Evaluating hybrid closed loop therapy for adults with type 1 diabetes from underserved communities

Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

This study is testing if a new type of insulin pump therapy can help adults with type 1 diabetes from underserved communities manage their blood sugar better and improve their overall health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Boston Medical Center (Academic / other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT06236607 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the effectiveness and safety of hybrid closed loop (HCL) pump therapy in adults with type 1 diabetes (T1D) from underserved communities, who typically experience higher A1c levels and complications. Participants will be randomized to receive one of three FDA-approved HCL systems or continuous glucose monitoring, with a focus on broader eligibility criteria and longer follow-up than previous studies. A mixed-methods approach will be utilized to capture user experiences and treatment outcomes. The study seeks to address disparities in diabetes management among minoritized populations.

Who should consider this trial

Good fit: Ideal candidates are adults with a clinical diagnosis of type 1 diabetes for at least 12 months, currently using multiple daily injections, and with an A1c greater than 7.5%.

Not a fit: Patients currently using an insulin pump or closed loop system may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve diabetes management and health outcomes for underserved adults with type 1 diabetes.

How similar studies have performed: While previous studies have focused on more socially advantaged populations, this approach is novel in targeting underserved communities with type 1 diabetes.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Boston, Massachusetts and 1 other locations

• Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
• Montefiore Einstein Medical Center — The Bronx, New York, United States (Recruiting)

Study contacts

• Principal investigator: Howard Wolpert, MD — Boston Medical Center
• Study coordinator: Howard Wolpert, MD

Conditions Diabetes Mellitus, Type 1; Diabetes Complications; Hybrid closed loop; HCL pump therapy; Multiple daily injections; Continuous glucose monitoring; Glucose time-in-range; Glucose management indicator