NCT07171684 Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)
| NCT ID | NCT07171684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Diabetes in Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2025-11-26 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 176 participants in total. It began in 2025-11-26 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with type 2 diabetes mellitus or A2 gestational diabetes mellitus requiring insulin use during pregnancy * Aged between 18-50 * Speak English or Spanish 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
Contact & Investigator
Emily Rosenfeld, DO
PRINCIPAL INVESTIGATOR
Rutgers Robert Wood Johnson Medical School
Frequently Asked Questions
Who can join the NCT07171684 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Diabetes in Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07171684 currently recruiting?
Yes, NCT07171684 is actively recruiting participants. Contact the research team at mcd189@rwjms.rutgers.edu for enrollment information.
Where is the NCT07171684 trial being conducted?
This trial is being conducted at New Brunswick, United States, New York, United States.
Who is sponsoring the NCT07171684 clinical trial?
NCT07171684 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Emily Rosenfeld, DO at Rutgers Robert Wood Johnson Medical School. The trial plans to enroll 176 participants.
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