Hybrid Closed Loop Therapy for Type 1 Diabetes
Trial Summary
What is the purpose of this trial?
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).
Research Team
Howard Wolpert, MD
Principal Investigator
Boston Medical Center
Eligibility Criteria
This trial is for adults with Type 1 Diabetes, particularly from underserved communities who may have higher A1c levels and more complications. It's designed to be inclusive, even if participants have significantly elevated A1c values.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Device specific training
- Study clinician/educator visit
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Medical Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator