What to do for CGM device users following reports of skin reactions
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
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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.
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Report skin reactions to the device manufacturer and to MHRA via the Yellow Card scheme.
Advice for clinicians
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Identify patients who have reported or may be experiencing skin reactions, which may include erythema, itching and blistering
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Consider if continued use of this device for patients with skin reactions is suitable
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Consider use of alternative glucose monitoring systems for these patients
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Report skin reactions to the device manufacturer and to MHRA via the Yellow Card scheme.
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