The primary aim of this clinical study is to find signal characteristics of VOCs detected by Sokru device during fasting, insulin injection and after glucose intake and to find the association with blood glucose variation in variant states of glycemia and hypoglycemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Different induced glycaemic states in people living with diabetes (PwD).
Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) Inselspital, Universitätsspital
Bern, Switzerland
Characteristics of volatile organic compound (VOC) signals measured by the Sokru device
The primary outcome are changes in VOC signals measured by the Sokru at low glucose levels (below 3.0 -3.9 mmol/L) or during the time when the blood glucose level is decreasing (from 10 and 3.9 mmol/L).
Time frame: During the study procedure (approximately 5 hours)
Volatile Organic Compound Signals
VOC signals measured by the Sokru device at different blood glucose levels
Time frame: During the study procedure (approximately 5 hours)
Blood glucose concentration
Blood glucose levels are measured with the continuous glucose measurement system and in the venous blood at the time of the appearance of VOC signal peaks or drops
Time frame: During the study procedure (approximately 5 hours)
Time of onset of subjective symptoms of hypoglycemia
Self-reported onset of subjective symptoms of hypoglycemia
Time frame: During the study procedure (approximately 5 hours)
Heart rate
Heart rate is measured with a Mindray device
Time frame: During the study procedure (approximately 5 hours)
Oxygen saturation
Oxygen saturation is measured with a Mindray device
Time frame: During the study procedure (approximately 5 hours)
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