Public advisory

Unauthorized blood glucose (sugar)-reading smartwatches may pose serious health risks to people with diabetes

Last updated

Summary

Product
Unauthorized blood glucose (sugar)-reading smartwatches
Issue
Health products - Unauthorized product
Medical devices - Inaccurate test or measurement results
Medical devices - Increased risk or new adverse events
Medical devices - Lack of efficacy
What to do

Do not use blood glucose-reading smartwatches that are not authorized by Health Canada. Consult a healthcare professional if you have used any of these products and have health concerns. Use only blood glucose-measuring devices listed on Health Canada's Medical Device Active License Listing (MDALL).

Affected products

Unauthorized blood glucose (sugar)-reading smartwatches

Issue

Health Canada is warning people with diabetes and parents/caregivers of people with diabetes that various social media and online retail platforms are promoting unauthorized blood glucose-reading smartwatches. These devices have not been assessed for safety and effectiveness and may pose serious health risks to consumers because they may give false blood glucose readings or they may not provide timely alerts, which could lead to errors in diabetes management.

Health Canada has authorized devices to be inserted under the patient's skin that can be used with their smartwatch or smartphone to monitor blood glucose levels. Authorized devices can be found by searching Medical Devices Active Licence Listing (MDALL). Health Canada has not authorized any smartwatches that can independently monitor blood glucose levels.

If a false blood sugar reading is used to make diabetes treatment decisions or an important alert is not provided in time, serious errors can occur such as:

  • taking too little insulin, which can lead to high blood sugar (called hyperglycemia),
  • taking too much insulin, which can lead to low blood sugar (called hypoglycemia), and
  • failing to treat low or high blood sugar.

These serious errors can lead to health consequences requiring medical treatment, such as hyperglycemic emergencies, severe low blood sugar, loss of consciousness, seizure, coma, and death.

Health Canada will take necessary action to stop the sale and advertisement of unauthorized blood glucose-reading smartwatches in Canada. The Department's compliance and enforcement approach is to mitigate the risk to Canadians using the most appropriate level of intervention, in accordance with our Compliance and enforcement policy for health products.

What you should do

  • Do not use blood glucose-reading smartwatches that are not authorized by Health Canada.
  • Consult a healthcare professional if you have used any of these products and have health concerns.
  • Talk to your healthcare professional about which blood glucose monitoring system is right for you. You can search Health Canada authorized medical devices at Medical Devices Active Licence Listing (MDALL).
  • Report any health product-related side effects or complaints to Health Canada.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Medical devices
Companies
Published by
Health Canada
Audience
General public
Health professionals
Identification number
RA-74673
Media and public enquiries

Media Enquiries:
Health Canada
613-957-2983
media@hc-sc.gc.ca

Public Enquiries:
613-957-2991
1-866-225-0709
info@hc-sc.gc.ca