The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
21
Lowering of the participants blood glucose with the application of insulin to induce hypoglycaemia, followed by the application of glucose to induce hyperglycaemia and finally insulin to restore euglycemia. During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid).
Markus Laimer
Bern, Canton of Bern, Switzerland
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels
The primary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of venous blood glucose levels in ranges of hypoglycaemic and hyperglycaemic states.
Time frame: The data is collected during the study procedure (6 to 8 hours)
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels
The secondary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of interstitial fluid glucose levels in ranges of hypoglycaemic and hyperglycaemic states.
Time frame: The data is collected during the study procedure (6 to 8 hours)
Spectral fingerprints measured by the Lab Demo 1.0
This secondary objective consists of describing the spectral fingerprints at different blood glucose levels (defined by both venous blood glucose and interstitial fluid glucose)
Time frame: The data is collected during the study procedure (6 to 8 hours)
Blood glucose levels
Blood glucose levels at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Time frame: During the study procedure (6 to 8 hours)
Heart rate
Heart rate at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Time frame: During the study procedure (6 to 8 hours)
Oxygen saturation
Oxygen saturation at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
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Time frame: During the study procedure (6 to 8 hours)