Roche Enters CGM Market with CE-Certified Accu-Chek SmartGuide

Source: Medtech Dive

July 9, 2024Roche announces that its first CGM (Continuous Glucose Monitoring) product – the Accu-Chek® SmartGuide CGM Solution – has received the CE mark.

This product provides 14 days of continuous real-time blood glucose monitoring for Type 1 and Type 2 diabetes patients aged 18 and above who are receiving flexible insulin therapy. Its built-in artificial intelligence training algorithm indicates the risk of hypoglycemia within the next 30 minutes, continuously predicts how glucose levels will develop over the next 2 hours, and estimates the risk of nocturnal hypoglycemia, enabling users to proactively intervene before complications occur.

The European approval of the product marks Roche's official entry into the CGM market, competing with traditional giants such as Abbott and Dexcom.

The Accu-Chek SmartGuide solution consists of three parts: the Accu-Chek SmartGuide CGM sensor, the Accu-Chek SmartGuide App, and the Accu-Chek SmartGuide Predict App.

Every five minutes, the Accu-Chek SmartGuide CGM sensor sends the real-time measured glucose values to the Accu-Chek SmartGuide interface and the Accu-Chek Smart Guide Predict app, which then use these glucose values and other available information to detect glucose patterns and predict future glucose levels. A fingerstick calibration is required when using it for the first time.

The key innovation lies in the integrated artificial intelligence prediction algorithm, which can indicate the risk of hypoglycemia in the next 30 minutes, continuously predict how glucose levels will develop over the next 2 hours, and estimate the risk of nocturnal hypoglycemia.

Therefore, Roche's new CGM solution aims to alleviate the concerns of patients with diabetes and caregivers about nocturnal hypoglycemia and reduce its risk. It is designed to support informed self-treatment management decisions, enabling patients to achieve proactive intervention before glucose levels require immediate attention.

The Accu-Chek SmartGuide solution can also seamlessly integrate with the Accu-Chek® Care platform, allowing healthcare professionals (HCPs) to access comprehensive and accurate treatment-related data provided by the CGM solution, analyze lifestyle and treatment plans together with patients, and make more informed decisions. Such personalized care can lead to better outcomes.

Despite the positive impact of existing CGM technology on blood glucose control, a significant proportion of diabetes patients still fail to achieve their glycemic targets even with the use of CGM. Such patients typically experience an average of two episodes of hypoglycemia per week, with one to two severe episodes annually requiring medical intervention. Notably, nocturnal hypoglycemia is associated with reduced quality of life and increased anxiety and fear. Persistent fear of hypoglycemia among CGM users, impaired hypoglycemia awareness, sleep disturbances, and diabetes-related distress are often correlated with elevated blood glucose levels.

Roche Diagnostics CEO Matt Sause stated: "For people with diabetes, maintaining optimal blood glucose levels and preventing adverse glucose episodes remains a complex task, often requiring 180 therapeutic decisions daily. Our innovative CGM solution and predictive algorithm will help address significant unmet needs related to diabetes management, empowering users to take control of their condition and lead better, healthier lives."

Clinical evaluation demonstrated the high system accuracy of the Accu-Chek SmartGuide solution, with an overall mean absolute relative difference (MARD) of 9.2% for measured glucose values, and 99.8% falling within zones A and B of the Parkes Error Grid. Evaluation of predictive capabilities showed that all advanced predictive features exceeded high-performance requirements, such as accuracy, sensitivity, specificity, and detected events.

Considering that Abbott's Freestyle Libre 3 has an overall MARD value of only 7.9% without the need for fingerstick calibration, and Dexcom's G7 also does not require fingerstick calibration, with an adult G7 MARD of 8.2% and a pediatric MARD of 8.1%, Roche's Accu-Chek SmartGuide still faces significant competitive pressure.

Not only that, but in March 2024, Dexcom's "Stelo Continuous Glucose Monitor" was approved, becoming the first FDA-approved over-the-counter (OTC) continuous glucose monitoring device. Stelo is based on Dexcom's existing G7 CGM platform, with each sensor wearable for approximately 15 days, longer than the company's main products, the G6 and G7 sensors.

Following the mid-2024, Abbott's two over-the-counter CGM products, Lingo and Libre Rio, received FDA approval.

This marks that CGM has expanded to the vast majority of Type 2 diabetes patients who do not use insulin injections, as well as health management for the general population. This shift signifies a further escalation in the competitive landscape of CGM.

It is expected that with the continuous increase in the number of diabetes patients and the improvement in market awareness, the industry scale will grow rapidly.

The market size of CGM in China increased from US$8.78 million in 2015 to US$100 million in 2020, and is expected to grow to US$2.6 billion by 2030, with a compound annual growth rate of 34.0% from 2020 to 2030.

Chinese CGM products have been approved intensively since 2021 and are currently rising rapidly. Leading domestic brands such as Sinocare, Yuwell, and Silicon Base have achieved breakthroughs.