T1D Pregnancy & Me

ID#: NCT06959316

Age: 18 years - 66+

Gender: Female

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: April 25, 2025

End Date: April 01, 2027

Contact Information:
Robin Gal, MSPH
813-975-8690
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 Criteria:

1. Age ≥18 years

2. Clinical diagnosis of presumed T1D for at least 6 months duration

3. Less than 15 weeks gestation at time of enrollment based on due date from provider

4. 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

5. Following intensive insulin therapy regimen defined as basal-bolus delivery via an insulin pump (including a closed loop system) or multiple daily injections (MDI)

6. Have access to technology that may be required to complete study questionnaires and share diabetes device data.

7. Resident of the United States and plans to reside in the U.S. for the duration of the study

8. Comprehends written and spoken English or Spanish

9. Willing and able to provide informed consent, complete surveys and provide the device data that are part of the protocol

Exclusion Criteria:

1. Multiple pregnancy

2. Current renal dialysis or plan to begin renal dialysis during the study

3. History of liver cirrhosis

4. Active cancer treatment with systemic chemotherapy

5. Current participation in other studies involving an investigational insulin delivery device or planning to participate in an investigational insulin delivery device study during pregnancy

6. Prior participation in this study
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