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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.
The study is divided into 3 sub-studies focusing on
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational arm | Experimental | Induction of glycose dynamics and collection of transcutaneous spectral data and reference glucose values |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabien Rebeaud, PhD | Liom Health AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liom Health AG | Pfaeffikon | Canton of Schwyz | 8808 | Switzerland |
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