Non-invasive Measurement of Glucose with Advanced Spectroscopy Techniques and Machine Learning Models
Not Applicable
Completed
- Conditions
- Healthy
- Interventions
- Device: Lab demo 1.0
- Registration Number
- NCT06406075
- Lead Sponsor
- Liom Health AG
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigational arm Lab demo 1.0 Induction of glycose dynamics and collection of transcutaneous spectral data and reference glucose values
- Primary Outcome Measures
Name Time Method Comparison of glucose changes measured over a time series of transcutaneous measurements with reference measurements 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Liom Health AG
🇨🇭Pfäffikon, Schwyz, Switzerland