Roche's AI-Powered CGM Accu-Chek SmartGuide Receives CE Mark, Challenging Abbott and Dexcom

Jul 10, 2024 22:15 CST Updated 22:15

Roche

Oncology Drug Research, Development, and Manufacturing

Roche announces its first CGM product--Accu-Chek SmartGuideApproved for marketing in China, it is suitable for Type 1 and Type 2 diabetes patients over 18 years old who are receiving insulin treatment.

Executive Evaluation

"For people with diabetes, maintaining optimal glucose levels and preventing adverse glucose excursions remains a complex task, often requiring up to 180 treatment decisions daily. Our new CGM solution and its predictive algorithms will help address the significant unmet needs associated with diabetes management, empowering users to take control of their condition and lead better, healthier lives."

---Matt Sause Chief Executive of Roche DiagnosticsOfficial

In the eyes of outsiders, the CGM field is already a highly competitive market. Overseas, Abbott and Dexcom basically monopolize this market, and latecomers cannot make a breakthrough unless they achieve significant technological advancements.AbbottHedekang Defense Line.

And Roche saw a breakthrough through market research.AbbottAnd Dekang Defense Line Opportunity. Roche believesDespite the proven positive impact of CGM on glucose control, a significant proportion of diabetes patients still fail to achieve their glycemic targets, even with the use of CGM.In addition, these diabetic patients usually experience hypoglycemia twice a week, with 1-2 severe episodes requiring medical intervention each year.It is worth noting that nocturnal hypoglycemia is associated with a decline in quality of life and an increase in anxiety and fear.CGM users' ongoing fear of hypoglycemia, impaired hypoglycemia awareness, sleep disruption, and diabetes-related distress is often associated with elevated blood glucose levels.

These aspects are lacking in the FreeStyle Libre series and Dexcom G series. To address this, Roche has developed a new type of CGM with AI-assisted functionality ---Accu-Chek SmartGuide。Accu-Chek SmartGuideAimed at alleviating the concerns of diabetic patients and caregivers about nocturnal hypoglycemia and reducing its risks. Meanwhile, it supports self-management treatment decisions by enabling proactive intervention before blood glucose levels require immediate attention.

Roche's clinical research shows:Accu-Chek SmartGuideWith high system accuracy, the overall mean absolute relative difference (MARD) is 9.2%, and 99.8% of the measured glucose values fall within zones A and B of the Parkes Error Grid. Evaluation of predictive capabilities shows that all advanced prediction functions exceed high-performance requirements, such as accuracy, sensitivity, specificity, and detected events.

Accu-Chek SmartGuideThe accuracy is slightly inferior compared to FreeStyle Libre 3 (MARD less than 8, only 7.9%), and also lower than Dexcom G7's 8.2%. However,Accu-Chek SmartGuideFreeStyle Libre 3 and Dexcom G7 do not have predictive capabilities.Accu-Chek SmartGuideCan predict blood glucose levels for the next 2 hours and hypoglycemia risk in half an hour, which is also Roche's entry intoFierce Competition in CGM Capital. MeanwhileAccu-Chek SmartGuideIt can also well supplement Roche's diabetes business,Especially in blood glucose monitoring, it collaborates with its Accu-Chek series of blood glucose meters to provide comprehensive blood glucose monitoring solutions for diabetes patients.

Accu-Chek SmartGuide

Accu-Chek SmartGuideIt is a new type of Continuous Glucose Monitoring (CGM) product that provides accurate real-time blood glucose readings and predictions for different time periods.

Accu-Chek SmartGuideIncluding 3 components: Accu-Chek SmartGuide CGM Sensor, Accu-Chek SmartGuide APP, and Accu-Chek SmartGuide Predict APP.

Accu-Chek SmartGuide CGM sensors are the same as Abbott's.With an integrated applicator and the ability to be worn continuously for 14 days.Accu-Chek SmartGuide CGM sensors are also waterproof.

The Accu-Chek SmartGuide CGM sensor measures glucose levels in real-time every five minutes and sends the data to the Accu-Chek SmartGuide APP. Subsequently, the Accu-Chek SmartGuide Predict APP uses these blood glucose values along with other available information to detect blood glucose patterns and predict future blood glucose levels.

The artificial intelligence predictive algorithm integrated into the Accu-Chek SmartGuide can indicate the risk of hypoglycemia within the next 30 minutes, continuously predict glucose level trends for the upcoming two hours, and estimate the risk of nocturnal hypoglycemia.

Accu-Chek SmartGuide Technical Features

Can predict blood glucose levels for the next 2 hours;
Not only displays arrows but also shows glucose curves;
Predict hypoglycemia within 30 minutes;
Predicting nocturnal hypoglycemia before bedtime;
Can be used with Apple Watch;
Calibration is required at the start of each session.

Roche

Roche is the world's largest biotechnology company and a global leader in the field of in vitro diagnostics. It pursues scientific excellence, discovering and developing medicines and diagnostic methods to improve and save the lives of people around the world. As a pioneer in personalized healthcare, Roche aims to further transform the delivery of healthcare to make an even greater impact. To provide the best care for everyone.