i-SENS' 'CareSens Air' meets European CGM accuracy standards

[Financial News] i-SENS' continuous glucose monitoring (CGM) system, 'CareSens Air,' has met all accuracy requirements under eCGM, a CGM performance standard proposed by European experts. Notably, even in the hypoglycemic range, where accuracy is relatively difficult to achieve, 91.0% of readings were within ±15 mg/dL of the reference blood glucose value.
On the 12th, i-SENS said an integrated analysis of data from three clinical trials conducted in South Korea and Germany found that CareSens Air met all eCGM accuracy requirements assessed in the study. The researchers described it as the first case in which a CGM system was explicitly shown to meet those criteria. The findings were published in Diabetes Therapy, an international journal specializing in diabetes.
eCGM is a performance standard proposed by European experts to assess the accuracy and reliability of CGM systems. It comprehensively evaluates accuracy across low, normal and high glucose ranges, measurement errors, and the direction of glucose changes. It also imposes strict requirements on clinical study size and the distribution of blood glucose data. Its key accuracy requirements are similar to those of the integrated continuous glucose monitoring (iCGM) standard set by the U.S. Food and Drug Administration (FDA).
The analysis used data from two previous clinical studies and one post-market clinical follow-up (PMCF) study conducted in Germany. Additional studies were included to supplement the data for the low and high glucose ranges.
The analysis found that 91.0% of readings in the hypoglycemic range were within ±15 mg/dL of the reference blood glucose value. The one-sided 95% lower confidence bound for that proportion was also 88.5%, above the eCGM requirement of 85%.
Performance stability throughout the sensor-wear period was also confirmed. Accuracy remained stable after the initial wear period during the 15-day sensor-use period, and average data availability was 99.7%. Data availability refers to the proportion of expected readings for which data were actually obtained.
The researchers said the results could provide performance evidence supporting non-adjunctive use, in which CGM readings are used directly to guide insulin dosing, as well as the potential for integration with automated insulin delivery (AID) systems.
CareSens Air's compliance with performance-related standards was also confirmed in assessments by overseas professional organizations. In a product-by-product assessment table released by the Australian Diabetes Society (ADS), current as of September 2026, CareSens Air was listed as meeting anzCGM, the recommended minimum CGM performance standard for Australia and New Zealand.
CareSens Air also received a perfect score of 5 for study design in a CGM product comparison table from DSN Forum UK, a UK forum for diabetes specialist nurses.
An i-SENS representative said, "This paper is significant because it demonstrated that CareSens Air meets the eCGM accuracy criteria and presented clinical evidence in an international journal supporting the product's accuracy and reliability." The representative added, "Along with meeting the recommendations for Australia and New Zealand, we will build on this achievement to strengthen the product's competitiveness in the global market and accelerate our expansion into overseas markets."

[email protected] Sanghee Jeong Reporter