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Tandem Control IQ HCL system for 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 39 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 39 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glucose time-in-range (TIR) of 70-180 mg/dL

Secondary outcome measures

A1C

Body weight

Diabetic Ketoacidosis events

+2 more

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor

382 Previous Clinical Trials

869,259 Total Patients Enrolled

3 Trials studying Diabetes

99 Patients Enrolled for Diabetes

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

2,356 Previous Clinical Trials

4,314,926 Total Patients Enrolled

107 Trials studying Diabetes

138,663 Patients Enrolled for Diabetes

Howard Wolpert, MDPrincipal InvestigatorBoston Medical Center

5 Previous Clinical Trials

58 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently ongoing efforts to enroll participants in this clinical trial?

"According to the information available on clinicaltrials.gov, this specific study is not currently accepting participants. The trial was initially posted on May 1st, 2024 and was last updated on January 24th, 2024. However, it's important to note that there are currently 1220 other studies actively seeking patients for enrollment at this time."

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