About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Multiple pregnancy
Current renal dialysis or plan to begin renal dialysis during the study
History of liver cirrhosis
Active cancer treatment with systemic chemotherapy
Trial design
Treatments tested in this trial
- Hybrid closed loop insulin delivery system
Treatment groups
Locations
10Sponsors and collaborators
Jaeb Center for Health Research
Lead sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator