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Roche receives CE Mark for its Accu-Chek SugarView app

10 December 2019

  • Accu-Chek SugarView is the first app that determines blood glucose ranges by taking photos with the smartphone camera without the need of a blood glucose meter.
  • It is designed to help non-insulin-dependent people with type 2 diabetes or pre-diabetes live healthier lives in-between doctors’ visits.
  • Type 2 diabetes is the most common form of diabetes, accounting for around 90 % of all diabetes cases.

Roche today announced that it has obtained the CE Mark for its Accu-Chek SugarView app. This paves the way for the launch of the innovative diabetes management solution in the UK, across Europe and further countries around the world requiring the CE Mark. Now officially classified as in-vitro diagnostics (IVD) software, the app will be made widely accessible by Roche first for certain smartphone models via the Google Play Store, thus enabling broader access to therapy relevant information for non-insulin dependent people with type 2 diabetes or pre-diabetes.

The Accu-Chek SugarView app determines the blood glucose range using the Accu-Chek Active test strip and two photos taken off the strip with a smartphone camera. An easy-to-follow, step-by-step guide leads the user through the testing process. A dedicated algorithm assigns the blood glucose result on the test strip to one of the categories ranging from "low" to "very high". Based on the testing result, it combines the blood glucose range with basic information on how to take action, such as exercise or eating.

“The broad launch of this state-of-the art digital solution can offer a huge benefit to people in-between doctors’ visits and to those not having access to appropriate diabetes care and blood glucose monitoring. Non-insulin dependent people with type 2 diabetes or pre-diabetes can gain a better understanding of how to live a healthier life through learning how their blood glucose range can vary as a result of their actions,” said Marcel Gmuender, Global Head of Roche Diabetes Care. “Accu-Chek SugarView is an easy-to-use app. In addition, it bypasses the need for a blood glucose meter, making it a very affordable and convenient diabetes management solution. This is especially crucial in emerging markets with often limited access to care and scarce healthcare resources, as the app enables availability of relevant therapy information and support in everyday life.”

Welcoming the news, Dr Claire Marriott, Medical Affairs Lead for Roche Diabetes Care in the UK & Ireland said: "Accu-Chek SugarView is a potentially transformative product that could enable affordable blood glucose monitoring without the use of a meter for millions of people living with, or at risk of type 2 diabetes and so we are delighted that it has been possible to meet the necessary standards for a CE mark. We look forward to engaging with the local diabetes community to understand how this new solution could add value in care pathways." 

A timeline for release in the UK and Ireland has not been confirmed, healthcare professionals interested in learning more about Accu-Chek SugarView can contact with Roche Diabetes Care Medical Affairs team on burgess_hill.dcmedinfouk@roche.com

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