Yesterday I received a letter from Medtronic, informing me of a new approval after some recent changes to their CGMS products. Medtronic has completed a study titled “An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance” which proved that sensors can be used for 6 days instead of 3. Additionally, sensors where also tested in alternate sites, instead of just the abdomen.
According to the study “The Medtronic MiniMed Subcutaneous Glucose Sensor was originally approved by the FDA for commercialization as part of the Continuous Glucose Monitoring System (CGMS) on June 15, 1999 (PMA 980022). The Sensor is composed of a microelectrode with a thin coating of glucose oxidase beneath several layers of biocompatible membrane. This same sensor is used as part of the Guardian REAL-Time System, the latest advance in continuous glucose monitoring, which is based on the CGMS. Similar to the CGMS, the Guardian REAL-Time System has been developed for use in conjunction with a standard home blood glucose meter. The Guardian REAL-Time received regulatory approval from the FDA in 2006. As currently used, the Subcutaneous Glucose Sensor is labeled for a maximum use duration of 72 hours, using only the abdomen area as an insertion site. Recent studies have shown that the useful sensor life could extend beyond three days, and it is reasonable to expect a significant percentage of sensors to last six days. It is the goal of this study to confirm sensor performance accuracy data from one of these recent studies. The sensor is also commonly worn in body areas other than the abdomen (such as the buttock). This study will also demonstrate sensor accuracy when used in an alternate site.”
This is a very positive piece of news that means that people here in Australia can now get Continuous Monitoring for about half the cost of what was possible previously. This is particularly important since insurance coverage for CGMS is not available here in Australia and patients wanting to use it have to pay out of pocket.
Now, a lot of people where reusing the sensors to achieve the 6 day mark, even if it was not officially approved. It would be interested if that same people will now try to get it to work even longer than 6 days…