United States of America. The Food and Drug Administration has approved a new medical device that provides physicians with continuous measures of tissue glucose levels in adults with diabetes.

The Continuous Glucose Monitoring System (MiniMed) consists of a replaceable glucose sensor, a monitor and a unit with a special programme for transferring data from the monitor to a computer. The sensor is inserted under the skin at the abdomen like a tiny needle. It is connected by wire to the monitor, which is worn externally by the patient and is about the size of a pager. The sensor measures tissue glucose every five minutes and stores the data in the monitor’s memory.

After up to 72 hours, the patient removes and discards the sensor. The information collected is then transferred to a computer in a doctor’s office for review. The patient does not see the tissue glucose information while wearing the device because it is not displayed on the monitor. However, the doctor may review the results with the patient as part of ongoing therapy planning.

Diabetics currently monitor glucose by testing blood samples obtained from finger pricks several times a day. The new system is not intended to replace this standard fingerstick testing but to supplement it. The continuous glucose monitoring system is currently intended for one-time or occasional testing, rather than ongoing daily use. Diabetics must continue to do finger-stick tests while using this system.

Glucose levels can fluctuate widely throughout the day in people with diabetes: from very high to very low. This makes it difficult to determine when it is important to do finger-stick tests. Until now, there has been no way to continuously monitor these fluctuations.

Reference: HHS News P99-12, dated 16 June 1999.