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February 28, 2024
On Feb. 21, 2024, the Food and Drug Administration (FDA) issued a safety communication warning against using “smartwatches and smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin.” None of these devices have been authorized for use, and they pose substantial risks to patients who might mistakenly rely upon them to manage diabetes.[1] By contrast, FDA-authorized devices more directly measure blood glucose, and their use typically...
February 28, 2024
On Feb. 21, 2024, the Food and Drug Administration (FDA) issued a safety communication warning against using “smartwatches and smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin.” None of these devices have been authorized for use, and they pose substantial risks to patients who might mistakenly rely upon them to manage diabetes.[1] By contrast, FDA-authorized devices more directly measure blood glucose, and their use typically involves obtaining a blood sample by piercing the skin.
Recent FDA surveillance identified “dozens of companies” and “multiple brand names” that are linked to wearable devices that purport to monitor blood glucose without piercing the skin. Thus, the FDA now recommends that consumers, patients and caregivers do not buy such smart devices, which are sold online, directly by manufacturers or in stores. The agency advised clinicians to talk to their patients about the risks of using “unauthorized blood glucose measuring devices” and to help the patients that need them select authorized devices.
Inaccurate blood glucose measurements can lead to errors in diabetes management that include incorrect dosing of insulin and other diabetes medications, which in turn can result in dangerously low or high blood glucose levels, mental confusion, coma or even death within hours of the error. FDA-authorized techniques to measure blood glucose in near real time involve finger pricks or other means of piercing the skin, which may be uncomfortable or painful, followed by the direct measurement of blood glucose. Although there are efforts underway to develop accurate noninvasive methods for measuring blood glucose (such as wearable through-the-skin sensors or saliva-based tests), those noninvasive approaches are still unproven.[2]
If you have questions about monitoring your blood glucose, consult with your clinician. To report a problem with inaccurate blood glucose measurement or adverse events related to the use of an unauthorized smartwatch or smart ring, use the Medwatch Online Voluntary Reporting Form or call 1-888-INFO-FDA (1-888-463-6332) and press 2.
References
[1] U.S. Food and Drug Administration. Do not use smartwatches or smart rings to measure blood glucose levels: FDA safety communication. February 21, 2024. https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication?utm_medium=email&utm_source=govdelivery. Accessed February 23, 2024.
[2] Moses JC, Adibi S, Wickramasinghe N, et al. Non-invasive blood glucose monitoring technology in diabetes management: review. Mhealth. 2023;10:9.
