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Gestational Diabetes and Pharmacotherapy (GAP)

NCT ID: NCT03527537

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-04

Study Completion Date

2026-10-01

Brief Summary

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The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.

Detailed Description

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Gestational diabetes mellitus (GDM) affects 5-8% of pregnant women, many of whom will require treatment beyond diet and exercise. Despite this high prevalence, there is no consensus regarding the glycemic threshold for conversion from diet to medical treatment for GDM. No randomized studies have been performed on how to define failure with diet and exercise and currently, the need to start insulin or oral hypoglycemic agents is at the provider's discretion. It is important to establish criterion of pharmacotherapy initiation for GDM in pregnancy as GDM under-treatment leads to increased rates of adverse obstetric outcomes associated with poor glycemic control including macrosomia, pre-eclampsia, cesarean delivery, shoulder dystocia, birth trauma, neonatal hypoglycemia and hyperbilirubinemia, childhood obesity and metabolic syndrome in the offspring. In contrast, overtreatment for women comes at increased cost due to overutilization of resources, increased expense, and adverse effects of the medications themselves.

The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM (N=416) will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.

Aim 1: Determine the effect of earlier insulin initiation (20% threshold) for GDM management on adverse neonatal and maternal outcomes associated with GDM.

Hypothesis 1.1: The composite adverse neonatal outcome associated with GDM (LGA, macrosomia, birth trauma, preterm birth, neonatal hypoglycemia, and hyperbilirubinemia) will be lower in earlier insulin initiation compared with the active control group.

Hypothesis 1.2: Preeclampsia and cesarean birth frequencies will be lower in earlier insulin initiation compared with the active control group.

Hypothesis 1.3: The composite neonatal and maternal outcomes will not differ between racial and ethnic groups within each study group.

Aim 2:Assess the safety of earlier insulin initiation in pregnant patients and their neonates.

Hypothesis 2.1: The SGA rate will be higher in earlier insulin initiation compared with the active control group; however, in both groups it will be lower than the national rate of 10%. Hypothesis 2.2: Maternal hypoglycemia and perinatal death will not differ between groups.

Aim 3:Determine the effect of earlier insulin initiation on patient-reported outcomes using standardized measures and qualitative interviews.

Hypothesis 3: Anxiety, depression, perceived stress and diabetes self-efficacy will be better in patients randomized to earlier insulin initiation compared with the active control group.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a randomized, controlled trial of 284 women with a diagnosis of GDM. Women will be consented and randomized at the time of their diagnosis. All women with GDM will receive counseling regarding diet and exercise and instructions on self-monitoring blood glucose values. The investigators will apply cutoffs of 95 mg/dL for fasting and 120 mg/dL for 2-hour post-prandial levels. Once randomized, the first treatment arm will be assigned to a limit of 20% abnormal values before we start treatment and to titrate up dosages as needed, while using the 20% threshold of abnormal CBG values at each subsequent review of glucose log. To specify, if more than 20% of values for the week are elevated, treatment would be initiated. Once treatment is initiated, the dosage of medication will be adjusted with cutoff of 20% of abnormal values per week. The second treatment arm will utilize the same protocol, however, the limit to start medications or adjust dosages will be 40% abnormal values.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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20% cutoff group

Treatment intervention will be initiated with insulin if 20% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Insulin may be administered base on glucose log values. The dosing of the insulin will be determined by the provider using typical management of gestational diabetes.

40% cutoff group

Treatment intervention will be initiated with insulin if 40% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Insulin may be administered base on glucose log values. The dosing of the insulin will be determined by the provider using typical management of gestational diabetes.

Interventions

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Insulin

Insulin may be administered base on glucose log values. The dosing of the insulin will be determined by the provider using typical management of gestational diabetes.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Viable singleton pregnancy
* Age \>= 18 years old
* Diagnosed with gestational diabetes mellitus
* Able to communicate in English

Exclusion Criteria

* Pre-gestational diabetes
* Significantly abnormal GDM testing, suggestive of the presence of pre-gestational diabetes, either with fasting values \>=126 mg/dL or 2-hour post-prandial levels \>=200 mg/dL
* Patients who check blood sugars on average less than 2 times per day after appropriate counseling
* Already started pharmacotherapy prior to referral to the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Anna Palatnik, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anna Palatnik, MD

Role: CONTACT

Phone: 414-805-6627

Email: [email protected]

Zaira Peterson, RN, MSN

Role: CONTACT

Phone: (414) 805-1124

Email: [email protected]

References

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ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.

