Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser

NCT05933616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-08-16

No results posted yet for this study

Summary

The breath analysis (BreathSpec® device) data of all participants that were included into the VAARA study (NCT05771090) will be analysed, this includes data from up to 40 breath samples from each of the 10 participants who underwent 2 insulin-induced hypoglycaemic episodes during two visits. The primary objective is to find a possible association between volatile organic compounds (VOCs) measured by the BreathSpec® device and blood glucose. For this we will use descriptive statistics, correlation coefficients, as well as a Principal Component Analysis and a partial least squares discriminant analysis. Furthermore, the time lag between hypoglycaemia onset and change in VOCs will be quantified.

Conditions

  • Diabetes Mellitus
  • Metabolic Disease
  • Glucose Metabolism Disorders
  • Endocrine System Diseases

Interventions

DEVICE

Device: Sokru device

Different induced glycaemic states in people living with diabetes (PwD).

Sponsors & Collaborators

  • DCB Research AG

    collaborator OTHER
  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER
  • University of Bern

    lead OTHER

Principal Investigators

  • Witthauer Lilian, Prof.Dr. · University of Bern

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2023-06-16
Completion
2024-07-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05933616 on ClinicalTrials.gov