Guidance on reporting problems with continuous glucose monitoring devices for diabetes
Patients experiencing issues with insulin pumps and related diabetes management devices offered support.
People living with diabetes who use a continuous glucose monitor (CGM) or insulin pump are being asked to report any safety problem with their device.
The Medicines and Healthcare products Regulatory Agency (MHRA) has shared information about their MHRA Yellow Card scheme – and advise problems should be reported without delay.
More than 5.6 million people in the UK live with diabetes, with many using insulin pump and CGM devices to manage the condition. Using these devices can significantly improve the quality of life for people living with diabetes.
However, the MHRA reports problems with these devices can happen, and while most incidents do not result in harm to people with diabetes, they can potentially lead to the incorrect amount of insulin which can lead to abnormal blood glucose 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 had received less than 300 Yellow Card reports from healthcare professionals and members of the public relating to diabetes management devices, which is significantly fewer than expected given their widespread use.
The MHRA is reminding users how to report adverse incidents and potential safety issues.
THE MHRA has recently introduced new step-by-step guidance, providing people 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: “Patient safety is our top priority, which is why we urge anyone using devices to manage their diabetes to report to us without delay any safety concerns they may have. We know adverse incidents can occur with the use of these devices. The vast majority of these incidents don’t result in harm but potentially could have serious consequences.
“Every report is valuable to us as it will provide valuable insight and potentially inform future regulatory measures designed to protect patients. We are ready to take whatever action is needed.
If you are concerned that there is an issue with any of your diabetes devices, please use the guidance to complete a Yellow Card report online using the Yellow Card website or via the free Yellow Card app.”
Professor Partha Kar, NHS England Type 1 Diabetes and Technology lead, said: “We welcome this work and its important role in ensuring safety while we oversee the widespread adoption of diabetes technologies using continuous glucose monitors and insulin pumps.
“These devices can be life-changing for people living with diabetes, giving them the confidence to go about their days knowing they are safe and able to enjoy themselves, so their operational effectiveness is of paramount importance.
“This initiative will help to ensure standards stay at the highest level as the market continues to expand with new developers.”
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:
- Concerns with accuracy of delivery from the insulin pump (for example, suspected underdose or overdose, unexpected bolus doses, non-delivery of insulin)
- Concerns with accuracy of results from a continuous glucose monitor (CGM)
- Skin reaction to the sensor adhesive
- Technology concerns, including connectivity issues between the various parts of the diabetes management system; and concerns with the touchscreen, display or buttons
- Physical failures, including leaks and cracks
Read MHRA Guidance Report safety concerns with insulin pumps and continuous glucose monitoring equipment
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