Commercial or Open Source Closed Loop Impact on Pregnancy Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of California, San Francisco
About this trial
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
Qualifiers
Pregnant
Diagnosis of type 1 diabetes (T1D) prior to pregnancy
Active use of automated insulin delivery (AID) system
Disqualifiers
Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)
Trial design
Treatments tested in this trial
- Commercial AID system
- Open source AID system
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov