Devices for Self-management of Type 1 and Insulin-Dependent Type 2 Diabetes

On May 21, 2024, the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The MEDCAC panel will examine what clinical endpoints should be of interest to CMS in studies of new devices for self-management of type 1 and insulin-dependent type 2 diabetes in older adults. The goal of the meeting will be to provide recommendations to CMS regarding a guidance document on this topic, to be issued under the Clinical Endpoints Guidance program.

This need has arisen because the available devices for monitoring and controlling glucose levels have been studied and used primarily in individuals with type 1 diabetes, who historically have not been Medicare-age adults. Although type 2 diabetes is much more common than type 1 diabetes among older adults, better management of type I diabetes is leading to more prolonged survival among patients with type 1 diabetes and, thus, greater numbers of these individuals among the Medicare population. Furthermore, the prevalence of insulin-dependent type 2 diabetes, especially among older adults, is rising. Relevant clinical endpoints for assessing the effectiveness and safety of diabetes management devices may be unique for older adults. For example, the issue of hypotension as a complication of glucose control is a more significant issue among older compared with younger adults.

Studies of devices submitted through the Food & Drug Administration’s Breakthrough Technology pathway have often focused on shorter term data with greater reliance upon intermediate and surrogate outcomes. Although these endpoints may help in answering FDA questions on safety and efficacy, they are generally less helpful for CMS whose focus is on the more ultimate health outcomes associated with the technologies, and particularly for older adults. As a result, there are more frequent evidence gaps in the research literature with respect to the clinically meaningful health outcomes for CMS beneficiaries in assessments of these kinds of medical interventions.

For these reasons, CMS commissioned a Clinical Endpoints Review (CER) of the literature to identify endpoints that should be considered when designing studies of devices for self-management of type 1 or insulin-dependent type 2 diabetes. An endocrinologist with expertise in managing patients with diabetes contributed to the CER. The CER revealed little consensus on outcomes specific to older adults and found few definitions of minimally clinically important differences (MCIDs).

The MEDCAC panel members will make use of the CER as well as their own professional expertise in considering recommendations for CMS. A subcommittee of the full MEDCAC panel reviewed the CER along with responses to the CER from a second external endocrinologist. The subcommittee then assisted CMS in formulating voting questions and a discussion guide for the full panel meeting. By voting on specific questions, and through discussion, MEDCAC panel members will advise CMS on these issues: 1) clinical endpoints considered important for older adults and suggested instruments for measuring those endpoints, 2) MCIDs, and 3) the duration of patient follow-up necessary to demonstrate effectiveness and safety, device durability, and patient adherence.

March 26, 2024

May 2, 2024

02/08/2024 - MEDCAC subcommittee (Devices for Self-management of Type 1 and Insulin-Dependent Type 2 Diabetes)

Joseph Ross, MD, Committee Chair

Dhruva Sanket, MD, Committee Vice-Chair

Tamara Syrek Jensen, JD, Director, Coverage and Analysis Group

Tara Hall, MEDCAC Coordinator

10:00 – 10:05 AM

10:05 – 10:10 AM

10:10 – 10:25 AM

10:25 – 10:35 AM

10:35 – 11:40 AM

11:40 – 11:50 AM

11:50 – 12:35 PM

Public attendees, who have contacted the MEDCAC Coordinator prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether they have any financial involvement with manufacturers of any products being discussed or with their competitors.

12:35 – 12:50 PM

12:50 – 1:10 PM

1:10 – 2:10 PM

2:10 – 2:15 PM

Following presentations of background information and a time for public comments, the Panel will be asked to provide feedback that CMS will use to draft a Clinical Endpoints Guidance document on this topic. To that end, the remainder of the Panel meeting will be structured as follows:

*According to Endocrine Society practice guidelines, A1C should be used for glucose monitoring only on the basis of shared-decision making when patients are not in good health, i.e., they have ≥ 3 nondiabetes chronic illnesses, mild cognitive impairment, dementia (any stage), ≥ 2 ADL impairments, end-stage medical condition, or residence in a long-term nursing facility. The American Diabetes Association also cautions against using A1C to monitor patients in very poor health.

Health outcomes

Quality of life

Device-related safety