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:
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.
Twenefour, Head of Care at Diabetes
UK, said:
Diabetes technology can be a life-changing tool, helping people
living with the condition improve their quality of life.
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.
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 &
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.
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). As part of your report, please tell us what the
readings were on both the CGM and the approved
blood glucose meter (see page 6)including the time elapsed
between the 2 readings
-
Skin reaction to the sensor adhesive. If a patch test was
carried out, please let us know.
-
Technology concerns, such as:
-
Connectivity issues between the various parts of the
diabetes management system
-
Concerns with the touchscreen, display or buttons
- Physical failures, including leaks and cracks
