Performance of the i-SENS CareSens Air CGM System in Compliance with the European CGM (eCGM) Clinical Performance Criteria: A Pooled Analysis.

INTRODUCTION

The eCGM designation is a recently proposed framework for the approval of continuous glucose monitoring (CGM) systems in Europe. The aim of this analysis was to assess whether the performance of the CareSens Air CGM system (i-SENS, Inc., Republic of Korea), derived from a pooled dataset comprising three clinical investigations, complies with eCGM requirements.

METHODS

A total of 164 participants (86% type 1 diabetes, 50% female, 66% on multiple daily injections) across the three studies contributed 17,655 data points to the data analysis. Meal and/or insulin challenges were implemented to obtain sufficient data points at comparator glucose concentrations <70 mg/dL (10.9%) and >300 mg/dL (5.7%). Measurement accuracy was assessed by applying eCGM accuracy requirements.

RESULTS

The CareSens Air CGM system complies with eCGM accuracy requirements in this data analysis. Approximately 91.0% of the CGM readings <70 mg/dL were found within ±15 mg/dL from the paired comparator value. At eu- (70-180 mg/dL) and hyperglycemic (>180 mg/dL) CGM readings, 78.6% and 84.4% of CGM readings exhibited differences ≤ ±15%. Overall, 90.3% of CGM readings were found within ±20% of the paired comparator values across the measuring range. Accuracy remained stable throughout the sensor lifetime.

CONCLUSIONS

The CareSens Air CGM system is suitable for nonadjunctive insulin dosing decisions and integration with automated insulin delivery systems.

TRIAL REGISTRATION: The three studies whose data were used in this pooled analysis were registered in the Republic of Korea's Clinical Research Information Service (KCT0009215) and the German Clinical Trials Register (DRKS00028739 and DRKS00037132).