Some 29 million Americans have diabetes. Between 5% and 10% of them have Type 1, an autoimmune condition in which the body is unable to convert glucose into energy. People with Type 1 diabetes rely on taking insulin and regular monitoring to make sure their blood sugar doesn’t go dangerously high or low, both of which can cause life-threatening conditions. The DexCom monitor uses a hair’s-width sensor under the skin to measure blood glucose levels every five minutes.
Notably, while the DexCom monitor is a Class III device, the software that displays the data on the Apple Watch only needs to be registered with the FDA and does not require prior marketing approval.
“We felt that the risks that the app imposed weren’t as high,” said Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health.
Of course, DexCom still needs to ensure its Apple Watch app complies with FDA rules; however, it will be able to release the app without going through an approval process.
Apple has announced that it will ship the Apple Watch in April. Please follow iClarified on Twitter, Facebook, Google+, or RSS for updates.