Minimally Invasive and Non-Invasive Glucose Meters
Researchers are exploring new technologies for glucose testing that avoid fingersticks. One of these is based on near-infrared spectroscopy for measurement of glucose. Essentially, this amounts to measuring glucose by shining a beam of light on the skin. It is painless. There are increasing numbers of reports in the scientific literature on the challenges, strengths, and weaknesses of this and other new approaches to testing glucose without fingersticks.
FDA has approved one "minimally invasive" meter and one "non-invasive" glucose meter. Neither of these should replace standard glucose testing. They are used to obtain additional glucose values between fingerstick tests. Both devices require daily calibration using standard fingerstick glucose measurements and both remain the subject of continuing studies to find how they are best used as tools for diabetes management.
MiniMed Continuous Glucose Monitoring System. The MiniMed system consists of a small plastic catheter (very small tube) inserted just under the skin. The catheter collects small amounts of liquid that is passed through a "biosensor" to measure the amount of glucose present.
Minimed is intended for occasional use and to discover trends in glucose levels during the day. It does not give you readings for individual tests and therefore you can't use it for typical day-to-day monitoring. The device collects measurements over a 72-hour period and then must be downloaded by the patient or healthcare provider. Understanding trends over time might help patients know the best time to do their standard fingerstick tests. You need a prescription to buy MiniMed.
For more information about MiniMed, use the following link: [This document is in PDF format and requires Adobe Acrobat to read.]
Mimimed Continuous Glucose Monitoring System (CGMS)
http://www.fda.gov/cdrh/pdf/p980022b.pdf
Cygnus GlucoWatch Biographer. GlucoWatch is worn on the arm like a wristwatch. It pulls tiny amounts of fluid from the skin and measures the glucose in the fluid without puncturing the skin. The device requires 3 hours to warm up after it is put on. After this, it can provide up to 3 glucose measurements per hour for 12 hours. Unlike the MiniMed device, the GlucoWatch displays results that can be read by the wearer, although like the MiniMed device, these readings are not meant to be used as replacements for fingerstick-based tests. The results are meant to show trends and patterns in glucose levels rather than report any one result alone. It is useful for detecting and evaluating episodes of hyperglycemia and hypoglycemia. However, you must confirm its results with a standard glucose meter before you take corrective action. You need a prescription to buy GlucoWatch.
For more information about GlucoWatch, use the following link:
Cygnus GlucoWatch Automatic Glucose Biographer http://www.fda.gov/cdrh/mda/docs/p990026.html
