The FDA recently issued a warning that could impact the plans of major tech companies like Apple and Samsung to incorporate non-invasive blood glucose sensors into their smartwatches. This feature would have allowed insulin-dependent diabetics to test their blood sugar conveniently and affordably using these devices.

Currently, diabetics use a small needle called a lancet to draw blood from their finger and then place a drop of blood on an expensive non-reusable test strip inserted inside a glucometer. The first-generation smartwatch sensors might only let the user know if their blood sugar is high, but eventually, the goal is to enable users to measure their blood sugar before each meal without pain or the need for disposable test strips.

However, the FDA’s warning advised consumers not to use smartwatches or smart rings claiming to measure blood glucose levels without piercing the skin. The regulatory agency emphasized that it has not authorized any such devices for measuring or estimating blood glucose values independently.

While this warning may not halt Apple or Samsung’s plans, it highlights the potential risks of relying on inaccurate blood glucose readings. Injecting too much or too little insulin based on inaccurate measurements could lead to serious health consequences for diabetics.

In light of this warning, the FDA recommended the following precautions:

– Do not purchase or use smartwatches or smart rings claiming to measure blood glucose levels, as these devices may provide inaccurate measurements.
– Be aware that the safety and effectiveness of these unapproved devices have not been reviewed by the FDA.
– If accurate blood glucose measurements are crucial for your medical care, consult your healthcare provider about an appropriate FDA-authorized device for your needs.

It is essential for anyone relying on accurate blood glucose measurements to ensure they are using authorized and reliable devices approved by regulatory agencies like the FDA.