NCT06883344NARecruiting

Automated Insulin for Management of Intrapartum Glycemia

University of California, San Francisco

Start Date

12/5/2025

Completion Date

12/31/2028

Summary

The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are * What are the neonatal glycemic outcomes with use of AID systems during labor/delivery? * Do patients report higher birth satisfaction with use of AID systems during labor/delivery? * Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery? Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.

Eligibility Criteria

Age Range: 18 years to 55 years

Inclusion Criteria: * Currently pregnant at ≥ 34 weeks * Known diagnosis of type 1 diabetes ≥ 1 year * Use of commercially available AID system since at least 28 weeks gestation * Singleton pregnancy * English- or Spanish-speaking Exclusion Criteria: * Multifetal gestation * Planned cesarean delivery * Use of medications known to interfere with glucose metabolism * Intrauterine fetal demise * Physical or psychological disease likely to interfere with the conduct of the study and/or the ability to participate in own healthcare

Interventions

DEVICE

Automated insulin delivery (AID) system

OTHER

Intravenous (IV) insulin

Interested in This Trial?

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Conditions

Type 1 Diabetes (T1D)PregnancyPre-Gestational Diabetes

Locations

University of California, Los Angeles

Los Angeles, California 90095

United States

University of California, San Diego

San Diego, California 92121

United States

University of California, San Francisco

San Francisco, California 94143

United States