T1D Pregnancy & Me

Description

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

Diabetes Mellitus, Type 1, Pregnancy in Diabetics, Pregnancy, High-Risk, Insulin Dependent Diabetes

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

T1D Pregnancy & Me

Condition
Diabetes Mellitus, Type 1
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Aurora

Barbara Davis Center for Diabetes & University of Colorado Health, Aurora, Colorado, United States, 80045

Tampa

Jaeb Center for Health Research, Tampa, Florida, United States, 33647

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Boston

Mass General Brigham, Boston, Massachusetts, United States, 02114

Boston

Joslin Diabetes Center, Boston, Massachusetts, United States, 02215

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Philadelphia

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jaeb Center for Health Research,

Robin Gal, MSPH, PRINCIPAL_INVESTIGATOR, Jaeb Center for Health Research

Camille Powe, MD, STUDY_CHAIR, Massachusetts General Hospital

Study Record Dates

2027-04