T1D Pregnancy & Me
Pregnancy Data Repository to Assess Management of Type 1 Diabetes With Diabetes Technology
Jaeb Center for Health Research
500 participants
Apr 25, 2025
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria9
- 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
- Following intensive insulin therapy regimen defined as basal-bolus delivery via an insulin pump (including a closed loop system) or multiple daily injections (MDI)
- Have access to technology that may be required to complete study questionnaires and share diabetes device data.
- Resident of the United States and plans to reside in the U.S. for the duration of the study
- Comprehends written and spoken English or Spanish
- Willing and able to provide informed consent, complete surveys and provide the device data that are part of the protocol
Exclusion Criteria6
- Multiple pregnancy
- Current renal dialysis or plan to begin renal dialysis during the study
- History of liver cirrhosis
- Active cancer treatment with systemic chemotherapy
- Current participation in other studies involving an investigational insulin delivery device or planning to participate in an investigational insulin delivery device study during pregnancy
- Prior participation in this study
Interventions
Hybrid 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.
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06959316