FDA warning could lead Apple and Samsung to halt work on major smartwatch feature،
The FDA made an announcement yesterday that could put an end to plans by Apple and Samsung to install 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 to take before each meal, a diabetic uses a small needle called a lancet to draw blood from their finger. A drop of blood is placed on an expensive, non-reusable test strip that has already been inserted into a machine called a glucometer.
While first-generation sensors might only allow the watch owner to know if their blood sugar is high, the long-term goal is to allow the watch owner to use the device to measure their blood sugar before each meal. Through the use of a smart watch sensor, this could be done painlessly and without having to spend money on disposable test strips.
But yesterday the FDA sent a warning consumers not to use smart watches or smart rings that claim to measure blood sugar without piercing the user's skin. The regulatory agency warned that it “has not authorized, authorized or approved any smart watch or smart ring intended to measure or estimate blood glucose values on its own.”
Currently, diabetics use a glucometer to know their blood sugar levels
This warning may not stop Apple or Samsung's plans since it simply indicates that the FDA has not approved a non-invasive system for measuring a person's blood sugar. If both or either tech company got FDA approval for a method they developed, that would be a different matter.
The reason the FDA must issue this warning is because relying on an inaccurate blood sugar reading could lead the diabetic to inject too much or too little insulin. These could cause the disease to spiral out of control, destroying organs such as the eyes and heart, and possibly causing infections. Taking too much insulin could cause a hypoglycemic reaction that could lead the diabetic to pass out or even die.
The FDA made the following recommendations on Wednesday:
- Do not buy or use smart watches or smart rings claiming to measure blood sugar. These devices can be sold on online marketplaces or directly from the seller.
- Please be aware that these devices have not been reviewed by the FDA for safety and effectiveness and their use may result in inaccurate blood glucose readings.
- If your medical care depends on accurate blood sugar measurements, talk to your healthcare provider about an FDA-cleared device appropriate for your needs.
