Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Clinical diagnosis of T1D for at least 12 months, on MDI for at least 6 months;

• 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.

Locations
United States
Massachusetts
Boston Medical Center
RECRUITING
Boston
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Howard Wolpert, MD
howard.wolpert@bmc.org
617-285-9096
Backup
Astrid Atakov Castillo, BA
Astrid.AtakovCastillo@bmc.org
617-638-5906
Time Frame
Start Date: 2025-02-27
Estimated Completion Date: 2027-06
Participants
Target number of participants: 140
Treatments
Active_comparator: Multiple daily injections
Participants randomized into this arm will use multiple daily injections of insulin.
Experimental: BetaBionics iLet HCL system
Participants randomized into this arm will use the BetaBionics iLet HCL system.
Experimental: Insulet OP 5 HCL system
Participants randomized into this arm will use the Insulet OP 5 HCL system.
Experimental: Tandem Control IQ HCL system
Participants randomized into this arm will use the Tandem Control IQ HCL system.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Boston Medical Center

This content was sourced from clinicaltrials.gov