There are more and more adverts on social media and online platforms for so-called 'non-invasive' glucose meters. These are devices such as smartwatches, rings or finger meters that claim to measure blood glucose levels without a finger prick and without using needles or other invasive techniques. Although this technology sounds alluring, there is no product on the European market that can do this safely and reliably.
Researchers are working intensively on a non-invasive way to measure blood sugar levels, but up until now have not been able to do so reliably enough without a finger prick or a sensor wire in tissue fluid. The non-invasive products you can find online often come from countries outside the EU, and have not undergone the necessary clinical testing and approval. The FAMHP has not yet received any official reports of incidents, but we have seen that these products are also available online in Belgium. In the online reviews, users confirm that the blood sugar values measured do not match those of their invasive glucose meters. There are suggestions that the adverts are misleading, playing on frustration with the traditional finger prick and touting cheap, painless alternatives.
What's the problem?
The measurements given by these devices are often unreliable or inaccurate. These inaccuracies can have serious consequences for patients with diabetes. Their insulin or diet regime will be based on glucose measurements. Incorrect information about blood sugar levels can result in people taking the wrong action, with the risk of:
- too low blood sugar (hypoglycaemia) when too much insulin is incorrectly administered;
- too high blood sugar (hyperglycaemia) when the actual blood sugar value is estimated too low, and not enough insulin is administered. In the long term, this can cause damage to the eyes, kidneys and heart.
Currently, no non-invasive glucose meter is recognised as a medical device within Europe. They do not feature a valid four-digit CE mark, which confirms that an independent body has tested the device for safety and effectiveness. These devices therefore cannot be legally sold in Europe.
In the interests of the health of diabetes patients, the FAMHP urges people not to be misled by these adverts and not to use these products until they have been scientifically validated.
How to choose a reliable glucose meter?
- Check that the device has a CE mark with a four-digit code.
- Check if your device is registered in Eudamed, you can easily look for glucose meters using the EMDN code W0201060102. View the list here.
- Consult the list of approved meters at the bottom of this webpage of the NIHDI; this list is not exhaustive but includes reimbursed glucose meters
- Individuals attending a diabetes convention can get information about reliable (continuous) glucose meters (CGM) through a diabetes educator.
If in doubt, it is always best to contact a health care provider.
Who watches over your safety?
Patients or caregivers who have questions about a glucose meter can contact the FAMHP at info.meddev@fagg.be.
Adverse reactions or incidents with a medical device - regardless of whether it was purchased through a pharmacy, hospital or online - can be reported to the FAMHP at vigilance.meddev@fagg.be, please use the notification form. These reports help the FAMHP monitor medical device safety and take action where necessary.
Conclusion
Don't be fooled by enticing adverts. There is currently no legal, reliable non-invasive glucose meter on the European market. Adverts claiming otherwise may be misleading and pose a health risk to patients with diabetes. It is therefore essential that users are well-informed and seek advice from their health care provider if in doubt.