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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06406075
• Other study ID #: SPN-006
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Spiden AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 81
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	Spiden AG	Pfäffikon	Schwyz

Sponsors (1)

Lead Sponsor	Collaborator
Spiden AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)