New CGM System Meets European Safety Standards for Insulin Dosing

Europe recently created a new framework called eCGM (European CGM) to set clear accuracy standards that continuous glucose monitors must meet. These standards are designed to ensure that CGM systems are reliable enough for people to use them when deciding how much insulin to take—without needing to confirm readings with fingerstick tests.

The stricter the accuracy requirements, the more confident people can be that their CGM readings reflect their actual blood sugar levels.

Researchers combined data from three separate clinical studies to evaluate the CareSens Air system, a continuous glucose monitor made by i-SENS. In total, 164 people with diabetes participated across these studies—86% had Type 1 diabetes, and about half were using multiple daily insulin injections.

The studies collected over 17,600 glucose readings and tested the system's accuracy across a wide range of blood sugar levels, including very low and very high readings. Researchers deliberately created meal and insulin challenges to ensure they had enough data points across the full spectrum.

The CareSens Air system met the European eCGM accuracy requirements in this analysis. Specifically, over 90% of all readings were accurate within ±20% of the reference values—the gold standard comparison method. When looking at readings in the normal to moderately high range, accuracy was even stronger, with 78.6% to 84.4% of readings falling within ±15%.

One notable finding was that the system's accuracy remained consistent throughout the sensor's lifetime, meaning early readings were just as reliable as later ones.

When a CGM system meets European standards for accuracy, it means people can use those readings to make insulin dosing decisions confidently. Some advanced insulin pumps and closed-loop systems require this level of accuracy to operate safely and effectively.

This analysis suggests that CareSens Air could be suitable for these types of integrated insulin delivery systems. However, individual experiences with any device can vary, and people using a new CGM should work with their healthcare team to understand how to use it in their specific diabetes management plan.

Source: Diabetes therapy : research, treatment and education of diabetes and related disorders. Evidence type: PubMed indexed literature. Type1Cure is an information and intelligence hub, not a medical advice service. This article summarizes published research and does not provide diagnosis, treatment, or personal medical guidance. Always talk to your own care team before changing anything about your Type 1 diabetes management.