Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes VOC Patterns over time as gallery plots
研究概览
简要总结
The breath analysis (BreathSpec® device) data of all participants that were included into the VAARA study (NCT05771090) will be analysed, this includes data from up to 40 breath samples from each of the 10 participants who underwent 2 insulin-induced hypoglycaemic episodes during two visits. The primary objective is to find a possible association between volatile organic compounds (VOCs) measured by the BreathSpec® device and blood glucose. For this we will use descriptive statistics, correlation coefficients, as well as a Principal Component Analysis and a partial least squares discriminant analysis. Furthermore, the time lag between hypoglycaemia onset and change in VOCs will be quantified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Type 1 Diabetes with Multiple daily insulin injection (MDI) or Continuous subcutaneous insulin infusion therapy (CSII) >1 year
- •Age 18 - 50 (inclusive)
- •Caucasian ethnicity
- •BMI between 18.5 and 24.9 kg/m2 (inclusive)
- •Usage of a continuous glucose monitoring (CGM)
排除标准
- •Pregnancy or lactation period
- •History of cardiovascular diseases
- •Diabetes-related comorbidities
- •HbA1c >9 %
- •Smoking (last cigarette within past 6 months)
- •Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome.
- •Known sensitivity to Latex.
- •Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation.
结局指标
主要结局
Changes VOC Patterns over time as gallery plots
时间窗: During the study procedure (approximately 5 hours)
Difference in gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.
Correlation between blood glucose and patterns
时间窗: During the study procedure (approximately 5 hours)
Signals will be classified into euglycemic (between 4 and 10 mmol/l), hypoglycaemic (smaller than 4 mmol/l) and hyperglycaemic (above 10 mmol/l) phases or stable and changing phases. A principal component analysis (PCA) of the data will be performed to identify which VOCs are characteristic for certain glucose levels. A partial least squares discriminant analysis (PLS-DA) will be used to further identify important features of the VOC fingerprints.
Changes VOC Patterns over time as boxplots
时间窗: During the study procedure (approximately 5 hours)
Difference in box plots from selected VOC peaks over time.
次要结局
- Association between the onset of change in glucose, vital signs and VOC spectra(During the study procedure (approximately 5 hours))
- Time lag(During the study procedure (approximately 5 hours))