NCT06654713 · University of California, San Francisco
Commercial or Open Source Closed Loop Impact on Pregnancy Study
(COSCLIP)
What this study is about
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.
View original scientific description
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
Primary neonatal outcome. LGA defined as birth weight \> 90th percentile for gestational age
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.
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).
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 7, 2025 · Source of record for eligibility and locations