Insulin Dependent Diabetes, Pregnancy, High Risk, Pregnancy Related, Type 1 Diabetes
Conditions
Brief summary
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.
Interventions
OTHERCommercial AID system
AID system that is commercially available and FDA approved for use
OTHEROpen source AID system
AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor
Sponsors
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Large for gestational age (LGA) | At delivery | Primary neonatal outcome. LGA defined as birth weight \> 90th percentile for gestational age |
| Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS) | From enrollment to 8 weeks postpartum | Primary behavioral outcome. Score ranges from 1-5. Higher scores indicate higher degrees of diabetes distress. |
| Hypertensive disorders of pregnancy (HDP) | From enrollment to 8 weeks postpartum. | Primary maternal outcome. As defined by the American College of Obstetricians and Gynecologists (ACOG). |
| Time in pregnancy-specific range (psTIR) | From enrollment to 8 weeks postpartum. | Primary glycemic outcome. Defined as percent of time spent with sensor glucose in pregnancy range of 63-140 mg/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cesarean delivery | At delivery | — |
| Incidence of neonatal hypoglycemia | From delivery to 28 days-of-life | — |
| Incidence of neonatal hyperbilirubinemia | From delivery to 28 days-of-life | — |
| Incidence of neonatal ICU admission | From delivery to 28 days-of-life | — |
| Incidence of major congenital malformations | From enrollment to delivery (up to 40 weeks of delivery) | — |
| Incidence of small for gestational age (SGA) | At delivery | SGA defined as birth weight \< 10th percentile for gestational age. |
| Incidence of pregnancy loss | From enrollment to delivery (up to 40 weeks of delivery) | — |
| Incidence of perinatal mortality | From delivery to 28 days-of-life | Includes intrauterine fetal demise and neonatal demise |
| Incdience of diabetic ketoacidosis | From enrollment to 8 weeks postpartum | — |
| Incidence of maternal hypoglycemia | From enrollment to 8 weeks postpartum | — |
| Time above pregnancy-specific range (psTAR) | From enrollment to 8 weeks postpartum. | Defined as percent of time spent with sensor glucose \> 140 mg/dL. |
| Time spent below pregnancy-specific range (psTBR) | From enrollment to 8 weeks postpartum. | Defined as percent of time spent with sensor glucose \< 63 mg/dL. |
Countries
United States
Contacts
CONTACTPrimary Investigator
PRINCIPAL_INVESTIGATORNasim Sobhani, MD
University of California, San Francisco
Outcome results
None listed