NCT06959316Active, not recruiting
T1D Pregnancy & Me
Pregnancy Data Repository to Assess Management of Type 1 Diabetes With Diabetes Technology
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 28 Apr 2025
- Start date
- 25 Apr 2025
- Primary completion date
- Apr 2027
- Lead sponsor
- Jaeb Center for Health Research
- Diseases
- Type 1 diabetes
- NCT number
- NCT06959316
What you commit to
- Study type: Observational
- Planned participants: 500
- From 25 Apr 2025 to the primary completion date, Apr 2027
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active cancer treatment with systemic chemotherapy
- Prior participation in this study
Other illness
- History of liver cirrhosis
Other
- Multiple pregnancy
- Current renal dialysis or plan to begin renal dialysis during the study
- Current participation in other studies involving an investigational insulin delivery device or planning to participate in an investigational insulin delivery device study during pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barbara Davis Center for Diabetes & University of Colorado Health Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Mass General Brigham Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Joslin Diabetes Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Jaeb Center for Health Research Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.