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Cited by 40Gestational Diabetes Research and ManagementDiabetes Management and ResearchDiabetes, Cardiovascular Risks, and Lipoproteins

One-step or 2-step testing for gestational diabetes: which is better?

Open access
Coustan, Donald R., Dyer, Alan R., Metzger, Boyd E.·2021·American Journal of Obstetrics and Gynecology
DOI 10.1016/j.ajog.2021.05.009
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Abstract

In the United States, the common approach to detecting gestational diabetes mellitus is the 2-step protocol recommended by the American College of Obstetricians and Gynecologists. A 50 g, 1-hour glucose challenge at 24 to 28 weeks' gestation is followed by a 100 g, 3-hour oral glucose tolerance test when a screening test threshold is exceeded. Notably, 2 or more elevated values diagnose gestational diabetes mellitus. The 2-step screening test is administered without regard to the time of the last meal, providing convenience by eliminating the requirement for fasting. However, depending upon the cutoff used and population risk factors, approximately 15% to 20% of screened women require the 100 g, 3-hour oral glucose tolerance test. The International Association of Diabetes and Pregnancy Study Groups recommends a protocol of no screening test but rather a diagnostic 75 g, 2-hour oral glucose tolerance test. One or more values above threshold diagnose gestational diabetes mellitus. The 1-step approach requires that women be fasting for the test but does not require a second visit and lasts 2 hours rather than 3. Primarily because of needing only a single elevated value, the 1-step approach identifies 18% to 20% of pregnant women as having gestational diabetes mellitus, 2 to 3 times the rate with the 2-step procedure, but lower than the current United States prediabetes rate of 24% in reproductive aged women. The resources needed for the increase in gestational diabetes mellitus are parallel to the resources needed for the increased prediabetes and diabetes in the nonpregnant population. A recent randomized controlled trial sought to assess the relative population benefits of the above 2 approaches to gestational diabetes mellitus screening and diagnosis. The investigators concluded that there was no significant difference between the 2-step screening protocol and 1-step diagnostic testing protocol in their impact on population adverse short-term pregnancy outcomes. An accompanying editorial concluded that perinatal benefits of the 1-step approach to diagnosing gestational diabetes mellitus "appear to be insufficient to justify the associated patient and healthcare costs of broadening the diagnosis." We raise several concerns about this conclusion. The investigators posited that a 20% improvement in adverse outcomes among the entire pregnancy cohort would be necessary to demonstrate an advantage to the 1-step approach and estimated the sample size based on that presumption, which we believe to be unlikely given the number of cases that would be identified. In addition, 27% of the women randomized to the 1-step protocol underwent 2-step testing; 6% of the study cohort had no testing at all. A subset of women assigned to 2-step testing did not meet the criteria for gestational diabetes mellitus but were treated as such because of elevated fasting plasma glucose levels, presumably contributing to the reduction in adverse outcomes but not to the number of gestational diabetes mellitus identified, increasing the apparent efficacy of the 2-step approach. No consideration was given to long-term benefits for mothers and offspring. All these factors may have contributed to obscuring the benefits of 1-step testing; most importantly, the study was not powered to identify what we understand to be the likely impact of 1-step testing on population health.

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Crossref · 10.1016/j.ajog.2021.05.009

Cites

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Claims the paper makes

0 of 84 cited sources checked · 0 supported · 0 flagged

  • Findingcitation

    When all HAPO participants with gestational diabetes are compared with all non-gestational-diabetes participants, rather than only those at mean glucose, the likelihood of an adverse outcome is roughly doubled, not 1.75.

    “When all HAPO participants with one or more glucose value above the cutoff (GDMs) are compared with all the rest of HAPO participants (non-GDMs) and not just those whose glucose values are at the mean, the likelihood of an adverse outcome is not 1.75, but in fact is roughly doubled (Table 2).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [17] Metzger, 2010, International Association of Diabetes and Pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy, Diabetes Care source

      Not checked in the free run.

  • Findingreasoning

    Applying ACHOIS's 35% preeclampsia reduction to the additional 12% undiagnosed mild gestational diabetes cases in group 2 yields a relative risk estimate of 1.107, again lower than 1.2.

    “A similar analysis applies to the 35% reduction in preeclampsia, reported with diagnosis and treatment in ACHOIS, 28 to the additional 12% undiagnosed cases of mild GDM in group 2. The reported rate of preeclampsia or gestational hypertension in the treated GDM women in group 2 was 20.3%.Based on these values and calculations similar to those above for LGA, we obtain a relative risk estimate of 1.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [28] Crowther, 2005, Effect of treatment of gestational diabetes mellitus on pregnancy outcomes, N Engl J Med source

      Not checked in the free run.

  • Findingnone given

    If all 11,870 women in group 2 had received the 1-step test, an estimated 19.9% (2362 women) would have been diagnosed with gestational diabetes.

    “If all 11,870 women in group 2 had the 1-step test, an estimated 19.9% (2362) would have been diagnosed as having GDM.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The 1-step GDM rate estimated from group 1 (19.9%) applies to all women in group 2 if they had received 1-step testing.
  • Findingreasoning

    If the 795 untested group 1 women and 708 untested group 2 women had been tested by the assigned protocols, there would have been an estimated 158 and 58 more gestational diabetes cases in groups 1 and 2, respectively.

