Performance of the i-SENS CareSens Air CGM System in Compliance with the European CGM (eCGM) Clinical Performance Criteria: A Pooled Analysis
5 affiliations
- 1Institut für Diabetes-Technologie Ulm GmbH, Ulm, Germany
- 2Department of Internal Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea
- 3Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
- 4Division of Endocrinology and Metabolism, Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea
- 5Department of Internal Medicine, Samsung Kangbuk Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
Abstract
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).
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BibTeX
@article{jendrike2026performance,
title = {{Performance of the i-SENS CareSens Air CGM System in Compliance with the European CGM (eCGM) Clinical Performance Criteria: A Pooled Analysis}},
author = {Nina Jendrike and Kyung-Soo Kim and Seung-Hwan Lee and Won Sang Yoo and Cheol-Young Park and Sükrü Öter and Lorena Morent and Manuel Eichenlaub and Guido Freckmann},
journal = {Diabetes Therapy},
year = {2026},
month = sep,
doi = {10.1007/s13300-026-01917-w},
url = {https://doi.org/10.1007/s13300-026-01917-w},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Performance of the i-SENS CareSens Air CGM System in Compliance with the European CGM (eCGM) Clinical Performance Criteria: A Pooled Analysis
AU - Nina Jendrike
AU - Kyung-Soo Kim
AU - Seung-Hwan Lee
AU - Won Sang Yoo
AU - Cheol-Young Park
AU - Sükrü Öter
AU - Lorena Morent
AU - Manuel Eichenlaub
AU - Guido Freckmann
PY - 2026
DA - 2026/09/15
JO - Diabetes Therapy
DO - 10.1007/s13300-026-01917-w
UR - https://doi.org/10.1007/s13300-026-01917-w
AB - 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).
SN - 1869-6953
SN - 1869-6961
ER -