RECRUITING

Commercial or Open Source Closed Loop Impact on Pregnancy Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-13
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06654713

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant
  2. * Diagnosis of type 1 diabetes (T1D) prior to pregnancy
  3. * Active use of automated insulin delivery (AID) system
  1. * Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)

Contacts and Locations

Study Contact

Primary Investigator
CONTACT
(415) 307-9319
cosclipstudy@ucsf.edu

Principal Investigator

Nasim Sobhani, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-13
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2025-03-13
Study Completion Date2029-12-31

Terms related to this study

Additional Relevant MeSH Terms

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