    “Furthermore, if the 795 untested group 1 women and the 708 untested group 2 women had been tested by the assigned protocols, there would have been an estimated 158 and 58 more GDMs in groups 1 and 2, respectively.”
    Quote in the paperSubstantial claim
  • Findingreasoning

    Using midpoint risk reductions for large-for-gestational-age babies (50%) and hypertensive disorders (35%) and midpoint routine-care GDM rates (20% LGA; 16% hypertensive disorders), identifying and treating 1417 additional GDM cases would have led to 141 fewer LGA babies and 79 fewer hypertensive disorder cases.

    “Applying the midpoint risk reductions for LGA babies (50%) and hypertensive disorders of pregnancy (35%) reported in Table 3 and using midpoint rates in the routine care GDMs in Table 3 (20% LGA; 16% hypertensive disorders of pregnancy), identifying and treating these 1417 (2362À945) additional cases of GDM would have resulted in 141 fewer LGA babies and 79 fewer cases”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The risk reductions for LGA and hypertensive disorders from mild GDM RCTs apply to the additional GDM cases identified by 1-step testing.
  • May combine two claims. 43
  • Classified as probably not a substantial claim. 20

  • May combine two claims.

    Findingcitation

    The perinatal composite outcome occurred in 4% of untreated gestational diabetes cases in ACHOIS, yet the current trial estimated its incidence as 4% in the entire sample.

    “For example, the perinatal composite outcomes occurred in 4% of the untreated GDMs in ACHOIS yet the current study estimated its incidence as 4% in the entire sample.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [28] Crowther, 2005, Effect of treatment of gestational diabetes mellitus on pregnancy outcomes, N Engl J Med source

      Not checked in the free run.

  • May combine two claims.

    Findingreasoning

    In group 2, this would reduce the overall large-for-gestational-age rate from 9.2% to 8.4%, giving a relative risk of 1.095, which is lower than the prespecified 1.2.

    “In group 2, this would result in a reduction in LGA within the entire group of 6.66% of 12%¼0.79%,meaning that the LGA rate in the group 2 would be reduced from 9.2% (the observed overall LGA rate) to 8.4%.The relative risk would be 9.2/ 8.4¼1.095,substantially lower than the prespecified relative risk of 1.2.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingreasoning

    If the 130 mg/dL cutoff had been used consistently, 987 gestational diabetes cases would have been diagnosed in group 2; if the 140 mg/dL cutoff had been chosen, 853 would have been diagnosed and treated.

    “This means that if the 130 mg/dL cutoff for the 1hour screen was used consistently, a total of 987 (945þ42) GDMs would be diagnosed in group 2, but if a cutoff of 140 mg/dL was chosen, the total number of GDMs diagnosed and treated in group 2 would be 853 (945e92).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    If all group 1 women who were tested had received the intended 1-step protocol, an additional 378 gestational diabetes cases would have been detected, giving a gestational diabetes rate of 19.9%.

    “If all of group 1 women who were tested had received the intended testing protocol, an additional 378 GDMs would have been detected, for a GDM rate of 19.9%.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    If all group 2 women who were tested had received the intended 2-step screening, 24 fewer gestational diabetes cases would have been diagnosed, giving a rate of 8.26%.

    “If all of group 2 women who were tested had received the intended 2-step screening 24 fewer GDMs would have been diagnosed, for a rate of 8.26%.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingcitation

    Applying Landon et al's 51% large-for-gestational-age reduction and 37% preeclampsia/hypertensive disorder reduction yields relative risks of 1.16 for large-for-gestational-age and 1.12 for hypertensive disorders, below the 1.2 used in sample size estimates.

    “The Landon et al 29 study, a similar RCT to the ACHOIS study, but which used the more stringent diagnostic criteria of the 2-step procedure as long as the fasting plasma glucose was <95 mg/ dL, demonstrated a 51% reduction in LGA and a 37% reduction in preeclampsia and hypertensive disorders.Applying these reductions as above would yield relative risks of 1.16 for LGA Clinical Opinion ajog.org and”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [29] Landon, 2009, A Multicenter, randomized trial of treatment for mild gestational diabetes, N Engl J Med source

      Not checked in the free run.

    • Rests on an assumption: The treatment effect sizes observed in Landon et al can be applied to the current trial to estimate expected outcome reductions.

  • May combine two claims.

    Findingreasoning

    In group 2, LGA babies would have fallen from 1015 to 874, a 14% reduction, and hypertensive disorders of pregnancy would have fallen from 1472 to 1393, a 5% reduction.

    “Overall, LGA babies in group 2 would have been reduced from 1015 to 874, a 14% reduction; hypertensive disorders of pregnancy”
    • Also stated in: § Clinical Opinion ajog.org · hedged
      “would have been reduced from 1472 to 1393, a 5% reduction.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The risk reductions for LGA and hypertensive disorders from mild GDM RCTs apply to the additional GDM cases identified by 1-step testing.

  • May combine two claims.

    Premisecitation

    The O'Sullivan and Mahan criteria were based on predicting future diabetes in mothers, while the WHO criteria were adaptations of nonpregnant diagnostic criteria; neither was based on adverse pregnancy outcomes.

