FDA Warns Against Self-Monitoring Glucose Using Smartwatches. What About in Czechia?

According to its statement, the FDA has not yet authorized any smartwatches or rings for non-invasive blood glucose measurement. Nevertheless, many American diabetics use them for this purpose. FDA officials warn that this measurement method can be very inaccurate and lead to errors in diabetes management, which may subsequently result in incorrect insulin or other medication doses, thereby posing risks of hypoglycemia.

The FDA therefore urges diabetics not to use these devices for non-invasive glucose measurement, and calls on their attending physicians to emphasize the importance of accurate glucose measurements. The warning is general; it did not label any specific products or brands as problematic. It also does not concern devices using continuous glucose monitoring (CGM) methods, simply because CGM is an invasive method – data about glucose concentrations are obtained via a special sensor placed under the skin.

Non-invasive methods are cheap and free the patient from pricks

In connection with this issue, we asked some Czech diabetologists about their experience with this method of glucose measurement and how they communicate about it with their patients. We were also interested in whether they believe the topic should be discussed with diabetics preventively:

A patient using a smartwatch of Asian origin with this function is under the care of MUDr. Barbora Doležalová from Chrudim. Fortunately, in glucose measurement, he does not rely on them exclusively, as a sensor was implanted. However, he has a unique opportunity to assess the accuracy of the measurement method. “The trend values more or less agreed; the absolute values were not inaccurate. For the patient's orientation regarding short-term insulin doses, it suffices because he has type 2 diabetes and adjusts the dose by plus or minus 2 units, and does not experience hypoglycemia,” the physician explains. She would definitely not recommend the method to type 1 diabetics. For tech enthusiasts, she suggests re-measuring with a traditional glucometer if adjusting the insulin dose.

The non-invasive measurement method is spreading mainly because of its affordability. The price of (some) smartwatches with this function is comparable to the cost of measurement using a sensor for 4 weeks, which is significant especially if diabetics cannot have the sensor cost covered by public health insurance. The method may also be attractive to patients because it avoids regular finger pricks.

According to prof. MUDr. Alexandra Jirkovská, CSc., from the IKEM Diabetes Center, non-invasive glucose monitoring using smartwatches in the past was burdened with “quite a large” error rate, for example, during normal sweating. Most of the diabetologists surveyed expected to learn more about this topic at the World Congress of Diabetes Technology & Therapeutics.

Discuss the topic with diabetics preventively? Every diabetologist has a different opinion

For the Czech Diabetes Society ČLS JEP (ČDS), its chairman prof. MUDr. Martin Prázný, CSc., Ph.D., from the 3rd Internal Clinic - Clinic of Endocrinology and Metabolism at the First Faculty of Medicine, Charles University and General University Hospital in Prague, stated: “ČDS supports the use of certified medical devices according to applicable legislation and at the same time strives to respect patients' preferences. We cannot recommend the use of devices that determine glucose levels without sufficient accuracy to diabetic patients, especially at a time when the use and availability of accurate glucose sensors for continuous glucose monitoring is increasing. It is appropriate to educate the public that using inaccurate blood sugar values to evaluate the success of diabetes treatment can be misleading and even dangerous for treatment decisions.”

Conversely, the head of the IKEM Diabetes Center, prof. MUDr. Martin Haluzík, DrSc., who has not yet encountered this phenomenon among his patients, believes that as long as smartwatches with this function are not available in our country, there is no need to discuss the topic with patients.

MUDr. Doležalová is convinced that it is essential to monitor the development of the measuring device segment in the future, because the offer of such technological innovations will sooner or later reach our patients. “I believe that we should not hinder patient initiatives, but use them constructively. Therefore, I would suggest correlating the values from the watches with values from one or two sensors next time, pointing out possible discrepancies and the need for correlation with occasional glucometer measurements. I would deliver a definitive judgment on a specific device based on the development of glycated hemoglobin concentration values,” she concludes.

(pok)

Source: Do not use smartwatches or smart rings to measure blood glucose levels: FDA Safety Communication. FDA, 2024 Feb 21. Available at: www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication