NCT06236607

Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Diabetes Mellitus, Type 1
• Diabetes Complications

Interventions

Type	Name	Description
DEVICE	Device specific training	Device-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs.
OTHER	Study clinician/educator visit	Participants will receive insulin dose and other diabetes management guidance.

Timeline

• Start date: 2025-02-27
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2024-02-01
• Last updated: 2026-04-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study