Low Carb Program receives CE Mark approval for medical device status

Jack Woodfield
Tue, 19 Jun 2018
Low Carb Program receives CE Mark approval for medical device status
Diabetes.co.uk's award-winning Low Carb Program has received a CE Mark, meaning it is registered with the Medicines &Healthcare products Regulatory Agency (MHRA).

CE Mark approval is indicative that the Low Carb Program conforms to European Union laws as a registered medical device meeting all of the MHRA’s health and safety regulations.

The Low Carb Program, winner of the Positive Social Impact Award at the Lloyds Bank National Business Awards UK 2016, now has a community of more than 326,000 people since its inception in 2015.

The 10-week evidence-based structural behaviour intervention has helped thousands of people with type 2 diabetes control their blood sugar or even put the condition into remission. By outlining a lifestyle low in carbohydrates, supported with healthy, unprocessed fats, our users have been able to improve their health while also enjoying delicious meals.

To celebrate Diabetes Week last week, we spotlighted some of our incredible success stories on the Low Carb Program, including healthcare professional Tina Thorpe who lost 20 kg, and Mark Chadbourne who lost 42 kg and put his type 2 diabetes into remission.

This CE Mark approval adds to the recent certification of the Low Carb Program being green-lighted for NHS use by the Quality Institute for Self Management Education and Training (QISMET), a leading accreditation body.

One of the significant successes of the Low Carb Program is that on average completers achieve an HbA1c reduction of 13 mmol/mol (1.2%), and also lose 7% of their body weight. Additionally, the Low Carb Program has shown to be hugely cost effective, saving the NHS £835 per person, per year in prescription costs.

Charlotte Summers, Chief Operating Officer of Diabetes.co.uk, said: "We are delighted to receive CE Mark approval. For over two years the Low Carb Program has been showing that type 2 diabetes does not have been be a chronic or progression disease; this approval provides additional quality assurance needed to scale out the Low Carb Program and support even more people with type 2 diabetes."

Diabetes.co.uk is now in the process of launching a similar program for people with type 1 diabetes, the Type 1 Program. This upcoming program has been designed to help people with type 1 diabetes improve their blood sugar control and is currently open for people to register their interest in joining.
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