Benefits
Several clinical studies, including multiple randomized controlled clinical trials, have been performed to determine the benefits of using CGM devices to monitor glucose levels. Based on these studies, the following conclusions can be made on the benefits of CGM usage:
- CGMs can help with the overall management of an individual’s diabetes in predicting low and/or high glucose levels as well as tracking glucose trends over time.
- Generally, type 1 and 2 diabetics can use CGMs to help lower Hgb A1c levels.
- CGMs can assist in lowering the chance of acute diabetes complications such as ketoacidosis (DKA) and severe hypoglycemia.
- Can help make better decisions on medication, food, and exercise.
- Can decrease or eliminate the need for daily or frequent finger sticks for assessing blood glucose levels.
Note: Most individuals benefiting from CGM usage are type 1 and type 2 diabetics on insulin therapies. Indeed, most diabetics on intensive insulin therapies such as multiple daily injections or insulin pump therapy are encouraged to assess glucose levels using either a BGM or CGM before meals and snacks, at bedtime, after meals, and before physical activity.
Moreover, individuals on noninsulin therapies have not consistently shown clinically significant reductions in A1C. However, CGM usage may still be helpful for those individuals when altering nutrition plans, physical activity, and/or medications (particularly medications that can cause hypoglycemia) in conjunction with a treatment adjustment program.
Patient Criteria and Intended Use
In general, most FDA-cleared CGMs are approved for use by individuals with type 1 diabetes and type 2 diabetes who are on insulin therapy and require several daily monitoring of glucose levels for frequent adjustments of the insulin treatment based on glucose levels. The CGM also requires a prescription by the individual clinician.
In addition, more detailed patient criteria may be needed for applicable insurance coverage for a CGM. For example, Medicare requires the following patient criteria:
- Patient has type 1 or type 2 diabetes
- Patient has an insulin regimen that requires frequent adjustment based on BGM or CGM values
- Patient’s insulin regimen involves at least 3 injections per day or an insulin pump
- Patient checks blood glucose levels at least 4 times daily
The clinician has in-person patient visits every 6 months after the initial prescription for the CGM to assess adherence to CGM criteria and diabetes treatment plan.
