Recruiting

Closed Loop

Sponsor:

UCLA

Code:

NCT06654713

Conditions

Type 1 Diabetes

Pregnancy, High Risk

Insulin Dependent Diabetes

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Commercial AID system

Open source AID system

Study Details

Brief 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.

Conditions

Type 1 Diabetes

Pregnancy, High Risk

Insulin Dependent Diabetes

Pregnancy Related

Study ID

NCT06654713

Start date

Mar 13, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Commercial AID system

AID system that is commercially available and FDA approved for use

Open source AID system

AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor

Primary outcome measure

  • Large for gestational age (LGA) [ Time Frame: At delivery ]
  • Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS) [ Time Frame: From enrollment to 8 weeks postpartum ]
  • Hypertensive disorders of pregnancy (HDP) [ Time Frame: From enrollment to 8 weeks postpartum. ]
  • Time in pregnancy-specific range (psTIR) [ Time Frame: From enrollment to 8 weeks postpartum. ]

Central Contacts and Locations

Central contacts

Primary Investigator

(415) 307-9319cosclipstudy@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Nasim Sobhani

415-307-9319COSCLIPStudy@UCSF.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-27.