An observational study in Type 1 Diabetes, Pregnancy, High Risk and Insulin Dependent Diabetes, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by University of California, San Francisco · Observational
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:
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant individuals with type 1 diabetes (T1D) using any form of automated insulin delivery (AID) system in pregnancy
Exclusion criteria:
Pregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy
Other: Commercial AID system
Pregnant individuals with type 1 diabetes T1D) using open source automated insulin delivery (AID) systems (also known as do-it-yourself AID systems or hacked AID systems) for glycemic management in pregnancy
Other: Open source AID system
AID system that is commercially available and FDA approved for use
AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor
Large for gestational age (LGA)
Primary neonatal outcome. LGA defined as birth weight \> 90th percentile for gestational age
Time frame: At delivery
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 postpartum
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.
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.
Incidence of cesarean delivery
Time frame: At delivery
Incidence of neonatal hypoglycemia
Time frame: From delivery to 28 days-of-life
Incidence of neonatal hyperbilirubinemia
Time frame: From delivery to 28 days-of-life
Incidence of neonatal ICU admission
Time frame: From delivery to 28 days-of-life
Incidence of major congenital malformations
Time frame: From enrollment to delivery (up to 40 weeks of delivery)
Incidence of small for gestational age (SGA)
SGA defined as birth weight \< 10th percentile for gestational age.
Time frame: At delivery
Incidence of pregnancy loss
Time frame: From enrollment to delivery (up to 40 weeks of delivery)
Incidence of perinatal mortality
Includes intrauterine fetal demise and neonatal demise
Time frame: From delivery to 28 days-of-life
Incdience of diabetic ketoacidosis
Time frame: From enrollment to 8 weeks postpartum
Incidence of maternal hypoglycemia
Time frame: From enrollment to 8 weeks postpartum
Time above pregnancy-specific range (psTAR)
Defined as percent of time spent with sensor glucose \> 140 mg/dL.
Time frame: From enrollment to 8 weeks postpartum.
Time spent below pregnancy-specific range (psTBR)
Defined as percent of time spent with sensor glucose \< 63 mg/dL.
Time frame: From enrollment to 8 weeks postpartum.
Plan to share: Yes — De-identified IPD that underlie results in a publication
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of California, San Francisco