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.
Study Type
OBSERVATIONAL
Enrollment
1,000
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
University of California, San Francisco
San Francisco, California, United States
RECRUITINGLarge 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.
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