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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Diagnosed with type 2 diabetes mellitus or A2 gestational diabetes mellitus requiring insulin use during pregnancy

• Aged between 18-50

• Speak English or Spanish

Locations
United States
New Jersey
Robert Wood Johnson Univeristy Hospital
RECRUITING
New Brunswick
New York
Maternal-Fetal Medicine at NYU Langone Obstetrics & Gynecology Associates
NOT_YET_RECRUITING
New York
Contact Information
Primary
Morgan Dunn, MD
mcd189@rwjms.rutgers.edu
(732) 235-6632
Backup
Emily Rosenfeld, DO
er720@rwjms.rutgers.edu
Time Frame
Start Date: 2025-11-26
Estimated Completion Date: 2027-05-15
Participants
Target number of participants: 176
Treatments
Experimental: Insulin glargine alone
Once daily dosing of insulin glargine
Active_comparator: Insulin glargine + Insulin lispro
Once daily dosing of insulin glargine plus three times per day dosing of insulin lispro with each meal
Related Therapeutic Areas
Sponsors
Collaborators: NYU Langone Health
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov