NCT06097689已完成不适用
A Pilot Study to Assess the Feasibility of a Novel Non-Invasive Technology to Measure Glucose Dynamics in Adults Living with Type 1 Diabetes Mellitus: a Single-Arm Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels
研究概览
简要总结
The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.1nformed Consent signed by the subject
- •1.2 Male and female subjects 18 - 60 years of age (inclusive)
- •1.3 Skin colour Type I, II, or III according to Fitzpatrick Scale (see Appendix 1)
- •1.4 Type 1 diabetes diagnosed > 12 months ago
- •1.5 Intensified insulin therapy scheme using multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) for more than 6 months
- •1.6 BMI between 18.5 and 28.0 kg/m2
- •1.7 Using a CGM/FGM system (Freestyle Libre2, Freestyle Libre3, Dexcom G6 or Dexcom G7)
- •1.8 Willingness to follow the study procedure
排除标准
- •2.1 In female subjects: pregnancy or breastfeeding period (self-reported)
- •2.2 HbA1c of > 9.0% (based on last measurement by treating physician but not older than 120 days) Note: To be repeated at the study site if measurement is older than 120 days or not available
- •2.3 History of cardiovascular diseases
- •2.4 Irregular 12-lead ECG upon investigator's judgement
- •2.5 Medical history of epilepsy or other neurological disease associated with seizure events
- •2.6 Atypical skin condition (e.g., Hyperkeratosis, Hyperpigmentation) or presence of tattoos or scars in the measurement area (wrist) that could impair validity of measurement upon investigator's judgement
- •2.7 Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
- •2.8 Not able to understand, write or read German
- •2.9 Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
- •2.10 Enrolment of the PI, his/her family members, employees and other dependent persons
结局指标
主要结局
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels
时间窗: The data is collected during the study procedure (6 to 8 hours)
The primary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of venous blood glucose levels in ranges of hypoglycaemic and hyperglycaemic states.
次要结局
- Blood glucose levels(During the study procedure (6 to 8 hours))
- Spectral fingerprints measured by the Lab Demo 1.0(The data is collected during the study procedure (6 to 8 hours))
- Heart rate(During the study procedure (6 to 8 hours))
- Oxygen saturation(During the study procedure (6 to 8 hours))
- Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels(The data is collected during the study procedure (6 to 8 hours))
研究者
研究点 (2)
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