Once-daily long-acting insulin versus long-acting plus mealtime insulin for blood sugar control in pregnancy
Official title: Single vs Multi-Dose Insulin for Glycemic Control (SUGAR): A Randomized Noninferiority Trial
Run by Rutgers, The State University of New Jersey · NCT07171684 · Data updated 2026-11-12
This trial will test whether once-daily long-acting insulin alone can control blood sugars as well as long-acting insulin plus mealtime short-acting insulin for pregnant people with gestational or type 2 diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 176 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | November 26, 2025 |
| Main results expected | October 1, 2026 |
| Study ends | May 15, 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07171684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–50 with A2 gestational diabetes or type 2 diabetes in pregnancy who require insulin, speak English or Spanish, and plan prenatal care and delivery at the participating study hospitals are ideal candidates.
✕Probably not a fit
People already using insulin before pregnancy, those with fetal anomalies, those who cannot or will not send weekly glucose logs, or those planning to deliver outside the participating hospitals are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Pregnant people with gestational or type 2 diabetes who require insulin are assigned to either once-daily long-acting insulin (glargine) alone or long-acting insulin plus mealtime short-acting insulin (lispro). Participants send weekly blood glucose logs to study staff for dose adjustments rather than to their usual OB care team. The trial's primary outcome is a composite neonatal measure including NICU admission, neonatal hypo- or hyperglycemia, large-for-gestational-age, shoulder dystocia, hyperbilirubinemia, stillbirth, and neonatal death, and the design tests noninferiority of the simpler regimen. Recruitment occurs at Rutgers/RWJ and NYU Langone affiliated clinics and requires planned delivery at the participating hospitals.
Why it matters
Potential benefit: If successful, the simpler once-daily insulin plan could let many pregnant people manage diabetes with fewer injections and less daily complexity, improving convenience and adherence.
How similar studies have gone: Long-acting insulins like glargine have been used in pregnancy with reassuring safety data, but direct randomized comparisons of basal-only versus basal-plus-mealtime regimens focused on composite neonatal outcomes are limited, making this question relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Robert Wood Johnson Univeristy Hospital
New Brunswick, New Jersey, United States Recruiting -
Maternal-Fetal Medicine at NYU Langone Obstetrics & Gynecology Associates
New York, New York, United States Not yet recruiting
Study contacts
- Principal investigator: Emily Rosenfeld, DO — Rutgers Robert Wood Johnson Medical School
- Study coordinator: Morgan Dunn, MD
- Email: mcd189@rwjms.rutgers.edu
- Phone: (732) 235-6632
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.