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T1D Pregnancy & Me

NCT06959316 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-05-06

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Hybrid 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.

Sponsors & Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Robin Gal, MSPH · Jaeb Center for Health Research

  • Camille Powe, MD · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-25
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06959316 on ClinicalTrials.gov