Status:
RECRUITING
T1D Pregnancy & Me
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Conditions:
Diabetes Mellitus, Type 1
Pregnancy in Diabetics
Eligibility:
FEMALE
18+ years
Brief 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 ...
Detailed Description
Type 1 diabetes (T1D) management during pregnancy is a critical area as pregnancy complicated by T1D is still associated with a markedly elevated risk of maternal and fetal complications. Because the ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06959316
Start Date
April 25 2025
End Date
April 1 2027
Last Update
May 6 2025
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Barbara Davis Center for Diabetes & University of Colorado Health
Aurora, Colorado, United States, 80045
3
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
4
Indiana University
Indianapolis, Indiana, United States, 46202