The FDA yesterday made an announcement that could put the kibosh on the plans drummed up by Apple and Samsung to put a non-invasive blood glucose sensor on their smartwatches. Such a feature would allow insulin-dependent diabetics to test their blood sugar painlessly and inexpensively using these devices. Currently, to determine how much insulin they need to take before each meal, a diabetic uses a small needle called a lancet to draw blood from his/her finger. A drop of the blood is placed on an expensive non-reusable test strip which has already been inserted inside a machine called a glucometer.
While the first-generation sensors might only let the watch owner know if his or her blood sugar is running high, eventually the goal is to allow the watch owner to use the device to measure his/her blood sugar before each meal. With the use of a smartwatch sensor, this could be done without pain and without having to spend money on disposable test strips.
But yesterday the FDA sent out a warning to consumers not to use smartwatches or smart rings that claim to measure blood glucose levels without piercing the user’s skin. The regulatory agency warned that it “has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.”
Currently, diabetics use a glucometer to obtain their blood glucose level
This warning might not stop Apple or Samsung’s plans since it just states that the FDA has not approved a non-invasive system for measuring a person’s blood glucose level. Should both or either of the two tech firms gain FDA approval for a method that they have developed, that would be another matter.
The reason why the FDA needs to issue this warning is because relying on an inaccurate blood glucose reading could lead the diabetic to inject too much or too little insulin. The latter could lead the disease to get out of hand destroying organs such as the eyes, and the heart and could cause infections. Taking too much insulin could lead to a hypoglycemic reaction which could lead the diabetic to pass out or even die.
The FDA made the following recommendations on Wednesday:
- Do not buy or use smartwatches or smart rings that claim to measure blood glucose levels. These devices may be sold through online marketplaces or directly from the seller.
- Be aware that the safety and effectiveness of these devices have not been reviewed by FDA, and the use of these devices could result in inaccurate measurements of blood glucose levels.
- If your medical care depends on accurate blood glucose measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs.