Reference Type BACKGROUND
PMID: 29370047 (View on PubMed)

Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.

Reference Type BACKGROUND
PMID: 23712381 (View on PubMed)

Langer O, Yogev Y, Most O, Xenakis EM. Gestational diabetes: the consequences of not treating. Am J Obstet Gynecol. 2005 Apr;192(4):989-97. doi: 10.1016/j.ajog.2004.11.039.

Reference Type BACKGROUND
PMID: 15846171 (View on PubMed)

Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.

Reference Type BACKGROUND
PMID: 15951574 (View on PubMed)

Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.

Reference Type BACKGROUND
PMID: 19797280 (View on PubMed)

Athukorala C, Crowther CA, Willson K; Austrailian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Women with gestational diabetes mellitus in the ACHOIS trial: risk factors for shoulder dystocia. Aust N Z J Obstet Gynaecol. 2007 Feb;47(1):37-41. doi: 10.1111/j.1479-828X.2006.00676.x.

Reference Type BACKGROUND
PMID: 17261098 (View on PubMed)

Gilbert WM, Nesbitt TS, Danielsen B. Associated factors in 1611 cases of brachial plexus injury. Obstet Gynecol. 1999 Apr;93(4):536-40. doi: 10.1016/s0029-7844(98)00484-0.

Reference Type BACKGROUND
PMID: 10214829 (View on PubMed)

Boney CM, Verma A, Tucker R, Vohr BR. Metabolic syndrome in childhood: association with birth weight, maternal obesity, and gestational diabetes mellitus. Pediatrics. 2005 Mar;115(3):e290-6. doi: 10.1542/peds.2004-1808.

Reference Type BACKGROUND
PMID: 15741354 (View on PubMed)

Clausen TD, Mathiesen ER, Hansen T, Pedersen O, Jensen DM, Lauenborg J, Schmidt L, Damm P. Overweight and the metabolic syndrome in adult offspring of women with diet-treated gestational diabetes mellitus or type 1 diabetes. J Clin Endocrinol Metab. 2009 Jul;94(7):2464-70. doi: 10.1210/jc.2009-0305. Epub 2009 May 5.

Reference Type BACKGROUND
PMID: 19417040 (View on PubMed)

Dabelea D, Snell-Bergeon JK, Hartsfield CL, Bischoff KJ, Hamman RF, McDuffie RS; Kaiser Permanente of Colorado GDM Screening Program. Increasing prevalence of gestational diabetes mellitus (GDM) over time and by birth cohort: Kaiser Permanente of Colorado GDM Screening Program. Diabetes Care. 2005 Mar;28(3):579-84. doi: 10.2337/diacare.28.3.579.

Reference Type BACKGROUND
PMID: 15735191 (View on PubMed)

American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S64-71. doi: 10.2337/dc12-s064. No abstract available.

Reference Type BACKGROUND
PMID: 22187472 (View on PubMed)

HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.

Reference Type BACKGROUND
PMID: 18463375 (View on PubMed)

Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care. 2002 Oct;25(10):1862-8. doi: 10.2337/diacare.25.10.1862.

Reference Type BACKGROUND
PMID: 12351492 (View on PubMed)

Caissutti C, Berghella V. Scientific Evidence for Different Options for GDM Screening and Management: Controversies and Review of the Literature. Biomed Res Int. 2017;2017:2746471. doi: 10.1155/2017/2746471. Epub 2017 Apr 10.

Reference Type BACKGROUND
PMID: 28497042 (View on PubMed)

Rumbold AR, Crowther CA. Guideline use for gestational diabetes mellitus and current screening, diagnostic and management practices in Australian hospitals. Aust N Z J Obstet Gynaecol. 2001 Feb;41(1):86-90. doi: 10.1111/j.1479-828x.2001.tb01301.x.

Reference Type BACKGROUND
PMID: 11284655 (View on PubMed)

American Diabetes Association. 13. Management of Diabetes in Pregnancy. Diabetes Care. 2017 Jan;40(Suppl 1):S114-S119. doi: 10.2337/dc17-S016. No abstract available.

Reference Type BACKGROUND
PMID: 27979900 (View on PubMed)

Other Identifiers

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PRO00030802

Identifier Type: -

Identifier Source: org_study_id