Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

Launched by BOSTON MEDICAL CENTER · Jan 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a new type of insulin delivery system called a hybrid closed loop (HCL) pump for adults with Type 1 Diabetes (T1D), especially those from underserved communities. The goal is to see how well this technology can help manage blood sugar levels, reduce complications, and improve the overall experience of using the pump. Participants will be randomly assigned to use one of three FDA-approved HCL systems or continue with their current treatment, which involves daily insulin injections and continuous glucose monitoring. The trial will last for 9 months, during which researchers will gather information on blood sugar control, any safety issues, and how participants feel about using the system.

To be eligible for this trial, participants must have been diagnosed with T1D for at least a year and have an average blood sugar level (A1c) over 7.5%. They should be able to read and understand English and be willing to use specific types of insulin. However, those currently using an insulin pump or with certain medical conditions, like pregnancy or severe kidney issues, cannot join. This trial is important because it aims to include more diverse participants, which can help ensure that the benefits of this technology are understood for everyone, not just those from more advantaged backgrounds.

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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.