Roche has secured the CE Mark approval for its artificial intelligence (AI)-enabled Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution.

Accu-Chek SmartGuide provides precise real-time glucose readings and predictions for various timeframes. 

The CGM has three parts including the Accu-Chek SmartGuide CGM sensor, the Accu-Chek SmartGuide app, and the Accu-Chek SmartGuide Predict app.

Accu-Chek SmartGuide features an all-in-one applicator and a wear time of 14 days. It is designed for individuals aged 18 years and older to manage diabetes type 1 and type 2 on flexible insulin therapy.

Roche has designed the CGM to empower diabetes patients by anticipating future glucose trends, enabling timely therapeutic adjustments to prevent complications.

According to the Swiss healthcare company, the solution integrates with the Accu-Chek Care platform, providing healthcare professionals (HCPs) with access to comprehensive and precise therapy-relevant data from the CGM system.

The integration allows HCPs to analyse the impact of lifestyle and treatment on glucose levels, facilitating more informed decision-making and personalised care.

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.”

The CGM solution offers real-time glucose values every five minutes via its sensor to the Accu-Chek SmartGuide app.

The app uses this data and other inputs to identify glucose patterns and predict future levels.

It employs AI-enabled algorithms to forecast glucose trends over the next two hours, detect hypoglycaemia risk within 30 minutes, and estimate the likelihood of nocturnal hypoglycaemia.  

Roche’s CGM solution is intended to lower concerns about nighttime hypoglycaemia for both individuals with diabetes and their caregivers.

In clinical evaluations, the system had shown high accuracy, with an overall mean absolute relative difference (MARD) of 9.2%, and 99.8% of measured glucose values falling within zones A and B on the Parkes Error Grid.

Additionally, its advanced predictive features demonstrated superior performance in terms of accuracy, sensitivity, specificity, and event detection.

The Swiss health technology company is planning to launch Accu-Chek SmartGuide in selected Europe countries in the upcoming months.