Commercial or Open Source Closed Loop Impact on Pregnancy Study

a study on Diabetes Diabetes Type 1 Pregnancy

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Nasim Sobhani, MD
Headshot of Nasim Sobhani
Nasim Sobhani

Description

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.

Official Title

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

Keywords

Type 1 Diabetes, Pregnancy, High Risk, Insulin Dependent Diabetes, Pregnancy Related, Diabetes Mellitus, Type 1 Diabetes Mellitus, Commercial AID system, Open source AID system

Eligibility

You can join if…

Open to females ages 18 years and up

You CAN'T join if...

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

Location

  • UCSF accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Nasim Sobhani, MD
    Dr. Nasim Sobhani is a perinatologist, an obstetrician who specializes in care during high-risk pregnancies. She provides comprehensive care for women with preexisting conditions that can affect pregnancy and for women with pregnancy-specific health conditions. She also cares for developing fetuses when genetic or structural conditions have been diagnosed in utero.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06654713
Study Type
Observational [Patient Registry]
Participants
Expecting 1000 study participants
Last Updated
Contact us about this trial