Swiss healthcare company Roche has received the CE mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution.
The regulatory approval provides a new monitoring solution for adult individuals living with type 1 and type 2 diabetes, using flexible insulin therapy.
Accu-Chek SmartGuide is a CGM solution designed to provide accurate real-time glucose readings and predictions for different timeframes.
The solution comprises three elements, the Accu-Chek SmartGuide CGM sensor, the Accu-Chek SmartGuide App and the Accu-Chek SmartGuide Predict App.
Accu-Chek SmartGuide easily integrates with the Accu-Chek Care platform, providing healthcare professionals with accurate therapy-relevant data from the CGM solution.
The integration allows healthcare professionals to analyse how their patient’s lifestyle and therapy affect their glucose levels and make more informed decisions.
Roche Diagnostics CEO Matt Sause said: “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.
“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.”
With an all-in-one applicator and 14-day wear time, the Accu-Chek SmartGuide CGM solution aims to address the critical unmet needs in diabetes treatment.
The Accu-Chek SmartGuide CGM sensor measures glucose values every five minutes and sends the data to the Accu-Chek SmartGuide app in real time.
The Accu-Chek SmartGuide Predict app uses glucose values and other information to detect glucose patterns and predict future glucose levels.
Its integrated AI-powered predictive algorithms indicate hypoglycaemia risk within 30 minutes, continuously forecast glucose levels, and estimate the risk of nocturnal hypoglycaemia.
Roche said that its new CGM solution showed high accuracy in clinical evaluations and is designed to mitigate the risk associated with nighttime hypoglycaemia.
