Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are: * What are the maternal and neonatal outcomes with AID system use in pregnancy? * What are the glycemic outcomes with AID system use in pregnancy? * What are the behavioral and emotional outcomes with AID system use in pregnancy? Researchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems. Participants will be asked to remotely share their AID system data with the research team; complete online surveys regarding behavioral and emotional health; and sign an authorization to release health information to allow the research team to access medical records.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Pregnant

• Diagnosis of type 1 diabetes (T1D) prior to pregnancy

• Active use of automated insulin delivery (AID) system

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Primary Investigator
cosclipstudy@ucsf.edu
(415) 307-9319
Time Frame
Start Date: 2025-03-13
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 1000
Treatments
Commercial AID system
Pregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy
Open source AID system
Pregnant individuals with type 1 diabetes T1D) using open source automated insulin delivery (AID) systems (also known as do-it-yourself AID systems or hacked AID systems) for glycemic management in pregnancy
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov