Continuous glucose monitoring (CGM) systems have become a standard tool in diabetes management. However, the quality of CGM devices available on the market is not always consistent. For this reason, the International Diabetes Federation Europe (IDF Europe) is calling for clearer and more stringent requirements to ensure the reliability of systems that directly influence treatment decisions.
The Problem: Regulations Exist, but They Are Not Specific Enough
The current European regulatory framework for medical devices (MDR) does not adequately address the unique characteristics and challenges of CGM technology. As a result, devices with varying levels of quality can receive approval and become available to patients.
IDF Europe believes this needs to change.
EU-Level Measures: Stronger Oversight and Standardization
Key recommendations proposed by IDF Europe include:
- Strengthening EU oversight of medium- and high-risk medical devices
- Requiring mandatory post-market clinical follow-up
- Establishing harmonized assessment criteria for notified bodies responsible for device certification
- Developing dedicated regulatory guidance specifically for CGM systems
The goal is to reduce inconsistencies in quality assessment across different countries and certification bodies.
National-Level Measures: Transparency as the Foundation of Quality
IDF Europe also calls on healthcare systems to improve transparency by publishing:
- Clinical studies used to support device approval
- Accuracy metrics for all CGM systems
- Real-world performance data collected during routine use
Greater transparency would enable healthcare professionals, policymakers, and people living with diabetes to make better-informed decisions.
Technical Requirements for High-Quality CGM Systems
IDF Europe clearly outlines the characteristics that define a high-quality CGM system:
1. Accuracy in Real-World Conditions
CGM readings should closely reflect capillary blood glucose values not only in laboratory settings but also during everyday use.
2. Consistent Performance Throughout Sensor Wear
Sensor accuracy and reliability should remain stable throughout the entire wear period and should not deteriorate toward the end of the sensor's lifespan.
3. Resistance to Interference
The sensor must maintain its accuracy in the presence of substances that could potentially affect glucose readings.
4. Continuous Data Transmission
Reliable and uninterrupted data transfer is essential, particularly for connected systems such as insulin pumps and mobile applications.
5. Sensor Expiration Control
Technical safeguards should prevent the use of sensors beyond their approved wear duration. Not all users who pay for sensors out of pocket may agree with this requirement, but it is intended to ensure safety and performance.
What This Means for Users
When these standards are not met, the risk of incorrect insulin dosing increases. Automated insulin delivery and closed-loop systems become less reliable, and users may be forced to make treatment decisions based on inaccurate or incomplete data.
Conclusion
The International Diabetes Federation sends a clear message: a CGM is not a consumer gadget—it is a critical medical device.
Implementing these recommendations would help reduce the number of substandard devices reaching the market and improve the safety and effectiveness of diabetes management for people who rely on CGM technology every day.
If you're interested in this topic, be sure to read our article: "I Visited a Sensor and Pump Factory in China".
