Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)
Single vs Multi-Dose Insulin for Glycemic Control (SUGAR): A Randomized Noninferiority Trial
Rutgers, The State University of New Jersey
176 participants
Nov 26, 2025
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
Inclusion Criteria3
- 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 Criteria6
- Pre-existing use of insulin
- Gestational Age \> or = 35w0d
- Planning to follow-up with a doctor not associated with RWJ Barnabas and/or deliver at a hospital other than RWJUH
- 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
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Interventions
Once daily dosing of insulin glargine
Once daily dosing of insulin glargine + three times daily dosing of insulin lispro with meals
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07171684