T1D Pregnancy & Me

NCT06959316 | Recruiting

• 1 other identifier: PRAM-T1D
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• CGM Outcome (BG 63-140 mg/dl)

  Percentage of time spent with glucose 63-140 mg/dl

  Up to 37 weeks gestation

Secondary Outcomes (3)

• CGM Outcome (BG<63 mg/dl)

  Up to 37 weeks gestation

• CGM Outcome (BG<54 mg/dl)

  Up to 37 weeks gestation

• CGM Outcome (BG>140 mg/dl)

  Up to 37 weeks gestation

Other Outcomes (4)

• Hypertensive disorder of pregnancy

  Up to 37 weeks gestation

• LGA Status (defined as birthweight percentile > 90th)

  At birth

• Preterm delivery

  Delivery after 20 weeks and before 37 weeks gestation

Study Arms (2)

HCL Use

Pregnant individuals with type 1 diabetes (T1D) using HCL systems for glycemic management in pregnancy

Device: Hybrid closed loop insulin delivery system

HCL Non-Use

Pregnant individuals with type 1 diabetes (T1D) not using HCL systems for glycemic management in pregnancy

Interventions

Hybrid closed loop insulin delivery system DEVICE

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.

HCL Use

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant adults with type 1 diabetes from across the United States who use a continuous glucose monitor.

You may qualify if:

• 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

You may not qualify if:

• Multiple pregnancy
• Current renal dialysis or plan to begin renal dialysis during the study
• History of liver cirrhosis
• Active cancer treatment with systemic chemotherapy
• Current participation in other studies involving an investigational insulin delivery device or planning to participate in an investigational insulin delivery device study during pregnancy
• Prior participation in this study

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Barbara Davis Center for Diabetes & University of Colorado Health

Aurora, Colorado, 80045, United States

RECRUITING

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Mass General Brigham

Boston, Massachusetts, 02114, United States

RECRUITING

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Pregnancy in Diabetics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Robin Gal, MSPH

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

• Camille Powe, MD

  Massachusetts General Hospital

  STUDY CHAIR

Central Study Contacts

Robin Gal, MSPH

CONTACT

813-975-8690; T1DPregnancy@jaeb.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-04

Locations

US (10)