Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Randomized Clinical Trial
University of California, San Francisco
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
- Age range
- 18–55 years
- Sex
- Female
- Healthy volunteers
- No
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
- 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.
Location
- University of California, San FranciscoSan Francisco, California