The Food and Drug Administration (FDA) in the United States issued a stern warning last month, cautioning the public and healthcare professionals against the use of smartwatches and smart rings that claim to measure blood glucose levels without skin piercing. The warning extends to Indian consumers as well, given the surge in similar devices available on popular online platforms such as Amazon, Meesho, and Flipkart.
Despite the proliferation of these devices in the Indian market, no non-invasive technology for blood glucose monitoring has received approval from health regulators worldwide. This includes well-known brands like Apple, which do not offer blood glucose monitoring capabilities in their watches.
Vishal Gondal, the founder and CEO of GOQii, a preventive healthcare company selling wearable devices, emphasized that traditional methods involving skin penetration or pricking remain more reliable for monitoring blood glucose levels. Many devices claiming to measure blood glucose levels using heart rate data and algorithms are often inaccurate, with error rates sometimes exceeding 50 percent, according to Gondal.
As per global research firm Counterpoint, India witnessed a 50 percent year-on-year growth in smartwatch shipments in 2023, with over 125 active smartwatch brands. However, renowned brands like Samsung, Noise, Fire Boltt, and boAt do not provide blood glucose monitoring capabilities. Despite this, a plethora of local players claiming to offer such functionality flood online marketplaces.
Top endocrinologists have strongly discouraged the use of such tracking devices unless they are continuous glucose monitoring devices (CGMS), which are small sensors inserted under the skin. Doctors emphasize that non-piercing devices lack accuracy, and no device of this nature has gained approval from top regulators.
Dr. Ambrish Mithal, chairman and head of endocrinology and diabetes at Max Healthcare, noted that accurate blood sugar trends obtained from approved devices help doctors adjust medication and insulin doses. Anoop Misra, chairman at Fortis C-DOC Hospital for Diabetes and Allied Sciences, echoed this sentiment, advising patients to refrain from using such smartwatches.
Doctors suggest waiting for technology that addresses the issues of frequent finger pricking and discomfort associated with wearing continuous glucose monitoring devices (CGMS). While non-invasive glucose monitoring holds promise for the future, present technologies are not accurate enough for reliable monitoring, potentially leading to errors in treatment.
In February, the FDA’s warning highlighted the risks associated with smartwatches or smart rings claiming to measure blood glucose levels without skin piercing. The FDA emphasized that no authorized or approved smartwatch or smart ring for independent blood glucose measurement exists. Healthcare providers were urged to discuss the risks of using unauthorized blood glucose measuring devices with their patients.
