Roche has received CE mark approval for its AI-enabled Accu-Chek SmartGuide continuous glucose monitoring (CGM) system, designed for adults with type 1 and type 2 diabetes on flexible insulin therapy. The system, which features a 14-day wear time and a one-step application process, uses predictive AI to provide real-time glucose predictions and assess hypoglycemia risk with clinical evaluations showing high accuracy, with 99.8% of glucose values within acceptable zones.

The following article originally appeared in Drug Delivery Business News.

Roche announced today that it received CE mark approval for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) system.

CE mark approval covers the use of the CGM for people over 18 with type 1 and type 2 diabetes on flexible insulin therapy.

The company first unveiled its Accu-Chek SmartGuide in an event at the Advanced Technologies & Treatments for Diabetes (ATTD) conference earlier this year. Accu-Chek SmartGuide features a 14-day wear time, a one-step application process and watertight properties.

Accu-Chek SmartGuide also utilizes predictive AI to provide glucose predictions showing estimated developments for different timeframes. Based on the CGM data, the system’s app shows where glucose levels might go in the next two hours.

Roche says it designed the CGM to address the critical unmet needs associated with managing diabetes and glycemic targets. Every five minutes, the CGM sensor sends glucose values measured in real time to an application. The predictive app then utilizes those values and other available information to detect patterns and predict future glucose levels. Integrated AI helps to indicate hypoglycemia risk within the next 30 minutes. It also helps to forecast low glucose levels and estimate the risk of nocturnal hypoglycemia.

Clinical evaluations of the Roche CGM delivered a mean absolute relative difference (MARD) — a measure of CGM accuracy — of 9.2%. Roche reports that 99.8% of measured glucose values fall within zones A and B on the Parkes Error Grid. The CGM’s predictive capabilities also exceeded performance requirements such as accuracy, sensitivity, specificity and events detected.

“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.”

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