Insulin for Diabetes in Pregnancy (SUGAR) Study

This study is looking at how to best manage diabetes during pregnancy. Researchers want to see if taking insulin glargine (a long-acting insulin) once a day works as well as taking insulin glargine once a day plus insulin lispro (a fast-acting insulin) with each meal. You might be able to join if you are a woman between 18 and 50 years old, have type 2 diabetes or gestational diabetes (diabetes that develops during pregnancy) requiring insulin, and speak English or Spanish. The study will compare how well these two insulin plans control blood sugar and affect the health of babies after birth. The goal is to see if the once-daily insulin plan is just as effective as the current standard of care.

Study design
This is an interventional study planning to enroll 176 participants. It compares two different insulin treatment plans.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome will be measured from enrollment until delivery.

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NCT07171684

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

Recruiting
NAAges 18–50InterventionalTreatment
Rutgers, The State University of New Jersey
~176 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Insulin glargine aloneInsulin glargine + insulin lispro

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite outcome
Measured over From enrollment to delivery
Diabetes in Pregnancy
Gestational Diabetes
2 sites across 2 states
New Jersey1
New York1
  • Emily Rosenfeld, DO · PRINCIPAL_INVESTIGATOR · Rutgers Robert Wood Johnson Medical School

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Eligibility criteria

Inclusion

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

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
  • Composite outcomeFrom enrollment to delivery

    NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia stillbirth, and neonatal death