Brief 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).
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).
Brief Title
Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
617-285-9096
Central Contact Email
howard.wolpert@bmc.org
Central Contact Role
Contact
Central Contact Phone
617-638-5906
Central Contact Email
Astrid.AtakovCastillo@bmc.org
Completion Date
Completion Date Type
Estimated
Conditions
Diabetes Mellitus, Type 1
Diabetes Complications
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
Hybrid closed loop (HCL)
HCL pump therapy
Multiple daily injections (MDI)
Continuous glucose monitoring (CGM)
Glucose time-in-range (TIR)
Glucose management indicator (GMI)
Diabetic ketoacidosis
Patient reported outcomes (PRO)
Ecological momentary assessment (EMA)
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
18 Years
NCT Id
NCT06236607
Org Class
Other
Org Full Name
Boston Medical Center
Org Study Id
H-44351
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes
Primary Outcomes
Outcome Description
The glucose TIR will be measured over 2 weeks using continuous glucose monitoring (CGM).
Outcome Measure
Glucose time-in-range (TIR) of 70-180 mg/dL
Outcome Time Frame
baseline, 39 weeks
Secondary Ids
Secondary Id
1R01DK138309-01
Secondary Outcomes
Outcome Description
The glucose time \<70 mg/dL will be measured over 2 weeks using continuous glucose monitoring (CGM).
Outcome Time Frame
baseline, 39 weeks
Outcome Measure
Glucose time < 70 mg/dL
Outcome Description
The GMI will be measured using continuous glucose monitoring (CGM).
Outcome Time Frame
baseline, 39 weeks
Outcome Measure
Glucose management indicator (GMI)
Outcome Description
A hemoglobin A1C test is a blood test that measures a person's average blood glucose level over the previous three months.
Outcome Time Frame
baseline, 39 weeks
Outcome Measure
A1C
Outcome Description
Participants' body weight will be measured and recorded.
Outcome Time Frame
baseline, 39 weeks
Outcome Measure
Body weight
Outcome Description
Events of diabetic ketoacidosis with be abstracted electronic and medical record review and from patient report.
Outcome Time Frame
baseline, 39 weeks
Outcome Measure
Diabetic Ketoacidosis events
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Justin Mathew
Investigator Email
jusmathew@montefiore.org