Understanding Type 1 Diabetes Management During Pregnancy
Pregnancy Data Repository to Assess Management of Type 1 Diabetes With Diabetes Technology
Jaeb Center for Health Research · NCT06959316
This study is trying to see how well hybrid closed loop insulin delivery systems work for pregnant people with type 1 diabetes compared to other methods to improve their health and their baby's health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Jaeb Center for Health Research (other) |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Birmingham, Alabama and 9 other locations) |
| Trial ID | NCT06959316 on ClinicalTrials.gov |
What this trial studies
T1D Pregnancy & Me is an observational study that partners with pregnant individuals living with type 1 diabetes in the United States to gather real-world data on diabetes management during pregnancy. Participants will complete online surveys and share data from continuous glucose monitors and insulin delivery systems. The study aims to assess glycemic outcomes and pregnancy results associated with the use of hybrid closed loop insulin delivery systems compared to other methods. This research seeks to fill gaps in evidence regarding the management of diabetes in pregnancy and improve care and outcomes for both mothers and babies.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 and older with a clinical diagnosis of type 1 diabetes for at least six months and who are less than 15 weeks gestation.
Not a fit: Patients with multiple pregnancies or those currently undergoing renal dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for pregnant individuals with type 1 diabetes, enhancing maternal and fetal health outcomes.
How similar studies have performed: Other studies have explored diabetes management during pregnancy, but this specific approach focusing on hybrid closed loop systems is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 9 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
- Barbara Davis Center for Diabetes & University of Colorado Health — Aurora, Colorado, United States (RECRUITING)
- Jaeb Center for Health Research — Tampa, Florida, United States (RECRUITING)
- Indiana University — Indianapolis, Indiana, United States (RECRUITING)
- Mass General Brigham — Boston, Massachusetts, United States (RECRUITING)
- Joslin Diabetes Center — Boston, Massachusetts, United States (RECRUITING)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
- The Ohio State University — Columbus, Ohio, United States (RECRUITING)
- Oregon Health and Science University — Portland, Oregon, United States (RECRUITING)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Robin Gal, MSPH — Jaeb Center for Health Research
- Study coordinator: Robin Gal, MSPH
- Email: T1DPregnancy@jaeb.org
- Phone: 813-975-8690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 1, Pregnancy in Diabetics, Pregnancy, High-Risk, Insulin Dependent Diabetes, Type 1 diabetes, Pregnant, Pregnancy, Insulin pump