Monday, July 15, 2024

Continuous Glucose Monitoring Milestone as Roche’s Accu-Chek SmartGuide Receives CE Mark

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Roche has received the CE Mark for its Accu-Chek SmartGuide® continuous glucose monitoring (CGM) solution for diabetes management, marking a significant milestone. This approval paves the way for the Accu-Chek SmartGuide to be available to adults with type 1 and type 2 diabetes on flexible insulin therapy across selected European markets in the coming months.

The Accu-Chek SmartGuide CGM solution offers 14 days of accurate, real-time glucose values. It uses AI-trained algorithms to empower users to intervene proactively when their glucose levels require attention, helping to prevent complications. “Managing optimal blood glucose levels and preventing adverse glycaemic episodes is complex, requiring up to 180 therapy decisions a day,” said Matt Sause, CEO of Roche Diagnostics. “Our novel continuous glucose monitoring solution addresses significant unmet needs in diabetes management, empowering users to take control of their condition and live healthier lives.”

Despite the proven benefits of CGM technology, a significant number of people with diabetes still do not meet their glycemic targets, even when using continuous glucose monitoring systems. Additionally, these individuals typically experience an average of two hypoglycaemic episodes a week, with one to two severe episodes requiring medical intervention each year. Nighttime hypoglycemia is particularly troubling, leading to reduced quality of life, increased anxiety, and disrupted sleep.

Roche’s Advanced CGM Solution for Accurate Continuous Glucose Monitoring and Prediction

The Accu-Chek SmartGuide CGM solution is designed to address these critical needs. Every five minutes, the continuous glucose monitoring sensor sends real-time glucose values to the Accu-Chek SmartGuide app. The Predict app then uses these values and other information to detect glucose patterns and predict future levels. Its AI-enabled predictive algorithms indicate hypoglycemia risk within the next 30 minutes, continuously forecast glucose levels for the next two hours, and estimate the risk of nocturnal hypoglycemia.

This innovative solution aims to reduce the fear of nighttime hypoglycemia, supporting informed therapy decisions and enabling proactive intervention. Clinical evaluations have demonstrated the high accuracy of the Accu-Chek SmartGuide system, with a mean absolute relative difference (MARD) of 9.2% and 99.8% of glucose values within zones A and B on the Parkes Error Grid. The predictive features also exceeded performance requirements for accuracy, sensitivity, specificity, and event detection.

The Accu-Chek SmartGuide is a CGM solution developed by Roche that provides accurate real-time glucose readings and predictions for different timeframes. It includes three elements: the continuous glucose monitoring sensor, the SmartGuide App, and the Predict App. With an all-in-one applicator and a 14-day wear time, it is designed for adults with type 1 and type 2 diabetes on flexible insulin therapy. The solution empowers users to prepare for future glucose levels and take preventive action by adjusting their therapy promptly.

Continuous Glucose Monitoring

Accu-Chek SmartGuide Integration with Care Platform Enhances Diabetes Management

The Accu-Chek SmartGuide seamlessly integrates with the Accu-Chek® Care platform, offering healthcare professionals access to comprehensive and accurate therapy-relevant data. This integration allows healthcare providers to analyze how lifestyle and therapy impact glucose levels and make more informed decisions, leading to improved outcomes.

Roche, founded in 1896 in Basel, Switzerland, has grown into the world’s largest biotechnology company and a global leader in in-vitro diagnostics. The company focuses on scientific excellence to discover and develop medicines and diagnostics that improve and save lives. Roche pioneers personalized healthcare and aims to transform healthcare delivery by combining strengths in Diagnostics and Pharma with clinical practice data insights.

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Recognizing Roche’s long-term perspective and sustainability efforts, the company has been named one of the most sustainable companies in the pharmaceutical industry by the Dow Jones Sustainability Indices for fifteen consecutive years. This distinction reflects Roche’s commitment to improving access to healthcare in collaboration with local partners worldwide. Genentech, in the United States, is a wholly owned member of the Roche Group, and Roche is the majority shareholder in Chugai Pharmaceutical, Japan.


Resource: Roche, July 09, 2024

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