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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 13
Maximum Age: 55
Healthy Volunteers: f
View:

• Known diagnosis of type 1 diabetes ≥ 1 year

• Current use of commercially available AID system ≥ 6 months

• Currently pregnant at ≥ 34 weeks

• Singleton pregnancy

• English- or Spanish-speaking

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Principal Investigator
dappresearch@ucsf.edu
(415) 307-9319
Time Frame
Start Date: 2025-12-05
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Treatments
Active_comparator: Intravenous (IV) insulin
Experimental: Automated insulin delivery (AID) system
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov