Healthy
Conditions
Keywords
Continuous glucose monitoring, Noninvasive, Transcutaneous
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
Interventions
DEVICELab 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.
Sponsors
Liom Health AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of glucose changes measured over a time series of transcutaneous measurements with reference measurements | 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. |
Countries
Switzerland
Outcome results
None listed