    “The O'Sullivan and Mahan criteria were based on their predictive value for future diabetes in mothers with GDM, whereas the WHO criteria in use at the time 15 were adaptations of the diagnostic criteria used for nonpregnant individuals.None were based on adverse pregnancy outcomes, the prediction of which is presumably the rationale for detecting GDM.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [15] 1980, WHO Expert Committee on diabetes mellitus: second report, World Health Organ Tech Rep Ser

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    The Hyperglycemia and Adverse Pregnancy Outcome Study was a multinational blinded observational study of the association between 75 g 2-hour oral glucose tolerance test results at 24 to 32 weeks and pregnancy outcomes in more than 23,000 women across 15 centers.

    “The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study was a multinational blinded observational study of the association between 75 g, 2hour OGTT results at 24 to 32 weeks and pregnancy outcomes in more than 23,000 gravidas in 15 centers in 9 different countries on 4 different continents and the Caribbean.16”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [16] Metzger, 2008, Hyperglycemia and adverse pregnancy outcomes, N Engl J Med source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    A 1991 international conference concluded that there was no international agreement on gestational diabetes testing, and that varied glucose loads and cutoffs made prevalence comparisons and cross-population application impossible.

    “In 1991, the summary of an international conference 14 concluded that there was a lack of international agreement regarding testing for GDM, with various recommendations for 50-, 75-, and 100-g challenges and different sets of cutoffs making it impossible to compare prevalences across various populations or to apply findings between populations.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [14] Metzger, 1991, Summary and recommendations of the Third International Workshop-Conference on Gestational Diabetes Mellitus, Diabetes source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    A 2013 systematic review estimated that the 140 mg/dL screening cutoff had 70% to 88% sensitivity and 69% to 89% specificity, while the 130 mg/dL cutoff had 88% to 99% sensitivity and 66% to 77% specificity, using the 100 g 3-hour oral glucose tolerance test as the gold standard.

    “A 2013 systematic review of screening cutoffs estimated the sensitivity and specificity of the various cutoffs, using the 100 g, 3hour OGTT as the gold standard, as 140 mg/dL (70% to 88% sensitivity, 69% to 89% specificity) and 130 mg/dL (88% to 99% sensitivity, 66% to 77% specificity).13”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [13] Donovan, 2013, Screening tests for gestational diabetes: a systematic review for the U.S. Preventive Services Task Force, Ann Intern Med source

      Not checked in the free run.

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

    Premisecitation

    United States guidelines have conflicted: the ADA endorsed the IADPSG approach in 2011, a 2013 NIH consensus recommended continuing the 2-step approach, the ADA later allowed either approach and then favored the 1-step approach, while ACOG continues to recommend the 2-step approach.

    “In the United States, the American Diabetes Association (ADA) endorsed the IADPSG approach in January of 2011.21 In 2013, the National Institutes of Health (NIH) hosted a Consensus Development Conference to address issues in diagnosing GDM.22 Owing to a number of concerns that arose mainly from the dramatic increase in GDM incidence that would occur, the conferees recommended that the IADPSG 1-st”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [21] 2011, Diagnosis and classification of diabetes mellitus, Diabetes Care

      Not checked in the free run.

    • cites [22] 2013, National Institutes of Health Consensus Development Conference statement: diagnosing gestational diabetes mellitus, March 4-6, 2013, Obstet Gynecol source

      Not checked in the free run.

    • cites [23] 2014, Diagnosis and classification of diabetes mellitus, Diabetes Care

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  • May combine two claims.

    Premisecitation

    In the Hillier et al trial, gestational diabetes was more common in the 1-step group (16.5% vs 8.5%), but there were no significant differences in large-for-gestational-age infants, gestational hypertension or preeclampsia, primary cesarean delivery, or the primary composite outcome.

    “Although GDM was more common in the women randomized to receive 1-step testing (16.5% vs 8.5%), there were no significant differences between the 2 groups with respect to large for gestational age (LGA) infants (8.9% vs 9.2%), gestational hypertension or preeclampsia (13.6% vs 13.5%), primary cesarean delivery (24% vs 24.6%), or the primary composite outcome (3.1% vs 3.0%).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [1] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Using a single elevated oral glucose tolerance test value is justified because each of the three values independently predicts adverse pregnancy outcomes and because laboratory precision and accuracy have improved since the 1960s.

    “This use of a single elevated value is justified by the finding that each of the 3 OGTT values is independently predictive of adverse pregnancy outcomes 16 and the fact that laboratory precision and accuracy are much improved now 20 compared with the 1960s when O'Sullivan and Mahan 7 required 2 elevated values to guard against errors.”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [16] Metzger, 2008, Hyperglycemia and adverse pregnancy outcomes, N Engl J Med source

      Not checked in the free run.

    • cites [20] Sacks, 2011, Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus, Diabetes Care source

      Not checked in the free run.

    • cites [7] O’Sullivan, 1964, Criteria for the oral glucose tolerance test in pregnancy, Diabetes

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Premisecitation

    The trial assumed gestational diabetes would be diagnosed in 18% of women randomized to 1-step testing and 6% of women randomized to 2-step screening, a 12% difference.

