Roche Wins CE Mark for its AI-Enabled Continuous Glucose Monitoring Solution

Roche has received CE Mark approval for its Accu-Chek SmartGuide CGM solution, an AI-enabled continuous glucose monitoring system that offers critical predictions for people with diabetes.

Key points:

  • The Accu-Chek SmartGuide CGM provides 14 days of accurate real-time glucose values for adults with type 1 and type 2 diabetes on flexible insulin therapy.
  • The system’s AI-trained algorithms can predict hypoglycemia risk within 30 minutes and forecast glucose levels for the next two hours.
  • The solution aims to address unmet needs in diabetes management, including nighttime hypoglycemia and the fear associated with it.

Market estimate: The global continuous glucose monitoring devices market is expected to expand at a compound annual growth rate (CAGR) of 9.6% from 2023 to 2030, according to Grand View Research.

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Revolutionary Technology Receives CE Mark

Roche has announced a significant breakthrough in diabetes management with its newly CE-marked Accu-Chek SmartGuide CGM solution. This AI-enabled continuous glucose monitoring system is set to transform the lives of people living with diabetes by offering critical predictions and real-time glucose values.

Addressing Unmet Needs in Diabetes Care

Despite advances in CGM technology, many diabetics still struggle to meet glycemic targets and face frequent hypoglycemic episodes. The Accu-Chek SmartGuide aims to tackle these challenges head-on. Matt Sause, CEO of Roche Diagnostics, emphasized, “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.”

AI-Powered Predictions: A Game-Changer

The system’s standout feature is its AI-trained algorithms, which can:

  • Predict hypoglycemia risk within the next 30 minutes
  • Forecast glucose levels for the next two hours
  • Estimate the risk of nocturnal hypoglycemia

This predictive capability allows users to intervene proactively, potentially avoiding dangerous glucose fluctuations before they occur.

Impressive Accuracy and Wear Time

Clinical evaluations have shown the system’s high accuracy, with a mean absolute relative difference (MARD) of 9.2%. The CGM sensor offers an extended 14-day wear time, providing convenience for users.

Source: https://www.globenewswire.com/news-release/2024/07/09/2910036/0/en/Roche-receives-CE-Mark-for-its-AI-enabled-continuous-glucose-monitoring-solution-offering-critical-predictions-to-people-living-with-diabetes.html

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