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Cited by 348Diabetes Management and ResearchDiabetes Treatment and ManagementDiabetes Management and Education

7. Diabetes Technology: Standards of Care in Diabetes—2025

Open access
American Diabetes Association Professional Practice Committee, ElSayed, Nuha A., McCoy, Rozalina G., Aleppo, Grazia, Balapattabi, Kirthikaa, Beverly, Elizabeth A., Briggs Early, Kathaleen, Bruemmer, Dennis +15 more·2025·Diabetes Care
DOI 10.2337/dc25-s007PMC PMC11635043
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Abstract

The American Diabetes Association (ADA) “Standards of Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

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Crossref · 10.2337/dc25-s007

Cites

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Claims the paper makes

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  • Premisecitation
    § Initiation of Device Use

    Interruption of access to CGM is associated with worsening outcomes.

    “Interruption of access to CGM is associated with a worsening of outcomes (7,15); therefore, it is important for individuals on CGM to have consistent access to devices.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [7] Addala, 2020, Uninterrupted continuous glucose monitoring access is associated with a decrease in HbA1c in youth with type 1 diabetes and public insurance, Pediatr Diabetes source

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    • cites [15] Aleppo, 2021, The effect of discontinuing continuous glucose monitoring in adults with type 2 diabetes treated with basal insulin, Diabetes Care source

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  • Premisecitation
    § Education and Training

    People with diabetes who receive more education about device use achieve better outcomes.

    “Those with more education regarding device use have better outcomes (1,2); therefore, the need for additional education should be periodically assessed, particularly if outcomes are not being met.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [1] Broos, 2021, Diabetes knowledge and metabolic control in type 1 diabetes starting with continuous glucose monitoring: FUTURE-PEAK, J Clin Endocrinol Metab source

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    • cites [2] Yoo, 2022, Effect of structured individualized education on continuous glucose monitoring use in poorly controlled patients with type 1 diabetes: a randomized controlled trial, Diabetes Res Clin Pract source

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  • Premisecitation
    § People With Diabetes Using Basal Insulin and/or Oral Agents and Noninsulin Injectables

    A trial of once-daily BGM with enhanced feedback through messaging found no clinically or statistically significant change in A1C at 1 year.

    “A trial of once-daily BGM that included enhanced feedback from people with diabetes through messaging found no clinically or statistically significant change in A1C levels at 1 year (31).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [31] Young, 2017, Glucose self-monitoring in non-insulin-treated patients with type 2 diabetes in primary care settings: a randomized trial, JAMA Intern Med source

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  • Interpretationreasoning
    § BLOOD GLUCOSE MONITORING

    For people using insulin, BGM is an integral component of effective therapy.

    “BGM is thus an integral component of effective therapy for individuals using insulin.”
    Quote in the paperSubstantial claim
  • Premisecitation
    § People With Diabetes Using Basal Insulin and/or Oral Agents and Noninsulin Injectables

    For people with type 2 diabetes taking basal insulin, assessing fasting glucose with BGM to inform dose adjustments to achieve blood glucose goals results in lower A1C levels.

    “However, for those taking basal insulin, assessing fasting glucose with BGM to inform dose adjustments to achieve blood glucose goals results in lower A1C levels (30).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [30] Garber, 2014, Treat-to-target trials: uses, interpretation and review of concepts, Diabetes Obes Metab source

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  • May combine two claims. 60
  • The quote only partly states this claim. 1
  • Classified as probably not a substantial claim. 13

  • May combine two claims.

    Premisecitation
    § Initiation of Device Use

    In youth with newly diagnosed type 1 diabetes, starting an AID system within 21 days of diagnosis resulted in 10% higher time in range and lower A1C at 12 months compared with usual care.

    “In an openlabel, multicenter, randomized, parallel clinical trial enrolling youth with newly diagnosed type 1 diabetes, initiation of an AID system within 21 days from diagnosis showed 10% higher time in range (TIR) (70-180 mg/dL [3.9-10.0mmol/L]) and lower A1C at 12 months versus usual care (13).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [13] Boughton, 2024, The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT

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    Premisecitation
    § Initiation of Device Use

    In youth with type 1 diabetes, starting CGM soon after diagnosis lowers A1C and is associated with high parental satisfaction and reliance on CGM for diabetes management.

    “In addition, early CGM initiation after diagnosis of type 1 diabetes in youth has been shown to decrease A1C levels and is associated with high parental satisfaction and reliance on this technology for diabetes management (5,6).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [5] Prahalad, 2022, Teamwork, targets, technology, and tight control in newly diagnosed type 1 diabetes: the Pilot 4T Study, J Clin Endocrinol Metab source

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    • cites [6] Tanenbaum, 2021, “I was ready for it at the beginning”: parent experiences with early introduction of continuous glucose monitoring following their child's type 1 diabetes diagnosis, Diabet Med source

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    Premisecitation
    § Initiation of Device Use

    Use of diabetes technology overall improves A1C and increases the proportion of people achieving A1C below 7%.

    “In addition, use of diabetes technology overall improves A1C and increases the number of people achieving an A1C <7% (14).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [14] Karakus, 2023, Association between diabetes technology use and glycemic outcomes in adults with type 1 diabetes over a decade, Diabetes Care source

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    Premisecitation
    § People With Diabetes Using Basal Insulin and/or Oral Agents and Noninsulin Injectables

    In trials where structured BGM data were used to adjust medications, A1C reductions were greater (0.3%), but A1C did not change significantly without such structured therapy adjustment.

    “Reductions in A1C levels were greater (À0.3%) in trials where structured BGM data were used to adjust medications, but A1C levels were not changed significantly without such structured diabetes therapy adjustment (35).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [35] Mannucci, 2018, Effects of structured versus unstructured self-monitoring of blood glucose on glucose control in patients with non-insulin-treated type 2 diabetes: a meta-analysis of randomized controlled trials, J Diabetes Sci Technol source

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    Premisecitation
    § People With Diabetes Using Basal Insulin and/or Oral Agents and Noninsulin Injectables

    Meta-analyses suggest BGM can reduce A1C by 0.25-0.3% at 6 months, but the effect was attenuated at 12 months in one analysis.

    “Meta-analyses have suggested that BGM can reduce A1C levels by 0.25-0.3%at 6 months (33-35), but the effect was attenuated at 12 months in one analysis (33).”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [33] Malanda, 2012, Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin, Cochrane Database Syst Rev

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    • cites [34] Willett, 2012, Meta-analysis: self-monitoring in non-insulin-treated type 2 diabetes improved HbA1c by 0.25%, Ann Intern Med source

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    • cites [35] Mannucci, 2018, Effects of structured versus unstructured self-monitoring of blood glucose on glucose control in patients with non-insulin-treated type 2 diabetes: a meta-analysis of randomized controlled trials, J Diabetes Sci Technol source

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  • May combine two claims.

    Premisecitation
    § People With Diabetes on Intensive Insulin Therapies

    In a database study of almost 27,000 children and adolescents with type 1 diabetes, after adjusting for multiple confounders, increased daily BGM frequency was significantly associated with lower A1C (0.2% per additional check per day) and fewer acute complications.

    “A database study of almost 27,000 children and adolescents with type 1 diabetes showed that, after adjusting for multiple confounders, increased daily frequency of BGM was significantly associated with lower A1C levels (À0.2% per additional check per day) and with fewer acute complications (29).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [29] Ziegler, 2011, Frequency of SMBG correlates with HbA1c and acute complications in children and adolescents with type 1 diabetes, Pediatr Diabetes source

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    Premisecitation
    § People With Diabetes Using Basal Insulin and/or Oral Agents and Noninsulin Injectables

    In people with type 2 diabetes not taking insulin, routine glucose monitoring may have limited additional clinical benefit; by itself, even with education, it has shown limited improvement in outcomes.

    “In people with type 2 diabetes not taking insulin, routine glucose monitoring may be of limited additional clinical benefit.By itself, even when combined with education, this practice has shown limited improvement in outcomes (31).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [31] Young, 2017, Glucose self-monitoring in non-insulin-treated patients with type 2 diabetes in primary care settings: a randomized trial, JAMA Intern Med source

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  • May combine two claims.

    Interpretationreasoning
    § People With Diabetes Using Basal Insulin and/or Oral Agents and Noninsulin Injectables

    Performing BGM alone does not lower blood glucose levels; to be useful, the information must be integrated into clinical and self-management treatment plans.

    “A key consideration is that performing BGM alone does not lower blood glucose levels.To be useful, the information must be integrated into clinical and self-management treatment plans.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation
    § Glucose Meter Inaccuracy

    Glucose oxidase monitors are sensitive to oxygen and should only be used with capillary blood in people with normal oxygen saturation; high oxygen tensions may cause false low-glucose readings and low oxygen tensions may cause falsely elevated glucose readings.

    “Glucose oxidase monitors are sensitive to the oxygen available and should only be used with capillary blood in people with normal oxygen saturation.Higher oxygen tensions (i.e., arterial blood or oxygen therapy) may result in false low-glucose readings, and low oxygen tensions (i.e., high altitude, hypoxia, or venous blood readings) may lead to falsely elevated glucose readings.”
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    • cites [37] Sacks, 2023, Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus, Diabetes Care source

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    Premisecitation
    § Data From Randomized Controlled Trials

    The primary outcome was met and showed benefit in adults of all ages, including seniors.

    “The primary outcome was met and showed benefit in adults of all ages (38,53,54), including seniors (55-57).”
    Quote in the paperSubstantial claim0 of 6 sources checked
    • cites [38] Tamborlane, 2008, Continuous glucose monitoring and intensive treatment of type 1 diabetes, N Engl J Med source

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    • cites [53] Friedman, 2023, Beyond A1C: exploring continuous glucose monitoring metrics in managing diabetes, Endocr Connect source

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    • cites [54] Teo, 2022, Effectiveness of continuous glucose monitoring in maintaining glycaemic control among people with type 1 diabetes mellitus: a systematic review of randomised controlled trials and meta-analysis, Diabetologia source

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    • cites [55] Pratley, 2020, Effect of continuous glucose monitoring on hypoglycemia in older adults with type 1 diabetes: a randomized clinical trial, JAMA source

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    • cites [56] Miller, 2022, Benefit of continuous glucose monitoring in reducing hypoglycemia is sustained through 12 months of use among older adults with type 1 diabetes, Diabetes Technol Ther source

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    • cites [57] Bao, 2022, Effectiveness of continuous glucose monitoring in older adults with type 2 diabetes treated with basal insulin, Diabetes Technol Ther source

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  • May combine two claims.

    Premisecitation
    § Data From Randomized Controlled Trials

    RCT data on rtCGM use in individuals with type 2 diabetes on MDI, mixed therapies, and basal insulin consistently show reductions in A1C and increases in TIR but not a reduction in hypoglycemia rates.

    “RCT data on rtCGM use in individuals with type 2 diabetes on MDI (59), mixed therapies (10, 60), and basal insulin (61,62) have consistently shown reductions in A1C levels and increases in TIR (70-180 mg/dL [3.9-10 mmol/L]) but not a reduction in rates of hypoglycemia (63).”
    Quote in the paperSubstantial claim0 of 5 sources checked
    • cites [59] Beck, 2017, Continuous glucose monitoring versus usual care in patients with type 2 diabetes receiving multiple daily insulin injections: a randomized trial, Ann Intern Med source

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    • cites [10] Grace, 2022, Use of real-time continuous glucose monitoring improves glycemic control and other clinical outcomes in type 2 diabetes patients treated with less intensive therapy, Diabetes Technol Ther source

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    • cites [60] Ehrhardt, 2011, The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus, J Diabetes Sci Technol source

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    • cites [61] Martens, 2021, Effect of continuous glucose monitoring on glycemic control in patients with type 2 diabetes treated with basal insulin: a randomized clinical trial, JAMA source

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    • cites [62] Price, 2021, Episodic real-time CGM use in adults with type 2 diabetes: results of a pilot randomized controlled trial, Diabetes Ther source

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  • The quote only partly states this claim.

    Premisecitation
    § Data From Randomized Controlled Trials

    Behavioral support of parents of young children with diabetes using rtCGM reduced hypoglycemia concerns and diabetes distress.

    “children with diabetes using rtCGM showed the benefits of reducing hypoglycemia concerns and diabetes distress (38,49,58).”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [38] Tamborlane, 2008, Continuous glucose monitoring and intensive treatment of type 1 diabetes, N Engl J Med source

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    • cites [49] Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group, 2021, A randomized clinical trial assessing continuous glucose monitoring (CGM) use with standardized education with or without a family behavioral intervention compared with fingerstick blood glucose monitoring in very young children with type 1 diabetes, Diabetes Care source

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    • cites [58] Van Name, 2023, Long-term continuous glucose monitor use in very young children with type 1 diabetes: one-year results from the SENCE study, J Diabetes Sci Technol source

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    Premisecitation
    § Data From Randomized Controlled Trials

    In a study of individuals with type 1 or type 2 diabetes taking insulin, the primary outcome of reduced severe hypoglycemia was not met, and severe hypoglycemia incidence did not differ significantly between isCGM users and the BGM group.

    “In a study of individuals with type 1 or type 2 diabetes taking insulin, the primary outcome of a reduction in severe hypoglycemia was not met and the incidence of severe hypoglycemia was not significantly different between isCGM users and the BGM group (71).”
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    • cites [71] Davis, 2020, Efficacy of intermittently scanned continuous glucose monitoring in the prevention of recurrent severe hypoglycemia, Diabetes Technol Ther source

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  • May combine two claims.

    Premisecitation
    § Data From Randomized Controlled Trials

    In an RCT, isCGM plus diabetes education versus diabetes education alone decreased A1C, increased TIR, and increased time in tight target range (70-140 mg/dL) in the isCGM-plus-education group.

    “Additionally, benefits of isCGM were also reported in an RCT where the use of isCGM plus diabetes education versus diabetes education alone showed decreased A1C levels and increased TIR as well as increased time in tight target range (70-140 mg/dL [3.9-7.8 mmol/L]) in the isCGMplus-education group (8).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [8] Aronson, 2023, IMpact of flash glucose Monitoring in pEople with type 2 Diabetes Inadequately controlled with non-insulin Antihyperglycaemic ThErapy (IMMEDIATE): a randomized controlled trial, Diabetes Obes Metab source

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  • May combine two claims.

    Interpretationnone given
    § Data From Randomized Controlled Trials

    RCT data for isCGM are fewer but increasing.

    “RCT data for isCGM are fewer but increasing.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation
    § Data From Randomized Controlled Trials

    RCT data for rtCGM benefits in people with type 2 diabetes not using insulin are increasing and generally show greater benefits of CGM compared with BGM for A1C, TIR, TBR, and TAR, as well as greater user-reported satisfaction.

