Recruiting

Long-Acting Insulin

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07171684

Conditions

Diabetes in Pregnancy

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Insulin glargine alone

Insulin glargine + insulin lispro

Study Details

Brief 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

Study ID

NCT07171684

Start date

Nov 26, 2025

Status verified date

Apr, 2026

Completion date

May 15, 2027

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Insulin glargine alone

Once daily dosing of insulin glargine

active comparator: Insulin glargine + Insulin lispro

Once daily dosing of insulin glargine plus three times per day dosing of insulin lispro with each meal

Interventions

Insulin glargine alone

Once daily dosing of insulin glargine

Insulin glargine + insulin lispro

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

Primary outcome measure

  • Composite outcome [ Time Frame: From enrollment to delivery ]

Central Contacts and Locations

Central contacts

Morgan Dunn, MD

(732) 235-6632mcd189@rwjms.rutgers.edu

Emily Rosenfeld, DO

er720@rwjms.rutgers.edu

Locations

Robert Wood Johnson Univeristy Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Emily Rosenfeld, DO

7322356632er720@rwjms.rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • insulin glargine
  • insulin lispro
  • gestational diabetes
  • diabetes
  • pregnancy
  • noninferiority

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-04-16.