A Pilot Study to Assess the Ability of Advanced Spectroscopy Techniques and Machine Learning Models to Non-invasively Measure Glucose Robustly and Accurately
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Liom Health AG
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Comparison of glucose changes measured over a time series of transcutaneous measurements with reference measurements
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Comparison of glucose changes measured over a time series of transcutaneous measurements with reference measurements
Time Frame: 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.