New Blood Sugar Monitor Has Warning Alarm
System Designed to Alert Diabetes Patients to High, Low Blood Sugar Levels
Feb. 11, 2004 -- The FDA today approved a new continuous blood sugar monitoring device designed to protect diabetes patients by alerting them to potentially dangerous fluctuations in blood sugar levels.
By sounding an alarm when blood sugar levels become too high or too low, the Guardian Continuous Glucose Monitoring System warns patients to take action to bring their blood sugar levels back to normal.
When blood sugar remains high, as in poorly controlled or untreated diabetes, complications such as blindness, kidney failure, amputation, impotence, and heart disease can result. Dangerously low blood sugar levels can occur from treatment, excess exercise, or nutritional problems and can result in loss of consciousness or even death.
"Each year, thousands of children with nighttime [low blood sugar] and adults who are unaware that they have [low blood sugar] are at risk of serious complications and death due to having low blood sugar," says Jeffery A. McCaulley, vice president and general manager of Medtronic's Diabetes business, in a news release. Medtronic is a WebMD sponsor.
Medtronic is working on plans to combine the continuous glucose monitoring system with a diabetes insulin pump, with the hopes of one day creating an artificial pancreas, says Scott Ward, senior vice president and president of Medtronic's Neurological and Diabetes business. If all goes as planned, this new system would not only continuously monitor blood sugar levels but would be equipped to respond to these levels with a proper dose of insulin.
The new blood sugar monitoring device is worn outside the body and uses a blood sugar sensor placed under the skin to continuously record blood sugar readings for up to three days. These blood sugar readings are transmitted to the monitor, which is designed to sound an alarm when blood sugar levels reach high or low limits preset by the patient or health care professional. Information from the blood sugar monitor can be downloaded to a computer for record keeping. The system requires a prescription and is calibrated a minimum of twice a day using a discrete blood glucose meter.
The Guardian system can be used for any type 1 or type 2 diabetes patients -- both children and adults -- to help reduce erratic blood sugar fluctuations, according to Medtronic. The system is ideal for parents closely monitoring their children's disease, patients who have lost their ability to detect rapid changes in blood sugar levels, and women with gestational diabetes or patients wishing to become pregnant.
SOURCE: News release, Medtronic Inc.