The Medicines and Healthcare products Regulatory Agency (MHRA) has been made aware that patients have been directly contacted by a manufacturer or other organisation inviting them to trial a new insulin delivery system.
It is crucial people do not suddenly stop using or change their insulin devices without first discussing it with their diabetes specialist.
Patients who suddenly stop using or change their insulin delivery devices can run the risk of low blood glucose (hypoglycaemia), too much blood glucose (hyperglycaemia) and may not get the right insulin dose, risking a potentially life-threatening complication of diabetes caused by a lack of insulin in the body (diabetic ketoacidosis).
John Wilkinson, 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.
Speak to a qualified healthcare professional if you are unsure or if you have any questions.
Natasha Marsland, Senior Clinical Advisor at Diabetes UK, said:
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.
Report any issues involving medical devices to MHRA at: www.yellowcard.gov.uk
Notes to Editor
- Please see the link to the Medical Device Alert.
- Please find the link to the Yellow Card Scheme.
- MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk