from other sources (Lundh 2017).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Lundh 2017

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Interpretationcitation

    This definition did not adhere to the WHO or ADA definition, but was very close to the glycaemic levels recommended by ADA 2003.

    “This definition did not adhere to the definition by the WHO or American Diabetes Association (ADA), however, the definition was very close to the glycaemic levels recommended by ADA 2003 (FPG 5.6 mmol/L to 6.9 mmol/L) (ADA 2003).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites ADA 2003

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Two trials explicitly stated that glycaemic measures were masked for the investigators and participants until diabetes was confirmed.

    “Two trials explicitly stated that glycaemic measures were masked for the investigators and participants until diabetes was confirmed (DPP 2002;DPS 2001).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductcitation

    In one trial, a significantly larger proportion of control participants reported engaging in regular physical activity at least once a week compared with intervention participants (53% versus 24%), and there were fewer women than men in the control group compared with the diet plus physical activity group.

    “In one trial a significantly larger proportion of control participants reported engaging in regular physical activity at least once a week compared with intervention participants (53% versus 24%) and there were fewer women (10/32 (32%)) than men (22/32 (69%)) in the control group compared with the diet plus physical activity group (Oldroyd 2005).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Subgroup analyses according to sex and previous gestational diabetes could not be performed due to lack of data.

    “We could not perform subgroup analyses according to sex and previous gestational diabetes due to lack of data.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Subgroup or sensitivity analyses for cardiovascular mortality were not performed due to lack of data.

    “We did not perform subgroup or sensitivity analyses due to lack of data.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Sensitivity analysis according to publication status and language of publication could not be performed because all included trials were published and all were published in English.

    “Sensitivity analysis: we could not perform sensitivity analysis according to publication status (all included trials were published) and language of publication (all included trials were published in English).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Subgroup analyses according to sex, diagnostic criteria of participants with IGT versus other, and previous gestational diabetes could not be performed due to lack of data.

    “We could not perform subgroup analyses according to sex, diagnostic criteria of participants with IGT versus other and previous gestational diabetes due to lack of data.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    TSA showed that diversity-adjusted information size was accrued to detect or reject a difference in fasting plasma glucose at -0.17 mmol/L in favour of the diet plus physical activity group; diversity was 70%.

    “TSA showed that diversity-adjusted information size was accrued to detect or reject a difference in fasting plasma glucose at -0.17 mmol/L in favour of the diet plus physical activity group.Diversity was 70%.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    A person aged 65 years or more with newly diagnosed T2DM with a HbA1c of 7% has a theoretical life-time risk of blindness or endstage renal disease of less than 0.5%.

    “A person aged 65 years or more with newly diagnosed T2DM with a HbA1c of 7% has a theoretical life-time risk of blindness or endstage renal disease of less than 0.5% (Vijan 1997).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Vijan 1997

      Not checked in the free run.

  • May combine two claims.

    Study design and conductown data

    The reporting on mortality and macrovascular as well as microvascular diabetes complications was insufficient, and the quality of evidence for these outcome measures was judged low or very low.

    “The reporting on mortality and macrovascular as well as microvascular diabetes complications was insufficient and we judged the quality of evidence for these outcome measures as low or very low.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Interpretationreasoning

    The higher number of T2DM diagnoses in control groups might be explained by regular glycaemic testing of people participating in a RCT.

    “This might be explained by the regular glycaemic testing of people participating in a RCT.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationnone given

    A potential selection bias exists because more healthy and motivated people may participate in a clinical trial.

    “A potential selection bias exists as more healthy and motivated people may participate in a clinical trial.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    All programmes in the review were conducted in adults, so the results may not apply to children and adolescents.

    “In our review, all programmes were conducted in adults.Therefore, our results may not apply to children and adolescents.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The DPP 2002 trial was stopped one year earlier than originally planned because the intervention effect of diet and physical activity was larger than anticipated.

    “Trial terminated early: yes, the trial was stopped one year earlier than originally planned due to larger intervention effect of diet and physical activity than anticipated”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    In the DPP 2002 trial, other bias was judged to be at high risk because the trial was terminated early for benefit and received funding from a pharmaceutical company.

    “Other bias High risk Comment: trial terminated early for benefit Comment: received funding from a pharmaceutical company”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductnone given

    In DPS 2001, incomplete outcome data for incidence of T2DM was at unclear risk of attrition bias.

    “Incomplete outcome data (attrition bias) incidence of T2DM”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The review was unable to draw funnel plots to assess small-study bias due to lack of data for most outcomes.

    “We were unable to draw funnel plots to assess small-study bias due to lack of data for most outcomes.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    In the DPS 2001 trial, random sequence generation was judged to be at low risk of selection bias.

    “Random sequence generation (selection bias) Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    Two review authors carried out data extraction, but the review authors extracting the data were not blinded as to which trial they were extracting data from.

    “Two review authors carried out data extraction.However, the review authors extracting the data were not blinded as to which trial they were extracting data from.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Not only people with intermediate hyperglycaemia but also people with manifest T2DM are recommended to increase physical activity and lower calorie intake.

    “Not only people with intermediate hyperglycaemia but also people with manifest T2DM are recommended to increase physical activity and lower calorie intake (ADA 2017).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites ADA 2017

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, blinding of outcome assessment for non-fatal myocardial infarction/stroke and congestive heart failure was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) non-fatal myocardial infarction/stroke, congestive heart failure Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductreasoning

    In EDIPS 2009, blinding of outcome assessment for measures of blood glucose control was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) measures of blood glucose control Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In EDIPS 2009, incomplete outcome data for hypoglycaemia was at low risk of attrition bias.

    “Incomplete outcome data (attrition bias) hypoglycaemia Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductnone given

    In DPS 2001, blinding of participants and personnel for time to progression to T2DM was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) time to progression to T2DM”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Several trials were published in more than one publication, which for some trials made it difficult to separate the primary publication from companion papers.

    “Several trials were published in more than one publication, which for some trials made it difficult to separate the primary publication from companion papers.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In the Da Qing 1997 trial, blinding of participants and personnel for non-serious adverse events was judged to be at high risk of performance bias.

    “Blinding of participants and personnel (performance bias) non-serious adverse events High risk Comment: investigator-assessed and selfreported outcome measurement.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductreasoning

    In EDIPS 2009, blinding of outcome assessment for incidence of T2DM was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) incidence of T2DM Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In the DPS 2001 trial, allocation concealment was judged to be at low risk of selection bias.

    “Allocation concealment (selection bias) Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, blinding of outcome assessment for all-cause/cardiovascular mortality was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) all-cause/cardiovascular mortality Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    In the DPP 2002 trial, incomplete outcome data for the incidence of T2DM was judged to be at low risk of attrition bias.

    “Incomplete outcome data (attrition bias) incidence of T2DM Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, blinding of participants and personnel for non-fatal myocardial infarction/stroke and congestive heart failure was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) non-fatal myocardial infarction/stroke, congestive heart failure Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In the DPP 2002 trial, blinding of participants and personnel for health-related quality of life was judged to be at high risk of performance bias.

    “Blinding of participants and personnel (performance bias) Health related quality of life High risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, blinding of participants and personnel for hypoglycaemia was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) hypoglycaemia Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Interpretationnone given

    The interventions in the included trials would be challenging and costly to implement in daily life.

    “On the other hand, the interventions in the included trials would be challenging and costly to implement in daily life.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In the Da Qing 1997 trial, incomplete outcome data for the incidence of T2DM was judged to be at unclear risk of attrition bias.

    “Incomplete outcome data (attrition bias) incidence of T2DM Unclear risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, blinding of participants and personnel for measures of blood glucose control was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) measures of blood glucose control Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductreasoning

    In DPS 2001, blinding of outcome assessment for all-cause/cardiovascular mortality was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) all-cause/cardiovascular mortality”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, incomplete outcome data for serious adverse events was at low risk of attrition bias.

    “Incomplete outcome data (attrition bias) serious adverse events Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, blinding of participants and personnel for time to progression to T2DM was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) time to progression to T2DM Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

    Study design and conductnone given

    In the DPP 2002 trial, blinding of participants and personnel for the incidence of T2DM was judged to be at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) incidence of T2DM Low risk”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    For the comparison 'diet plus physical activity', more data were available, but most outcome measures were associated with low- or very low-quality evidence.

    “For the comparison 'diet plus physical activity' more data were available.However, again most outcome measures were associated with low-or very low-quality evidence.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In EDIPS 2009, incomplete outcome data for non-fatal myocardial infarction/stroke and congestive heart failure was at low risk of attrition bias.

    “Incomplete outcome data (attrition bias) non-fatal myocardial infarction/stroke, congestive heart failure Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    In the Da Qing 1997 trial, blinding of outcome assessment for all-cause/cardiovascular mortality was judged to be at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) all-cause/cardiovascular mortality Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, blinding of participants and personnel for all-cause mortality/cardiovascular mortality was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) all-cause mortality/cardiovascular mortality Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In the Da Qing 1997 trial, random sequence generation was judged to be at unclear risk of selection bias.

    “Random sequence generation (selection bias) Unclear risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, blinding of participants and personnel for amputation, blindness/severe vision loss, and end-stage renal disease was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) amputation, blindness/severe vision loss, end-stage renal disease Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In DPS 2001, other bias was at high risk.

    “Other bias High risk Comment: trial terminated early for benefit”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In the Da Qing 1997 trial, allocation concealment was judged to be at unclear risk of selection bias.

    “Allocation concealment (selection bias) Unclear risk Comment: no information.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In EDIPS 2009, incomplete outcome data for measures of blood glucose control was at unclear risk of attrition bias.

    “Incomplete outcome data (attrition bias) measures of blood glucose control Unclear risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductnone given

    In the DPS 2001 trial, blinding of participants and personnel for the incidence of T2DM was judged to be at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) incidence of T2DM Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, blinding of participants and personnel for incidence of T2DM was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) incidence of T2DM Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    In the Da Qing 1997 trial, blinding of participants and personnel for the incidence of T2DM was judged to be at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) incidence of T2DM Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In EDIPS 2009, blinding of participants and personnel for serious adverse events was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) serious adverse events Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    To reduce the risk of random errors, the review conducted TSA on all predefined outcomes and calculated prediction intervals whenever possible.

    “To reduce the risk of random errors, we conducted TSA on all predefined outcomes and calculated prediction intervals, whenever possible.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of participants and personnel for all-cause mortality/cardiovascular mortality was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) all-cause mortality/cardiovascular mortality Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In JDPP 2013, blinding of participants and personnel for all-cause/cardiovascular mortality was at low risk of performance bias because the outcome was not likely to be influenced by lack of blinding.

    “Comment: investigator-assessed outcome measure.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Hellgren 2016, selective reporting was at low risk of reporting bias.

    “Selective reporting (reporting bias) Low risk Comment: trial protocol provided by the investigator.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Oldroyd 2005, other bias was at low risk because no other sources of bias were identified.

    “Other bias Low risk Comment: no other sources of bias identified”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of outcome assessment for serious adverse events was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) serious adverse events Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductreasoning

    In Hellgren 2016, blinding of outcome assessment for incidence of T2DM was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) incidence of T2DM Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In HELP PD 2011, blinding of outcome assessment for all-cause/cardiovascular mortality was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) all-cause/cardiovascular mortality Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In HELP PD 2011, blinding of participants and personnel for socioeconomic effects was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) socioeconomic effects Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of participants and personnel for serious adverse events was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) serious adverse events Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of outcome assessment for amputation, blindness/severe vision loss, and end-stage renal disease was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) amputation, blindness/severe vision loss, end-stage renal disease Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In IDPP 2006, incomplete outcome data for hypoglycaemia was at unclear risk of attrition bias because the proportion of missing outcomes was not enough to have a clinically relevant impact on the intervention effect estimate.

    “Comment: 7 participants in the DPPA group and 2 participants in the control group were lost to follow-up; 5 participants in the DPPA group were mentioned as not willing.The proportion of missing outcomes compared with observed event risk was not enough to have a clinically relevant impact on the intervention effect estimate”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    A comprehensive search was conducted for the review.

    “Was a comprehensive search conducted?Yes”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Hellgren 2016, blinding of outcome assessment for hypoglycaemia was at unclear risk of detection bias.

    “Blinding of outcome assessment (detection bias) hypoglycaemia Unclear risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Oldroyd 2005, blinding of outcome assessment for all-cause/cardiovascular mortality was at low risk of detection bias because the outcome was not likely to be influenced by lack of blinding.

    “Comment: investigator-assessed outcome measure.No blinding described.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    In JDPP 2013, incomplete outcome data for measures of blood glucose control was at unclear risk of attrition bias because a relatively large number of participants did not complete the trial, though the number and reasons for missingness were balanced between groups.

    “A relatively large number of participants did not complete the trial.However, the number and reasons for missingness were balanced between the intervention groups”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductreasoning

    In Hellgren 2016, blinding of outcome assessment for measures of blood glucose control was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) measures of blood glucose control Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductreasoning

    For the outcome socioeconomic effects, the lack of blinding could have influenced the outcome.

    “The outcome could have been influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In IDPP 2006, random sequence generation was at unclear risk of selection bias because there was insufficient information about the sequence generation process.

    “Comment: insufficient information about the sequence generation process”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Oldroyd 2005, blinding of participants and personnel for incidence of T2DM was at low risk of performance bias because the outcome was not likely to be influenced by lack of blinding.

    “Comment: investigator-assessed outcome measure.No blinding of participants.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Kosaka 2005, selective reporting was at high risk of reporting bias because no trial protocol was available and glycaemic measures were analysed but no data reported.

    “Selective reporting (reporting bias) High risk Comment: no trial protocol available.Glycaemic measures analysed but no data reported”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In HELP PD 2011, blinding of participants and personnel for all-cause mortality/cardiovascular mortality was at unclear risk of performance bias.

    “Blinding of participants and personnel (performance bias) all-cause mortality/cardiovascular mortality Unclear risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In IDPP 2006, other bias was at unclear risk because some of the publications were supported by Novo Nordisk.

    “Other bias Unclear risk Comment: some of the publications were supported by Novo Nordisk.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Hellgren 2016, incomplete outcome data for incidence of T2DM was at low risk of attrition bias.

    “Incomplete outcome data (attrition bias) incidence of T2DM Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of participants and personnel for measures of blood glucose control was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) measures of blood glucose control Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Grey literature was searched for the review.

    “Was grey literature searched?Yes”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Kosaka 2005, allocation concealment was at unclear risk of selection bias because no information was available.

    “Allocation concealment (selection bias) Unclear risk Comment: no information”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In JDPP 2013, other bias was at low risk because no other sources of bias were identified.

    “Other bias Low risk Comment: no other sources of bias identified”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    There was no industry influence on studies included in the review.

    “There was no industry influence on studies included in the review?Yes”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of outcome assessment for health-related quality of life was at high risk of detection bias.

    “Blinding of outcome assessment (detection bias) Health related quality of life High risk Comment: self-reported outcome measure.No blinding.The outcome was likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In EDIPS 2009, other bias was at low risk.

    “Other bias Low risk Comment: no other sources of bias identified”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, incomplete outcome data for all-cause/cardiovascular mortality was at low risk of attrition bias.

    “Incomplete outcome data (attrition bias) all-cause/cardiovascular mortality Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Hellgren 2016, other bias was at low risk.

    “Other bias Low risk Comment: no other sources of bias identified”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In IDPP 2006, incomplete outcome data for incidence of T2DM was at unclear risk of attrition bias because the proportion of missing outcomes was not enough to have a clinically relevant impact on the intervention effect estimate.

    “Comment: 7 participants in the DPPA group and 2 participants in the control group were lost to follow-up; 5 participants in the DPPA group were mentioned as not willing.The proportion of missing outcomes compared with observed event risk was not enough to have had a clinically relevant impact on the intervention effect estimate”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Kosaka 2005, blinding of outcome assessment for incidence of T2DM was at unclear risk of detection bias because no blinding of outcome assessors was described.

    “Comment: investigator-assessed outcome measure.No blinding of outcome assessors described.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Oldroyd 2005, blinding of participants and personnel for measures of blood glucose control was at low risk of performance bias because the outcome was not likely to be influenced by lack of blinding.

    “Comment: investigator-assessed outcome measure.No blinding of participants described.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In PODOSA 2014, blinding of participants and personnel for incidence of T2DM was at low risk of performance bias because the outcome was not likely to be influenced by lack of blinding.

    “Comment: investigator-assessed outcome measure.No blinding of participants or investigators.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

    Study design and conductnone given

    In Oldroyd 2005, random sequence generation was at low risk of selection bias because a random number table was used.

    “Comment: adequate generation of random sequence ensured”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

    Study design and conductreasoning

    In JDPP 2013, selective reporting was at high risk of reporting bias because adverse events were collected and HbA1c analysed but the data could not be entered in the meta-analysis.

    “Selective reporting (reporting bias) High risk Comment: it is clear from publication that adverse events were collected and HbA1c analysed, but data could not be entered in the meta-analysis”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In EDIPS 2009, incomplete outcome data for time to progression to T2DM was at unclear risk of attrition bias.

    “Incomplete outcome data (attrition bias) time to progression to T2DM Unclear risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductreasoning

    In HELP PD 2011, blinding of outcome assessment for measures of blood glucose control was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) measures of blood glucose control Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Oldroyd 2005, blinding of outcome assessment for incidence of T2DM was at low risk of detection bias because the outcome was not likely to be influenced by lack of blinding.

    “Comment: investigator-assessed outcome measure.No blinding described.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In HELP PD 2011, blinding of outcome assessment for socioeconomic effects was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) socioeconomic effects Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductreasoning

    In HELP PD 2011, blinding of outcome assessment for incidence of T2DM was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) incidence of T2DM Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Oldroyd 2005, blinding of outcome assessment for measures of blood glucose control was at low risk of detection bias because the outcome was not likely to be influenced by lack of blinding.

    “Comment: investigator-assessed outcome measure.No blinding described.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Hellgren 2016, incomplete outcome data for serious adverse events was at unclear risk of attrition bias.

    “Incomplete outcome data (attrition bias) serious adverse events Unclear risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Kosaka 2005, random sequence generation was at unclear risk of selection bias because there was insufficient information about the sequence generation process.

    “Comment: insufficient information about the sequence generation process”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In IDPP 2006, allocation concealment was at unclear risk of selection bias because no information was available.

    “Allocation concealment (selection bias) Unclear risk Comment: no information”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of outcome assessment for all-cause/cardiovascular mortality was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) all-cause/cardiovascular mortality Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of participants and personnel for non-fatal myocardial infarction/stroke and congestive heart failure was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) non-fatal myocardial infarction/stroke, congestive heart failure Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of outcome assessment for non-fatal myocardial infarction/stroke and congestive heart failure was at low risk of detection bias.

    “Blinding of outcome assessment (detection bias) non-fatal myocardial infarction/stroke, congestive heart failure Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In HELP PD 2011, blinding of participants and personnel for measures of blood glucose control was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) measures of blood glucose control Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductnone given

    In Oldroyd 2005, allocation concealment was at low risk of selection bias because researchers performing the randomisation were blinded to group allocation.

    “Comment: adequate allocation concealment ensured”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Hellgren 2016, incomplete outcome data for non-fatal myocardial infarction/stroke and congestive heart failure was at unclear risk of attrition bias.

    “Incomplete outcome data (attrition bias) non-fatal myocardial infarction/stroke, congestive heart failure Unclear risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    For the outcome non-serious adverse events, the lack of blinding was judged not likely to influence the outcome.

    “The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Oldroyd 2005, selective reporting was at unclear risk of reporting bias because no study protocol was available.

    “Selective reporting (reporting bias) Unclear risk Comment: no study protocol available”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of participants and personnel for hypoglycaemia was at unclear risk of performance bias.

    “Blinding of participants and personnel (performance bias) hypoglycaemia Unclear risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Hellgren 2016, incomplete outcome data for health-related quality of life was at high risk of attrition bias.

    “Incomplete outcome data (attrition bias) Health related quality of life High risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of participants and personnel for incidence of T2DM was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) incidence of T2DM Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In Hellgren 2016, incomplete outcome data for measures of blood glucose control was at unclear risk of attrition bias.

    “Incomplete outcome data (attrition bias) measures of blood glucose control Unclear risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of participants and personnel for amputation, blindness/severe vision loss, and end-stage renal disease was at low risk of performance bias.

    “Blinding of participants and personnel (performance bias) amputation, blindness/severe vision loss, end-stage renal disease Low risk”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Oldroyd 2005, blinding of participants and personnel for all-cause/cardiovascular mortality was at low risk of performance bias because the outcome was not likely to be influenced by lack of blinding.

    “Comment: investigator-assessed outcome measure.No blinding of participants described.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductreasoning

    In PODOSA 2014, random sequence generation was at low risk of selection bias because a random number generator program with permuted blocks of random size was used.

    “Comment: adequate generation of random sequence ensured”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    No restrictions were applied to study selection on the basis of language.

    “Were no restrictions applied to study selection on the basis of language?Yes”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Kosaka 2005, blinding of participants and personnel for incidence of T2DM was at low risk of performance bias because the outcome was not likely to be influenced by lack of blinding.

    “Comment: investigator-assessed outcome measure.No blinding of participants described.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In Hellgren 2016, blinding of participants and personnel for health-related quality of life was at high risk of performance bias.

    “Blinding of participants and personnel (performance bias) Health related quality of life High risk Comment: self-reported outcome measure.No blinding.The outcome was likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    In PODOSA 2014, blinding of participants and personnel for measures of blood glucose control was at low risk of performance bias because the outcome was not likely to be influenced by lack of blinding.

    “Comment: investigator-assessed outcome measure.No blinding of participants or investigators.The outcome was not likely to be influenced by lack of blinding”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Three trials were terminated early due to beneficial effects in the intervention group (DPP 2002; DPS 2001; IDPP 2006).

    “Three trials were terminated early due to beneficial effects in the intervention group (DPP 2002; DPS 2001; IDPP 2006).”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites DPP 2002

      Not checked in the free run.

    • cites DPS 2001

      Not checked in the free run.

    • cites IDPP 2006

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    One trial based the sample size calculation on an anticipated incidence of T2DM during six years of follow-up.

    “One trial based the sample size calculation on an anticipated incidence of T2DM during six years of follow-up.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    All trials except one had a balanced distribution of women and men in the intervention and comparator groups.

    “All trials except one had a balanced distribution of women and men in the intervention and comparator groups, this trial included 54% women in the intervention group compared with 31% in the comparator group (Oldroyd 2005).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Ten trials provided information about sample size and power calculations.

    “Ten trials provided information about sample size and power calculations (Da Qing 1997; DPP 2002; DPS 2001; EDIPS 2009; HELP PD 2011; IDPP 2006; JDPP 2013; Oldroyd 2005; PODOSA 2014; SLIM 2003).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    Several publications defined the increased risk of T2DM development to be associated with additional covariates, with intermediate hyperglycaemia being only one risk factor.

    “several publications defined the increased risk of T2DM development to be associated with additional covariates, with intermediate hyperglycaemia being only one risk factor”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites Ali 2012 source

      Not checked in the free run.

    • cites Ashra 2015

      Not checked in the free run.

    • cites Balk 2015 source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisecitation

    A recent meta-analysis of 22 studies with behaviour-changing interventions in people at high risk of T2DM concluded that the effect of lifestyle interventions on longer-term diabetes prevention had not been clarified.

    “A recent meta-analysis of 22 studies with behaviour-changing interventions in people at high risk of T2DM concluded that the effect of lifestyle interventions on longer-term diabetes prevention had not been clarified (Dunkley 2014).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Dunkley 2014

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The proportion of participants finishing the trial varied from 48% (SLIM 2003) to 98% (PODOSA 2014).

    “The proportion of participants finishing the trial varied from 48% (SLIM 2003) to 98% (PODOSA 2014).”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites SLIM 2003

      Not checked in the free run.

    • cites PODOSA 2014

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    One trial included 54% women in the intervention group compared with 31% in the comparator group (Oldroyd 2005).

    “All trials except one had a balanced distribution of women and men in the intervention and comparator groups, this trial included 54% women in the intervention group compared with 31% in the comparator group (Oldroyd 2005).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Oldroyd 2005

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    None of the trials reported blinding of the participants and investigators.

