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NCT Number: NCT06654713

Commercial or Open Source Closed Loop Impact on Pregnancy 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.

Recruiting

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Insulin Dependent Diabetes Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Related Pregnancy, High Risk

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Location status: Recruiting

Location contact

Nasim Sobhani

CONTACT

[email protected]

415-307-9319

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Commercial AID system

Other

AID system that is commercially available and FDA approved for use

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

Primary outcomes

  1. Large for gestational age (LGA)

    Time frame: At delivery

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

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

    Time frame: From enrollment to 8 weeks postpartum

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

  3. Hypertensive disorders of pregnancy (HDP)

    Time frame: From enrollment to 8 weeks postpartum.

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

  4. Time in pregnancy-specific range (psTIR)

    Time frame: 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 outcomes

  1. Incidence of cesarean delivery

    Time frame: At delivery

  2. Incidence of neonatal hypoglycemia

    Time frame: From delivery to 28 days-of-life

  3. Incidence of neonatal hyperbilirubinemia

    Time frame: From delivery to 28 days-of-life

  4. Incidence of neonatal ICU admission

    Time frame: From delivery to 28 days-of-life

  5. Incidence of major congenital malformations

    Time frame: From enrollment to delivery (up to 40 weeks of delivery)

  6. Incidence of small for gestational age (SGA)

    Time frame: At delivery

    SGA defined as birth weight < 10th percentile for gestational age.

  7. Incidence of pregnancy loss

    Time frame: From enrollment to delivery (up to 40 weeks of delivery)

  8. Incidence of perinatal mortality

    Time frame: From delivery to 28 days-of-life

    Includes intrauterine fetal demise and neonatal demise

  9. Incdience of diabetic ketoacidosis

    Time frame: From enrollment to 8 weeks postpartum

  10. Incidence of maternal hypoglycemia

    Time frame: From enrollment to 8 weeks postpartum

  11. Time above pregnancy-specific range (psTAR)

    Time frame: From enrollment to 8 weeks postpartum.

    Defined as percent of time spent with sensor glucose > 140 mg/dL.

  12. Time spent below pregnancy-specific range (psTBR)

    Time frame: From enrollment to 8 weeks postpartum.

    Defined as percent of time spent with sensor glucose < 63 mg/dL.

Study contacts

Contact information is provided by the study sponsor or research team.

Primary Investigator

CONTACT

[email protected]

(415) 307-9319

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: COSCLIP

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 23, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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