Commercial or Open Source Closed Loop Impact on Pregnancy Study

Description

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.

Conditions

Type 1 Diabetes, Pregnancy, High Risk, Insulin Dependent Diabetes, Pregnancy Related

Study Overview

Study Details

Study overview

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.

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

Commercial or Open Source Closed Loop Impact on Pregnancy Study

Condition
Type 1 Diabetes
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pregnant
  • * Diagnosis of type 1 diabetes (T1D) prior to pregnancy
  • * Active use of automated insulin delivery (AID) system
  • * Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Nasim Sobhani, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2029-12-31