The dream of an Apple Watch which can take blood sugar readings may be some time off yet, but if you want an iPhone-enabled blood glucose monitor, you will soon be able to buy one without a prescription.
The FDA has granted approval for Dexcom’s Stelo Glucose Biosensor System, which uses a Bluetooth connection to your iPhone …
The FDA says that the device is not intended for those who have been diagnosed with low blood sugar, nor those who have been prescribed with insulin. Prescription devices are available for those patients.
The new device is geared toward non-insulin dependent diabetics, as well as anyone who may be at risk of developing diabetes.
Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM).
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 other 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.
Top comment by Dominik Hoffmann
In 1999 I interviewed with Roche Diagnostics. They had just then given up on using optical/spectroscopic methods for doing non-invasive blood glucose measurements. I think, that had been set as a goal, after it had been shown that one can measure blood oxygenation optically very well.
This means that the holy grail mentioned in the article has been pursued for over 25 years. With an expected achievement of that goal in a few years, that may turn out to be never, as it was for Roche in 1999. However, with Apple’s enormous development budget and willingness to commit to risky ventures for many years (like the Apple Car), it would be the one company I would think could possibly get there.
The FDA says that the development is an important one because not everyone has equal access to doctors, and this provides greater “health equity by moving care and wellness into the home setting.”
Dexcon says the device will go on sale in the US 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.
This does, however, remain the long-term goal, and it seems certain that we will eventually see it in an Apple Watch – but likely not for some years yet.
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