Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06236607
• Other study ID #: H-44351
• Secondary ID: 1R01DK138309-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: Boston Medical Center
• Contact: Howard Wolpert, MD
• Phone: 617-285-9096
• Email: howard.wolpert[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Other:
• Study clinician/educator visit
Participants will receive insulin dose and other diabetes management guidance.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose time-in-range (TIR) of 70-180 mg/dL	The glucose TIR will be measured over 2 weeks using continuous glucose monitoring (CGM).	baseline, 39 weeks
Secondary	Glucose time < 70 mg/dL	The glucose time <70 mg/dL will be measured over 2 weeks using continuous glucose monitoring (CGM).	baseline, 39 weeks
Secondary	Glucose management indicator (GMI)	The GMI will be measured using continuous glucose monitoring (CGM).	baseline, 39 weeks
Secondary	A1C	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
Secondary	Body weight	Participants' body weight will be measured and recorded.	baseline, 39 weeks
Secondary	Diabetic Ketoacidosis events	Events of diabetic ketoacidosis with be abstracted electronic and medical record review and from patient report.	baseline, 39 weeks