RECRUITING

T1D Pregnancy & Me

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Conditions

Diabetes Mellitus, Type 1Pregnancy in DiabeticsPregnancy, High-RiskInsulin Dependent DiabetesType 1 diabetesPregnantPregnancyInsulin pumpContinuous glucose monitorRemote studyOnline studyT1DCGMInsulin injectionHybrid closed loopHCL

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-25
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06959316

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years
  2. 2. Clinical diagnosis of presumed T1D for at least 6 months duration
  3. 3. Less than 15 weeks gestation at time of enrollment based on due date from provider
  4. 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. 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. 6. Have access to technology that may be required to complete study questionnaires and share diabetes device data.
  7. 7. Resident of the United States and plans to reside in the U.S. for the duration of the study
  8. 8. Comprehends written and spoken English or Spanish
  9. 9. Willing and able to provide informed consent, complete surveys and provide the device data that are part of the protocol
  1. 1. Multiple pregnancy
  2. 2. Current renal dialysis or plan to begin renal dialysis during the study
  3. 3. History of liver cirrhosis
  4. 4. Active cancer treatment with systemic chemotherapy
  5. 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. 6. Prior participation in this study

Contacts and Locations

Study Contact

Robin Gal, MSPH
CONTACT
813-975-8690
T1DPregnancy@jaeb.org

Principal Investigator

Robin Gal, MSPH
PRINCIPAL_INVESTIGATOR
Jaeb Center for Health Research
Camille Powe, MD
STUDY_CHAIR
Massachusetts General Hospital

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Barbara Davis Center for Diabetes & University of Colorado Health
Aurora, Colorado, 80045
United States
Jaeb Center for Health Research
Tampa, Florida, 33647
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Mass General Brigham
Boston, Massachusetts, 02114
United States
Joslin Diabetes Center
Boston, Massachusetts, 02215
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-25
Study Completion Date2027-04

Study Record Updates

Study Start Date2025-04-25
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • Type 1 diabetes
  • Pregnant
  • Pregnancy
  • Insulin pump
  • Continuous glucose monitor
  • Remote study
  • Online study
  • T1D
  • CGM
  • Insulin injection
  • Hybrid closed loop
  • HCL

Additional Relevant MeSH Terms

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