T1D Pregnancy & Me (PRAM-T1D)

August 17, 2026 updated by: Jaeb Center for Health Research

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 1 diabetes (T1D) management during pregnancy is a critical area as pregnancy complicated by T1D is still associated with a markedly elevated risk of maternal and fetal complications. Because the risk of these complications is tightly linked to glucose levels, guidelines recommend lower glycemic targets than in non-pregnant individuals to optimize pregnancy outcomes. Hybrid closed loop (HCL) insulin delivery systems may aid in glycemic management during pregnancy, but options for use of HCL during pregnancy are limited and present challenges as systems are not approved for use in pregnancy and do not target pregnancy glycemic goals. Thus, pregnant individuals with T1D and their clinicians must consider off-label use of HCL systems with suboptimal glycemic targets. To get closer to pregnancy glycemic targets, individuals may adjust the way they use the system, but there is insufficient evidence to understand the impact of HCL systems available in the US on pregnancy glycemic metrics and pregnancy outcomes.

To address these gaps in evidence, we propose an observational study that will enable systematic assessment of HCL system use in pregnancies complicated by T1D. The focus of this study is to assess glycemic outcomes measured by continuous glucose monitors and clinical pregnancy outcomes associated with use of HCL versus other insulin delivery methods. Data collected from this study will provide important information about how individuals in the United States are managing their diabetes during pregnancy and will help us to identify factors that could minimize the risk of diabetes-associated pregnancy complications and reduce the burden that comes with managing T1D in pregnancy.

Pregnant individuals throughout the United States will be enrolled in this remote observational study. Participants will be asked to share details about their diabetes and pregnancy. Participants will also be asked to share diabetes device data from their continuous glucose monitor (CGM). Participants who use an insulin pump or connected insulin pen may also be asked to share these data.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion 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

Exclusion Criteria:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCL Use
Pregnant individuals with type 1 diabetes (T1D) using HCL systems for glycemic management in pregnancy
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.
HCL Non-Use
Pregnant individuals with type 1 diabetes (T1D) not using HCL systems for glycemic management in pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGM Outcome (BG 63-140 mg/dl)
Time Frame: Up to 37 weeks gestation
Percentage of time spent with glucose 63-140 mg/dl
Up to 37 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGM Outcome (BG<63 mg/dl)
Time Frame: Up to 37 weeks gestation
Percentage time spent with glucose <63 mg/dl
Up to 37 weeks gestation
CGM Outcome (BG<54 mg/dl)
Time Frame: Up to 37 weeks gestation
Percentage time spent with glucose <54 mg/dl
Up to 37 weeks gestation
CGM Outcome (BG>140 mg/dl)
Time Frame: Up to 37 weeks gestation
Percentage time spent with glucose >140 mg/dl
Up to 37 weeks gestation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertensive disorder of pregnancy
Time Frame: Up to 37 weeks gestation
Gestational hypertension or preeclampsia
Up to 37 weeks gestation
LGA Status (defined as birthweight percentile > 90th)
Time Frame: At birth
Large gestational age birthweight
At birth
Preterm delivery
Time Frame: Delivery after 20 weeks and before 37 weeks gestation
Preterm delivery
Delivery after 20 weeks and before 37 weeks gestation
Neonatal Morbidity
Time Frame: At birth
Hypoglycemia, hyperbilirubinemia, respiratory distress, or birth trauma
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

The Leona M. and Harry B. Helmsley Charitable Trust

Investigators

  • Principal Investigator: Robin Gal, MSPH, Jaeb Center for Health Research
  • Study Chair: Camille Powe, MD, 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 Major Dates

Study Start (Actual)

April 25, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 28, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRAM-T1D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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