Type 1 Diabetes (T1D) Clinical Trials

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

Status: Recruiting
Location: See all (3) locations...
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: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
University of California, San Diego
RECRUITING
San Diego
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
DAPP Principal Investigator
dappresearch@ucsf.edu
(415) 307-9319
Time Frame
Start Date: 2025-12-05
Estimated Completion Date: 2028-12-31
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