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

NCT ID: NCT06406075

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2024-10-25

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Investigational arm

Induction of glycose dynamics and collection of transcutaneous spectral data and reference glucose values

Group Type: EXPERIMENTAL

Lab demo 1.0

Intervention Type: 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.

Interventions

Lab demo 1.0

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Liom Health AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabien Rebeaud, PhD

Role: STUDY_DIRECTOR

Liom Health AG

Locations

Liom Health AG

Pfaeffikon, Canton of Schwyz, Switzerland

Countries

Switzerland

Other Identifiers

SPN-006

Identifier Type: -

Identifier Source: org_study_id