Commercial or Open Source Closed Loop Impact on Pregnancy Study

Recruiting

• Conditions: Type 1 Diabetes; Pregnancy, High Risk; Insulin Dependent Diabetes; Pregnancy Related

• Registration Number: NCT06654713
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Study Start: 2025-03-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Large for gestational age (LGA)	At delivery	Primary neonatal outcome. LGA defined as birth weight \> 90th percentile for gestational age
Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS)	From enrollment to 8 weeks postpartum	Primary behavioral outcome. Score ranges from 1-5. Higher scores indicate higher degrees of diabetes distress.
Hypertensive disorders of pregnancy (HDP)	From enrollment to 8 weeks postpartum.	Primary maternal outcome. As defined by the American College of Obstetricians and Gynecologists (ACOG).
Time in pregnancy-specific range (psTIR)	From enrollment to 8 weeks postpartum.	Primary glycemic outcome. Defined as percent of time spent with sensor glucose in pregnancy range of 63-140 mg/dL.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States