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NCT06236607 · ClinicalTrials.gov registry record · NA
Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes
A NA study of Diabetes Mellitus, Type 1 and Diabetes Complications, sponsored by Boston Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 2
- Study locations
NCT06236607 is a NA study of Diabetes Mellitus, Type 1 and Diabetes Complications that is actively recruiting participants, run by Boston Medical Center. The registered enrollment target is 140 participants, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06236607, a NA study of Diabetes Mellitus, Type 1 and Diabetes Complications, is actively recruiting participants, sponsored by Boston Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 2
- Study locations
Study Summary
Minoritized individuals with type 1 diabetes (T1D) have approximately 2% higher average A1c levels and twice the rate of hospitalizations, complications, and mortality as their white counterparts. However, the efficacy trials establishing the benefits of hybrid closed loop (HCL) pump therapy in T1D have been in more socially advantaged and predominantly non-Hispanic white patients. Use of this technology by individuals with T1D from underserved communities remains very low. 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).
Conditions Studied
Interventions
- DEVICE Device specific training
- OTHER Study clinician/educator visit
Study Locations (2)
Massachusetts
- Boston Medical Center - Boston
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2025-02-27 |
| Est. Completion | 2028-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06236607
The ClinicalTrials.gov registry entry for NCT06236607 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (89% lower). The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Device specific training is the first listed.
NCT06236607 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT06236607 about?
NCT06236607 is a clinical study titled "Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes". Minoritized individuals with type 1 diabetes (T1D) have approximately 2% higher average A1c levels and twice the rate of hospitalizations, complications, and mortality as their white counterparts. However, the efficacy trials establishing the benefits of hybrid closed loop (HCL) pump therapy in T1D ...
What is the current status of trial NCT06236607?
This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2025-02-27. Estimated completion is 2028-09.
What conditions does trial NCT06236607 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1, Diabetes Complications.
What interventions are being tested in trial NCT06236607?
The interventions under investigation include: Device specific training (DEVICE), Study clinician/educator visit (OTHER).
Who is sponsoring clinical trial NCT06236607?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06236607 being conducted?
This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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