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

NCT06406075 | Completed

• 1 other identifier: SPN-006
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Continuous glucose monitoring; Noninvasive; Transcutaneous

Outcome Measures

Primary Outcomes (1)

• Comparison of glucose changes measured over a time series of transcutaneous measurements with reference measurements

  The transcutaneous glucose measurements and the corresponding spectral fingerprints are compared with the values of interstitial fluid (ISF) and capillary blood glucose.

  The data is collected during the study procedure (up to 3 hours)

Study Arms (1)

Investigational arm

EXPERIMENTAL

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

Device: Lab demo 1.0

Interventions

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.

Investigational arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liom Health AG: lead

Study Sites (1)

Liom Health AG

Pfaeffikon, Canton of Schwyz, 8808, Switzerland

Location

Study Officials

• Fabien Rebeaud, PhD

  Liom Health AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: May 9, 2024
• Study Start: January 29, 2024
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)