A Single Centre, Open-label Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With or Without Known T2DM: a Confirmatory Performance Evaluation of the Glyconics SW Package Delivering the Dichotomised Screening Test Results in a Known Population.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Specificity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)
研究概览
简要总结
A single-site, open label, confirmatory study assessing two biomarkers indicative of levels of glycaemia; glycated keratin in fingernails and glycated haemoglobin (HbA1c). Screening for diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 known (n=50) or unknown T2DM status (n=50) willing to participate in and provide a written consent for the study
- •willingness to undertake assisted assessment of glycaemia by both the NIR spectra measurement, and HbA1c by finger prick test
- •Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail
排除标准
- •Individuals with any known medical conditions impacting the PoC device 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 the assay
- •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
- •known / diagnosed other diabetes such as T1DM, GDM, MODY, etc.
- •For the Glyconics-DS device / targeted nail:
- •Mechanical damage or marks on the surface of the nail after removal of nail polish, or
- •Use of acrylic or gel nail decoration and polish, which cannot be removed.
研究组 & 干预措施
Apparently healthy volunteers without known diabetes
Both methods for assessment of glycaemia will be applied in this group as well
干预措施: Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail (Device)
People with known T2DM
Both methods for assessment of glycaemia will be applied in this group as well
干预措施: Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail (Device)
结局指标
主要结局
Specificity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)
时间窗: 10 minutes
Acceptance criteria for specificity is to demonstrate a result being at least or above 75%
Sensitivity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)
时间窗: 10 minutes
Acceptance criteria for sensitivity is to demonstrate a result being at least or above 30%
次要结局
- Secondary performance measure and accuracy: False positive / negative rates for the screening test result(10 minutes)