Diabetes mellitus is a chronic condition associated with abnormally high levels of glucose in the blood whereas the body does not produce enough insulin or the insulin that is produced is ineffective. The blood sugar level may be monitored by the patient at various frequencies. The high blood glucose levels can sometimes be controlled with diet and exercise alone but may also require the use of insulin or other medications. The main goal of diabetes management is to control blood glucose levels and thereby to prevent the complications of diabetes. Diabetes when not well controlled is a leading cause of adult blindness, lower-limb amputation and kidney disease. The hemoglobin A1C test is a blood test that measures average blood glucose control over a three-month period that helps to identify longer-term trends in glucose levels and where adjustments in treatment are needed.
The MCAC will be reviewing evidence on:
(1) glycemic control using continuous glucose monitors;
(2) the relationship of outpatient glucose monitoring (type and frequency) to glycemic control and/or clinical outcomes in the various Medicare populations;
(3) the relationship of outpatient glycemic control to the clinical outcomes in the various Medicare populations;
(4) The linearity of the effects of glycemic control; and
(5) the relationship of increase hypoglycemic risk to glycemic control and/or clinical outcomes.
The clinical outcomes reviewed will include blunting the progression of disease, reversing diabetic complications, and altering morbidity/mortality in the Medicare populations.
The role of variables such as the type of diabetes, the therapeutic regimen employed, the age of hyperglycemic onset, the duration of diabetes, the duration of poor glycemic control, the level of hyperglycemia, and concomitant disease will be discussed.
In addition to evaluating the available data, the committee will identify areas in which the current data are deficient and in which additional research is warranted.