Clinical trial NCT06654713: Commercial or Open Source Closed Loop Impact on Pregnancy Study
Official title: Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Pregnancy, High Risk
Insulin Dependent Diabetes
Pregnancy Related
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant individuals with type 1 diabetes (T1D) using any form of automated insulin delivery (AID) system in pregnancy

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Large for gestational age (LGA)
timeFrame: At delivery
measure: Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS)
timeFrame: From enrollment to 8 weeks postpartum
measure: Hypertensive disorders of pregnancy (HDP)
timeFrame: From enrollment to 8 weeks postpartum.
measure: Time in pregnancy-specific range (psTIR)
timeFrame: From enrollment to 8 weeks postpartum.
Secondary outcomes:
measure: Incidence of cesarean delivery
timeFrame: At delivery
measure: Incidence of neonatal hypoglycemia
timeFrame: From delivery to 28 days-of-life
measure: Incidence of neonatal hyperbilirubinemia
timeFrame: From delivery to 28 days-of-life
measure: Incidence of neonatal ICU admission
timeFrame: From delivery to 28 days-of-life
measure: Incidence of major congenital malformations
timeFrame: From enrollment to delivery (up to 40 weeks of delivery)
measure: Incidence of small for gestational age (SGA)
timeFrame: At delivery
measure: Incidence of pregnancy loss
timeFrame: From enrollment to delivery (up to 40 weeks of delivery)
measure: Incidence of perinatal mortality
timeFrame: From delivery to 28 days-of-life
measure: Incdience of diabetic ketoacidosis
timeFrame: From enrollment to 8 weeks postpartum
measure: Incidence of maternal hypoglycemia
timeFrame: From enrollment to 8 weeks postpartum
measure: Time above pregnancy-specific range (psTAR)
timeFrame: From enrollment to 8 weeks postpartum.
measure: Time spent below pregnancy-specific range (psTBR)
timeFrame: From enrollment to 8 weeks postpartum.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Nasim Sobhani, MD
role: PRINCIPAL_INVESTIGATOR
References: