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Hybrid Closed Loop Therapy for Type 1 Diabetes

N/A
Waitlist Available
Led By Howard Wolpert, MD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Total daily dose of insulin of at least 10 units/day
Willingness to use either lispro or aspart insulin and no other insulin or new non-insulin diabetes pharmacotherapy during the study
Must not have
Females who are pregnant or intending to become pregnant
Active cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 39 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the use of a new type of insulin pump therapy called hybrid closed loop (HCL) in adults with type 1 diabetes from underserved communities. Previous studies have shown that

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include risks associated with diabetic management devices such as diabetic ketoacidosis or severe hypoglycemia events due to fluctuations in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I take 10 or more units of insulin daily.
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I am willing to use only lispro or aspart insulin during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am pregnant or planning to become pregnant.
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I am currently receiving treatment for cancer.
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I am currently taking SGLT-2 inhibitors or sulfonylureas.
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I am unable to understand and give consent for treatment.
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I am currently on kidney dialysis or will start it during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 39 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 39 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Glucose time-in-range (TIR) of 70-180 mg/dL
Secondary study objectives
A1C
Body weight
Diabetic Ketoacidosis events
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
402 Previous Clinical Trials
883,755 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,692 Total Patients Enrolled
Howard Wolpert, MDPrincipal InvestigatorBoston Medical Center
5 Previous Clinical Trials
58 Total Patients Enrolled
~93 spots leftby Jun 2027
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