The Medicines and Healthcare products Regulatory Agency (MHRA) is asking patients who use a continuous glucose monitor (CGM) or insulin pump to report any safety problem with their device through the MHRA Yellow Card scheme without delay
Over 5.6 million people in the UK live with diabetes, many of whom rely on these devices to manage their condition, and their use can significantly improve the quality of life for patients.
However, adverse incidents relating to these devices can occur, and while most of these incidents do not result in harm to the patient, they can potentially lead to the incorrect amount of insulin which can lead to abnormal blood sugar levels, with potentially serious health consequences.
The MHRA utilises the Yellow Card reporting scheme for signal detection and trending activities to identify safety concerns that may require action. As of January 2023, the MHRA has received fewer than 300 Yellow Card reports from healthcare professionals and members of the public relating to these devices, which is significantly fewer than we would expect given their widespread use. The MHRA is therefore reminding users how to report adverse incidents and potential safety issues to us.
To aid this vital reporting, the MHRA has today, Tuesday 08 October, introduced new step-by-step guidance, giving individuals living with diabetes detailed information on how to report any safety concerns with their device and what information they need to include. This guidance provides examples of the types of issues which should be flagged and images to help guide users in their reporting.
Dr Alison Cave, MHRA Chief Safety Officer, said:
Douglas Twenefour, Head of Care at Diabetes UK, said:
Professor Partha Kar, NHS England Type 1 Diabetes & Technology lead, said:
The MHRA also urges people to speak to a healthcare professional without delay if they have concerns that their health may have been impacted by a potential safety issue relating to their device.
Examples of the types of issue with continuous glucose monitors and insulin pumps that should be reported include:
ENDS
Notes to Editors