Gestational Diabetes and Pharmacotherapy (GAP) (NCT03527537)
Gestational Diabetes and Pharmacotherapy (GAP) - A Randomized Controlled Trial Investigating Timing of Pharmacotherapy Initiation for Patients With Gestational Diabetes
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (5 items).
Location: Medical College of Wisconsin — Milwaukee, Wisconsin
Age range: 18 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Medical College of Wisconsin — Milwaukee, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Gestational Diabetes
- Preventing Obstetric Complications With Dietary Intervention — Milwaukee, Wisconsin
- DETERMINE: Detemir vs NPH — Los Angeles, California
- Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes — Birmingham, Alabama
- Immediate Postpartum Glucose Tolerance Testing — Long Beach, California
- Healthy Eating in Women at Risk of Gestational Diabetes — Québec, Quebec
- Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2) — Rochester, New York
Explore by condition: All Gestational Diabetes clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.