Actively Recruiting
T1D Pregnancy & Me
Led by Jaeb Center for Health Research · Updated on 2025-05-06
500
Participants Needed
10
Research Sites
100 weeks
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
T
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
T1D Pregnancy & Me
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of type 1 diabetes for at least 6 months
- Less than 15 weeks pregnant at enrollment based on provider due date
- Planned use of continuous glucose monitoring (CGM) regularly (e.g., 10 out of 14 days) and willing to continue
- Following intensive insulin therapy via an insulin pump (including closed loop systems) or multiple daily injections
- Access to technology needed to complete study questionnaires and share device data
- Resident of the United States and plans to remain for study duration
- Understands written and spoken English or Spanish
- Willing and able to give informed consent, complete surveys, and provide diabetes device data
You will not qualify if you...
- Multiple pregnancy (twins or more)
- Currently on kidney dialysis or planning to start during the study
- History of liver cirrhosis
- Undergoing active cancer treatment with systemic chemotherapy
- Participating or planning to participate in other studies using investigational insulin delivery devices during pregnancy
- Prior participation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Barbara Davis Center for Diabetes & University of Colorado Health
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
Actively Recruiting
4
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
Mass General Brigham
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
8
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
10
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
R
Robin Gal, MSPH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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