Automated Insulin Delivery for Type 1 Diabetes
(AIMING Trial)

Recruiting in Palo Alto (17 mi)

Overseen byIvonne Verduzco, MD

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for pregnant individuals with type 1 diabetes or gestational diabetes. They are looking to see if an automated insulin delivery system can better manage blood sugar during labor compared to the standard IV insulin treatment.

Inclusion Criteria

Currently pregnant at 34 weeks or more

Current use of commercially available AID system for at least 6 months

Singleton pregnancy

+2 more

Exclusion Criteria

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

Planned cesarean delivery

+1 more

Participant Groups

The study compares two methods of controlling blood sugar during labor: a traditional intravenous (IV) insulin approach and an automated insulin delivery (AID) system. Participants will be randomly assigned to one of these treatments.

2Treatment groups

Experimental Treatment

Active Control

Group I: Automated insulin delivery (AID) systemExperimental Treatment1 Intervention

Group II: Intravenous (IV) insulinActive Control1 Intervention