Pregnancy Data Repository to Assess Management of Type 1 Diabetes With Diabetes Technology
Jaeb Center for Health Research
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.
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 risk of these complications is tightly linked to glucose levels, guidelines recommend lower glycemic targets than in non-pregnant individuals to optimize pregnancy outcomes. Hybrid closed loop (HCL) insulin delivery systems may aid in glycemic management during pregnancy, but options for use of HCL during pregnancy are limited and present challenges as systems are not approved for use in pregnancy…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 questionn…
Interventions
- DeviceHybrid closed loop insulin delivery system
Hybrid closed loop insulin delivery system is a system that uses a continuous glucose monitor (CGM) to send blood glucose values to an insulin pump that automatically provides insulin based on the blood glucose value and anticipated future level.
Locations (10)
- University of Alabama at BirminghamBirmingham, Alabama
- Barbara Davis Center for Diabetes & University of Colorado HealthAurora, Colorado
- Jaeb Center for Health ResearchTampa, Florida
- Indiana UniversityIndianapolis, Indiana
- Mass General BrighamBoston, Massachusetts
- Joslin Diabetes CenterBoston, Massachusetts