The MiniMed continuous glucose monitoring system.

S-13 DIABETES is a major source of morbidity, mortality, and economic expense. All patients with type 1 diabetes and an estimated 3–4 million patients in the United States with type 2 diabetes must take insulin to control their glucose levels. The majority of these patients selfmonitor their blood glucose one or more times each day, using fingerstick blood sampling and analysis with a portable glucose meter device. Approximately 200,000 type 1 diabetes patients in the United States practice intensive insulin therapy, requiring four or more blood glucose measurements each day coupled with either multiple daily injections of insulin or an insulin pump. The Diabetes Control and Complications Trial (DCCT) clearly demonstrated the importance of frequent self-monitoring of blood glucose (SMBG) in attaining tight glycemic control.1 Patients undergoing intensive therapy had a 39–76% reduced occurrence of long-term complications as compared to patients treated with conventional therapy. The primary drawback of intensive therapy was a threefold increase in the occurrence of severe hypoglycemia, despite performing four or more SMBG tests per day. Consequently, methods to improve the ability to achieve intensive control without hypoglycemia are being explored. There is a tremendous need to develop and commercialize a truly simple, accurate method of measuring glucose that can provide a basis for more accurate and directed disease selfmanagement. Generally, it is not practical to perform SMBG frequently enough throughout the day to accurately identify every blood glucose excursion. MiniMed® has taken a first step in advancing the practice of glucose self-monitoring by developing a short-term, continuous glucose sensor. The sensor is inserted subcutaneously and is capable of reliable operation for up to 3 days, followed by replacement with a new sensor at a different location, if necessary. The assay method is based on electrochemical detection of glucose through its reaction with glucose oxidase. Data are collected once every 5 min by a pager-sized monitor device and can be periodically downloaded into a computer for analysis and interpretation. In future product iterations, the sensor will function as a hypoglycemia and hyperglycemia alarm, by notifying the user when blood glucose levels reach preselected thresholds (such as 60 mg/dL and 200 mg/dL), and will provide real-time glucose readouts. The alarm feature will be especially important in patients with hypoglycemic unawareness, which is believed to occur in anywhere from 25% to 50% of patients with type 1 diabetes,2 especially those who have neuropathy or those without complications who are following intensive glycemic control regimens.3 Fanelli et al.4 have shown that meticulous control to prevent low glucose excursions can result in a significant recovery of hypoglycemic awareness.