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
This trial does not accept healthy volunteersQualifiers
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 population
Pregnant individuals with type 1 diabetes (T1D) using any form of automated insulin delivery (AID) system in pregnancy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Commercial AID system
Other interventionAID system that is commercially available and FDA approved for use
Open source AID system
Other interventionAID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Commercial AID system1 intervention
Group B: Open source AID system1 intervention
Trial outcomes
Primary outcomes
1
Large for gestational age (LGA)
Primary neonatal outcome. LGA defined as birth weight \> 90th percentile for gestational age
Time frame
At delivery2
Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS)
Primary behavioral outcome. Score ranges from 1-5. Higher scores indicate higher degrees of diabetes distress.
Time frame
From enrollment to 8 weeks postpartum3
Hypertensive disorders of pregnancy (HDP)
Primary maternal outcome. As defined by the American College of Obstetricians and Gynecologists (ACOG).
Time frame
From enrollment to 8 weeks postpartum.4
Time in pregnancy-specific range (psTIR)
Primary glycemic outcome. Defined as percent of time spent with sensor glucose in pregnancy range of 63-140 mg/dL.
Time frame
From enrollment to 8 weeks postpartum.Secondary outcomes
1
Incidence of cesarean delivery
Time frame
At delivery2
Incidence of neonatal hypoglycemia
Time frame
From delivery to 28 days-of-life3
Incidence of neonatal hyperbilirubinemia
Time frame
From delivery to 28 days-of-life4
Incidence of neonatal ICU admission
Time frame
From delivery to 28 days-of-lifeSponsors and contacts
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Source ClinicalTrials.gov