T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.
Age ≥18 years
Clinical diagnosis of presumed T1D for at least 6 months duration
Less than 15 weeks gestation at time of enrollment based on due date from provider
Planned CGM use on a regular basis (e.g., ≥10 out of 14 days) and willing to continue using CGM regularly with no plans to discontinue CGM use during the study
Multiple pregnancy
Current renal dialysis or plan to begin renal dialysis during the study
History of liver cirrhosis
Active cancer treatment with systemic chemotherapy
Pregnant adults with type 1 diabetes from across the United States who use a continuous glucose monitor.
Cohort
Prospective
Hybrid closed loop insulin delivery system
DeviceHybrid closed loop insulin delivery system is a system that uses a continuous glucose monitor (CGM) to send blood glucose values to an insulin pump that automatically provides insulin based on the blood glucose value and anticipated future level.
CGM Outcome (BG 63-140 mg/dl)
Percentage of time spent with glucose 63-140 mg/dl
CGM Outcome (BG<63 mg/dl)
Percentage time spent with glucose \<63 mg/dl
CGM Outcome (BG<54 mg/dl)
Percentage time spent with glucose \<54 mg/dl
CGM Outcome (BG>140 mg/dl)
Percentage time spent with glucose \>140 mg/dl
Hypertensive disorder of pregnancy
Gestational hypertension or preeclampsia
LGA Status (defined as birthweight percentile > 90th)
Large gestational age birthweight
Preterm delivery
Preterm delivery
Neonatal Morbidity
Hypoglycemia, hyperbilirubinemia, respiratory distress, or birth trauma
Click on the lead sponsor to view all of their trials.
Jaeb Center for Health Research
Lead sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
