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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Type 1 Diabetes; Pregnancy Related; Pregnancy, High Risk; Insulin Dependent Diabetes

Treatments: Other: Commercial AID system; Other: Open source AID system

Study type: Observational

Funder types: Other

Identifiers

NCT06654713

24-42036

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant
• Diagnosis of type 1 diabetes (T1D) prior to pregnancy
• Active use of automated insulin delivery (AID) system

Exclusion criteria

• Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)

Trial design

1,000 participants in 2 patient groups

Commercial AID system

Description:

Pregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy

Treatment:

Other: Commercial AID system

Open source AID system

Description:

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

Treatment:

Other: Open source AID system