Do Not Use Smartwatches or Smart Rings to Measure ...

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Date Released: February 21,

The U.S. Food and Drug Administration (FDA) has issued a cautionary alert regarding the usage of smartwatches or smart rings that purport to gauge blood glucose levels without the need for skin penetration. These devices are distinct from smartwatch applications that present data derived from FDA-approved blood glucose monitoring devices, such as continuous glucose monitoring (CGM) systems that do require needle-like access. Currently, the FDA has neither authorized nor approved any smartwatch or smart ring designed for the independent measurement or estimation of blood glucose levels.

For individuals managing diabetes, unreliable blood glucose readings could lead to critical errors in treatment management. This includes incorrect dosages of insulin or other medications that might significantly lower blood glucose levels. Overdosage can swiftly progress to dangerously low levels, potentially resulting in mental confusion, loss of consciousness, or even fatality within hours of the incident.

Guidelines for Consumers, Patients, and Caregivers

• Avoid purchasing or utilizing smartwatches or smart rings that claim to measure blood glucose levels. Such devices may be available through online platforms or from unauthorized sellers.
• Understand that the safety and efficacy of these devices have not been evaluated by the FDA, and relying on them could result in erroneous blood glucose readings.
• If precise blood glucose readings are critical for your health care, consult your medical provider for suitable FDA-approved devices tailored to your requirements.

Guidance for Health Care Providers

• Refer to the recommendations specified for consumers, patients, and caregivers.
• Discuss the hazards associated with the use of unapproved blood glucose measuring devices with your patients.
• Assist your patients in selecting appropriate FDA-sanctioned blood glucose measuring devices as necessary.

Device Overview

Manufacturers of these smart devices assert that their gadgets can assess blood glucose levels without drawing blood from the finger. They allege to employ non-invasive techniques. However, these smartwatches and smart rings do not perform direct blood glucose assessments.

These products are produced by various companies and marketed under different brand labels. This advisory serves any smartwatch or smart ring alleging to measure blood glucose without performing skin penetration, irrespective of the manufacturer or brand.

FDA Measures

The FDA consistently oversees the medical device marketplace and has become aware of unauthorized products targeting consumers. The agency is actively working to prevent the illegal marketing of smartwatches or smart rings that claim to measure blood glucose levels. Moreover, the FDA is informing consumers about this matter and emphasizing the importance of not employing smartwatches or smart rings for blood glucose measurement.

The FDA will provide updates to the public should significant new information emerge.

Reporting Device Malfunctions

If you suspect an issue related to inaccurate blood glucose measurements or experience any adverse reaction from using an unauthorized smartwatch or smart ring, the FDA urges you to report your experience via the MedWatch Voluntary Reporting Form.

Healthcare professionals in facilities governed by the FDA's reporting protocols should follow established reporting procedures as mandated by their institutions.

Timely reporting can facilitate enhanced patient safety by aiding the FDA in identifying and understanding risks associated with medical devices.

Any Questions?

If you have inquiries, the Division of Industry and Consumer Education (DICE) is available at the relevant contact numbers.

Devices Under Consideration

This advisory applies to any smartwatch or smart ring across all brands that claims to assess blood glucose levels.

In summary, traditional blood glucose monitors remain the standard, while new non-invasive technologies are being developed to alleviate the discomfort and inconvenience associated with glucose monitoring.

For information on alternatives to finger-pricking blood sugar monitors, a non-invasive continuous glucose monitor (CGM) might be suitable. Depending on your chosen device, a sensor may need to be periodically switched out.

Consult with your healthcare provider regarding any concerns about blood glucose monitoring and the potential benefits of non-invasive alternatives.

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