Published on 28 April 2021

The MHRA finds people with diabetes using a brand of continuous glucose monitor device have experienced irritation to skin where patch is placed.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that they have been made aware about some users of the Dexcom G6 Sensor, a continuous glucose monitoring (CGM) system experiencing adverse skin reactions at the site of the adhesive patch.

Reported symptoms can include redness, swelling and blistering.

For certain users this is a skin hypersensitivity reaction rather than an irritation reaction.

An MHRA statement said: “We are aware that barrier creams or patches are being used by some patients to reduce the skin reactions and it is possible that the use of barrier products could affect device performance.

“This problem may not be unique to the Dexcom G6 sensor adhesive.”#

The MHRA recommend the following actions for anyone affected:

Actions for patients

  • If you are experiencing skin reactions, we would advise you to contact your healthcare professional for advice to determine if continued use of this device is suitable.

  • Report skin reactions to the device manufacturer and to MHRA via the Yellow Card scheme.

Advice for clinicians

  • Identify patients who have reported or may be experiencing skin reactions, which may include erythema, itching and blistering

  • Consider if continued use of this device for patients with skin reactions is suitable

  • Consider use of alternative glucose monitoring systems for these patients

  • Report skin reactions to the device manufacturer and to MHRA via the Yellow Card scheme.

Call to action - How you can support DRWF during this time

Sarah Tutton, Chief Executive of DRWF, said: “Research is the only way to find new treatments and a cure for diabetes. We have multi-year grant awards in place right now which we must do our utmost to honour and we must be able to react to ongoing applications that we receive for research work that could truly make a difference to the lives of people with diabetes. 

“We exist on voluntary donations and fundraised income and like most charities, Covid-19 has had a huge impact on our ability to raise the funds we need. We expect the months ahead will be just as challenging, and sadly this may have an impact on our ability to fund the volume and value of research work that could fuel the next big breakthrough.

“Charities need us, as we need them, more than ever before. Our supporters enable us to keep our research funding on track meaning that the diabetes research community has funds available to find the cure that could transform the lives of millions. We can’t thank our supporters enough for their continued support during these challenging times.”

Read Lockdown guidance for staying home and safe for people living with diabetes during Covid-19 pandemic
Read How people with diabetes could become more ill if diagnosed with Covid-19
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