The goal of this study is to evaluate correlations between VOCs in the breath and venous blood glucose values in various glycaemic states in people living with Type 2 Diabetes. VOCs are measured with a gold-standard GC-IMS device and a prototype of a novel breath analyzer. Participants will be exposed to different blood glucose levels at different rates of change by administering glucose solution and insulin and by a meal challenge.
The research project aims to expand the understanding of correlations between VOCs in the breath and venous blood glucose levels in non-insulin-dependent people with Type 2 Diabetes. To better understand correlations, the subjects are exposed to hyperglycaemic, euglycaemic and hyposglcycaemic states at different rates of change by applying a hand clamp procedure, and the VOCs are compared after a standardized meal and the same excursion by applying a hand clamp procedure. Inter- and intraparticipant variability as well as the timing of changes in the VOC spectra compared to changes in the glucose values are of interest. Secondarily, the feasibility of estimating glycaemic states with a prototype of a novel breath analyzer is being investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Going through visit-specific blood glucose excursions by the administration of glucose and insulin (clamp), monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC IMS and the MIBs (investigational devices). Going through visit-specific blood glucose excursions by consuming a standardized meal, monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC-IMS and the MIBs (investigational devices) Imitating the glucose excursion from the meal excursion by infusing glucose and insulin (clamp), monitoring physiological processes, and measuring reference blood glucose values and VOC measurements in the breath using a GC-IMS and the MIBs (investigational devices).
VOC spectra
Primary outcome focuses on VOC spectra (measured with the GC-IMS) across varying intravenous blood glucose levels
Time frame: 6-8 hour study visit
Inter-Participant VOC Variability
Evaluation of VOC spectral differences measured with the GC-IMS among participants under identical glycemic states.
Time frame: 6-8 hour study visit
Intra-Participant VOC Variability
Comparison of VOC spectral differences measured with the GC-IMS within the same participant across different glycemic states.
Time frame: 6-8 hour study visit
MIB VOC Spectra Analysis
Investigation of VOC spectra (measured with the MIB) in diverse intravenously measured glycemic states.
Time frame: 6-8 hour study visit
VOC Spectra Response Time
Assessment of the delay in VOC spectral shifts relative to changes in venous glucose from fluctuating to stable states at different change rates.
Time frame: 6-8 hour study visit
Comparison of meal vs clamp induced VOC changes
Analysis of VOC spectral differences between natural post-meal glucose increases and clamp-induced glucose elevations measured with the GC-IMS.
Time frame: 6-8 hour study visit
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