Non-invasive Measurement of Glucose with Advanced Spectroscopy Techniques and Machine Learning Models

Liom Health AG

Status

Completed

Conditions

Healthy

Treatments

Device: Lab demo 1.0

Study type

Interventional

Funder types

Industry

Identifiers

NCT06406075

SPN-006

Details and patient eligibility

About

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.

Full 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

Enrollment

43 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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