    “RCT data for rtCGM benefits in people with type 2 diabetes not using insulin are increasing and generally have shown greater benefits of CGM compared with BGM for A1C, TIR, time below range (TBR), and time above range (TAR) as well as greater user-reported satisfaction (66).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [66] Ferreira, 2024, Continuous glucose monitoring systems in noninsulin-treated people with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials, Diabetes Technol Ther source

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    Premisecitation
    § Data From Randomized Controlled Trials

    In adults with type 2 diabetes using insulin, one study did not meet its primary A1C reduction end point but achieved a secondary reduction in hypoglycemia, and another study met its primary Diabetes Treatment Satisfaction Questionnaire score end point and a secondary A1C reduction end point.

    “In adults with type 2 diabetes using insulin, two studies were done: one study did not meet its primary end point of A1C level reduction (69) but achieved a secondary end point of a reduction in hypoglycemia, and the other study met its primary end point of an improvement in the Diabetes Treatment Satisfaction Questionnaire score as well as a secondary end point of A1C level reduction (70).”
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    • cites [69] Haak, 2017, Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial, Diabetes Ther source

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    • cites [70] Yaron, 2019, Effect of flash glucose monitoring technology on glycemic control and treatment satisfaction in patients with type 2 diabetes, Diabetes Care source

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    Premisecitation
    § Data From Randomized Controlled Trials

    CGM discontinuation in individuals with type 2 diabetes on basal insulin caused partial reversal of A1C reduction and TIR improvements, suggesting that continued CGM use achieves the greatest benefits.

    “CGM discontinuation in individuals with type 2 diabetes on basal insulin caused partial reversal of A1C reduction and TIR improvements, suggesting that continued CGM use achieves the greatest benefits (15).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [15] Aleppo, 2021, The effect of discontinuing continuous glucose monitoring in adults with type 2 diabetes treated with basal insulin, Diabetes Care source

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  • May combine two claims.

    Premisecitation
    § Data From Randomized Controlled Trials

    One study in youth with type 1 diabetes did not show a reduction in A1C, but the device was well received and was associated with increased testing frequency and improved diabetes treatment satisfaction.

    “One study in youth with type 1 diabetes did not show a reduction in A1C levels (72); however, the device was well received and was associated with an increased frequency of testing and improved diabetes treatment satisfaction (72).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [72] Boucher, 2020, Effect of 6 months of flash glucose monitoring in youth with type 1 diabetes and high-risk glycemic control: a randomized controlled trial, Diabetes Care source

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  • May combine two claims.

    Premisecitation
    § Data From Randomized Controlled Trials

    rtCGM benefits were reported in a mixed population of adults with type 2 diabetes, including people not using insulin, with reduction in A1C, increase in TIR, and reduction of time in hyperglycemia.

    “In addition, rtCGM benefits were reported in a mixed population (including people not using insulin) of adults with type 2 diabetes with reduction in A1C levels, increase in TIR, and reduction of time in hyperglycemia (>180 mg/dL [>10 mmol/L] and >250 mg/dL [>13.9 mmol/L]) (10).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [10] Grace, 2022, Use of real-time continuous glucose monitoring improves glycemic control and other clinical outcomes in type 2 diabetes patients treated with less intensive therapy, Diabetes Technol Ther source

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  • May combine two claims.

    Premisecitation
    § Data From Randomized Controlled Trials

    Short-term rtCGM use in youth with type 2 diabetes did not impact short-term glucose changes or A1C improvement, but users reported behavioral changes including increased blood glucose measurements, increased insulin administration, and improved diabetes management and quality of life.

    “Although short-term use of rtCGM in youth with type 2 diabetes did not impact short-term glucose changes or A1C improvement, users reported behavioral changes with increased blood glucose measurements, increased insulin administration, and overall improved diabetes management and quality of life (64,65).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [64] Manfredo, 2023, Short-term use of CGM in youth onset type 2 diabetes is associated with behavioral modifications, Front Endocrinol (Lausanne) source

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    • cites [65] Chesser, 2024, Real-time continuous glucose monitoring in adolescents and young adults with type 2 diabetes can improve quality of life, J Diabetes Sci Technol source

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    Premisecitation
    § Data From Randomized Controlled Trials

    In a post hoc analysis, isCGM effects were present 1 week after initiation for weekly mean glucose, GMI, TIR, TAR, and mean amplitude glucose excursion, and remained stable from baseline to 12 weeks.

    “In a subsequent post hoc analysis, the isCGM group showed that the effects of isCGM were present 1 week after isCGM initiation for weekly mean glucose, glucose management indicator (GMI), percentage of TIR, percentage of TAR, and mean amplitude glucose excursion and remained stable from baseline to 12 weeks (74).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [74] Hayase, 2023, Improved glycemic control after the use of flash glucose monitoring accompanied by improved treatment satisfaction in patients with non-insulin-treated type 2 diabetes: a post-hoc analysis of a randomized controlled trial, Prim Care Diabetes source

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  • May combine two claims.

    Premisecitation
    § Observational and Real-world Studies

    In adults with type 2 diabetes treated with basal insulin or noninsulin therapy, initiation of intermittently scanned CGM reduces acute diabetes events and all-cause inpatient hospitalizations at 6 months.

    “Similar reductions of acute diabetes events and all-cause inpatient hospitalizations were seen in a retrospective review of adults with type 2 diabetes treated with basal insulin or with noninsulin therapy 6 months after initiation of isCGM (82).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [82] Miller, 2021, Flash CGM associated with event reduction in nonintensive diabetes therapy, Am J Manag Care source

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    Premisecitation
    § Observational and Real-world Studies

    In adults with type 2 diabetes not treated with insulin, real-time CGM use at 6 and 12 months versus baseline reduces mean glucose and GMI, increases time in range and time in tight target range 70-140 mg/dL, and reduces time above range >180 and >250 mg/dL.

    “In this study, rtCGM benefits were observed at 6 month and 12 months versus baseline, with reduction of mean glucose levels, reduction of GMI, increase in TIR, increase in time in tight target range (70-140 mg/dL [3.9-7.8 mmol/L]), and reduction in TAR >180 and >250 mg/dL (88).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [88] Layne, 2024, Long-term improvements in glycemic control with Dexcom CGM use in adults with noninsulin-treated type 2 diabetes, Diabetes Technol Ther. source

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    Premisecitation
    § Observational and Real-world Studies

    In adults with type 1 or type 2 diabetes treated with insulin, real-time CGM significantly lowers A1C and reduces emergency department visits or hospitalizations for hypoglycemia, but does not significantly lower overall rates of emergency department visits, hospitalizations, or hyperglycemia.

    “Retrospective data from rtCGM use in adults (87) with type 1 or type 2 diabetes treated with insulin showed that the use of rtCGM significantly lowered A1C levels and reduced rates of emergency department visits or hospitalizations for hypoglycemia but did not significantly lower overall rates of emergency department visits, hospitalizations, or hyperglycemia.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [87] Karter, 2021, Association of real-time continuous glucose monitoring with glycemic control and acute metabolic events among patients with insulin-treated diabetes, JAMA source

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    Premisecitation
    § Observational and Real-world Studies

    In adults with nonintensively treated type 2 diabetes, continued use of intermittently scanned CGM reduces A1C and GMI, increases time in range, and reduces time above range >180 mg/dL.

    “Finally, a retrospective study of continued use of isCGM in adults with nonintensively treated type 2 diabetes showed reduction of A1C and GMI, increase in TIR, and reduction of TAR (>180 mg/dL) (86).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [86] Al Hayek, 2023, Use of flash glucose monitoring and glycemic control in patients with type 2 diabetes mellitus not treated with an intensive insulin regimen: 1-year real-life retrospective cohort study, Adv Ther source

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    Premisecitation
    § Observational and Real-world Studies

    In youth with type 1 diabetes, intermittently scanned CGM is associated with a slight increase in A1C and weight but a high user satisfaction rate.

    “In an observational study in youth with type 1 diabetes, a slight increase in A1C levels and weight was seen, but the device was associated with a high user satisfaction rate (76).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [76] Charleer, 2020, Intermittently scanned continuous glucose monitoring is associated with high satisfaction but increased HbA1c and weight in well-controlled youth with type 1 diabetes, Pediatr Diabetes source

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    Premisecitation
    § Observational and Real-world Studies

    In adults with type 1 or type 2 diabetes, intermittently scanned CGM reduces acute diabetes complications such as diabetic ketoacidosis, severe hypoglycemia or diabetes-related coma, and hospitalizations for hypoglycemia and hyperglycemia.

    “Reductions in acute diabetes complications, such as diabetic ketoacidosis (DKA), episodes of severe hypoglycemia or diabetes-related coma, and hospitalizations for hypoglycemia and hyperglycemia, have been observed in adults with type 1 or type 2 diabetes (43,78,80)”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [43] Hohendorff, 2021, Intermittently scanned continuous glucose monitoring data of polish patients from real-life conditions: more scanning and better glycemic control compared to worldwide data, Diabetes Technol Ther source

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    • cites [78] Nathanson, 2021, Effect of flash glucose monitoring in adults with type 1 diabetes: a nationwide, longitudinal observational study of 14,372 flash users compared with 7691 glucose sensor naive controls, Diabetologia source

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    • cites [80] Roussel, 2021, Important drop in rate of acute diabetes complications in people with type 1 or type 2 diabetes after initiation of flash glucose monitoring in France: the RELIEF study, Diabetes Care source

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    Premisecitation
    § Use of Professional Continuous Glucose Monitoring and Intermittent Use of Continuous Glucose Monitoring

    In a real-world study, professional CGM in individuals with type 2 diabetes not on insulin at baseline and at 6 months resulted in lower A1C at 6 months and a shift toward greater use of glucose-lowering medications with cardiometabolic benefits.

    “Furthermore, in a real-world study, the use of professional CGM in individuals with type 2 diabetes not on insulin at baseline and at 6 months of followup resulted in lower A1C at 6 months as well as a shift toward greater use of glucose-lowering medications with cardiometabolic benefits, such as sodiumglucose transporter 2 inhibitors and glucagon-like peptide 1 receptor agonists (113).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [113] Nemlekar, 2023, Association between change in A1C and use of professional continuous glucose monitoring in adults with type 2 diabetes on noninsulin therapies: a real-world evidence study, Clin Diabetes source

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    Premisecitation
    § Use of Professional Continuous Glucose Monitoring and Intermittent Use of Continuous Glucose Monitoring

    Professional CGM devices provide retrospective data, either blinded or unblinded, for analysis and can be used to identify patterns of hypoglycemia and hyperglycemia.

    “Professional CGM devices, which provide retrospective data, either blinded or unblinded, for analysis can be used to identify patterns of hypoglycemia and hyperglycemia (111,112).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [111] Ajjan, 2019, Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: a pilot, multicentre, randomised controlled trial, Diab Vasc Dis Res source

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    • cites [112] Ribeiro, 2021, Impact of blinded retrospective continuous glucose monitoring on clinical decision making and glycemic control in persons with type 2 diabetes on insulin therapy, Nutr Metab Cardiovasc Dis source

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    Premisecitation
    § Data Analysis

    CGM is essential for creating an ambulatory glucose profile and providing data on time in range, percentage of time above and below range, and glycemic variability.

    “CGM is essential for creating an ambulatory glucose profile (AGP) and providing data on TIR, percentage of time spent above and below range, and glycemic variability (94).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [94] Battelino, 2019, Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International Consensus on Time in Range, Diabetes Care source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Real-time Continuous Glucose Monitoring Device Use in Pregnancy

    In pregnant adults with type 1 diabetes on multiple daily injections or insulin pump therapy, real-time CGM in addition to standard care reduces A1C levels, increases pregnancy-specific time in range 63-140 mg/dL, reduces time in hyperglycemia, and reduces large-for-gestational-age births, infant hospital length of stay, and severe neonatal hypoglycemia without increasing hypoglycemia.

    “Prior data from one well-designed RCT showed a reduction in A1C levels in pregnant adults with type 1 diabetes on MDI or insulin pump therapy and using rtCGM in addition to standard care; CGM users experienced more pregnancy-specific TIR (63-140 mg/dL [3.5-7.8 mmol/L]) and less time in hyperglycemia (103).”
    • Also stated in: § Real-time Continuous Glucose Monitoring Device Use in Pregnancy · boosted
      “This study demonstrated the value of rtCGM in pregnancy complicated by type 1 diabetes by showing a mild improvement in A1C levels and a significant improvement in the maternal glucose TIR for pregnancy (63-140 mg/dL [3.5-7.8 mmol/L]), without an increase in hypoglycemia, as well as reductions in large-for-gestational-age births, infant hospital length of stay, and severe neonatal hypoglycemia (”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [103] Feig, 2017, Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial, Lancet source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Real-time Continuous Glucose Monitoring Compared With Intermittently Scanned Continuous Glucose Monitoring

    In a 12-month real-world nonrandomized study in adults with type 1 diabetes, at 12 months A1C, time in level 1 hypoglycemia (<70 mg/dL), and time in level 2 hypoglycemia (<54 mg/dL) were lower in the real-time CGM group than in the intermittently scanned CGM group, and time in range was higher in the real-time CGM group.

    “At 12 months, A1C levels, time in level 1 hypoglycemia (<70 mg/dL [<3.9 mmol/L]), and time in level 2 hypoglycemia (<54 mg/dL [<3.0 mmol/L]) were all lower in the rtCGM group than in the isCGM group; similarly, the TIR was higher in the rtCGM group than in the isCGM group (92).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [92] Radovnická, 2022, Lower glycated hemoglobin with real-time continuous glucose monitoring than with intermittently scanned continuous glucose monitoring after 1 year: the CORRIDA LIFE study, Diabetes Technol Ther source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Insulin Pumps

    Adoption of pump therapy in the U.S. shows geographical variations, which may be related to health care professional preference or center characteristics and socioeconomic status, as pump therapy is more common in individuals of higher socioeconomic status.

    “Adoption of pump therapy in the U.S. shows geographical variations, which may be related to health care professional preference or center characteristics (165,166) and socioeconomic status, as pump therapy is more common in individuals of higher socioeconomic status, as reflected by private health insurance, family income, and education (165,166).”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [165] Lin, 2013, Race, socioeconomic status, and treatment center are associated with insulin pump therapy in youth in the first year following diagnosis of type 1 diabetes, Diabetes Technol Ther source

      Not checked in the free run.

    • cites [166] Willi, 2015, Racial-ethnic disparities in management and outcomes among children with type 1 diabetes, Pediatrics source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Insulin Pumps

    A systematic review and meta-analysis concluded that pump therapy has modest advantages for lowering A1C levels (−0.30% [95% CI −0.58 to −0.02]) and for reducing severe hypoglycemia rates in children and adults.

    “However, a systematic review and meta-analysis concluded that pump therapy has modest advantages for lowering A1C levels (À0.30% [95% CI À0.58 to À0.02]) and for reducing severe hypoglycemia rates in children and adults (163).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [163] Yeh, 2012, Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis, Ann Intern Med source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § INSULIN PUMPS AND AUTOMATED INSULIN DELIVERY SYSTEMS,

    Connected insulin pens and pen caps are useful to people with diabetes for real-time insulin dosing and allow clinicians to retrospectively review insulin delivery times and, in some cases, doses and glucose data to make informed insulin dose adjustments.

