Gestational Diabetes and Pharmacotherapy (GAP)

NCT03527537 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: PRO00030802
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Composite Neonatal Outcome

  Our primary outcome will be a composite adverse neonatal outcome associated with gestational diabetes: large-for-gestational age macrosomia birth trauma preterm birth neonatal hypoglycemia hyperbilirubinemia

  The data will be collected up to 6 weeks of life

Secondary Outcomes (2)

• Cesarean Delivery Rate

  The data will be collected up to 6 weeks postpartum

• Preeclampsia

  The data will be collected up to 6 weeks postpartum

Study Arms (2)

20% cutoff group

ACTIVE COMPARATOR

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

Drug: Insulin

40% cutoff group

ACTIVE COMPARATOR

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

Drug: Insulin

Interventions

Insulin 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.

20% cutoff group; 40% cutoff group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only women will be randomized as this is a pregnancy-focused study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (16)

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

  PMID: 29370047 BACKGROUND

• 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.

  PMID: 23712381 BACKGROUND

• 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.

  PMID: 15846171 BACKGROUND

• 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.

  PMID: 15951574 BACKGROUND

• 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.

  PMID: 19797280 BACKGROUND

• 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.

  PMID: 17261098 BACKGROUND

• 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.

  PMID: 10214829 BACKGROUND

• 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.

  PMID: 15741354 BACKGROUND

• 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.

  PMID: 19417040 BACKGROUND

• 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.

  PMID: 15735191 BACKGROUND

• 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.

  PMID: 22187472 BACKGROUND

• 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.

  PMID: 18463375 BACKGROUND

• 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.

  PMID: 12351492 BACKGROUND

• 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.

  PMID: 28497042 BACKGROUND

• 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.

  PMID: 11284655 BACKGROUND

• 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.

  PMID: 27979900 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Insulin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 17, 2018
• Study Start: May 4, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)