Commercial or Open Source Closed Loop Impact on Pregnancy Study

NCT06654713 | Recruiting

• 1 other identifier: 24-42036
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Large for gestational age (LGA)

  Primary neonatal outcome. LGA defined as birth weight \> 90th percentile for gestational age

  At delivery

• Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS)

  Primary behavioral outcome. Score ranges from 1-5. Higher scores indicate higher degrees of diabetes distress.

  From enrollment to 8 weeks postpartum

• Hypertensive disorders of pregnancy (HDP)

  Primary maternal outcome. As defined by the American College of Obstetricians and Gynecologists (ACOG).

  From enrollment to 8 weeks postpartum.

• Time in pregnancy-specific range (psTIR)

  Primary glycemic outcome. Defined as percent of time spent with sensor glucose in pregnancy range of 63-140 mg/dL.

  From enrollment to 8 weeks postpartum.

Secondary Outcomes (12)

• Incidence of cesarean delivery

  At delivery

• Incidence of neonatal hypoglycemia

  From delivery to 28 days-of-life

• Incidence of neonatal hyperbilirubinemia

  From delivery to 28 days-of-life

• Incidence of neonatal ICU admission

  From delivery to 28 days-of-life

• Incidence of major congenital malformations

  From enrollment to delivery (up to 40 weeks of delivery)

Study Arms (2)

Commercial AID system

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

Other: Commercial AID system

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

Other: Open source AID system

Interventions

Commercial AID system OTHER

AID system that is commercially available and FDA approved for use

Commercial AID system

Open source AID system OTHER

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

Open source AID system

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant individuals with type 1 diabetes (T1D) using any form of automated insulin delivery (AID) system in pregnancy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nasim Sobhani, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Primary Investigator

CONTACT

(415) 307-9319; cosclipstudy@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 23, 2024
• Study Start: March 13, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months and ending 2 years after the publication of results

Locations

US (1)