Purpose of Technology

Continuous glucose monitoring (CGM) systems are minimally invasive or noninvasive devices that measure glucose levels in interstitial fluid at frequent intervals over a period of several days. CGM systems are designed to obtain information regarding diurnal patterns in glucose levels that, when evaluated in real time or reviewed retrospectively by a physician, can guide adjustments to therapy, with the goal of improving overall glycemic control. The glucose measurements provided during continuous monitoring are not intended to replace standard self-monitoring of blood glucose (SMBG) obtained using fingerstick blood samples, but can alert the patient to the need to perform SMBG.

Questions addressed in this report include:

• Does the information obtained from CGM systems improve patient management or health outcomes in pediatric patients with type 1 diabetes?
• Does the information obtained from CGM systems improve patient management or health outcomes in adults with type 1 or type 2 diabetes?
• Does the information obtained from CGM systems improve patient management or health outcomes in pregnant women with type 1, type 2, or gestational diabetes?
• Are CGM systems safe?
• Have definitive patient selection criteria been established for CGM systems?

These questions provide a framework for review and synthesis of the best available evidence, which is presented in this report, along with the Hayes Ratings for the technology. This report also provides background information about the condition being treated, a description of the technology, and the context for development of the technology. Other key elements addressed in the report include the regulatory status; applicable Medicare and commercial payer coverage policies; relevant ICD-9 and ICD-10 diagnosis codes; cost and cost effectiveness; credentialing; hospital length of stay; need for large case management; and ongoing and future clinical trials of the technology.

Posted in Directory Reports
This entry was posted on Wednesday, December 1st, 2010 at 12:00 pm.