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

NCT07171684 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • Diabetes in Pregnancy
  • Gestational Diabetes

Interventions

DRUG

Insulin glargine alone

Once daily dosing of insulin glargine

DRUG

Insulin glargine + insulin lispro

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

Sponsors & Collaborators

  • NYU Langone Health

    collaborator OTHER

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Emily Rosenfeld, DO · Rutgers Robert Wood Johnson Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-26
Primary Completion
2026-10-01
Completion
2027-05-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07171684 on ClinicalTrials.gov