    “These pens and pen caps are useful to people with diabetes for realtime insulin dosing and allow clinicians to retrospectively review the insulin delivery times and, in some cases, doses and glucose data to make informed insulin dose adjustments (153).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [153] Seo, 2023, Patients' preferences for connected insulin pens: a discrete choice experiment among patients with type 1 and type 2 diabetes, Patient source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Insulin Pumps

    Real-world data on insulin pump use in individuals with type 1 diabetes show benefits in A1C levels and hypoglycemia reductions as well as total daily insulin dose reduction.

    “Real-world data on insulin pump use in individuals with type 1 diabetes show benefits in A1C levels and hypoglycemia reductions as well as total daily insulin dose reduction (164).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [164] Aleppo, 2023, Improvements in glycemic outcomes in 4738 children, adolescents, and adults with type 1 diabetes initiating a tubeless insulin management system, Diabetes Ther source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § INSULIN PUMPS AND AUTOMATED INSULIN DELIVERY SYSTEMS,

    In a multicenter randomized controlled trial in people with type 1 diabetes, use of an insulin pen cap was associated with improved glycemic outcomes at 6 weeks, with an increase in time in range and a decrease in GMI and time above range.

    “In a multicenter RCT in people with type 1 diabetes, the use of an insulin pen cap was associated with improved glycemic outcomes at 6 weeks in the insulin cap group, with an increase in TIR and decrease in GMI and TAR (154).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [154] Gomez-Peralta, 2023, Efficacy of a connected insulin pen cap in people with noncontrolled type 1 diabetes: a multicenter randomized clinical trial, Diabetes Care source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § INSULIN PUMPS AND AUTOMATED INSULIN DELIVERY SYSTEMS,

    In a recent real-world study with multinational data from 3,954 adults with diabetes using a connected pen and CGM, treatment engagement with a connected insulin pen is positively associated with glycemic outcomes, and missing as little as two basal doses or four bolus insulin doses over a 14-day period is associated with a clinically relevant decrease in time in range of ≥5%.

    “A recent realworld study with multinational data collected from 3,954 adults with diabetes using a connected pen and CGM validated the fact that treatment engagement with a connected insulin pen is positively associated with glycemic outcomes.”
    • Also stated in: § INSULIN PUMPS AND AUTOMATED INSULIN DELIVERY SYSTEMS, · hedged
      “On the other hand, missing as little as two basal doses or four bolus insulin doses over a 14-day period would be associated with a clinically relevant decrease in TIR of $5% (156).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [156] Danne, 2024, Association between treatment adherence and continuous glucose monitoring outcomes in people with diabetes using smart insulin pens in a real-world setting, Diabetes Care source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Insulin Pumps

    Current reasons for pump therapy attrition are problems with cost or wearability, loss of insurance, dislike of the pump, suboptimal glycemic outcomes, or mood disorders.

    “Current reasons for attrition are problems with cost or wearability, loss of insurance, dislike of the pump, suboptimal glycemic outcomes, or mood disorders (e.g., anxiety or depression) (175).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [175] Wong, 2015, Insulin pump use and glycemic control in adolescents with type 1 diabetes: predictors of change in method of insulin delivery across two years, Pediatr Diabetes source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisecitation
    § Insulin Pumps in Youth

    Pump therapy may be the preferred mode of insulin delivery for children under 7 years of age.

    “In particular, pump therapy may be the preferred mode of insulin delivery for children under 7 years of age (188).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [188] Sundberg, 2017, ISPAD Guidelines. Managing diabetes in preschool children, Pediatr Diabetes source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Insulin Pumps in Youth

    Evidence suggests insulin pump therapy may reduce diabetic ketoacidosis risk and diabetes complications, particularly retinopathy and peripheral neuropathy in youth, compared with multiple daily injections.

    “There is also evidence that insulin pump therapy may reduce DKA risk (182,186) and diabetes complications, particularly retinopathy and peripheral neuropathy in youth, compared with MDI (169).”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [169] Peters, 2016, Diabetes technology-continuous subcutaneous insulin infusion therapy and continuous glucose monitoring in adults: an Endocrine Society clinical practice guideline, J Clin Endocrinol Metab source

      Not checked in the free run.

    • cites [182] Karges, 2017, Association of insulin pump therapy vs insulin injection therapy with severe hypoglycemia, ketoacidosis, and glycemic control among children, adolescents, and young adults with type 1 diabetes, JAMA source

      Not checked in the free run.

    • cites [186] Maahs, 2015, Rates of diabetic ketoacidosis: international comparison with 49,859 pediatric patients with type 1 diabetes from England, Wales, the U.S., Austria, and Germany, Diabetes Care source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Automated Insulin Delivery Systems in Pregnancy

    Recent data show clinical benefits and safety of AID use in pregnancy, though only one study used an AID system with a pregnancy-specific glycemic target.

    “Recent data have shown the clinical benefits and safety of AID use, even though only one study used an AID system with a pregnancyspecific glycemic target.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [236] Lee, 2023, Automated insulin delivery in women with pregnancy complicated by type 1 diabetes, N Engl J Med source

      Not checked in the free run.

    • Rests on an assumption: Current FDA-approved AID systems, except one approved but not commercially available, have glucose goals not pregnancy-specific and algorithms not designed for pregnancy-specific goals.

  • May combine two claims.

    Premisecitation
    § Data From Real-world Studies

    Real-world studies analyzed longer duration of AID use than pivotal trials, mostly >6 months, average 9 months.

    “Newer systems have shown increased time spent in automation, and the real-world studies have retrospectively analyzed longer duration of system use compared with their respective pivotal trials, with most analyses occurring for more than 6 months and an average duration of 9 months (227).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [227] Considine, 2024, Real-world evidence of automated insulin delivery system use, Diabetes Technol Ther source

      Not checked in the free run.

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

    Study design and conductcitation
    § Data From Real-world Studies

    For some AID systems, all data are automatically collected to a database; for others, data are collected by voluntary sharing.

    “It is important to emphasize that for some AID systems all data are automatically collected to the database (228), whereas for other systems data are collected based on voluntary sharing to the database by AID users.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [228] Forlenza, 2024, Real-world evidence of Omnipod 5 automated insulin delivery system use in 69,902 people with type 1 diabetes, Diabetes Technol Ther source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Data From Real-world Studies

    A recent systematic review of 20 AID real-world studies covering 171,209 individuals substantiated pivotal trial results and confirmed clinical benefits of AID in type 1 diabetes.

    “A recent systematic review of AID real-world studies, with 20 studies representing 171,209 individuals, substantiated the results observed in the pivotal trials and have confirmed the clinical benefits of AID systems in people with type 1 diabetes.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [227] Considine, 2024, Real-world evidence of automated insulin delivery system use, Diabetes Technol Ther source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Data From Real-world Studies

    Real-world AID benefits include improvement in A1C, TIR, other glucometrics, and psychosocial benefits.

    “Benefits include improvement in A1C levels, TIR, and other glucometrics as well as psychosocial benefits (229)(230)(231)(232)(233)(234).”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [229] Amigó, 2023, Switching from treatment with sensor augmented pump to hybrid closed loop system in type 1 diabetes: impact on glycemic control and neuropsychological tests in the real world, Diabetes Res Clin Pract source

      Not checked in the free run.

