Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2) (NCT06419803)
Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Continuous Glucose Monitoring Use - A Randomized Control Trial (START 2 Trial)
🩺 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 study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.
Who can join: Review the eligibility criteria below.
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 ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- University of Rochester Medical Center — Rochester, New York
- Thomas Jefferson University — Philadelphia, Pennsylvania
💰 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.
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- Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development — Sherbrooke, Quebec
- Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Continuous Glucose Monitoring — Calgary, Alberta
- Role of NADPH Oxidase in Microvascular Dysfunction Following GDM — Iowa City, Iowa
- Gestational Diabetes and Pharmacotherapy (GAP) — Milwaukee, Wisconsin
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.