FDA APPROVES NEW GLUCOSE MONITORING SYSTEM FOR DIABETICS
FDA approved a new medical device that provides physicians with continuous measures of tissue glucose levels in adults with diabetes. The product is the first of its kind.
The Continuous Glucose Monitoring System, made by MiniMed Inc., of Sylmar, Calif., records tissue glucose levels at five-minute intervals for up to three days. The information is then downloaded on a computer for review by health care professionals.
"Continuous tissue glucose monitoring is breakthrough technology that ultimately could revolutionize the care of diabetics," said FDA Commissioner Jane E. Henney, M.D. "This new system is a first step in that direction. It identifies patterns or trends in the fluctuation of a patient's glucose level above or below the desired range. That information can help the doctor make adjustments in therapy."
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.
The continuous glucose monitoring system is currently intended for one-time or occasional testing, rather than ongoing daily use. The information collected is intended to supplement that obtained by standard fingerstick testing. Diabetics must continue to do fingerstick tests while using the 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 fingerstick tests. Until now, there has been no way to continuously monitor those fluctuations.
The new system, available only by prescription, consists of a replaceable glucose sensor, a monitor, and a unit with a special program for transferring data from the monitor to a computer.
The sensor, which contains a glucose-sensing mechanism, is inserted under the skin at the abdomen like a tiny needle. The sensor 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.
FDA based approval of the monitoring system on results of a study involving more than 7,000 glucose readings in 62 diabetic adults who were evaluated at four medical centers in the United States.
The study showed that the system could help identify glucose trends and supplement standard readings obtained with traditional blood glucose fingerstick measurements.
Diabetes mellitus is a chronic disease that affects the body's ability to produce or respond to insulin, a hormone that allows blood glucose to enter the body's cells and be used for energy. There are two main forms of diabetes mellitus: Type I, which occurs mainly in young people and is controlled by diet and daily injections of insulin, and Type II, which usually affects overweight people over 40 and can be controlled in most cases by diet alone.
The MiniMed system was approved for use based on experience in Type I patients. As a condition of approval, FDA is requiring the manufacturer to conduct post-marketing studies to assess its safety and effectiveness in people with other types of diabetes, as well as in children and non-Caucasians.
An estimated 16 million people in the United States have diabetes. While there is no known cure, studies have shown that patients who regularly monitor their blood glucose levels and work closely with their healthcare providers have fewer complications such as blindness, amputation and heart disease.
