Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

January 24, 2024 updated by: Boston Medical Center

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
    • New York
      • Bronx, New York, United States, 10467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of T1D for at least 12 months, on MDI for at least 6 months;
  • A1c >7.5% with no upper limit at screening (The investigator will consider the participant A1c level, compliance with current diabetes management, and prior acute diabetic complications. For this reason, there is no upper limit on A1c specified for eligibility);
  • Able to understand, speak and read English (Given the language limitations in currently available pump interfaces, subjects who are not able to understand written English will not be eligible);
  • Willingness to use either lispro or aspart insulin and no other insulin or new non-insulin diabetes pharmacotherapy during the study;
  • Total daily dose of insulin of at least 10 units/day;
  • Investigator believes that the participant will be able to successfully adhere to the study protocol.

Exclusion Criteria:

  • Current use of insulin pump or closed loop insulin pump system;
  • Unable to provide informed consent;
  • Currently taking hydroxyurea or have medical condition that may necessitate use of hydroxyurea;
  • Current use of SGLT-2 inhibitors or sulfonylureas (If using GLP-1RA, pramlintide or metformin, must be on a stable dose for 3 months prior to enrollment);
  • Tape allergy or skin condition precluding use of pump or CGM;
  • Females who are pregnant or intending to become pregnant (since automated algorithm adaption for some of the HCL systems used in the trial cannot be configured to adjust to changing insulin demands of pregnancy);
  • Current renal dialysis or plan to begin renal dialysis during study. Most recent eGFR <30 ml/min is exclusionary (within last 2 years is acceptable);
  • Active cancer treatment;
  • Extreme visual or hearing impairment that would impair ability to use CGM and pump;
  • Cognitive concerns;
  • Significant psychiatric diagnosis or substance abuse disorder that in the investigator's opinion impairs ability of the individual to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Multiple daily injections
Participants randomized into this arm will use multiple daily injections of insulin.
Other: Study clinician/educator visit
Participants will receive insulin dose and other diabetes management guidance.
Experimental: BetaBionics iLet HCL system
Participants randomized into this arm will use the BetaBionics iLet HCL system.
Device: Device specific training
Device-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs.
Experimental: Insulet OP 5 HCL system
Participants randomized into this arm will use the Insulet OP 5 HCL system.
Device: Device specific training
Device-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs.
Experimental: Tandem Control IQ HCL system
Participants randomized into this arm will use the Tandem Control IQ HCL system.
Device: Device specific training
Device-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose time-in-range (TIR) of 70-180 mg/dL
Time Frame: baseline, 39 weeks
The glucose TIR will be measured over 2 weeks using continuous glucose monitoring (CGM).
baseline, 39 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose time < 70 mg/dL
Time Frame: baseline, 39 weeks
The glucose time <70 mg/dL will be measured over 2 weeks using continuous glucose monitoring (CGM).
baseline, 39 weeks
Glucose management indicator (GMI)
Time Frame: baseline, 39 weeks
The GMI will be measured using continuous glucose monitoring (CGM).
baseline, 39 weeks
A1C
Time Frame: baseline, 39 weeks
A hemoglobin A1C test is a blood test that measures a person's average blood glucose level over the previous three months.
baseline, 39 weeks
Body weight
Time Frame: baseline, 39 weeks
Participants' body weight will be measured and recorded.
baseline, 39 weeks
Diabetic Ketoacidosis events
Time Frame: baseline, 39 weeks
Events of diabetic ketoacidosis with be abstracted electronic and medical record review and from patient report.
baseline, 39 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Howard Wolpert, MD, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-44351
  • 1R01DK138309-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Complications

Clinical Trials on Study clinician/educator visit

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe