Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2025-04-25
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HCL Use
Pregnant individuals with type 1 diabetes (T1D) using HCL systems for glycemic management in pregnancy
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
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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Robin Gal, MSPH
Role: PRINCIPAL_INVESTIGATOR
Jaeb Center for Health Research
Camille Powe, MD
Role: STUDY_CHAIR
Massachusetts General Hospital
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Barbara Davis Center for Diabetes & University of Colorado Health
Aurora, Colorado, United States
Jaeb Center for Health Research
Tampa, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Mass General Brigham
Boston, Massachusetts, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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PRAM-T1D
Identifier Type: -
Identifier Source: org_study_id
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