RecruitingNot ApplicableNCT06883344

Automated Insulin for Management of Intrapartum Glycemia

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

Sponsor

University of California, San Francisco

Enrollment

150 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Pregnancy Type 1 Diabetes (T1D)Pre-Gestational Diabetes

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

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria5

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 Criteria5

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

DEVICEAutomated insulin delivery (AID) system

An AID system incorporates data from a continuous glucose monitor (CGM) to automatically adjust the amount of insulin delivered by an insulin pump via an algorithm that incorporates multiple factors, including predicted glucose level in the next 30-60 minutes, target glucose level, and recent insulin delivery.

OTHERIntravenous (IV) insulin

Variable rate IV insulin infusions are used in most labor/delivery units as the standard of care for glycemic management for pregnant people with T1D. A continuous rate of IV insulin is infused, with manual rate adjustments made based on current glucose level and hospital-specific protocols.