2024-07-11| Licensing

Roche Secures CE Mark for AI-Powered Glucose Monitoring Solution, Enhancing Diabetes Care with Predictive Insights

by Bernice Lottering
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Roche has received CE Mark approval for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution, allowing distribution and use in the EEA for individuals aged 18 and older with type 1 and type 2 diabetes on flexible insulin therapy.

On July 9th, Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This milestone signifies compliance with essential health and safety standards within the European Economic Area (EEA). Consequently, the CGM system is now authorized for distribution and use among individuals aged 18 and older with type 1 and type 2 diabetes who are on flexible insulin therapy.

The Accu-Chek SmartGuide an Innovative AI Solution for Diabetes Management

The Accu-Chek SmartGuide CGM solution is an advanced medical device that helps diabetes patients effectively manage their blood glucose levels. The system provides accurate and real-time blood glucose data for 14 days. Using built-in AI algorithms, users can take proactive medical measures before blood glucose levels deviate, thereby avoiding subsequent complications.

Roche Diagnostics CEO Matt Sause stated: “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.” This new CGM system addresses a critical need in diabetes management through predictive algorithms.

Despite the advancements in CGM technology and its proven benefits in managing blood sugar levels, many people with diabetes still struggle to achieve target glucose levels. This difficulty is evident even among CGM users, who experience frequent hypoglycemic episodes, particularly at night, which can significantly impact their quality of life. The fear of hypoglycemia, coupled with its unpredictability and the associated emotional distress, often leads to higher glucose levels and worsened diabetes management outcomes.

Instant High-Accuracy Data and Disease Prediction Capability in 5 Minutes

Clinical studies have confirmed that the Accu-Chek SmartGuide CGM solution exhibits high accuracy, with a mean absolute relative difference (MARD) of 9.2%. Additionally, nearly all measured glucose values (99.8%) fall within clinically acceptable zones A and B on the Parkes Error Grid, indicating precise and reliable performance. The Parkes Error Grid categorizes blood glucose measurement device accuracy into five zones, where zones A and B indicate medically accurate results and deviations that do not lead to harmful outcomes. This classification system helps clinical doctors evaluate the reliability of blood glucose meters, ensuring patients can confidently depend on their results for precise treatment decisions.

In addition, this novel technology demonstrates good performance in accuracy, sensitivity, specificity, and detection of critical events, surpassing stringent performance benchmarks in evaluations of its predictive capabilities.

The system operates by sending real-time blood glucose values to the Accu-Chek SmartGuide app every 5 minutes. Utilizing this data and additional information, the Accu-Chek SmartGuide Predict app detects glucose patterns and predicts future levels. Integrated AI-enabled predictive algorithms assess the risk of hypoglycemia within the next 30 minutes, continuously forecast glucose trends over the next two hours, and estimate nocturnal hypoglycemia risk. Roche’s new CGM solution aims to alleviate concerns about nighttime hypoglycemia among people with diabetes and their caregivers, supporting proactive therapy management decisions and enabling interventions before glucose levels necessitate immediate attention.

Three Components of the Accu-Chek SmartGuide: A Comprehensive Integrated Diabetes Management Solution

The Accu-Chek SmartGuide Solution consists of three components: Accu-Chek SmartGuide CGM Sensor, Accu-Chek SmartGuide App, and Accu-Chek SmartGuide Predict App. The system includes an integrated application device worn for up to 14 days, enabling patients to anticipate changes in future blood glucose levels and take preventive measures promptly, adjusting treatments accordingly.

Accu-Chek SmartGuide Solution seamlessly integrates into the Accu-Chek Care platform, providing healthcare professionals (HCPs) with comprehensive and accurate treatment-related data. This integration allows HCPs to analyze with patients how lifestyle and treatments affect blood glucose levels, making more informed decisions to improve treatment outcomes.

The launch of Accu-Chek SmartGuide Continuous Glucose Monitoring Solution marks a significant advancement in diabetes management. This solution not only provides precise real-time blood glucose data but also helps diabetes patients better control their condition, prevent complications, and enhance their quality of life.

With its CE mark and launch in the European market, more diabetes patients will benefit from this innovative technology. Products bearing the CE mark can be marketed and distributed freely within the EEA, ensuring they meet the necessary requirements for consumer safety and environmental protection.

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