Planning to Buy A Smartwatch That Claims to Measure Your Blood Sugar Levels? Here’s Why You Must Think Again – News18

American health regulator Food and Drug Administration warned public and doctors last month against using smartwatches or smart rings that claim to measure blood glucose levels without skin piercing.

The warning extends to Indian consumers and healthcare providers, given the influx of similar smartwatches and devices available on online platforms like Amazon, Meesho and Flipkart.

Despite the wide array of local options on these marketplaces, no non-invasive technology for blood glucose monitoring has been approved to date by health regulators across the globe. Even Apple watches do not offer blood glucose monitoring capabilities.

According to Vishal Gondal, founder and CEO, GOQii — a preventive healthcare company which sells wearable devices — traditional methods involving skin penetration or pricking remain more reliable in monitoring blood glucose levels.

“In the market, numerous devices claim to measure blood glucose levels using heart rate data and algorithms, but these technologies are often inaccurate, with error rates sometimes exceeding 50 per cent,” he said.

According to the global research firm, Counterpoint, India’s smartwatch shipments grew 50 per cent year-on-year in 2023 registering much aggressive growth. The market saw over 125 active smartwatch brands in 2023. In fact, 54 per cent market was under the retail price band of Rs 2,000.

While most well-known brands in the smartwatch sector such as Samsung, Noise, Fire Boltt, and boAt do not provide blood glucose monitoring capabilities, a simple Google search or browsing online marketplaces reveals numerous local players claiming to offer such functionality.

“Platforms like Amazon and Flipkart are flooded with these devices, primarily from China, claiming to accurately assess various health parameters. However, their accuracy is frequently questionable, posing risks when medical decisions are based on their data,” Gondal said.

Strict “no-no” from doctors

Top endocrinologists told News18 that they have been discouraging their patients from wearing such tracking devices unless they are continuous glucose monitoring devices (CGMS). These devices are small sensors that can be inserted under the skin, typically in the belly or arm area.

According to Dr Ambrish Mithal, chairman and head, endocrinology and diabetes at Max Healthcare, “Non-piercing devices don’t ensure accuracy and no such device has been approved by top regulators.”

“Such devices can be worn by those who are wearing these watches for style statement but it’s are not accurate enough to be worn by people with diabetes,” he said, adding that accurate blood sugar trends help doctors adjust the dose of medications and insulin.

“While non-invasive glucose monitoring offers great hope for the future, at present it should be avoided as a means of monitoring. Depending on blood glucose readings obtained from such devices can lead to major errors in treatment.”

Anoop Misra, chairman at Fortis C-DOC Hospital for Diabetes and Allied Sciences, echoed the sentiment. “Almost all of my patients are on CGMS devices rather than any smartwatches for continuous glucose monitoring. I don’t encourage the use of such smartwatches.”

Doctors advise patients to hold on until the development of technology that can address the issue of frequent finger pricking or the discomfort associated with wearing continuous glucose monitoring devices (CGMS).

“The watches and devices which are used to monitor sugar non-invasively are viable but their accuracy in testing is still questionable. We need to wait till we have full-fledged technology in place and necessary approvals before it is used regularly,” said Atul Gogia, senior consultant, department of Internal Medicine at New Delhi-based Sir Ganga Ram Hospital.

US FDA’s warning

In February, the Food and Drug Administration (FDA) warned consumers, patients, caregivers, and healthcare providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin.

“These devices are different than smartwatch applications that display data from FDA-authorised blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGMs).”

It clarified that the FDA has not authorised, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own. “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,” it said.

FDA has also asked healthcare providers to talk to their patients about the risk of using unauthorised blood glucose measuring devices.