Hybrid Closed-Loop Insulin Delivery Systems for People With Type 1 Diabetes

Abstract


 Blood glucose monitoring and insulin delivery are essential parts of the management of type 1 diabetes. Hybrid closed-loop insulin delivery (HCL) systems are a treatment option for people with type 1 diabetes and consist of an insulin pump, a continuous glucose monitor (CGM), and a computer program (algorithm) that allows the devices to communicate with each other and calculates insulin needs.
 CADTH conducted a Health Technology Assessment (HTA) of the use of HCL systems compared to other insulin delivery methods in people with type 1 diabetes to inform decisions regarding whether HCL systems have a place in the management of type 1 diabetes.
 HCL therapy generally improved the amount of time a person spent in target blood glucose ranges. Additionally, people who used HCL systems had improved average blood glucose levels (glycated hemoglobin [A1C]) over the preceding 2 or 3 months. However, the effectiveness or safety of HCL systems based on age, sex, race, glucose management, or other clinical features (e.g., those who are pregnant or planning pregnancy, or who have hypoglycemia unawareness or a history of severe hypoglycemia) is unknown. HCL systems were generally as safe as other insulin delivery methods. Additional studies with longer follow-up periods and more participants are needed to confirm the clinical effectiveness and safety of HCL systems.
 From a pan-Canadian, publicly funded health care system perspective, the cost of covering HCL systems for individuals with type 1 diabetes who are eligible for insulin pumps in their jurisdictions was estimated to be an additional $822,635,045 over 3 years compared with diabetes supplies that are currently covered. If HCL systems are covered for all individuals with type 1 diabetes, regardless of their current insulin-pump eligibility, the budget impact will be higher.
 HCL systems can help provide distance from demanding self-management and monitoring tasks for people living with type 1 diabetes; however, in order to do this, people using these systems must navigate complex relationships built on trust and collaboration. Given that type 1 diabetes self-management to date has required considerable attention to blood glucose numbers and technical tasks, developing these relationships of trust and collaboration will require a shift in understanding what it means to care for someone who has — or to self-manage — type 1 diabetes.
 It is not possible to conclude whether HCL systems will improve overall population health over the longer-term because the data for this are not available. It is also unclear which people with type 1 diabetes would benefit most from HCL systems. Eligibility criteria for the existing public insulin-pump program may be useful in making coverage decisions; trial periods may be considered to ensure HCL systems are working well for new users.
 Education and support are needed for people living with type 1 diabetes when they start to use HCL systems. Clinicians noted the need for interactions between diabetes educators and HCL system pump users. User-friendly devices and understandable reports are key to effective use.
 Eligibility for access through any publicly funded program for HCL systems should be based on evidence. The criteria for coverage should be consistent with broader public health goals and should not contribute to existing inequities in diabetes management.