People suffering skin reactions to the sensor adhesive on their flash glucose monitoring system must not use barrier creams, sprays or patches to reduce irritation because doing so could affect the device’s performance, the Medicines and Healthcare products Regulatory Agency (MHRA) has warned. It urged healthcare professionals to identify patients who have problems with the adhesive, and to consider whether those affected should switch to a different monitoring system.
Guidance already provided by manufacturer Abbott in the instructions for use of the FreeStyle Libre flash glucose sensor states: “Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your sensor, remove the sensor and stop using the FreeStyle Libre system. Contact your health care professional before continuing to use the FreeStyle Libre system.”
However, the MHRA reported yesterday that some users who are experiencing an immune response to the adhesive are applying barrier creams, patches or sprays under their sensor to reduce skin reactions. It warned that these barrier methods have not been tested by the manufacturer and might therefore affect the performance of the device.
The Agency said: “The severity of the skin reaction can vary from person to person and for certain users this is a skin hypersensitivity reaction rather than an irritation reaction. For this type of reaction, once the person has become sensitised to the adhesive, every time the sensor is reapplied a skin reaction will occur. With each reapplication, the symptoms might appear more quickly and may worsen.”
It said healthcare professionals should:
- 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.
The MHRA pointed out that this problem might not be unique to the Abbott FreeStyle Libre sensor adhesive, and users of a different brand of continuous glucose monitoring system who experience similar symptoms should also seek guidance from a healthcare professional on continuing the use of their device.
It added that Abbott has confirmed that it has revised the formulation of the adhesive, which will be available to customers in the UK from April 2019.
John Wilkinson, MHRA director of devices, said the Agency encourages patients as well as doctors and pharmacists to use the Yellow Card Scheme to report any issues with medical devices. He 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.”
Libby Dowling, senior clinical advisor at the charity Diabetes UK, commented: “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.”