Once-daily long-acting insulin versus long-acting plus mealtime insulin for blood sugar control in pregnancy
Single vs Multi-Dose Insulin for Glycemic Control (SUGAR): A Randomized Noninferiority Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Trial ID | NCT07171684 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New Brunswick, New Jersey and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.