    “None of the trials reported blinding of the participants and investigators.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    In one trial, the authors state that intention-to-treat analysis was performed but the data are presented as a per-protocol analysis.

    “d Trial authors state that ITT analysis was performed but data are presented as a per-protocol analysis.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    Trial authors said that they had planned six years' follow-up, but only reported three years of follow-up (JDPP 2013).

    “Trial authors said that they had planned six years' follow-up, but only reported three years of follow-up (JDPP 2013).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites JDPP 2013

      Not checked in the free run.

305 of 305

  • The paper relies on this without support.

    The projected rise in the incidence of type 2 diabetes mellitus could develop into a substantial health problem worldwide.

    “The projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide.”

  • The paper relies on this without support.

    People with moderately elevated blood glucose (often referred to as 'prediabetes') are at an increased risk of developing type 2 diabetes.

    “People with moderately elevated blood glucose (often referred to as 'prediabetes') are said to be at an increased risk of developing type 2 diabetes.”

  • The paper relies on this without support.

    It is currently recommended that all people with increased risk of developing type 2 diabetes should adjust their eating habits and physical activity levels.

    “It is currently recommended that all people with increased risk of developing type 2 diabetes should adjust their eating habits and physical activity levels.”

  • The paper relies on this without support.

    The most commonly used criteria to define people with a high risk of developing T2DM were established by the American Diabetes Association (ADA) and the World Health Organization (WHO).

    “The most commonly used criteria to define people with a high risk of developing T2DM were established by the American Diabetes Association (ADA) and the World Health Organization (WHO).”

  • The paper relies on this without support.

    The risk of progression from 'prediabetes' to T2DM depends on the diagnostic criteria used to identify 'prediabetes'.

    “The risk of progression from 'prediabetes' to T2DM depends on the diagnostic criteria used to identify 'prediabetes'.”

  • The paper relies on this without support.

    Some people diagnosed with 'prediabetes' will never develop T2DM, and some will return to normoglycaemia.

    “Some people diagnosed with 'prediabetes' will never develop T2DM, and some will return to normoglycaemia.”

  • The paper relies on this without support.

    IGT is often accepted as the best glycaemic variable for 'prediabetes' to predict progression to T2DM.

    “IGT is often accepted as the best glycaemic variable for 'prediabetes' to predict progression to T2DM.”

  • The paper relies on this without support.

    Less than half of the people defined as prediabetic by means of IGT will develop T2DM in the following 10 years.

    “However, studies indicate that less than half of the people defined as prediabetic by means of IGT will develop T2DM in the following 10 years.”

  • The paper relies on this without support.

    Nutritional advice usually consists of caloric restriction in overweight people, low total fat content (especially saturated fat) and high (predominantly unrefined) carbohydrate content.

    “Nutritional advice usually consists of caloric restriction in overweight people, low total fat content (especially saturated fat) and high (predominantly unrefined) carbohydrate content.”

  • The paper relies on this without support.

    Physical activity or diet interventions are not generally considered to be associated with any serious adverse event.

    “Physical activity or diet interventions are not generally considered to be associated with any serious adverse event.”

  • The paper relies on this without support.

    Physical activity may cause traumatic injuries of variable severity depending on the type and intensity of physical activity.

    “However, physical activity may cause traumatic injuries of variable severity depending on the type and intensity of physical activity.”

  • The paper relies on this without support.

    Exercising may produce adverse effects on the cardiovascular system in those people with insufficient training or unfavourable cardiovascular fitness (even cardiovascular events and death may potentially occur while exercising).

    “Additionally, exercising may produce adverse effects on the cardiovascular system in those people with insufficient training or unfavourable cardiovascular fitness (even cardiovascular events and death may potentially occur while exercising).”

  • The paper relies on this without support.

    The implementation of dietary measures may produce several deficiencies in nutritional status if restrictive low-calorie diets are used.

    “Also, the implementation of dietary measures may produce several deficiencies in nutritional status if restrictive low-calorie diets are used.”

  • The paper relies on this without support.

    Dieting may reduce quality of life of people under this treatment.

    “Further, dieting may reduce quality of life of people under this treatment.”

  • The paper relies on this without support.

    Differences of glycaemic measurements used to define 'prediabetes' may introduce substantial heterogeneity.

    “Differences of glycaemic measurements used to define 'prediabetes' may introduce substantial heterogeneity.”

  • The paper relies on this without support.

    Heterogeneity is likely to increase when future trials are included.

    “as heterogeneity is likely to increase when future trials are included”

  • The authors state this as an assumption.

    The independent end-points committee that confirmed newly diagnosed cases of diabetes in DPS 2001 was blinded.

    “Not described whether this committee was blinded.We assume that the outcome committee was blinded”
17 of 17

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Physical activity is effective in reducing mortality, comorbidities, and clinical parameters such as HbA1c in people with diabetes.

    “Physical activity has been shown to be effective in reducing mortality, comorbidities, and clinical parameters such as glycosylated hemoglobin (HbA 1c ) (6)(7)(8).”

    From Optimal Dose and Type of Physical Activity to Improve Glycemic Control in People Diagnosed With Type 2 Diabetes: A Systematic Review and Meta-analysis (2024) · cites this paper as [6]

    The Description of the intervention (page unavailable) says a trial in people with type 2 diabetes found no substantial effect of intensive diet plus physical activity on mortality or cardiovascular outcomes. The review’s Main results concern people at risk of diabetes, not people already diagnosed, and report very low-quality mortality evidence for physical activity alone. Its HbA1c results for diet plus physical activity are uncertain in the random-effects analysis, so they do not establish the claimed benefit either. (LLM, conf=0.86)

    Checked by a reasoning model — may be wrong.

    Experimental — accuracy not yet measured

  • Type 2 diabetes is preventable and can be delayed with lifestyle or medical interventions.

    “Despite the increasing prevalence of T2D in the UK, it is preventable and can be delayed with lifestyle or medical interventions [2,3].”

    From Economic evaluation of wearable fitness trackers versus metformin for preventing type 2 diabetes in the UK population (2025) · cites this paper as [2]

    The Authors’ Conclusions (Implications for practice; page unavailable) find that diet plus physical activity reduces or delays type 2 diabetes in people with impaired glucose tolerance. The discussion of pharmacological interventions says some findings suggest progression from prediabetes is reduced or perhaps only delayed, but notes that their preventive use is not generally accepted. The claim omits these population and uncertainty qualifiers. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • In people with impaired glucose tolerance, interventions including both diet and physical activity delay or reduce the incidence of type 2 diabetes.

    “In people with an impaired glucose tolerance, interventions that include both diet and physical activity were reported to delay, or even reduce, the incidence of T2D (Hemmingsen 2017).”

    From Mindfulness-based interventions for adults with type 2 diabetes mellitus (2021) · cites this paper as Hemmingsen 2017

  • Foods and macronutrients that score favorably on HEI-2010, AHEI-2010, Alternative Mediterranean Diet Score, and DASH scores are epidemiologically associated with lower diabetes prevalence.

    “Indeed, these foods and macronutrients coincide with favorable scores on the Healthy Eating Index-2010 (HEI-2010), the Alternative HEI-2010 (AHEI-2010), the Alternative Mediterranean Diet Score, and the DASH scores, which are associated epidemiologically with lower prevalence of DM.723,840”

    From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [840]

    The Incidence of type 2 diabetes section reports lower diabetes incidence in trials of diet plus physical activity, not epidemiological associations between diabetes prevalence and dietary-quality scores. Searches for HEI-2010, AHEI-2010, the Alternative Mediterranean Diet Score, DASH, and dietary-score associations found no passage addressing the attributed claim in our copy, whose end may be missing. (LLM, conf=0.72)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • IFG control-group diabetes percentage is incorrect

    Minor

    Two of 21 participants is 9.5%, not the reported 7.8%.

    Reported 7.8 · recomputed 9.52381

  • Cluster-adjusted physical-activity denominator differs between comparisons

    Minor

    The same Da Qing physical-activity group and its 58 diabetes cases are adjusted to 33/84 in one comparison but 33/81 in another.

  • Conflicting total of included trials in risk-of-bias discussion

    Minor

    The review repeatedly states that 12 trials were included, but this passage refers to 11 included trials.

  • Control-group diabetes cases exceed the reported total

    Minor

    The control-group glycaemic subgroups report five, two and four participants developing T2DM, summing to 11, although the trial total is seven.

    Reported 7 · recomputed 11

  • Physical-activity subgroup diabetes cases exceed the reported total

    Minor

    The three physical-activity glycaemic subgroups report seven, three and two T2DM cases, summing to 12 rather than the reported 10.

    Reported 10 · recomputed 12

  • Conflicting Da Qing IGT glucose thresholds

    Minor

    One section describes Da Qing's WHO 1985 two-hour glucose lower threshold as 6.7 mmol/L; another explicitly includes Da Qing among trials using a threshold of 7.8 mmol/L.

  • Number of trials reporting intervention costs conflicts

    Minor

    The abstract reports costs from three trials and 2755 participants, whereas the summary-of-findings entry reports four trials and 2775 participants.

  • Control-group subgroup size is misstated

    Minor

    The control group's mutually exclusive baseline glycaemic subgroups contain 15, 21 and six participants, totalling 42-not the stated 32. This also exceeds the reported control-group size of 39.

    Reported 32 · recomputed 42

  • Mortality estimate lies outside its stated confidence interval

    Minor

    The reported mortality rate of 2.2 per 1000 person-years is outside its stated 95% confidence interval, whose endpoints are also reversed.

9 of 9

Cites

Flagged first, then by citations

Research works printed but not linked: 18

  1. Diabetes Prevention Program (DPP) Research Group, 2009, 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study, Lancet, 374, 2054
  2. Ma, 2014, Physical function decline in the diabetes prevention program outcome study, Diabetes, 63, A344
  3. The Diabetes Prevention Program Research Group, 2003, Within-trial cost-effectiveness of lifestyle intervention or metformin for the primary prevention of type 2 diabetes, Diabetes Care, 26, 2518, 10.2337/diacare.26.9.2518 · DOI
  4. Penn, 2013, Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT, PloS One, 8, e57143, 10.1371/journal.pone.0057143 · DOI
  5. Penn, 2013, Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT, PloS One, 8, e57143, 10.1371/journal.pone.0057143 · DOI
  6. Rosa, 2007, Detecting and managing metabolic syndrome: preliminary results, Ethnicity and Disease, 17, 24
  7. Vlaar, 2012, Feasibility and effectiveness of a targeted diabetes prevention program for 18 to 60-year-old South Asian migrants: design and methods of the DH!AAN study, BMC Public Health, 12, 371, 10.1186/1471-2458-12-371 · DOI
  8. Tao, 2004, Effect of exercise training in patients with impaired glucose tolerance, Zhongguo Linchuang Kangfu, 8, 2912
  9. Fogelholm, 2015, PREVIEW-Design, methods and baseline participant description of an international intervention to prevent type-2 diabetes, Annals of Nutrition and Metabolism, 67, 414
  10. Raben A Fogelholm M Larsen TM Drummens M Poppitt S Formiguera JA PREVIEW: Prevention of diabetes through lifestyle intervention and population studies in Europe and a round the world. Over 2,000 volunteers randomized to the 3-y RCT Obesity Facts Conference: 22nd Congress of the European Congress on Obesity, ECO 2015 Prague Czech Republic 2015 126
  11. Knowler, 2002, Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin, New England Journal of Medicine, 346, 393, 10.1056/nejmoa012512 · DOI · Paper page
  12. Tuomilehto, 2001, Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance, New England Journal of Medicine, 344, 1343, 10.1056/nejm200105033441801 · DOI · Paper page
  13. Institute for Clinical and Economic Review Diabetes prevention programs: effectiveness and value Final Evidence Report and Meeting Summary July 2016
  14. International Conference on Harmonisation Expert Working Group International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline. Guideline for good clinical practice //1997 CFR & ICH Guidelines PA 19063-2043 USA: Barnett International/PAREXEL, 1997
  15. International Diabetes Federation (IDF), 2013, IDF Diabetes Atlas
  16. Penn, 2013, Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT, PloS One, 8, e57143, 10.1371/journal.pone.0057143 · DOI
  17. Nordic Cochrane Centre, The Cochrane Collaboration Review Manager 5 (RevMan 5) 2014
  18. Schünemann HJ Oxman AD Higgins JPT Vist GE Glasziou P Guyatt GH Chapter 11: Presenting results and ‘Summary of findings' tables. In: Higgins JPT, Green S (editors), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011 Available from handbook.cochrane.org

Cited by

Sorted by citations

Related

Authors
Hemmingsen, B., Gimenez-Perez, G., Mauricio, D., Roqué i Figuls, M., Metzendorf, M.-I., & Richter, B.
Affiliations
  • Herlev Hospital (DK)
  • Hospital General de Granollers and School of Medicine and Health Sciences. Universitat Internacional de Catalunya (UIC); Medicine Department; Francesc Ribas s/n Granollers Spain 08402
  • Hospital Universitari Germans Trias i Pujol - CIBERDEM; Department of Endocrinology and Nutrition; Carretera Canyet S/N Badalona Spain 08916
  • CIBER Epidemiología y Salud Pública (CIBERESP); Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau); Sant Antoni Maria Claret 171 Edifici Casa de Convalescència Barcelona Catalunya Spain 08041
  • Heinrich Heine University Düsseldorf (DE)
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2017-12-04
Volume
2017
Issue
12
Pages
CD003054-CD003054
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd003054.pub4
PMC
PMC6486271
OpenAlex
W2771834975
Semantic Scholar
67baf9f281193cf6605ad1a11229ad1484b74c8a
Cited by
316
References
231
Citations by year
2026: 11 · 2025: 39 · 2024: 42 · 2023: 46 · 2022: 56 · 2021: 44 · 2020: 35 · 2019: 22 · 2018: 21
FWCI
3.11
Type
journal article
Language
en
Open access
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, public-domain)
  • LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, public-domain)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
  • Health Sciences › Medicine › Physiology › Physical Activity and Health
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
type 2 diabetes, diabetes prevention, diabetes prevention programmes, diet, physical activity, impaired glucose tolerance, impaired fasting glucose, diabetes complications, cardiovascular events, mortality, lifestyle intervention, prediabetes
MeSH terms
Cause of Death, Combined Modality Therapy, Diabetes Mellitus, Type 2, Diet, Diabetic, Diet, Fasting, Glucose Tolerance Test, Humans, Risk, Exercise, Incidence, Randomized Controlled Trials as Topic, Diabetes Complications

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-09.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-09.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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