Hybrid Closed Loop Therapy for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByHoward Wolpert, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston Medical Center

No Placebo Group

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).

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

I take 10 or more units of insulin daily.

I am willing to use only lispro or aspart insulin during the study.

Exclusion Criteria

I am pregnant or planning to become pregnant.

I am currently receiving treatment for cancer.

I am currently taking SGLT-2 inhibitors or sulfonylureas.

I am unable to understand and give consent for treatment.

I am currently on kidney dialysis or will start it during the study.

Participant Groups

The study tests the effectiveness of three FDA-approved Hybrid Closed Loop (HCL) systems compared to standard glucose monitoring and injection therapy in managing diabetes over a 9-month period. Participants will be randomly assigned to one of these treatments.

4Treatment groups

Experimental Treatment

Active Control

Group I: Tandem Control IQ HCL systemExperimental Treatment1 Intervention

Participants randomized into this arm will use the Tandem Control IQ HCL system.

Group II: Insulet OP 5 HCL systemExperimental Treatment1 Intervention

Participants randomized into this arm will use the Insulet OP 5 HCL system.

Group III: BetaBionics iLet HCL systemExperimental Treatment1 Intervention

Participants randomized into this arm will use the BetaBionics iLet HCL system.

Group IV: Multiple daily injectionsActive Control1 Intervention

Participants randomized into this arm will use multiple daily injections of insulin.