NCT05198895已完成不适用
A Single-centre, Open-label Study Testing the Safety and Performance of the Glyconics-SX System in Individuals With or Without Type 2 Diabetes
Glyconics Ltd1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Accuracy of the Glyconics-SX System in detection of DM status based on dichotomised outcomes as per the chemometric model (HbA1c measurements as internal control)
研究概览
简要总结
The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status of the participants and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with validated, comparator device.
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 known or unknown T2DM status 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 two visually assessed apparently healthy, undamaged, and intact fingernails, one in both right- and left-hand middle fingers
排除标准
- •Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as
- •anaemia (iron deficiency sickle cell anaemia or similar)
- •haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular assays,
- •severe renal impairment (CKD stage III-IV) or decompensated hepatic disease
- •severe Vitamin D deficiency
- •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 structural, deviating and visually detectable deviations in the appearance of the nails 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
- •Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
结局指标
主要结局
Accuracy of the Glyconics-SX System in detection of DM status based on dichotomised outcomes as per the chemometric model (HbA1c measurements as internal control)
时间窗: 60 seconds
Overall probability of correct classification by the chemometric model output (yes / no DM)
次要结局
- Assessment of sensitivity and specificity for chemometric model outcomes(60 seconds)
- Calculation of negative and positive predictive value for the chemometric model(60 seconds)
- Calculation of area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model(60 seconds)
- Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device(4 minutes)
- Analysis of safety outcomes (AEs, SAEs), including any safety outcomes listed in the comments, such as potential, suspected de novo diabetes diagnosis cases based on HbA1c readings(15 minutes)
研究者
研究点 (1)
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