Hybrid Closed Loop Therapy for Type 1 Diabetes

Recruiting at 1 trial location

Overseen By Astrid Atakov Castillo, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Must be taking: Lispro, Aspart

Must not be taking: Hydroxyurea, SGLT-2 inhibitors

Disqualifiers: Renal dialysis, Active cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 39 weeks

140 Participants Needed

What You Need to Know Before You Apply

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).

Who Is on the Research Team?

Howard Wolpert, MD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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

My A1c level is above 7.5% at the time of screening.

I take 10 or more units of insulin daily.

Investigator believes that the participant will be able to successfully adhere to the study protocol

Exclusion Criteria

I am pregnant or planning to become pregnant.

I am currently receiving treatment for cancer.

I have concerns about my memory or thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy

39 weeks

Regular visits for monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Device specific training
• Study clinician/educator visit

Trial Overview 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.

How Is the Trial Designed?

Group I: Tandem Control IQ HCL system Experimental Treatment 1 Intervention

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

Group II: Insulet OP 5 HCL system Experimental Treatment 1 Intervention

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

Group III: BetaBionics iLet HCL system Experimental Treatment 1 Intervention

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

Group IV: Multiple daily injections Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+