    “The study design assumed that GDM would be diagnosed in 18% of women randomized to 1-step testing (group 1) and 6% of women randomized to 2-step screening (group 2), a 12% difference.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [1] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    The trial investigators did not describe the estimates of treatment effect that underpinned the estimated relative risk of 1.2 for most adverse outcomes.

    “The investigators do not describe estimates of the effect of treatment of GDM underpinning the estimated relative risk of 1.2 for most of the adverse outcomes.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [1] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    In HAPO, the associations between maternal oral glucose tolerance test results and adverse outcomes did not vary significantly by field center, maternal age, or body mass index, suggesting the findings could apply worldwide.

    “Importantly, although rates of adverse outcomes differed among the 15 centers, the associations between maternal OGTT results and adverse outcomes did not vary significantly by field center, maternal age, or body mass index at the time of the OGTT, suggesting that the findings could be applied to populations worldwide.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [16] Metzger, 2008, Hyperglycemia and adverse pregnancy outcomes, N Engl J Med source

      Not checked in the free run.

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

    Premisecitation

    The O'Sullivan and Mahan criteria required at least two elevated oral glucose tolerance test values so that diagnosis would not depend on a single laboratory test.

    “They required at least 2 elevated values so as not to rely on a single laboratory test for the diagnosis.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [7] O’Sullivan, 1964, Criteria for the oral glucose tolerance test in pregnancy, Diabetes

      Not checked in the free run.

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

    Premisecitation

    As of 2021, the WHO and FIGO endorsed the IADPSG 1-step approach, and the International Diabetes Federation adopted the 1-step procedure for communities.

    “As of 2021, the WHO has endorsed the IADPSG 1-step approach 4 as has the International Federation of Gynecology and Obstetrics 3 with some accommodations for underresourced areas.The International Diabetes Federation has adopted the 1-step procedure for use in communities.25”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [4]

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    • cites [3] Hod, 2015, The International Federation of Gynecology and Obstetrics (FIGO) initiative on gestational diabetes mellitus: a pragmatic guide for diagnosis, management, and care, Int J Gynaecol Obstet source

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    • cites [25]

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  • Classified as probably not a substantial claim.

    Premisecitation

    The Hillier et al randomized trial was intended to test whether 1-step or 2-step gestational diabetes screening and treatment improves outcomes in an entire obstetrical population under standard clinical care.

    “The recent RCT by Hillier et al 1 was intended to investigate whether the 1step or 2-step approach to GDM screening and treatment results in improved outcomes in an entire obstetrical population in the setting of standard clinical care, including the excellent Kaiser Permanente system's protocol-based approach to care.27”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [1] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

      Not checked in the free run.

    • cites [27] Pedula, 2019, A randomized pragmatic clinical trial of gestational diabetes screening (ScreenR2GDM): study design, baseline characteristics, and protocol adherence, Contemp Clin Trials source

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    The trial's prespecified primary outcomes and estimated incidences were gestational diabetes requiring insulin or oral agents 20%, gestational hypertension 15%, macrosomia 12%, cesarean delivery 25%, and a perinatal composite outcome 4%.

    “The prespecified primary outcomes (estimated incidences) were GDM requiring insulin or oral agents (20%), gestational hypertension (blood pressure of >140/90 twice after 20 weeks, no previous hypertension diagnosis, 15%), macrosomia (birthweight at the >90th percentile, 12%), cesarean delivery (25%), and a perinatal composite outcome consisting of stillbirth, neonatal death, shoulder dystocia, b”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [1] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    O'Sullivan and Mahan developed gestational diabetes diagnostic criteria by giving a 100 g 3-hour oral glucose tolerance test to 752 pregnant women, measuring whole blood glucose with the Somogyi-Nelson method, and choosing cutoffs two standard deviations above the mean.

    “In the mid-1960s, O'Sullivan and Mahan 7 developed their GDM diagnostic criteria by administering the 100 g, 3-hour OGTT to 752 pregnant women, measuring whole blood glucose values with the Somogyi-Nelson technique, and selecting values 2 standard deviations (SDs) above the mean as diagnostic cutoffs.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [7] O’Sullivan, 1964, Criteria for the oral glucose tolerance test in pregnancy, Diabetes

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

    Premisecitation

    The O'Sullivan and Mahan cutoffs were chosen mainly because they produced a gestational diabetes prevalence of 2%, similar to diabetes prevalence in nonpregnant communities.

    “The choice of these cutoffs was primarily because they would yield a GDM prevalence of 2% which was similar to the prevalence of diabetes mellitus in a nonpregnant community.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [7] O’Sullivan, 1964, Criteria for the oral glucose tolerance test in pregnancy, Diabetes

      Not checked in the free run.

  • May combine two claims.

    Premiseown data

    The Hillier et al randomized trial found no significant differences in adverse outcomes between women diagnosed by 1-step versus 2-step testing, even though about twice as many women in the 1-step group were diagnosed with gestational diabetes and treated.

    “The authors reported no signifi-cant between-group differences in adverse outcomes between women diagnosed using either approach, despite the fact that the number of women diagnosed as having GDM, and treated accordingly, were approximately doubled in women randomized to the 1step approach.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [1] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    The gestational diabetes rate among HAPO participants using IADPSG criteria would be about 18%, whereas the rate using O'Sullivan and Mahan criteria requiring at least two elevated values was generally 3.5% to 7.2% across the United States as of 2013.

    “The rate of GDM among HAPO participants, applying the IADPSG criteria, would have been in the range of 18%, whereas that with the O'Sullivan and Mahan criteria needing at least 2 elevated values was generally in the 3.5% to 7.2% range across the United States as of 2013, 19”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [19] Bardenheier, 2013, Variation in prevalence of gestational diabetes mellitus among hospital discharges for obstetric delivery across 23 states in the United States, Diabetes Care source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    When IADPSG criteria were applied to HAPO oral glucose tolerance tests, 36% of women had two or more elevated values, while 64% of those with gestational diabetes had only a single elevated value.

    “When the IADPSG criteria were applied to the OGTTs of the HAPO Study, 36% had 2 or more values above threshold whereas 64% of the women with GDM (GDMs) had only a single elevated value.18”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [18] Sacks, 2012, Frequency of gestational diabetes mellitus at collaborating centers based on IADPSG consensus panel-recommended criteria: the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study, Diabetes Care source

      Not checked in the free run.

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

    Premisecitation

    O'Sullivan et al adapted the 50 g 1-hour screening test to pregnancy and recommended a 130 mg/dL venous whole blood cutoff for deciding whether to perform the 100 g 3-hour oral glucose tolerance test.

    “In 1973, O'Sullivan et al 12 adapted the 50 g, 1-hour screening test to pregnancy, recommending that a cutoff of 130 mg/ dL (venous, whole blood glucose) be used to determine whether the 100 g, 3hour OGTT was to be administered.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [12] O’Sullivan, 1973, Screening criteria for high-risk gestational diabetic patients, Am J Obstet Gynecol source

      Not checked in the free run.

  • May combine two claims.

    Premiseown data

    In group 2, 281 of 11,870 women (2.4%) had 1-step screening instead of the assigned 2-step protocol, and 708 (6%) had neither type of screening.

    “In group 2, of 11,870 women, 281 (2.4%) had 1-step screening instead of the assigned 2-step protocol, and 708 (6%) had neither type of screening (672 had none at all; 36 had only a first trimester A1c).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [1] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

      Not checked in the free run.

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

    Interpretationreasoning

    Decisions to break protocol were primarily made by caregivers rather than patients and would be much less likely in usual clinical settings with a standard screening and testing approach.

    “Although this was an attempt to compare the 2 approaches in a pragmatic setting, the decisions to break protocol were primarily made by caregivers and not patients and would be much less likely in the usual clinical setting where there is a standard approach to screening and testing.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    The diagnostic criteria for prediabetes in nonpregnant individuals are slightly higher at fasting but lower at 2 hours than the IADPSG criteria for GDM.

    “The diagnostic criteria for prediabetes in nonpregnant individuals (fasting plasma glucose of 100e125 mg/ dL or 75 g OGTT plasma glucose of 140e199 mg/dL at 2 hours) are slightly higher at fasting but lower at 2 hours than the IADPSG criteria for GDM (fasting plasma glucose, !92 mg/dL; 2hour, !153 mg/dL).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [17] Metzger, 2010, International Association of Diabetes and Pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy, Diabetes Care source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    In the ACHOIS study, participants had 75 g 2-hour OGTT plasma glucose values between 140 and 198 mg/dL, which indicates a milder form of gestational diabetes than IADPSG criteria identify.

    “Participants in the ACHOIS study 28 had 75 g, 2-hour OGTT plasma glucose between 140 mg/dL and 198 mg/dL, indicating milder GDM than those diagnosed by IADPSG criteria.17”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [28] Crowther, 2005, Effect of treatment of gestational diabetes mellitus on pregnancy outcomes, N Engl J Med source

      Not checked in the free run.

    • cites [17] Metzger, 2010, International Association of Diabetes and Pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy, Diabetes Care source

      Not checked in the free run.

  • May combine two claims.

    Interpretationcitation

    The proportion of women needing a second visit after an overnight fast for the 3-hour 100 g oral glucose tolerance test with the 2-step process is not trivial and could favor the 1-step protocol.

    “We do not have figures for the number of positive screens in women randomized to 2-step screening, but the abovementioned data suggest that, with the 2-step process, the proportion of women needing to make a second visit, after an overnight fast, for the 3-hour, 100 g OGTT is not trivial and could be a consideration favoring the 1-step protocol!”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationreasoning

    Failure to diagnose GDM with the 2-step approach is a missed opportunity to prevent short-term problems such as preeclampsia and large-for-dates offspring and to prevent or reduce long-term adversity such as later maternal diabetes.

    “The failure to diagnose GDM with use of the 2-step approach represents a missed opportunity to prevent short-term problems such as preeclampsia and large for dates offspring, but also to prevent or ameliorate long-term adversity such as the development of maternal diabetes mellitus later in life.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    The 50 g 1-hour screening cutoff in group 2 was 130 mg/dL or higher at Kaiser Northwest (N=8140) but 140 mg/dL or higher in Hawaii (N=3730).

