Doctor's urgent warning over condition affecting millions - 'it's serious'

An expert has issued a warning over the use of insulin pumps and continuous glucose monitors (CGMs)

Millions of diabetes patients across the UK have been alerted to a concerning shortfall in reporting issues with vital devices. Over 5.6 million individuals in the country manage their condition using insulin pumps or continuous glucose monitors (CGMs).

The Medicines and Healthcare products Regulatory Agency (MHRA) has acknowledged that while these devices are generally dependable and enhance patient quality of life, problems can arise. They suspect not all issues are being reported.

The MHRA stated: "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."

To address this, the MHRA has a "Yellow Card" scheme for reporting malfunctions, but as of January 2023, they had received less than 300 reports from healthcare professionals and the public—far fewer than expected. The agency is now urging anyone with safety concerns to report them promptly.

Dr Alison Cave, MHRA Chief Safety Officer, emphasised the importance of reporting any safety concerns regarding diabetes management devices: "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.", reports Gloucestershire Live.

She added that each report is crucial for regulatory measures: "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."

For those concerned about their diabetes devices, she advised: "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."

Douglas Twenefour, Head of Care at Diabetes UK, also commented on the significance of reporting issues with diabetes technology: "Diabetes technology can be a life-changing tool, helping people living with the condition improve their quality of life."

He acknowledged the potential for problems: "Unfortunately, we know that sometimes this technology doesn't work as intended, so it is important that users of diabetes tech have a clear and accessible way to report any issues with continuous glucose monitors, insulin pumps and pens."

Twenefour welcomed the new guidance: "Diabetes UK welcomes any guidance that gives reassurance for people using diabetes tech to highlight potential problems quickly and easily. We would encourage anyone with a concern about diabetes tech to report it, as this vital information can help improve the quality of devices."

"However, if there is any immediate concern about technology that could affect a person's safety, advice from an appropriate healthcare professional should be sought first."

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 operationally effectiveness is of paramount importance."

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: Skin reaction to the sensor adhesive.

Technology concerns, such as connectivity issues between the various parts of the diabetes management system, concerns with the touchscreen, display or buttons.