A Pivotal Multi-centre, Open-label, Two-part Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package Delivering the Dichotomised Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- Dichotomised diabetes risk status
研究概览
简要总结
The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy adults (≥18 years of age) with unknown diabetes status willing to participate in and provide a written consent for the study
- •Willingness to undertake assisted assessment of glycaemia: by both the NIR spectral measurements in a chosen middle fingernail, and HbA1c (blood sample)
- •Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail.
排除标准
- •Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as:
- •Severe forms of anaemia (diagnosed iron deficiency, sickle cell anaemia or similar).
- •Haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular (local) laboratory assays for HbA1c.
- •Severe renal impairment (CKD stage III-IV) or decompensated hepatic disease.
- •Severe Vitamin D deficiency (diagnosed or measured 25(OH)D3 < 25 nmol/ml).
- •Known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia.
- •Eating disorders (as per clinical assessment)
- •Recent (within 28 days) blood donation
- •Any other type of known diabetes than T2DM, if diagnosed (T1DM, GDM, MODY, etc.)
- •Any structural, deviating and visually detectable deviations in the appearance of the (only/ to be assessed) middle fingernail potentially impacting the spectra measurement, including:
- •nail dystrophy or deformity
- •severe nail infections (onychomycosis causing visual changes in the appearance of the nail).
- •rare hereditable conditions impacting the structure of keratin.
- •mechanical damage or marks on the surface of the nail after removal of nail polish.
- •use of acrylic or gel nail decoration and polish, which cannot be removed with acetone (use of acetone necessitates a 15 min post-removal wash-out time)
- •Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
研究组 & 干预措施
All participants
All individuals will be screened for their diabetes risk / status (if previously undiagnosed)
干预措施: Near-infrared (NIR) (Device)
结局指标
主要结局
Dichotomised diabetes risk status
时间窗: 10 seconds
YELLOW: HbA1c value \< 48 mmol/mol OR ORANGE: HbA1c value \>= 48 mmol/mol.
次要结局
- Sensitivity and specificity(10 seconds)