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Recruiting NCT06654713

Commercial or Open Source Closed Loop Impact on Pregnancy Study

— Observational Type 1 Diabetes Pregnancy, High Risk Insulin Dependent Diabetes Pregnancy Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Commercial AID system, Open source AID system.
Who it may be relevant to
Registry conditions: Type 1 Diabetes, Pregnancy, High Risk, Insulin Dependent Diabetes, Pregnancy Related. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Commercial AID system
    AID system that is commercially available and FDA approved for use
  • 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

Primary outcome measures

  • 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.]
Secondary outcome measures (12)
  • Incidence of cesarean delivery [Time frame: At delivery]
  • Incidence of neonatal hypoglycemia [Time frame: From delivery to 28 days-of-life]
  • Incidence of neonatal hyperbilirubinemia [Time frame: From delivery to 28 days-of-life]
  • Incidence of neonatal ICU admission [Time frame: From delivery to 28 days-of-life]
  • Incidence of major congenital malformations [Time frame: From enrollment to delivery (up to 40 weeks of delivery)]
  • Incidence of small for gestational age (SGA) [Time frame: At delivery]
  • Incidence of pregnancy loss [Time frame: From enrollment to delivery (up to 40 weeks of delivery)]
  • Incidence of perinatal mortality [Time frame: From delivery to 28 days-of-life]
  • Incdience of diabetic ketoacidosis [Time frame: From enrollment to 8 weeks postpartum]
  • Incidence of maternal hypoglycemia [Time frame: From enrollment to 8 weeks postpartum]
  • Time above pregnancy-specific range (psTAR) [Time frame: From enrollment to 8 weeks postpartum.]
  • Time spent below pregnancy-specific range (psTBR) [Time frame: From enrollment to 8 weeks postpartum.]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT06654713 · 24-42036

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