    “Another inconsistency within the protocol was that the cutoff for the 50 g, 1-hour screen in group 2 was !130 mg/ dL for women recruited at the Kaiser Northwest site (N¼8140), but !140 mg/ dL in those recruited in Hawaii (N¼3730).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [1] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

      Not checked in the free run.

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

    Interpretationreasoning

    With 92 fewer gestational diabetes cases diagnosed and treated, there would presumably be higher rates of adverse outcomes in group 2.

    “With 92 fewer GDMs diagnosed and treated, there would presumably be higher rates of adverse outcomes in group 2.”
    Quote in the paperNot a substantial claim
    • Rests on an assumption: Having 92 fewer gestational diabetes cases diagnosed and treated in group 2 would lead to higher rates of adverse outcomes in that group.

  • May combine two claims.

    Premisecitation

    In an audit of 1026 Canadian women given 2-step screening, 231 met the 50 g 1-hour screening criteria of 140 to 183 mg/dL and were referred for an oral glucose tolerance test, but only 82 (35%) actually received it.

    “In an audit of 1026 Canadian women given a 2-step screening procedure, 231 met the 50-g, 1-hour screening criteria of 140 to 183 mg/dL and were referred for an OGTT.Only 82 (35%) actually received the OGTT.32”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [32] Sievenpiper, 2012, Missed follow-up opportunities using a two-step screening approach for gestational diabetes, Diabetes Res Clin Pract source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    When mild gestational diabetes was recognized and treated, relative risks for some major immediate adverse outcomes were significantly reduced by similar proportions: 40% to 60% for large-for-gestational-age and macrosomic babies and 30% to 40% for hypertensive disorders of pregnancy.

    “As shown in Table 3, the relative risk for some of the main adverse immediate outcomes were significantly reduced, by similar proportions of 40% to 60% for LGA and macrosomic babies and 30% to 40% for hypertensive disorders of pregnancy, when mild GDM was recognized and treated.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [28] Crowther, 2005, Effect of treatment of gestational diabetes mellitus on pregnancy outcomes, N Engl J Med source

      Not checked in the free run.

    • cites [29] Landon, 2009, A Multicenter, randomized trial of treatment for mild gestational diabetes, N Engl J Med source

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    Because treatment rates were similar between groups, more than 40% of women whose gestational diabetes diagnosis was missed were denied clinically indicated treatment and the chance to reduce adverse outcomes.

    “suggests that more than 40% of the women whose GDM diagnosis was missed were deprived of clinically indicated treatment and the opportunity to reduce adverse outcomes.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationreasoning

    Adherence to the proper protocol in each group would have resulted in an estimated 11.6% difference in gestational diabetes rates rather than the reported 8%, and might have increased the observed benefits of 1-step testing.

    “In short, adherence to the proper protocol in each group would have resulted in an estimated 11.6% difference in GDM rates rather than the reported 8% and might well have increased the observed benefits of 1-step testing.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Rates of impaired glucose tolerance and impaired fasting glucose were 10.6% and 9.2% in offspring of IADPSG GDM mothers versus 5.0% and 7.4% in offspring of non-GDM mothers.

    “Rates of impaired glucose tolerance and impaired fasting glucose were 10.6% and 9.2% in offspring of IADPSG GDMs vs 5.0% and 7.4% in offspring of non-GDMs”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [34] Lowe, 2019, Hyperglycemia and adverse pregnancy outcome follow-up study (HAPO FUS): maternal gestational diabetes mellitus and childhood glucose metabolism, Diabetes Care source

      Not checked in the free run.

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

    Premisenone given

    There is copious high-level evidence that identifying and treating milder forms of GDM benefits the individual mother and child.

    “There is copious high-level evidence that identification and treatment of milder forms of GDM are of benefit to the individual mother and child.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationcitation

    Associations between glucose metabolism disorders and long-term adverse outcomes are continuous and graded, and mothers with IADPSG GDM and their offspring have predictable long-term adverse outcomes that fall between those of non-GDM and Carpenter and Coustan GDM groups.

    “These associations demonstrate that, similar to the short-term outcomes of the HAPO Study, associations of disorders of glucose metabolism and long-term adverse outcomes are continuous and graded and that mothers with IADPSG GDM and their offspring have predictable long-term adverse outcomes which are intermediate between non-GDMs and Carpenter and Coustan GDMs.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [33] Lowe, 2018, Association of gestational diabetes with maternal disorders of glucose metabolism and childhood adiposity, JAMA source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Interpretationreasoning

    Diagnosing IADPSG GDM provides an important opportunity to prevent the development of diabetes mellitus in the mother.

    “Diagnosis of IADPSG GDM offers an important opportunity to prevent development of diabetes mellitus in the mother.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    The number needed to treat to prevent one case of diabetes over 3 years was 6 with metformin and 5 with intensive lifestyle modification.

    “The number needed to treat to prevent 1 case of diabetes mellitus over 3 years was 6 with metformin and 5 with intensive lifestyle modification.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [36] Ratner, 2008, Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions, J Clin Endocrinol Metab source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Based on specificity figures from a 2013 systematic review, a 140 mg/dL screening threshold would produce false positive screens requiring full oral glucose tolerance testing in 11% to 31% of women, while a 130 mg/dL threshold would require diagnostic testing in 23% to 34%.

    “Based on specificity figures from a 2013 systematic review, 13 when a screening threshold of 140 mg/dL is used, between 11% and 31% of women will have false positive screens and require the full 100 g, 3-hour OGTT, whereas, for a threshold of 130 mg/dL, 23% to 34% will need the diagnostic OGTT.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [13] Donovan, 2013, Screening tests for gestational diabetes: a systematic review for the U.S. Preventive Services Task Force, Ann Intern Med source

      Not checked in the free run.

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

    Interpretationreasoning

    Treating this subset of 165 women in group 2 as if they had the type of diabetes diagnosed by the 1-step process would be expected to reduce any difference in outcomes between groups 1 and 2.

    “This subset of 165 women in group 2 were identified and treated as though they had the type of diabetes mellitus diagnosed by the 1step process, which would be expected to reduce any difference in outcomes between groups 1 and 2.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Interpretationreasoning

    Even if this anomaly alone might not change the results, when combined with other issues, a significant impact is plausible.

    “However, even though this anomaly alone might not change the results, when combined with other issues, we have identified a significant impact is plausible.”
    Quote in the paperNot a substantial claim

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

    Premisecitation

    The United States Preventive Services Task Force currently recommends screening for GDM in asymptomatic pregnant women after 24 weeks' gestation.

    “The United States Preventive Services Task Force (USPSTF) currently recommends screening for GDM in asymptomatic pregnant women after 24 weeks' gestation.40”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [40] Moyer, 2014, Screening for gestational diabetes mellitus: U.S. Preventive Services Task Force Recommendation Statement, Ann Int Med source

      Not checked in the free run.

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

    Premisecitation

    During the same interval, diabetes mellitus (diagnosed and undiagnosed) increased from 2.4% to 4.9% and undiagnosed prediabetes increased from 11.9% to 24% among reproductive-age women.

    “During that same interval, diabetes mellitus (both diagnosed and undiagnosed) increased from 2.4% to 4.9% and undiagnosed prediabetes from 11.9% to 24% in reproductive age women!”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [39] Metzger BE, Buchanan TA. Chapter 4. Gestational diabetes. In: Cowie C, Casagrande SS, Menke A, et al, eds. Available at: https://www.niddk.nih.gov/-/media/Files/Strategic-Plans/DIA_Ch03.pdf Accessed April 29 2021 Diabetes in America. 3rd ed. Bethesda, MD: National Institute of Diabetes and Digestive Diseases and Kidney Diseases; 2018.

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    The USPSTF justifies screening by risk reduction to the individual mother and fetus, finding adequate evidence that treating screen-detected GDM with dietary changes, glucose monitoring, and insulin if needed significantly reduces preeclampsia, fetal macrosomia, and shoulder dystocia, with moderate net benefit for mother and infant, while the benefit on long-term metabolic outcomes in treated GDM,

    “The USPSTF justifies screening based on risk reduction to the individual mother and fetus: “The USPSTF found adequate evidence that treatment of screen-detected GDM with dietary modifications, glucose monitoring, and insulin (if needed) can significantly reduce the risk of preeclampsia, fetal macrosomia, and shoulder dystocia.When these outcomes are considered collectively, there is a moderate net”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [40] Moyer, 2014, Screening for gestational diabetes mellitus: U.S. Preventive Services Task Force Recommendation Statement, Ann Int Med source

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    The study ignored demonstrated opportunities to improve long-term morbidity such as future type 2 diabetes in women with GDM and potential opportunities to reduce long-term morbidity in offspring.

    “Demonstrated opportunities for improvement in long-term morbidity such as future type 2 diabetes mellitus in the woman with GDM were ignored in the study, as were potential opportunities for”
    • Also stated in: § Clinical Opinion ajog.org · plain
      “amelioration of long-term morbidity in the offspring.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [1] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

    Interpretationreasoning

    These estimates can reasonably represent the short-term improvement opportunities that would be lost by continuing the 2-step approach instead of moving to the 1-step approach.

    “These could serve as reasonable estimates as to what opportunities for short-term improvement might be lost by continuing the 2-step approach rather than moving to the 1-step approach.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premiseown data

    In group 1, 3247 of 11,922 women (27%) were screened by the 2-step protocol instead of the intended 1-step protocol, and 795 (6.7%) had neither type of screening.

    “In group 1, of 11,922 women, 3247 (27%) were screened by the 2-step protocol instead of the intended 1-step protocol, and 795 (6.7%) had neither type of screening (778 had none at all; 17 had only a first trimester A1c).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [1] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

      Not checked in the free run.

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

    Premisecitation

    In recent decades, combined overweight and obesity rates among women of reproductive age (20-44 years) increased from 33.7% in the 1976-1980 NHANES survey to 59.1% in the 2007-2010 survey.

    “with combined rates of overweight and obesity increasing from 33.7% in the 1976 to 1980 NHANES survey to 59.1% in the 2007 to 2010 survey.39”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [39] Metzger BE, Buchanan TA. Chapter 4. Gestational diabetes. In: Cowie C, Casagrande SS, Menke A, et al, eds. Available at: https://www.niddk.nih.gov/-/media/Files/Strategic-Plans/DIA_Ch03.pdf Accessed April 29 2021 Diabetes in America. 3rd ed. Bethesda, MD: National Institute of Diabetes and Digestive Diseases and Kidney Diseases; 2018.

