Hybrid Closed Loop Therapy for Type 1 Diabetes

Recruiting at 2 trial locations

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?

This trial aims to evaluate the effectiveness of different hybrid closed loop (HCL) insulin pump systems for people with type 1 diabetes (T1D) from underserved communities. These systems automatically adjust insulin delivery and may improve blood sugar management. Participants will either use one of three HCL systems or continue with regular insulin injections to compare effectiveness and user experience. The trial seeks adults with T1D who have had the condition for at least a year, use multiple daily insulin injections, and have an A1c level over 7.5% (a measure of average blood sugar levels). As an unphased trial, it offers participants the chance to contribute to significant research that could enhance diabetes management for underserved communities.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications to join the trial. If you are currently using SGLT-2 inhibitors, sulfonylureas, or hydroxyurea, you cannot participate. If you are on GLP-1RA, pramlintide, or metformin, you must be on a stable dose for 3 months before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Tandem Control IQ hybrid closed loop (HCL) system is generally safe for people with type 1 diabetes. Studies have found that it lowers A1c levels, which measure blood sugar control, without increasing the risk of low blood sugar. The system is approved for children as young as six, indicating it is well-tolerated across different ages.

The Insulet OP 5 HCL system is also considered safe, with FDA approval for children as young as two. However, it should not be used with certain medications like hydroxyurea. Some users have experienced high blood sugar levels shortly after starting the device, but these cases appear to be rare.

The BetaBionics iLet HCL system is approved for those aged six and older. Safety information suggests it helps people with type 1 diabetes manage their condition effectively. Reports of high A1c levels have occurred in users with complex medical conditions, but these are specific cases.

Overall, these systems are FDA-approved, meaning they have passed safety checks for managing type 1 diabetes. It's important to consider personal health needs and consult healthcare providers when choosing a treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hybrid Closed Loop (HCL) systems being tested for type 1 diabetes because these devices offer a more automated approach to insulin delivery than traditional methods like multiple daily injections or standard pumps. The Tandem Control IQ HCL system, Insulet OP 5 HCL system, and BetaBionics iLet HCL system each integrate continuous glucose monitoring with insulin pumping, providing real-time adjustments to insulin delivery without constant manual input. This could mean fewer blood sugar highs and lows and a more stable daily experience for users. These systems aim to simplify diabetes management, making it easier for people to maintain optimal blood glucose levels with less effort and stress.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

This trial will compare different hybrid closed-loop (HCL) systems for managing type 1 diabetes. Participants may be randomized to use the Tandem Control IQ system, which has proven to improve blood sugar control and enhance users' quality of life, maintaining blood sugar within a healthy range about 75% of the time. Another group will use the Insulet OP 5 system, which significantly lowers HbA1c levels and improves blood sugar management compared to traditional methods. The BetaBionics iLet system, newly approved by the FDA, is also being tested and has shown effective improvement in blood sugar control. These systems automate insulin delivery, simplifying life for people with diabetes. ^{6 7 8 9 10}

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

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

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

I take 10 or more units of insulin daily.

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+

Citations

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The user has multiple medical issues including poorly controlled type 1 diabetes (a1c prior to starting the ilet was 12%) and on hemodialysis.His hcp is ...