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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Commercial AID system | Pregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy |
| |
| Open source 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercial AID system | Other | AID system that is commercially available and FDA approved for use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Large for gestational age (LGA) | Primary neonatal outcome. LGA defined as birth weight > 90th percentile for gestational age | 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. | 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). | 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. | From enrollment to 8 weeks postpartum. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cesarean delivery | At delivery | |
| Incidence of neonatal hypoglycemia | From delivery to 28 days-of-life | |
| Incidence of neonatal hyperbilirubinemia |
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Inclusion criteria:
Exclusion criteria:
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Pregnant individuals with type 1 diabetes (T1D) using any form of automated insulin delivery (AID) system in pregnancy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Primary Investigator | Contact | (415) 307-9319 | cosclipstudy@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nasim Sobhani, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94158 | United States |
De-identified IPD that underlie results in a publication
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Beginning 6 months and ending 2 years after the publication of results
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Open source AID system | Other | AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor |
|
| 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) | SGA defined as birth weight < 10th percentile for gestational age. | At delivery |
| Incidence of pregnancy loss | From enrollment to delivery (up to 40 weeks of delivery) |
| Incidence of perinatal mortality | Includes intrauterine fetal demise and neonatal demise | From delivery to 28 days-of-life |
| 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) | Defined as percent of time spent with sensor glucose > 140 mg/dL. | 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. | From enrollment to 8 weeks postpartum. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |