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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: Recruiting NA study of Diabetes Mellitus, Type 1 and Diabetes Complications, sponsored by Boston Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The glucose TIR will be measured over 2 weeks using continuous glucose monitoring (CGM).
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 |
What NCT06236607 shows while recruiting
NCT06236607 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06236607's enrollment target sits among peer trials
140 42nd of 118 higher than 77 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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