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

Recruiting

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

Who can join

Ages 18 to 50 · Women

Full 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

About the study

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.

What is being tested

Insulin glargine alone (drug)
Insulin glargine + insulin lispro (drug)

Sponsor: Rutgers, The State University of New Jersey · Participants: 176 · Started: Nov 26, 2025

Contact the study team

Morgan Dunn, MD · Phone: (732) 235-6632

Official record on ClinicalTrials.gov — NCT07171684

Locations in the U.S.

New Jersey	Robert Wood Johnson Univeristy Hospital, New Brunswick
New York	Maternal-Fetal Medicine at NYU Langone Obstetrics & Gynecology Associates, New York (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.