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Hybrid Closed Loop Effectiveness Trial for Type 1 Diabetes in Underserved Adults

This study is looking at how well a Hybrid Closed Loop (HCL) pump system works for adults with type 1 diabetes, especially those from underserved communities. HCL systems are devices that help manage blood sugar. Researchers want to see if these systems can improve blood sugar control and reduce complications in a wider group of people than previous studies. You may be able to join if you are 18-75 years old, have had type 1 diabetes for at least 12 months, and your A1c (a measure of average blood sugar) is 7.0% or higher. Success in this study will be measured by how much time participants spend with their blood sugar levels in a healthy range (70-180 mg/dL) over 39 weeks. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 140 participants. It is designed as a randomized effectiveness trial.
What's involved
You would receive device-specific training and guidance on insulin dosing and diabetes management. Your glucose time-in-range will be measured at the beginning and after 39 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your glucose time-in-range will be measured at 39 weeks after the start of the study.

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NCT06236607

Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

Recruiting
NAAges 18–75InterventionalTreatment
Boston Medical Center
~140 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Device specific trainingStudy clinician/educator visit

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glucose time-in-range (TIR) of 70-180 mg/dL
Measured over baseline, 39 weeks

Conditions

Diabetes Mellitus, Type 1
Diabetes Complications

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

2 sites across 2 states
Massachusetts1
New York1

Study leadership

  • Howard Wolpert, MD · PRINCIPAL_INVESTIGATOR · Boston Medical Center

Who to contact

Howard Wolpert, MD
[email protected]
617-285-9096
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Clinical diagnosis of T1D for at least 12 months, on MDI for at least 6 months;
A1c ≥7.0% 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

Current use of insulin pump or closed loop insulin pump system;
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.

What this trial measures

  • Glucose time-in-range (TIR) of 70-180 mg/dLbaseline, 39 weeks

    The glucose TIR will be measured over 2 weeks using continuous glucose monitoring (CGM).