Managed Care - August 2008 - (Page 40) Evaluation of a Continuous Glucose Monitoring System for Home-Use Conditions Bruce Bode, MD1, Michael Silver, MD2, Richard Weiss, MS,3 Kathryn Martin, PharmD.3 1 3 Atlanta Diabetes Associates; 2Medical Director, United Health Care, NewYork Managed Solutions, Mount Freedom, New Jersey INTRODUCTION The cost burden of diabetes is significant. In 2007, the total costs associated with the disease were estimated at $174 billion (ADA 2008). Patients diagnosed with diabetes incur 2.3 times higher medical expenditures than those without the disease. Hypoglycemia severe enough to warrant third-party intervention results in mean costs exceeding $1,000 per episode (Bullano 2005, Heaton 2003). Several landmark trials have confirmed that tighter control of diabetes improves clinical outcomes (UKPDS Group 1998, DCCTRG 1993). The adoption of an intensive form of diabetes management can, however, come with increased risk, as was reported in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial (NHLBI 2008). There is speculation that the increased risk of Disclosures The authors disclose that they have received compensation from Abbott Diabetes Care for drafting, writing, and coordination of this manuscript during the publication process. ABSTRACT Objective: To evaluate the safety and effectiveness of the FreeStyle Navigator Continuous Glucose Monitoring System when used by adult patients with type 1 or 2 diabetes requiring insulin in the home environment. Research design and methods: Multicenter, prospective study enrolling 137 subjects. This was a two-phase study consisting of 20 days of use (“masked period”) without access to continuous glucose readings followed by 21 days of use (‘”unmasked period”) with access to continuous glucose readings and glucose alarms. At the conclusion of the study, all subjects were asked to complete a User’s Questionnaire. Results: A total of 11,487 paired continuous glucose sensor and blood glucose reference results from 961 sensors were evaluated; 77.2 percent were in Clarke error grid zone A and 19.6 percent were in zone B. Only 13.1 percent of the hypoglycemic and 0.5 percent of the hyperglycemic threshold alarms were false alerts. Subjects with type 1 diabetes demonstrated a 55 percent reduction in time spent with significant hypoglycemia (below 55 mg/dL) (P<.0001) from masked to unmasked periods. Their average number of hypoglycemic episodes (below 70 mg/dL) per day fell from 1.1 to 0.8 (P<.0001). Results from patient questionnaires demonstrated high levels of subject satisfaction and the ability to use and understand the system. Conclusions: FreeStyle Navigator Continuous Glucose Monitoring System is safe and effective, and results in a high level of subject satisfaction while used in the home setting. Utilization of continuous glucose monitors with alerts may result in cost offsets by reducing the number and severity of clinically significant events and assisting in the maintenance of optimal glycemic control. Key words: diabetes, continuous glucose monitor, FreeStyle Navigator Author correspondence Kathryn Martin, PharmD Managed Solutions P.O. Box 526 Mount Freedom, NJ 07970 E-mail: kmmartin@optonline.net Phone: (845) 357-5042 Fax: (845) 357-5091 cardiovascular death may be due to higher baseline cardiovascular risk; however, this has yet to be confirmed. Intensive management of diabetes would, therefore, require close monitoring of glycemic control with the goal of maintaining blood glucose levels within a defined optimal range (70–180 mg/dL) (ADA 2005). Continuous glucose monitoring (CGM) provides greater information regarding glycemic control than episodic blood glucose measurements. CGM has the ability to indicate a rate of change both in numeric form and through the use of prospective, directional trend arrows. In addition, alarms are activated when glucose levels approach critical hypoglycemic or hyperglycemic values. CGM provides the patient and health care provider with access to retrospective continuous glucose data over clinically relevant periods of 40 MANAGED CARE / AUGUST 2008
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