{
  "abstract": "Background:: Self-monitoring of blood glucose remains widely used in many individuals with type 2 diabetes (T2D), although the burden of capillary testing often limits the frequency of measurements. Noninvasive technologies may improve glucose monitoring. This study evaluated the analytical performance and applicability of a near-infrared spectroscopy–based noninvasive glucose monitoring device.\n\nMethods:: In this prospective, open-label clinical investigation, 52 adults with T2D performed 4 daily paired glucose measurements for more than 21 days using the investigational device and a reference capillary glucometer (Ascensia Contour Next). Following individualized calibration (10 paired measurements), post-calibration measurements within the 70 to 400 mg/dL range were included in the primary analysis. Accuracy was assessed using a combined mean absolute difference/mean absolute relative difference (MAD/MARD) metric, Parkes consensus error grid (CEG), and DTS error grid analyses.\n\nResults:: Forty-eight participants were included in the primary analysis, contributing 2,616 paired post-calibration measurements. The mean age was 58.0 ± 9.9 years, and 31.3% were female. The overall combined MAD/MARD value was 16.3, calculated by applying MAD to paired measurements with reference glucose values <100 mg/dL and MARD to paired measurements with reference glucose values ≥100 mg/dL. Overall, 69.8%, 86.3%, and 94.5% of measurements were within ±20%, ±30%, and ±40% of reference values, respectively. Parkes CEG analysis classified 69.9% of measurements in zone A, 29.1% in zone B, 1.0% in zone C, and none in zones D or E. Accuracy improved after the first week. No device-related adverse events were reported.\n\nConclusion:: The device demonstrated a favorable clinical risk profile, stable analytical performance, and good safety under real-world conditions. Although analytical precision remains lower than current continuous glucose monitoring systems, its fully noninvasive design supports further development as a complementary monitoring strategy for individuals with T2D unwilling or unable to use invasive monitoring technologies.\n\nTrial Registration:: ClinicalTrials.gov (NCT07075796).",
  "abstract_shown": true,
  "affiliations": [
    "Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Universitario Virgen del Rocío, Sevilla, Spain",
    "Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Spain",
    "Telematic Engineering Department, University of Seville, Spain",
    "GLUCUBE, Seville, Spain",
    "Unidad de Gestión Clínica de Cuidados Intensivos, Hospital Universitario Virgen Del Rocío, Sevilla, Spain"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 11,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Sandra Amuedo",
      "orcid": "0000-0002-8343-129X"
    },
    {
      "affs": [
        0
      ],
      "name": "Mónica Enríquez Macías"
    },
    {
      "affs": [
        2
      ],
      "name": "José Manuel Fornés"
    },
    {
      "affs": [
        3
      ],
      "name": "Arturo Moreno Arteaga"
    },
    {
      "affs": [
        3
      ],
      "name": "Jesús Riesgo Barrau"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Virginia Bellido",
      "orcid": "0000-0002-8384-043X"
    },
    {
      "affs": [
        0
      ],
      "name": "Fernando Losada Viñau"
    },
    {
      "affs": [
        0
      ],
      "name": "Luz María Hidalgo Pichardo"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Alfonso Soto Moreno"
    },
    {
      "affs": [
        4
      ],
      "name": "Antonio Puppo Moreno"
    },
    {
      "affs": [
        0
      ],
      "name": "Alfonso Pumar López"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/c49f8bnym07fn.bib",
  "cited_by": 0,
  "doi": "10.1177/19322968261496268",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13696587/",
  "id": "c49f8bnym07fn",
  "issns": [
    "1932-2968"
  ],
  "landing_url": "https://doi.org/10.1177/19322968261496268",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Original Article"
    ],
    [
      "openalex",
      "2712|Diabetes Management and Research"
    ]
  ],
  "openalex": "W7223565017",
  "pdf_url": "https://europepmc.org/articles/PMC13696587?pdf=render",
  "pmcid": "PMC13696587",
  "pmid": "42926350",
  "published": "2026-10-25",
  "publisher": "Diabetes Technology Society",
  "ris": "https://research.draconitic.com/paper/c49f8bnym07fn.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:17:55Z",
      "native_id": "PMC13696587",
      "source": "pmc",
      "url": "https://doi.org/10.1177/19322968261496268"
    },
    {
      "first_seen": "2026-10-30T12:21:18Z",
      "native_id": "MED:42926350",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42926350"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2712|Diabetes Management and Research",
      "subfield": "endocrinology-metabolism"
    }
  ],
  "title": "Real-World Evaluation of a Near-Infrared Spectroscopy–based Noninvasive Glucose Monitoring Device in Adults With Type 2 Diabetes",
  "title_text": "Real-World Evaluation of a Near-Infrared Spectroscopy–based Noninvasive Glucose Monitoring Device in Adults With Type 2 Diabetes",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:33:54Z",
  "url": "https://research.draconitic.com/paper/c49f8bnym07fn",
  "venue": "Journal of Diabetes Science and Technology",
  "versions": []
}