RecruitingNot ApplicableNCT07171684

Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)

Single vs Multi-Dose Insulin for Glycemic Control (SUGAR): A Randomized Noninferiority Trial


Sponsor

Rutgers, The State University of New Jersey

Enrollment

176 participants

Start Date

Nov 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Insulin glargine + insulin lispro and a drug called Insulin glargine alone for people with diabetes in pregnancy and gestational diabetes. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInsulin glargine alone

Once daily dosing of insulin glargine

DRUGInsulin glargine + insulin lispro

Once daily dosing of insulin glargine + three times daily dosing of insulin lispro with meals


Locations(2)

Robert Wood Johnson Univeristy Hospital

New Brunswick, New Jersey, United States

Maternal-Fetal Medicine at NYU Langone Obstetrics & Gynecology Associates

New York, New York, United States

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NCT07171684


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