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NOT YET RECRUITING
NCT06621030
NA

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

Sponsor: BOYDSENSE

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

45 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2024-10-01

Completion Date

2025-03-30

Last Updated

2024-10-01

Healthy Volunteers

No

Conditions

Interventions

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).