Single vs Multi-Dose Insulin for Glycemic Control (SUGAR) (NCT07171684)
Single vs Multi-Dose Insulin for Glycemic Control (SUGAR): A Randomized Noninferiority Trial
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to see if diabetes in pregnancy can be treated with once daily dosing of insulin instead of once daily dosing plus insulin with meals. The main question this study aims to answer is: 1. Can a once daily dose of long-acting insulin control blood sugars as well as long-acting insulin plus meal-time insulin? 2. Do babies born to mothers who take one dose of long-acting insulin have more complications after birth than babies born to mothers who take long-acting and meal-time insulin? Researchers will compare one dose of long-acting insulin per day to this plus three doses of short-acting insulin with each meal to see if blood sugars are controlled. Participants will send their blood sugar logs to the study staff weekly, instead of to their OB/GYN, for adjustments to their insulin dosing.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (7 items).
Location: Robert Wood Johnson Univeristy Hospital — New Brunswick, New Jersey
Age range: 18 Years to 50 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-existing use of insulin
- Gestational Age \> or = 35w0d
- Planning to follow-up with a doctor not associated with RWJ Barnabas or NYU Langone Health and/or deliver at a hospital other than RWJUH or NYU
- Unwilling or unable to upload or email weekly blood sugar logs
- Contraindication to Lispro or Lantus insulin, or patient chooses to not utilize insulin therapy
- Fetal anomaly present
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Robert Wood Johnson Univeristy Hospital — New Brunswick, New Jersey
- Maternal-Fetal Medicine at NYU Langone Obstetrics & Gynecology Associates — New York, New York
📞 Contact the Study Coordinator
Phone: (732) 235-6632
Email: mcd189@rwjms.rutgers.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.
Explore by condition: All Diabetes in Pregnancy 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.