Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (NCT06419777)
Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)
🩺 Plain-English Summary (8th-Grade Level)
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a strict and permissive threshold. The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (10 items).
Location: University of Rochester Medical Center — Rochester, New York
Age range: 18 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:
- \<18 years at EDD
- pre-existing diabetes or diagnosis of GDM before 24 weeks
- multi-fetal gestation
- known major fetal anomaly
- known allergy to insulin
- chronic maternal corticosteroid use
- diagnosis of GDM based on finger sticks alone
- patients who have contraindication to oral glucose tolerance test
- a primary language other than English, Spanish, Mandarin, or Arabic
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- University of Rochester Medical Center — Rochester, New York
- Thomas Jefferson University — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (215) 955-5000
Email: kxk334@jefferson.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.