Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subjects With Type 2 Diabetes (Evo)

Evaluation of Correlations Between Volatile Organic Compounds (VOCs) Spectra Measured With GC-IMS and MOx-sensors and Venous Blood Glucose in Subjects With Type 2 Diabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: MIB Breath Analyzer

Detailed Description

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
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefanie Hossmann, MSc; Phone Number: 041794217376; Email: stefanie.hossmann@dcberne.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed written informed consent
• T2D treated with one or more oral anti-diabetic drugs (incl GLP-1 and/or GIP)
• 10 years since T2D diagnosis
• HbA1c ≤8% (HbA1c based on last measurement by treating physician but not older than 120 days)
• Willingness to undergo study procedures
• Age 45 -70 years (inclusive)

Exclusion Criteria:

• Pregnancy and/or lactation period
• Currently on chronic or occasional treatment with pulmonary drugs
• Insulin dependency
• Smoking (last cigarette within the last six months)
• BMI above 30 kg/m²
• Lp(a) above 125 nmol/l
• LDL not in the individual target range of an earlier cholesterol goal according ESC guideline 2021 (LDL based on last measurement by treating physician but not older than 30 days)
• Irregular 12-lead ECG or increased carotid plaque burden based on a three-point sonography. Both examinations are performed and evaluated according to the investigator's judgment.
• History of, or manifested, cardiovascular diseases
• Medical history of epilepsy or other neurological disease associated with seizure events
• Known sensitivity to medical grade adhesives
• Comorbidities that are suspected to alter the VOC spectra
• Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
• Not able to understand, write or read German

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm; Exposure to various glycaemic states at different rates of change by administering glucose solution, insulin, or a standardized meal.

Device: MIB Breath Analyzer; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VOC spectra	Primary outcome focuses on VOC spectra (measured with the GC-IMS) across varying intravenous blood glucose levels	6-8 hour study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-Participant VOC Variability	Evaluation of VOC spectral differences measured with the GC-IMS among participants under identical glycemic states.	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.	6-8 hour study visit
MIB VOC Spectra Analysis	Investigation of VOC spectra (measured with the MIB) in diverse intravenously measured glycemic states.	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.	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.	6-8 hour study visit

Collaborators and Investigators

• Sponsor: BOYDSENSE
• Collaborators: DCB Research AG; Insel Gruppe AG, University Hospital Bern
• Investigators: Study Chair: Frank Flacke, Dr, BOYDSense SAS; Principal Investigator: Markus Laimer, Prof, Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Hyperglycaemia; Volatile Organic Compounds; Hypoglycaemia; Glucose excursions; Gas Chromatography - Ion Mobility Spectrometry; Rates of change of glucose values; Breath-analysis
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Evo Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No