NCT06406075已完成不适用
A Pilot Study to Assess the Ability of Advanced Spectroscopy Techniques and Machine Learning Models to Non-invasively Measure Glucose Robustly and Accurately
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Comparison of glucose changes measured over a time series of transcutaneous measurements with reference measurements
研究概览
简要总结
Primary aim of this pilot study is to provide evidence for a non-invasive, continuous, and transcutaneous measurement method to determine blood glucose levels robustly and accurately.
详细描述
The study is divided into 3 sub-studies focusing on
- Interchangeability of Lab demo 1.0
- Evaluation of advanced spectroscopy methods and their miniaturisation potential
- Robustness of machine learning model to changes over time
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide signed and dated written informed consent by study participant prior to any mandatory study-specific procedures, sample collection, or analysis
- •Apparently healthy Male or Female adult aged between 18 and 75
- •Willingness to follow the study procedures
排除标准
- •In Female subjects: pregnancy or breastfeeding period
- •A diagnosis of diabetes mellitus (any type) with ongoing insulin therapy (basal or basal plus bolus) or sulfonylurea therapy
- •Prior severe hypoglycemia event (stage 3 or above; e.g., seizure, loss of consciousness, emergency hospitalisation)
- •Prior event of severe hyperglycemia resulting in diabetic ketoacidosis or hyperosmolar hyperglycemic state, or emergency hospitalisation
- •Documented medical history of bleeding disorder
- •Being under anticoagulant medication
- •Insufficient knowledge of project languages (English/German)
- •Known sensitivity to medical-grade adhesives or other skin-related complications, which might influence the outcome
结局指标
主要结局
Comparison of glucose changes measured over a time series of transcutaneous measurements with reference measurements
时间窗: The data is collected during the study procedure (up to 3 hours)
The transcutaneous glucose measurements and the corresponding spectral fingerprints are compared with the values of interstitial fluid (ISF) and capillary blood glucose.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Neurostimulation Device for Treatment of Migraine HeadacheMigraine HeadacheNCT01630044Scion NeuroStim3
已完成
不适用
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence DeviceUrinary Bladder, OveractiveNCT04001426FemPulse Corporation2
已完成
不适用
Pilot Study: AI Algorithm for Dermatology Referral OptimizationSkin DiseasesSkin ConditionNCT06228014AI Labs Group S.L200
进行中（未招募）
不适用
Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO)Open AbdomenNCT06242925Tufts Medical Center20
已完成
不适用
Food Addiction Clinical Treatment ProgramFood AddictionNCT04373343Wake Forest University Health Sciences2