Recruiting

Automated Insulin for Management of Intrapartum Glycemia

NCT06883344 · University of California, San Francisco

Recruiting

In plain English

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Official title

Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled Trial

About this study

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

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

Study design

Enrollment target: 150 participants

Allocation: randomized

Masking: single

Age groups: adult

Timeline

Starts: 2025-12-05

Estimated completion: 2028-12-31

Last updated: 2026-05-18

Interventions

Device: Automated insulin delivery (AID) systemOther: Intravenous (IV) insulin

Primary outcomes

• First neonatal glucose value (Within 2 hours of birth)

Sponsor

University of California, San Francisco · other

Contacts & investigators

ContactPrincipal Investigator · contact · dappresearch@ucsf.edu · (415) 307-9319

InvestigatorNasim Sobhani, MD · principal_investigator, University of California, San Francisco

All locations (2)

University of California, San DiegoRecruiting

San Diego, California, United States

University of California, San FranciscoRecruiting

San Francisco, California, United States

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