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Adjusted odds ratios were 1.96 (95% CI, 1.41-2.73) for impaired glucose tolerance and 1.09 (95% CI, 0.78-1.52) for impaired fasting glucose.

    “adjusted odds ratios were 1.96 (CI, 1.41e2.73)and 1.09 (CI, 0.78e1.52),respectively.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [34] Lowe, 2019, Hyperglycemia and adverse pregnancy outcome follow-up study (HAPO FUS): maternal gestational diabetes mellitus and childhood glucose metabolism, Diabetes Care source

      Not checked in the free run.

55 of 55

  • The authors state this as an assumption.

    With full adherence to the protocol and no crossovers, all reduction in adverse outcomes would come from the additional 12% of gestational diabetes cases predicted to be diagnosed in group 1.

    “It can be assumed that, with full adherence to the protocol and no crossovers, all of the reduction in adverse outcomes would come from the additional 12% of GDMs predicted to be diagnosed in group 1.”

  • The paper relies on this without support.

    The treatment effect sizes observed in Landon et al can be applied to the current trial to estimate expected outcome reductions.

    “Applying these reductions as above would yield relative risks of 1.16 for LGA Clinical Opinion ajog.org and 1.12 for hypertensive disorders, again well short of the 1.2 relative risks called for in the sample size estimates.”

  • The paper relies on this without support.

    Having 92 fewer gestational diabetes cases diagnosed and treated in group 2 would lead to higher rates of adverse outcomes in that group.

    “With 92 fewer GDMs diagnosed and treated, there would presumably be higher rates of adverse outcomes in group 2.”

  • The authors state this as an assumption.

    Untested women in each group had the same GDM rates as tested women.

    “If untested women in each group had the same GDM rates as tested women, and each had the assigned protocol, an estimated 158 (795 X 19.9%) in group 1 and 58 (708 X 8.26%) in group 2 would have had GDM.”

  • The paper relies on this without support.

    The risk reductions for LGA and hypertensive disorders from mild GDM RCTs apply to the additional GDM cases identified by 1-step testing.

    “Applying the midpoint risk reductions for LGA babies (50%) and hypertensive disorders of pregnancy (35%) reported in Table 3 and using midpoint rates in the routine care GDMs in Table 3 (20% LGA; 16% hypertensive disorders of pregnancy), identifying and treating these 1417 (2362À945) additional cases of GDM would have resulted in 141 fewer LGA babies and 79 fewer cases”

  • The paper relies on this without support.

    The 1-step GDM rate estimated from group 1 (19.9%) applies to all women in group 2 if they had received 1-step testing.

    “If all 11,870 women in group 2 had the 1-step test, an estimated 19.9% (2362) would have been diagnosed as having GDM.”

  • The paper relies on this without support.

    The 2-step GDM rate estimated from group 2 (8.26%) applies to crossovers in group 1 who were tested by the 2-step protocol.

    “Applying 8.26% GDM rate for 2-step testing to the 3,247 crossovers tested by 2-step protocol, an estimated 268 GDMs in group 1 were diagnosed by 2-step protocol.”
7 of 7

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?

  • There is copious high-level evidence that identification and treatment of milder forms of GDM are of benefit to the individual mother and child.

    “Pros to the one-step approach: There is copious high-level evidence that identification and treatment of milder forms of GDM are of benefit to the individual mother and child [86].”

    From Gestational Diabetes Mellitus: Diagnostic Approaches and Maternal-Offspring Complications (2022) · cites this paper as [86]

Cites

Flagged first, then by citations

1 of the 39 references couldn’t be matched to a known paper.

Research works printed but not linked: 1

  1. 2015, Diagnosis and classification of diabetes mellitus, Diabetes Care, 38, S8

Cited by

Sorted by citations

Related

Authors
Coustan, D. R., Dyer, A. R., & Metzger, B. E.
Affiliations
  • Brown University (US)
  • Northwestern University (US)
Corresponding author
Coustan, Donald R.
ORCID
Venue
American Journal of Obstetrics and Gynecology
Publisher
Elsevier BV
Published
2021-12
Volume
225
Issue
6
Pages
634-644
ISSN
0002-9378 (ISSN-L)
DOI
10.1016/j.ajog.2021.05.009
OpenAlex
W3162143899
Cited by
40
References
39
Citations by year
2026: 4 · 2025: 5 · 2024: 6 · 2023: 14 · 2022: 7 · 2021: 4
FWCI
7.05
Type
journal article
Language
en
Open access
Licence
Locations
  • American Journal of Obstetrics and Gynecology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
gestational diabetes mellitus, oral glucose tolerance test, glucose challenge test, diagnostic thresholds, prediabetes, perinatal outcomes, sample size determination, health care costs, ACOG guidelines, diabetes in pregnancy, randomized controlled trial critique
MeSH terms
Female, Humans, Obstetrics, Pregnancy, Prenatal Diagnosis, Societies, Medical, Diabetes, Gestational, Practice Guidelines as Topic

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 2026-10-04.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-04.

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