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

Plain Language Summary

Simplified for easier understanding

This study is testing whether automated insulin delivery (AID) systems — sometimes called "closed-loop" or "artificial pancreas" devices — can safely manage blood sugar levels during labor and delivery in pregnant women with type 1 diabetes. **You may be eligible if...** - You are currently pregnant, at 34 weeks or more - You have had type 1 diabetes for at least 1 year - You have been using an approved automated insulin delivery system since at least 28 weeks of pregnancy - You are carrying one baby (not multiples) - You speak English or Spanish **You may NOT be eligible if...** - You are carrying twins or more - You are planning a cesarean (C-section) delivery - You are taking medications that affect blood sugar - You have had a fetal loss during this pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.