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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes; Pregnancy Related; Pregnancy, High Risk; Insulin Dependent Diabetes
• Intervention / Treatment: Other: Commercial AID system; Other: Open source AID system

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Primary Investigator; Phone Number: (415) 307-9319; Email: cosclipstudy@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California, San Francisco
      • Contact: Nasim Sobhani; Phone Number: 415-307-9319; Email: COSCLIPStudy@UCSF.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; AID system that is commercially available and FDA approved for use
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; AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 small for gestational age (SGA)	SGA defined as birth weight < 10th percentile for gestational age.	At delivery
Incidence of perinatal mortality	Includes intrauterine fetal demise and neonatal demise	From delivery to 28 days-of-life
Incdience of diabetic ketoacidosis		From enrollment to 8 weeks postpartum
Incidence of maternal hypoglycemia		From enrollment to 8 weeks postpartum
Incidence of major congenital malformations		From enrollment to delivery (up to 40 weeks of delivery)
Incidence of pregnancy loss		From enrollment to delivery (up to 40 weeks of delivery)
Time above pregnancy-specific range (psTAR)	Defined as percent of time spent with sensor glucose > 140 mg/dL.	From enrollment to 8 weeks postpartum.
Time spent below pregnancy-specific range (psTBR)	Defined as percent of time spent with sensor glucose < 63 mg/dL.	From enrollment to 8 weeks postpartum.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Nasim Sobhani, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 24-42036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD that underlie results in a publication
• IPD Sharing Time Frame: Beginning 6 months and ending 2 years after the publication of results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No