CE Mark Approved Accu-Chek SmartGuide Enhances Diabetes Care and Quality of Life

Roche has announced that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This approval allows the technology to be available to individuals over 18 years old with type 1 and type 2 diabetes on flexible insulin therapy. Despite the demonstrated benefits of CGM technology in improving glycaemic control, many individuals with diabetes still fail to meet their glycaemic targets, even while using CGM systems.

Individuals using CGM typically experience an average of two hypoglycaemic episodes weekly, with 1-2 severe episodes annually requiring medical intervention. Nighttime hypoglycemia is particularly problematic, as it is linked to a reduced quality of life, increased anxiety, and persistent fear. These issues, along with hypoglycemia unawareness and sleep disruption, contribute to elevated glucose levels among CGM users.

The Accu-Chek SmartGuide CGM solution is designed to address these critical needs. The system's sensor measures glucose values every five minutes and transmits them to the Accu-Chek SmartGuide app in real time. Using these values, the Accu-Chek SmartGuide Predict app employs predictive algorithms to detect glucose patterns and forecast future levels.

These AI-enabled algorithms can indicate hypoglycemia risk within the next 30 minutes, predict glucose levels for the next two hours, and estimate the risk of nocturnal hypoglycemia. This capability aims to reduce concerns about nighttime hypoglycaemia and support informed self-management decisions, allowing for proactive intervention before glucose levels become critical. Clinical evaluations have shown the system's high accuracy, with a mean absolute relative difference (MARD) of 9.2% and 99.8% of glucose measurements within zones A and B on the Parkes Error Grid.

Read the HLTH Community x Roche report “Digital Health: Getting From Idea to Market” here.