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

500 Participants
are divided into 2 treatment groups

Locations

10
Alabama
University of Alabama at Birmingham35294, Birmingham United States
Colorado
Barbara Davis Center for Diabetes & University of Colorado Health80045, Aurora United States
Florida
Jaeb Center for Health Research33647, Tampa United States
Indiana
Indiana University46202, Indianapolis United States

Sponsors and collaborators

Jaeb Center for Health Research

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator