Skin Reaction Alert for FreeStyle Libre Sensor Adhesive

Peter Russell

January 29, 2019

Patients with diabetes who have experienced skin reactions when using the FreeStyle Libre (Abbott) flash glucose monitoring system have been advised not to use creams, sprays, or patches under the sensor to alleviate symptoms.

The Medicines and Healthcare products Regulatory Agency (MHRA) said using such barrier methods could affect the performance of the device.

The manufacturer has confirmed it has revised the formulation of the medical-grade adhesive, which will be available to customers in the UK from April 2019.

Itching and Blistering

In the meantime, patients who notice redness, itching, or blistering, are being advised to seek guidance from a healthcare professional on whether they should continue to use the device.

One option could be switching to an alternative glucose monitoring system. However, the MHRA said the problem may not be unique to the FreeStyle Libre sensor, and patients should also seek medical advice if they experience similar symptoms with a different brand of continuous glucose monitoring system.

John Wilkinson, MHRA director of devices, said: "It is important people can rely on their medical devices.

"If you experience skin irritation after applying the sensor of your flash glucose monitoring system you should speak with your doctor, pharmacist or diabetes management team."

Previous Studies

A study published in the journal Diabetes Technology & Therapeutics in 2015, involving 72 users of the FreeStyle Libre system observed skin issues in 202 site examinations. These included moderate to severe itching (0.5% of the time) and moderate erythema (4% of the time).

A 2017 study in The Lancet reported that 8% of FreeStyle Libre sensor users had non-serious device-related adverse events, including itchiness/rash allergy, erythema, and oedema.

In the same year, a study in the journal Contact Dermatitis suggested that some patients may have reacted to isobornyl acrylate in the adhesive in the sensor.

Libby Dowling, senior clinical advisor at Diabetes UK, said: "People with diabetes who use flash should be aware that, as per recent reports, using barrier creams or sprays could affect the performance of their glucose monitoring sensors.

"If people are having skin reactions, they should consult with their healthcare professional or pharmacist in order to get advice on the measures they should take for the performance of their device to not be affected.

"We’re reassured that the manufacturer is currently revising the formulation of the adhesive and is looking to make this available to the public in response."

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