    • cites [230] Chico, 2023, Efficacy, safety, and satisfaction with the Accu-Chek Insight with Diabeloop closed-loop system in subjects with type 1 diabetes: a multicenter real-world study, Diabetes Technol Ther source

      Not checked in the free run.

    • cites [231] Benhamou, 2023, One-year real-world performance of the DBLG1 closed-loop system: data from 3706 adult users with type 1 diabetes in Germany, Diabetes Obes Metab source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Automated Insulin Delivery Systems in Pregnancy

    In that trial, there were no differences in preterm births, birth weight, neonatal complications, or NICU admission.

    “There were no differences in the number of preterm births, birth weight, neonatal complications, or admission to the neonatal intensive care unit.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [236] Lee, 2023, Automated insulin delivery in women with pregnancy complicated by type 1 diabetes, N Engl J Med source

      Not checked in the free run.

    • Rests on an assumption: Current FDA-approved AID systems, except one approved but not commercially available, have glucose goals not pregnancy-specific and algorithms not designed for pregnancy-specific goals.

  • May combine two claims.

    Premisecitation
    § Insulin Pumps and Automated Insulin Delivery Systems in People With Type 2 and Other Types of Diabetes

    Real-world reports show reduction of A1C and total daily insulin dose in type 2 diabetes initiating insulin pump therapy.

    “More recently, real-world reports have shown reduction of A1C levels and reduction of total daily insulin dose in individuals with type 2 diabetes initiating insulin pump therapy (247).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [247] Carlson, 2021, Improved glycemic control in 3,592 adults with type 2 diabetes mellitus initiating a tubeless insulin management system, Diabetes Res Clin Pract source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Automated Insulin Delivery Systems in Pregnancy

    In that study, time below range was lower over 24 h and overnight in the AID group.

    “Time spent below range was lower over 24 h and overnight in the AID group as well.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [239] Benhalima, 2024, Comparing advanced hybrid closed loop therapy and standard insulin therapy in pregnant women with type 1 diabetes (CRISTAL): a parallel-group, open-label, randomised controlled trial, Lancet Diabetes Endocrinol source

      Not checked in the free run.

    • Rests on an assumption: Current FDA-approved AID systems, except one approved but not commercially available, have glucose goals not pregnancy-specific and algorithms not designed for pregnancy-specific goals.

  • May combine two claims.

    Premisecitation
    § Insulin Pumps and Automated Insulin Delivery Systems in People With Type 2 and Other Types of Diabetes

    Insulin pump use in insulin-requiring people with any type of diabetes may improve user satisfaction and simplify therapy.

    “Use of insulin pumps in insulin-requiring people with any type of diabetes may improve user satisfaction and simplify therapy (171,241).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [171] Vigersky, 2018, Improved HBa1c, total daily insulin dose, and treatment satisfaction with insulin pump therapy compared to multiple daily insulin injections in patients with type 2 diabetes irrespective of baseline c-peptide levels, Endocr Pract source

      Not checked in the free run.

    • cites [241] Grunberger, 2020, Treatment intensification with insulin pumps and other technologies in patients with type 2 diabetes: results of a physician survey in the United States, Clin Diabetes source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Automated Insulin Delivery Systems in Pregnancy

    In that pilot RCT, safety and adverse pregnancy outcomes were similar between groups.

    “Time at <63 mg/dL was lower in the hybrid closed-loop group, whereas percentage of the pregnancy-specific TIR was greater in the SAP group in the third trimester, with similar safety and adverse pregnancy outcomes between groups (237).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [237] Polsky, 2024, Randomized trial of assisted hybrid closed-loop therapy versus sensor-augmented pump therapy in pregnancy, Diabetes Technol Ther source

      Not checked in the free run.

    • Rests on an assumption: Current FDA-approved AID systems, except one approved but not commercially available, have glucose goals not pregnancy-specific and algorithms not designed for pregnancy-specific goals.

  • Classified as probably not a substantial claim.

    Interpretationreasoning
    § Digital Health Technology

    Specific diabetes apps cannot be recommended without RCTs and validation unless they have FDA clearance, because data are insufficient.

    “There are insufficient data to provide recommendations for specific apps for diabetes management, education, and support in the absence of RCTs and validation of apps unless they are FDA cleared.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation
    § Open-Source Automated Insulin Dosing

    The code for these algorithms was not authored by any single person, and many users do not compile the software themselves.

    “No individual person has written all the code for these algorithms, and a large percentage of users do not build the software themselves (255).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [255] Lum, 2021, A real-world prospective study of the safety and effectiveness of the loop open source automated insulin delivery system, Diabetes Technol Ther source

      Not checked in the free run.

    • Rests on an assumption: OS-AID algorithms are largely designed, maintained, and curated by people with diabetes and their loved ones.

  • May combine two claims.

    Premisecitation
    § Open-Source Automated Insulin Dosing

    The OpenAPS heuristic algorithm is supported by large real-world studies and a multicenter RCT.

    “The OpenAPS heuristic algorithm (implemented on a system on a chip in OpenAPS, Android smartphones as An-droidAPS, and iPhone as iAPS/Trio) is supported by large real-world studies (256) and a multicenter RCT (257).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [256] Braune, 2021, Why #WeAreNotWaiting–motivations and self-reported outcomes among users of open-source automated insulin delivery systems: multinational survey, J Med Internet Res source

      Not checked in the free run.

    • cites [257] Burnside, 2022, Open-source automated insulin delivery in type 1 diabetes, N Engl J Med source

      Not checked in the free run.

    • Rests on an assumption: There are two main available algorithms, Open-APS and Loop, implemented on a variety of platforms.
    • Rests on an assumption: The OpenAPS algorithm is the only AID system to support unannounced meals.

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

    Premisecitation
    § Digital Health Technology

    Many online programs offer lifestyle counseling to achieve weight loss and increased physical activity.

    “Many online programs offer lifestyle counseling to achieve weight loss and increased physical activity (263).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [263] Chao, 2019, Enhanced self-efficacy and behavioral changes among patients with diabetes: cloud-based mobile health platform and mobile app service, JMIR Diabetes source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Digital Health Technology

    Established cloud-based data aggregator programs such as Tidepool and Glooko have appropriate data security features and are HIPAA compliant.

    “Established cloud-based data aggregator programs, such as Tidepool, Glooko, and others, have been developed with appropriate data security features and are compliant with the U.S. Health Insurance Portability and Accountability Act of 1996.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [262] Wong, 2018, A pilot study of use of a software platform for the collection, integration, and visualization of diabetes device data by health care providers in a multidisciplinary pediatric setting, Diabetes Technol Ther source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Digital Health Technology

    A real-world observational study in type 2 diabetes patients on basal insulin, oral agents, or no glucose-lowering drugs found that a digital health solution plus rtCGM lowered GMI and TAR above 180 and 250 mg/dL, raised TIR by 15%, and increased weekly engagement.

    “However, in a real-world observational study in individuals with type 2 diabetes treated with basal insulin, oral medications, or no medications, the use of a digital health solution and rtCGM resulted in reductions of GMI and TAR >180 and >250 mg/dL as well as an increase in TIR by 15% and participation in a least one engagement activity per week (274).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [274] Kumbara, 2023, Impact of a combined continuous glucose monitoring-digital health solution on glucose metrics and self-management behavior for adults with type 2 diabetes: real-world, observational study, JMIR Diabetes source

      Not checked in the free run.

  • May combine two claims.

    Interpretationnone given
    § Digital Health Technology

    There are limited RCT data for many digital health interventions, and long-term follow-up is lacking.

    “There are limited RCT data for many of these interventions, and long-term follow-up is lacking.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation
    § Digital Health Technology

    These cloud-based programs can help monitor people with diabetes and provide access to their health care teams.

    “These programs can help monitor people with diabetes and provide access to their health care teams (262).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [262] Wong, 2018, A pilot study of use of a software platform for the collection, integration, and visualization of diabetes device data by health care providers in a multidisciplinary pediatric setting, Diabetes Technol Ther source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Inpatient Care

    This approach was taken to reduce PPE use and more closely monitor patients so health care personnel do not have to enter a patient room solely to measure glucose.

    “This approach has been taken to reduce the use of personal protective equipment and more closely monitor patients so that health care personnel do not have to go into a patient room solely to measure a glucose level (283-286).”
    Quote in the paperSubstantial claim0 of 4 sources checked
    • cites [283] Davis, 2021, Remote continuous glucose monitoring with a computerized insulin infusion protocol for critically ill patients in a COVID-19 medical ICU: proof of concept, Diabetes Care source

      Not checked in the free run.

    • cites [284] Sadhu, 2020, Continuous glucose monitoring in critically ill patients with COVID-19: results of an emergent pilot study, J Diabetes Sci Technol source

      Not checked in the free run.

    • cites [285] Agarwal, 2021, Continuous glucose monitoring in the intensive care unit during the COVID-19 pandemic, Diabetes Care source

      Not checked in the free run.

    • cites [286] Galindo, 2020, Implementation of continuous glucose monitoring in the hospital: emergent considerations for remote glucose monitoring during the COVID-19 pandemic, J Diabetes Sci Technol source

      Not checked in the free run.

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

    Premisenone given
    § Inpatient Care

    Galactose produces falsely elevated blood glucose readings on glucose meters.

    “Galactose | Falsely higher blood glucose values”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation
    § Inpatient Care

    ISO 15197:2013 requires that 95% of blood glucose meter measurements fall within 15% of the reference value when glucose is at least 100 mg/dL, and within 15 mg/dL when glucose is below 100 mg/dL.

    “95% within 15% for BG $100 mg/dL”
    • Also stated in: § Inpatient Care · plain
      “95% within 15 mg/dL for BG <100 mg/dL”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites ISO 15197:2013

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Inpatient Care

    The FDA accuracy standard for blood glucose meters requires that 95% of measurements fall within 12% of the reference value when glucose is at least 75 mg/dL, and within 12 mg/dL when glucose is below 75 mg/dL.

    “95% within 12% for BG $75 mg/dL”
    • Also stated in: § Inpatient Care · plain
      “95% within 12 mg/dL for BG <75 mg/dL”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites FDA

      Not checked in the free run.

  • May combine two claims.

    Premisecitation
    § Inpatient Care

    The FDA accuracy standard for blood glucose meters requires that 98% of measurements fall within 15% of the reference value when glucose is at least 75 mg/dL, and within 15 mg/dL when glucose is below 75 mg/dL.

    “98% within 15% for BG $75 mg/dL”
    • Also stated in: § Inpatient Care · plain
      “98% within 15 mg/dL for BG <75 mg/dL”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites FDA

      Not checked in the free run.

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

    Premisenone given
    § Inpatient Care

    Xylose produces falsely elevated blood glucose readings on glucose meters.

    “Xylose | Falsely higher blood glucose values”
    Quote in the paperNot a substantial claim

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

    Premisenone given
    § Inpatient Care

    A high hematocrit produces falsely reduced blood glucose readings.

    “Hematocrit (high) | Falsely lower blood glucose values”
    Quote in the paperNot a substantial claim

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

    Premisenone given
    § Inpatient Care

    Vitamin C produces falsely reduced or falsely elevated blood glucose readings.

    “Vitamin C | Falsely lower or higher blood glucose values”
    Quote in the paperNot a substantial claim

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

    Premisenone given
    § Inpatient Care

    Acetaminophen produces falsely elevated blood glucose readings at low blood glucose levels.

    “Acetaminophen | Falsely higher blood glucose values at low blood glucose levels”
    Quote in the paperNot a substantial claim

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

    Premisenone given
    § Inpatient Care

    A low hematocrit produces falsely elevated blood glucose readings.

    “Hematocrit (low) | Falsely higher blood glucose values”
    Quote in the paperNot a substantial claim

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

    Premisenone given
    § Inpatient Care

    Uric acid produces falsely elevated blood glucose readings at very low or very high glucose levels.

    “Uric acid | Falsely higher blood glucose values at very low or”
    Quote in the paperNot a substantial claim

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

    Premisenone given
    § Inpatient Care

    Dopamine produces falsely elevated blood glucose readings at low blood glucose levels.

    “Dopamine | Falsely higher blood glucose values at low blood glucose levels”
    Quote in the paperNot a substantial claim

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

    Premisenone given
    § Inpatient Care

    Furosemide produces falsely reduced blood glucose readings.

    “Furosemide | Falsely lower blood glucose values”
    Quote in the paperNot a substantial claim
73 of 73

  • The paper relies on this without support.

    Diabetes technology, when combined with education, follow-up, pharmacotherapy if needed, and support, can improve the lives and health of people with diabetes.

    “Diabetes technology, coupled with education, follow-up, pharmacotherapy if needed, and support, can improve the lives and health of people with diabetes; however, the complexity and rapid evolution of the diabetes technology landscape can also be a barrier to implementation for people with diabetes, their care partners, and the health care team.”

  • The paper relies on this without support.

    No device used in diabetes management works optimally without education, training, and ongoing support.

    “In general, no device used in diabetes management works optimally without education, training, and ongoing support.”

  • The paper relies on this without support.

    Better outcomes cannot be achieved without training and education of health care professionals.

    “Better outcomes cannot be achieved, however, without the training and education of health care professionals.”

  • The paper relies on this without support.

    Preowned or secondhand glucose test strips may give incorrect results.

    “People with diabetes should be advised against purchasing or reselling preowned or secondhand test strips, as these may give incorrect results.”

  • The paper relies on this without support.

    CGM measures interstitial glucose, which correlates well with plasma glucose, although it can lag when glucose levels are rising or falling rapidly.

    “CGM measures interstitial glucose (which correlates well with plasma glucose, although at times, it can lag if glucose levels are rising or falling rapidly).”

  • The paper relies on this without support.

    Current FDA-approved AID systems, except one approved but not commercially available, have glucose goals not pregnancy-specific and algorithms not designed for pregnancy-specific goals.

    “The use of AID systems in diabetes and pregnancy presents particular challenges, as the current FDA-approved AID systems (except for one that has been FDA approved but is not yet commercially available) have glucose goals that are not pregnancy specific and do not have algorithms designed to achieve pregnancyspecific glucose goals.”

  • The paper relies on this without support.

    Use of insulin pumps and AID systems in type 2 diabetes is still limited, and only one system is FDA approved for type 2 diabetes.

    “The use of insulin pumps and AID systems in type 2 diabetes is still limited, and at this time only one system is FDA approved for use in type 2 diabetes.”

  • The paper relies on this without support.

    OS-AID algorithms are largely designed, maintained, and curated by people with diabetes and their loved ones.

    “OS-AID algorithms are largely designed, maintained, and curated by people with diabetes and their loved ones.”

  • The paper relies on this without support.

    Thousands of people with diabetes use these algorithms with cleared CGM systems and insulin pump components.

    “Thousands of people with diabetes use these algorithms with cleared CGM systems and insulin pump components.”

  • The paper relies on this without support.

