Reports that diabetes patients have been directly invited to trial a new insulin pen have sparked warnings about the risks of changing such devices without supervision from a nurse or doctor.
The Medicines and Healthcare products Regulatory Agency has today issued a medical device alert reminding patients to seek clinical advice before suddenly changing their insulin therapy devices.
“People have been approached to trial a new insulin delivery system”
The agency said it had been “made aware” that patients had been directly contacted by a manufacturer, or other organisation, inviting them to trial a new insulin delivery system.
In response, it said healthcare professionals were requested to have “systems in place” to remind their patients to use the devices recommended or prescribed for them by their diabetes specialist.
Clinicians should also remind patients not to stop or change their prescribed insulin management regimen without seeking the advice of their diabetes specialist and to contact their diabetes specialist if they were invited by a manufacturer to trial a new device, for example, via social media.
The response actions outlined in the alert must be underway by 9 November and completed by 21 December, said the MHRA.
It noted it was crucial that patients did not suddenly stop using or change their insulin devices without first discussing it with their diabetes specialist due to the risk of hypoglycaemia, hyperglycaemia and, potentially, diabetic ketoacidosis.
Examples of the insulin delivery systems affected by the alert included disposable patch pumps, reusable ambulatory infusion pumps, handsets and insulin cartridges, it added.
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John Wilkinson, the MHRA’s director of medical devices, said: “We have been made aware that people have been approached to trial a new insulin delivery system.
“It is vital people use insulin delivery devices which are recommended by their diabetes specialist and we urge everyone not to make changes to their device or delivery system without first seeking guidance from their specialist,” he said.
Natasha Marsland, senior clinical advisor at Diabetes UK, added: “People with diabetes should never stop using or change their insulin devices, which include insulin pens and insulin pumps, without first discussing with their healthcare team.”