The U.S. Food and Drug Administration (USFDA) has, for the first time, approved an Over-The-Counter (OTC) glucometer to monitor blood sugar levels. The integrated Continuous Glucose Monitor (iCGM) can be paired with an Apple iPhone. There are, however, some conditions and limitations, especially for diabetic patients.
Apple iPhone users who wish to monitor their blood sugar levels will now be able to purchase an FDA-approved device. Users won’t need to ask their doctors for a prescription to use this device. However, this freedom does have some caveats.
FDA Approves Dexcom’s Stelo Glucose Biosensor System As An OTC Glucometer
The USFDA has given its green signal to use Stelo, a Glucose Biosensor System from Dexcom, as an iCGM glucometer. The wearable sensor pairs with an iPhone over a Bluetooth connection.
The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM). This means it needs an active connection to the paired Apple iPhone in order to log its readings, which take place every 15 minutes. The device relies on a patch that must be stuck on the user’s arm.
Users can get readings for about 15 days from a single sensor before it needs to be replaced. Needless to add, users will need to download an app from the Apple App Store and pair the sensor. The official update from the FDA does mention that “other smart devices” could also be used with Stelo, but doesn’t elaborate on the same.
The creators of the Stelo glucometer system initially planned to sync their sensors with an Apple Watch. This may be possible in the near future. But, for now, only Apple iPhone users will be able to log their blood glucose levels using Stelo.
What Is Stelo And Will It Help Diabetic Patients Monitor Their Blood Glucose Levels?
The Stelo package includes a wearable sensor and smartphone app to continuously monitor glucose levels. Hence, anyone who owns an iPhone can slap on the sensor from Dexcom, pair it up with the app on their smartphone, and start logging readings.
However, the FDA has categorically noted that the Stelo iCGM is not for diabetic patients. In other words, Stelo is not meant for individuals with diabetes who are treating their condition with oral medications.
The FDA has approved Dexcom’s Stelo Glucose Biosensor System for adults, “who want to better understand how diet and exercise may impact blood sugar levels.” “This system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition.”
There are several smartwatches and wearable devices that currently claim to offer non-invasive blood sugar measurement. However, the FDA has warned against relying on them for medical advice citing lack of reliability. Dexcom’s Stelo essentially falls in this category, as far as diabetic patients are concerned.
2024-03-08 15:07:05