{
  "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.\n\nMethods: 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.\n\nResults: 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.\n\nConclusions: The CareSens Air CGM system is suitable for nonadjunctive insulin dosing decisions and integration with automated insulin delivery systems.\n\nTrial 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).",
  "abstract_shown": true,
  "affiliations": [
    "Institut für Diabetes-Technologie Ulm GmbH, Ulm, Germany",
    "Department of Internal Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea",
    "Division 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",
    "Division of Endocrinology and Metabolism, Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea",
    "Department of Internal Medicine, Samsung Kangbuk Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Nina Jendrike"
    },
    {
      "affs": [
        1
      ],
      "name": "Kyung-Soo Kim"
    },
    {
      "affs": [
        2
      ],
      "name": "Seung-Hwan Lee"
    },
    {
      "affs": [
        3
      ],
      "name": "Won Sang Yoo"
    },
    {
      "affs": [
        4
      ],
      "name": "Cheol-Young Park"
    },
    {
      "affs": [
        0
      ],
      "name": "Sükrü Öter"
    },
    {
      "affs": [
        0
      ],
      "name": "Lorena Morent"
    },
    {
      "affs": [
        0
      ],
      "name": "Manuel Eichenlaub",
      "orcid": "0000-0003-2150-3160"
    },
    {
      "affs": [
        0
      ],
      "name": "Guido Freckmann"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/9ypz53q8pjt3k.bib",
  "cited_by": 0,
  "doi": "10.1007/s13300-026-01917-w",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13728035/",
  "id": "9ypz53q8pjt3k",
  "issns": [
    "1869-6953",
    "1869-6961"
  ],
  "landing_url": "https://doi.org/10.1007/s13300-026-01917-w",
  "language": "en",
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Original Research"
    ],
    [
      "openalex",
      "2712|Diabetes Management and Research"
    ]
  ],
  "openalex": "W7213359946",
  "pdf_url": "https://link.springer.com/content/pdf/10.1007/s13300-026-01917-w.pdf",
  "pmcid": "PMC13728035",
  "pmid": "42742670",
  "published": "2026-09-15",
  "publisher": "Springer",
  "ris": "https://research.draconitic.com/paper/9ypz53q8pjt3k.ris",
  "sources": [
    {
      "first_seen": "2026-11-06T12:23:47Z",
      "native_id": "PMC13728035",
      "source": "pmc",
      "url": "https://doi.org/10.1007/s13300-026-01917-w"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2712|Diabetes Management and Research",
      "subfield": "endocrinology-metabolism"
    }
  ],
  "title": "Performance of the i-SENS CareSens Air CGM System in Compliance with the European CGM (eCGM) Clinical Performance Criteria: A Pooled Analysis",
  "title_text": "Performance of the i-SENS CareSens Air CGM System in Compliance with the European CGM (eCGM) Clinical Performance Criteria: A Pooled Analysis",
  "type": "peer-reviewed",
  "updated_at": "2026-11-07T12:21:06Z",
  "url": "https://research.draconitic.com/paper/9ypz53q8pjt3k",
  "venue": "Diabetes Therapy",
  "versions": []
}