Roche, a global healthcare company, has introduced the Accu-Chek SmartGuide Continuous Glucose Monitoring (CGM) system. This innovative device helps people with diabetes monitor their blood sugar levels continuously, providing real-time data and predictive insights to manage their condition effectively.
Roche has a long history in diabetes care and is known for its Accu-Chek line of blood glucose meters. The Accu-Chek SmartGuide CGM received CE Mark approval in July 2024, allowing its use in European markets.
Accu-Chek SmartGuide CGM Specs:
- Sensor Size and Weight: Specific dimensions and weight are not detailed, but the sensor is designed to be comfortable and discreet.
- Probe Depth: The sensor uses a small filament inserted under the skin to measure glucose levels.
- Water Resistance: The sensor is water-resistant, allowing users to engage in daily activities without concern.
- Approved Age Range: Designed for adults aged 18 and older with type 1 or type 2 diabetes on flexible insulin therapy.
Application and Usage
- Ease of Application: The sensor has an all-in-one applicator for simple and quick insertion.
- Usage Duration: Each sensor lasts 14 days, reducing the frequency of replacements.
- Warm-up Time: Specific warm-up time details are not provided; users should refer to the user manual for guidance.
Glucose Measurement Method
The Accu-Chek SmartGuide CGM measures glucose levels in the interstitial fluid—the fluid between cells—providing continuous real-time data.
Accuracy and Data Updates
- Mean Absolute Relative Difference (MARD): The system has demonstrated a MARD of 9.2%, indicating high accuracy in glucose readings.
- Data Update Frequency: Glucose readings are updated every five minutes, offering timely insights for users.
- Impact of Substances on Accuracy: Users should know that certain substances may affect sensor accuracy. It’s important to consult the user manual and healthcare provider for detailed information.
Glucose Measurement Range and Historical Data
- Measurement Range: The specific glucose measurement range is not detailed; users should refer to the user manual for this information.
- Accuracy in Hypoglycemia and Hyperglycemia: The system is designed to provide accurate readings across a wide range of glucose levels, with predictive alerts for impending highs and lows.
- Historical Data Retention: The app stores CGM session and logbook data as long as the mobile device has sufficient storage space.
Components and Training
- Included Components: The system consists of the Accu-Chek SmartGuide sensor and two integrated apps—the Accu-Chek SmartGuide App and the Accu-Chek SmartGuide Predict App—for monitoring and predicting glucose levels.
- Training: Designed for user-friendly application, with guidance available through the apps and customer support.
Mobile Application and Data Viewing
- Mobile Application: The Accu-Chek SmartGuide App displays real-time glucose data, while the Accu-Chek SmartGuide Predict App offers predictive insights.
- Data Display: The apps provide current and predictive glucose information, helping users manage their diabetes proactively.
- Data Transmission Distance: Data is transmitted wirelessly to the smartphone; a typical Bluetooth range applies.
Remote Data Access and Presentation
The system allows data sharing with healthcare professionals, facilitating collaborative diabetes management.
Battery Maintenance
The sensor is designed for single use over 14 days; no battery maintenance is required.
Cost and Availability
- Cost: Pricing details are not specified; users should contact local distributors or healthcare providers for information.
- Availability: Following its CE Mark approval, the system is set to launch in selected European markets in the coming months.
Medicare and Insurance Coverage
Coverage for CGM systems varies by country and insurance provider. In Europe, the Accu-Chek SmartGuide CGM is expected to be available in selected markets following its CE Mark approval. Users should consult their healthcare providers and insurance companies to determine eligibility and coverage specifics.
Advantages:
- Provides real-time and predictive glucose monitoring.
- User-friendly application with an all-in-one