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

NCT06621030 | Not Yet Recruiting

• 1 other identifier: Evo Study
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Volatile Organic Compounds; Gas Chromatography - Ion Mobility Spectrometry; Rates of change of glucose values; Breath-analysis; Hyperglycaemia; Hypoglycaemia; Glucose excursions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Inter-Participant VOC Variability

  6-8 hour study visit

• Intra-Participant VOC Variability

  6-8 hour study visit

• MIB VOC Spectra Analysis

  6-8 hour study visit

• VOC Spectra Response Time

  6-8 hour study visit

• Comparison of meal vs clamp induced VOC changes

  6-8 hour study visit

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Device: MIB Breath Analyzer

Interventions

MIB Breath Analyzer DEVICE

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).

Single Arm

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• T2D treated with one or more oral anti-diabetic drugs (incl GLP-1 and/or GIP)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BOYDSENSE: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• DCB Research AG: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Frank Flacke, Dr

  BOYDSense SAS

  STUDY CHAIR

• Markus Laimer, Prof

  Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie Hossmann, MSc

CONTACT

041794217376; stefanie.hossmann@dcberne.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The intervention consists of inducing different glycaemic states in people with diabetes.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share