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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liom Health AG

Pfaeffikon, Canton of Schwyz, 8808, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lab Demo 1.0

Device

During the intervention, transcutaneous spectral data are collected continuously with the Lab demo. Up to 20 whole blood glucose reference values are also collected, as well as interstitial fluid glucose values using a continuous glucose monitoring device. Some participants will attend multiple measurement sessions.

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.

Sponsors and collaborators

Lead sponsor

Liom Health AG

Industry

Registry information

Official study title

A Pilot Study to Assess the Ability of Advanced Spectroscopy Techniques and Machine Learning Models to Non-invasively Measure Glucose Robustly and Accurately

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: May 9, 2024
Registry last updated: Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed