Pregnancy Data Repository to Assess Management of Type 1 Diabetes With Diabetes Technology

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Colorado
Barbara Davis Center for Diabetes & University of Colorado Health
RECRUITING
Aurora
Florida
Jaeb Center for Health Research
RECRUITING
Tampa
Indiana
Indiana University
RECRUITING
Indianapolis
Massachusetts
Joslin Diabetes Center
RECRUITING
Boston
Mass General Brigham
RECRUITING
Boston
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
The Ohio State University
RECRUITING
Columbus
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Robin Gal, MSPH
T1DPregnancy@jaeb.org
813-975-8690
Time Frame
Start Date: 2025-04-25
Estimated Completion Date: 2027-04
Participants
Target number of participants: 500
Treatments
HCL Use
Pregnant individuals with type 1 diabetes (T1D) using HCL systems for glycemic management in pregnancy
HCL Non-Use
Pregnant individuals with type 1 diabetes (T1D) not using HCL systems for glycemic management in pregnancy
Related Therapeutic Areas
Sponsors
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
Leads: Jaeb Center for Health Research

This content was sourced from clinicaltrials.gov