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Commercial or Open Source Closed Loop Impact on Pregnancy Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows pregnant people with type 1 diabetes who use a system that automatically delivers insulin. It compares commercial systems with open-source systems, which use publicly shared software. Researchers will look at blood sugar, the health of the pregnant person and baby, and emotional health and behavior.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are pregnant.
  • You were diagnosed with type 1 diabetes before pregnancy.
  • You currently use a system that automatically delivers insulin.

Who can't join

  • You have another type of diabetes: gestational diabetes (diabetes that starts during pregnancy), type 2 diabetes, or monogenic diabetes (diabetes caused by a change in one gene).

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

CA