Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes
NCT ID: NCT06236607
Last Updated: 2025-12-19
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
NA
140 participants
INTERVENTIONAL
2025-02-27
2028-09-30
Brief Summary
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The investigators plan to conduct a randomized effectiveness trial - with broader eligibility criteria (including markedly elevated A1c) and longer follow up than the previous HCL efficacy trials - to evaluate the benefits, safety risks and treatment complications of HCL use in underserved adults with T1D. A comprehensive mixed-methods approach will be implemented to capture information about the user experience.
Participants will be randomized (3:1 ratio) to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy. Subjects will be followed for 9 months to collect data on effectiveness (glucose % time-in-range 70-180 mg/dL and % time \< 70 mg/dL), safety (diabetic ketoacidosis and severe hypoglycemia events) and patient experience using the systems (including benefits and burdens, the impact of life stressors on HCL use, and how the match between HCL system functionality and the individual's needs and expectations impacts on user experience).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Multiple daily injections
Participants randomized into this arm will use multiple daily injections of insulin.
Study clinician/educator visit
Participants will receive insulin dose and other diabetes management guidance.
BetaBionics iLet HCL system
Participants randomized into this arm will use the BetaBionics iLet HCL system.
Device specific training
Device-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs.
Insulet OP 5 HCL system
Participants randomized into this arm will use the Insulet OP 5 HCL system.
Device specific training
Device-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs.
Tandem Control IQ HCL system
Participants randomized into this arm will use the Tandem Control IQ HCL system.
Device specific training
Device-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs.
Interventions
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Device specific training
Device-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs.
Study clinician/educator visit
Participants will receive insulin dose and other diabetes management guidance.
Eligibility Criteria
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Inclusion Criteria
* A1c \>7.5% with no upper limit at screening (The investigator will consider the participant A1c level, compliance with current diabetes management, and prior acute diabetic complications. For this reason, there is no upper limit on A1c specified for eligibility);
* Able to understand, speak and read English (Given the language limitations in currently available pump interfaces, subjects who are not able to understand written English will not be eligible);
* Willingness to use either lispro or aspart insulin and no other insulin or new non-insulin diabetes pharmacotherapy during the study;
* Total daily dose of insulin of at least 10 units/day;
* Investigator believes that the participant will be able to successfully adhere to the study protocol.
Exclusion Criteria
* Unable to provide informed consent;
* Currently taking hydroxyurea or have medical condition that may necessitate use of hydroxyurea;
* Current use of SGLT-2 inhibitors or sulfonylureas (If using GLP-1RA, pramlintide or metformin, must be on a stable dose for 3 months prior to enrollment);
* Tape allergy or skin condition precluding use of pump or CGM;
* Females who are pregnant or intending to become pregnant (since automated algorithm adaption for some of the HCL systems used in the trial cannot be configured to adjust to changing insulin demands of pregnancy);
* Current renal dialysis or plan to begin renal dialysis during study. Most recent eGFR \<30 ml/min is exclusionary (within last 2 years is acceptable);
* Active cancer treatment;
* Extreme visual or hearing impairment that would impair ability to use CGM and pump;
* Cognitive concerns;
* Significant psychiatric diagnosis or substance abuse disorder that in the investigator's opinion impairs ability of the individual to participate.
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Howard Wolpert, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Montefiore Medical Center
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Howard Wolpert, MD
Role: primary
Stefanie Juell
Role: primary
Other Identifiers
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H-44351
Identifier Type: -
Identifier Source: org_study_id