Although an Apple Watch that can take blood sugar readings may still be a ways away, an iPhone-enabled blood glucose monitor may be available soon without a prescription.
The FDA has granted approval for Dexcom’s Stelo Glucose Biosensor System, which uses a Bluetooth connection to the user’s iPhone. The FDA has stipulated that the device is not intended for those who have been diagnosed with low blood sugar, nor those who have been prescribed insulin. Prescription devices are available for those patients. Instead, the new device is geared for non-insulin-dependent diabetics along with anyone at risk of developing diabetes.
Per the announcement:
“The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels […]
The Stelo Glucose Biosensor System uses a wearable sensor, paired with an application installed on a user’s smartphone or another smart device, to continuously measure, record, analyze and display glucose values.”
Measurements are taken automatically every 15 minutes, and each sensor can be worn for up to 15 days before replacement.
Dexcon has stated that the device will be available for retail sale in the U.S. at some point this summer.
Non-invasive blood sugar measurement remains the holy grail. It was reported last year that this was originally intended to launch as a feature of the original Apple Watch. That proved too ambitious, and the FDA recently warned people away from any non-invasive products, as they are not reliable.
Stay tuned for additional details as they become available.
One reply on “FDA grants approval for first iPhone-enabled blood glucose monitor without a prescription”
I have T2 Diabetes, but have an Apple Watch 7. Will this new technology be available to me?