Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution offering critical predictions to people living with diabetes 

Roche receives CE Mark for its AI-enabled continuous glucose monitoring solution offering critical predictions to people living with diabetes 

Roche has announced that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to be made available to people living with type 1 and type 2 diabetes over the age of 18 on flexible insulin therapy. 

“Maintaining optimal blood glucose levels and preventing adverse glycaemic episodes remains a complex task for people living with diabetes, often necessitating up to 180 therapy decisions a day,” said Matt Sause, CEO of Roche Diagnostics. “Our novel CGM solution with its predictive algorithms will help address significant unmet needs associated with diabetes management, empowering users to take control of their condition and live better and healthier lives.” 

Despite CGM technology’s demonstrated positive impact on glycaemic control, a significant proportion of people living with diabetes still do not meet glycaemic targets – even when using a CGM system. Moreover, they typically encounter an average of two hypoglycaemic episodes a week, with 1-2 of these being severe enough to require medical intervention each year. Notably, nighttime hypoglycaemia is associated with reduced quality of life, increased anxiety, and fear. The persistent fear of hypoglycaemia, hypoglycaemia unawareness, sleep disruption, and diabetes-related distress among CGM users frequently correlates with elevated glucose levels.