T1D Pregnancy & Me
Recruiting now
Conditions studied: Diabetes Mellitus, Type 1, Pregnancy in Diabetics, Pregnancy, High-Risk, Insulin Dependent Diabetes
In brief
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.
Key facts
- Study ID
- NCT06959316
- Run by
- Jaeb Center for Health Research
- People needed
- 500
- Starts
- 2025-04-25
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2025-05-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- Barbara Davis Center for Diabetes & University of Colorado Health — Aurora, Colorado, United States (enrolling)
- Jaeb Center for Health Research — Tampa, Florida, United States (enrolling)
- Indiana University — Indianapolis, Indiana, United States (enrolling)
- Mass General Brigham — Boston, Massachusetts, United States (enrolling)
- Joslin Diabetes Center — Boston, Massachusetts, United States (enrolling)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
- The Ohio State University — Columbus, Ohio, United States (enrolling)
- Oregon Health and Science University — Portland, Oregon, United States (enrolling)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.