    There are two main available algorithms, Open-APS and Loop, implemented on a variety of platforms.

    “There are two main available algorithms, the Open-APS algorithm and the Loop algorithm, which have been implemented on a variety of platforms.”

  • The paper relies on this without support.

    The OpenAPS algorithm is the only AID system to support unannounced meals.

    “The OpenAPS algorithm is the only AID system to support unannounced meals.”

  • The paper relies on this without support.

    Loop is an open-source model predictive control algorithm implemented on iPhones as an app.

    “Loop, an open-source model predictive control algorithm, is implemented on iPhones as an app.”

  • The paper relies on this without support.

    Both Loop and OpenAPS algorithms offer direct management of algorithm aggressiveness through conventional pump settings.

    “Both the Loop and OpenAPS algorithms offer direct management of algorithm aggressiveness through conventional pump settings.”

  • The paper relies on this without support.

    Many online programs include a health coach and can create small groups of similar participants on social networks.

    “Many include a health coach and can create small groups of similar participants on social networks.”

  • The paper relies on this without support.

    Point-of-care BGM remains the approved method for glucose monitoring in hospitals, especially for dosing insulin and treating hypoglycemia.

    “Pointof-care BGM remains the approved method for glucose monitoring in hospitals, especially for dosing insulin and treating hypoglycemia.”
15 of 15

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?

  • With the advent of newer studies of CGM in noninsulin-treated individuals and increasing uptake, the utility of CGM is progressively being endorsed in this population.

    “With the advent of newer studies of CGM in noninsulin‐treated individuals and increasing uptake, the utility of CGM is progressively being endorsed in this population.”

    From Continuous glucose monitoring in noninsulin‐treated type 2 diabetes: A critical review of reported trials with an updated systematic review and meta‐analysis of randomised controlled trials (2025) · cites this paper as [4]

    Recommendation 7.16 (Continuous Glucose Monitoring Devices; page unavailable) advises considering CGM for adults with type 2 diabetes using noninsulin glucose-lowering medication, and Data From Randomized Controlled Trials reports benefits in adults not using insulin. These passages support the claim that CGM’s utility is being endorsed for this population. The copy describes CGM as widely available but does not establish increasing uptake among noninsulin-treated individuals. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • Sensor‐augmented pump systems (SAP) enable adaptive insulin delivery, including dual‐wave or square‐wave boluses, which distribute insulin over several hours and better match the slow and prolonged glucose absorption typical of DGP, particularly in high‐fat or high‐protein meals.

    “Sensor‑augmented pump systems (SAP) enable adaptive insulin delivery, including dual‑wave or square‑wave boluses, which distribute insulin over several hours and better match the slow and prolonged glucose absorption typical of DGP [54, 112, 132, 148, 149], particularly in high‑fat or high‑protein meals [150–152].”

    From Diabetic gastroparesis: pathophysiology and impact on insulin timing choices (2026) · cites this paper as [132]

    Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

    Experimental — accuracy not yet measured

  • Digital innovations in glucose sensing and insulin delivery have improved glycemic management in diabetes and offer particular advantages in patients with DGP, where delayed and variable carbohydrate absorption leads to erratic glycemic excursions.

    “Digital innovations in glucose sensing and insulin delivery have improved glycemic management in diabetes and offer particular advantages in patients with DGP, where delayed and variable carbohydrate absorption leads to erratic glycemic excursions [131, 132].”

    From Diabetic gastroparesis: pathophysiology and impact on insulin timing choices (2026) · cites this paper as [132]

    Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

    Experimental — accuracy not yet measured

  • These data facilitate a dynamic, iterative optimization of insulin dosing, bolus timing, and fractionation, moving away from purely empirical adjustments.

    “These data facilitate a dynamic, iterative optimization of insulin dosing, bolus timing, and fractionation, moving away from purely empirical adjustments [132, 143, 145, 146].”

    From Diabetic gastroparesis: pathophysiology and impact on insulin timing choices (2026) · cites this paper as [132]

    The Data Analysis section (page unavailable) says CGM and automated-insulin-delivery reports reveal glucose patterns and insulin-delivery information that can guide therapy adjustments. The Automated Insulin Delivery Systems section also describes dose modulation based on CGM feedback. These passages support data-guided insulin adjustment, but do not specifically establish optimization of bolus timing or fractionation. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • Current algorithms are primarily responsive to immediate glycemic changes and may not fully compensate for delayed carbohydrate absorption, especially from meals rich in fat and protein that can induce delayed hyperglycemia.

    “However, current algorithms are primarily responsive to immediate glycemic changes and may not fully compensate for delayed carbohydrate absorption, especially from meals rich in fat and protein that can induce delayed hyperglycemia [131, 132, 158].”

    From Diabetic gastroparesis: pathophysiology and impact on insulin timing choices (2026) · cites this paper as [132]

    The Automated Insulin Delivery Systems section says current algorithms adjust insulin using CGM feedback and predicted glucose levels, commonly 30 minutes or 1 hour ahead, and still require meal announcements to calculate prandial doses. This supports the general description of glucose-responsive algorithms, but the paper does not say they fail to compensate for delayed carbohydrate absorption or link that limitation to high-fat, high-protein meals and delayed hyperglycemia. (LLM, conf=0.83)

    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.

  • Pump recommendation conflicts with the stated lack of evidence for youth with type 2 diabetes

    Major

    Recommendation 7.27 says insulin pump therapy should be offered to youth with type 2 diabetes on multiple daily injections. The youth section says there is insufficient evidence to make recommendations for that group.

  • Meter-accuracy claim cites a skin-reaction paper

    Minor

    The text attributes an analysis of glucose-meter accuracy to reference 20, but the listed reference 20 concerns skin issues associated with CGM use.

  • Basal-insulin retrospective study cites a type 1 diabetes trial

    Minor

    The cited reference 84 is a randomized trial comparing CGM devices in adults with type 1 diabetes, not a retrospective study of adults with type 2 diabetes using basal insulin.

3 of 3

Cites

Flagged first, then by citations

Research works printed but not linked: 2

  1. Boughton, 2024, The effect of closed-loop glucose control on C-peptide secretion in youth with newly diagnosed type 1 diabetes: the CLOuD RCT, 8
  2. Chandran, 2015, Adherence to insulin pen therapy is associated with reduction in healthcare costs among patients with type 2 diabetes mellitus, Am Health Drug Benefits, 8, 148

Cited by

Sorted by citations

Related

Authors
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Echouffo-Tcheugui, J. B., Ekhlaspour, L., Garg, R., Khunti, K., Lal, R., Lingvay, I., Matfin, G., Pandya, N., Pekas, E. J., Pilla, S. J., Polsky, S., Segal, A. R., Seley, J. J., Stanton, R. C., & Bannuru, R. R.
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2024-12-09
Volume
48
Issue
Supplement_1
Pages
S146-S166
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc25-s007
PMC
PMC11635043
OpenAlex
W4405187548
Semantic Scholar
247efba1a5237dc77552f3b09408f293abf81b6a
Cited by
348
References
292
Citations by year
2026: 147 · 2025: 184 · 2024: 16 · 2023: 1
FWCI
20.36
Type
journal article
Language
en
Update notices
correction (2025-02-23)
Open access
Licence
www.diabetesjournals.org/journals/pages/license (vor)
Locations
  • Diabetes Care (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
National Institute of Diabetes and Digestive and Kidney Diseases (K23DK121942)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords
diabetes technology, clinical guidelines, quality of care, treatment goals
MeSH terms
Diabetes Mellitus, Humans, Standard of Care

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 2026-10-05.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-05.

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.

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