MHRA: Over 200 reports of glucose sensors falling off in 3 years

The Medicines and Healthcare products Regulatory Agency (MHRA) has received more than 200 reports of continuous glucose monitor (CGM) sensors falling off prematurely since 2019, C+D has learned.

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CGMs
The MHRA received 9,850 reports of adverse effects with CGMs • Source: Shutterstock

Diabetic patients can use CGMs to measure their glucose levels continuously by attaching a sensor to their arm or abdomen and monitoring the results through their reader or smartphone. The devices are designed to be worn for several days at a time. 

However, the MHRA received 241 reports of patients' sensors falling off prematurely over the past three years, it told C+D. However, it was unable to specify which brands of sensors were affected by this issue due to confidentiality reasons.

C+D has asked the major manufacturers of CGMs whether they have received reports of their CGMs not staying in place.

MHRA reviewing reports

An MHRA spokesperson told C+D last week (September 9) that the regulator would “continue to carefully review all reports linked to [CGMs] and will take appropriate action as necessary”.

They urged patients to report any concerns about the quality or safety of their devices through the MHRA’s Yellow Card scheme.

Patients should also “carefully follow the instructions for use provided with their CGM to reduce the risk of the sensor detaching prematurely”, and perform alternative blood glucose tests if they experience symptoms of hyper- or hypoglycaemia, they added.

In total, the medicines watchdog received 9,850 reports of patients experiencing adverse effects with their CGMs.

CGMs: A “game changer”?

Pharmacist and managing director of the Manor Pharmacy Group Graham Phillips – who founded the lifestyle programme ProLongevity to tackle “lifestyle-related diseases” such as diabetes ­– seemed unfazed by the reports of CGMs falling off.

It is quite common for this to happen, he explained, particularly in hot weather.

“If the worst thing is that they’re falling off, so what? As long as they’re being replaced,” Mr Phillips stated. Companies tend to be “pretty good at replacing” fallen off sensors, he added.

Overall, CGMs are “an absolute game changer” for patients, he said, as long as “they get the right guidance” for using them.

He is under the impression that some GPs who prescribe CGMs do not really understand how they work, leaving patients with “a very expensive technology” whose “full benefits” they cannot access.

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