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

Sponsor

University of Bern (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05933616

Collaborator

DCB Research AG (Other), Insel Gruppe AG, University Hospital Bern (Other)

Enrollment

Location

Arm

3.9

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Metabolic Disease Glucose Metabolism Disorders Endocrine System Diseases	Device: Device: Sokru device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Arm Participants in the study arm will undergo the study procedure which are different induced glycaemic states.	Device: Device: Sokru device Different induced glycaemic states in people living with diabetes (PwD).

Arm

Intervention/Treatment

Experimental: Study Arm

Participants in the study arm will undergo the study procedure which are different induced glycaemic states.

Device: Device: Sokru device

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

Outcome Measures

Primary Outcome Measures

Association between VOCs measured by the BreathSpec® device and blood glucose. [During the study procedure (approximately 5 hours)]

Secondary Outcome Measures

Identify changes in VOCs measurements during changing blood glucose levels. [During the study procedure (approximately 5 hours)]
To evaluate the association between VOC spectra and glycaemic state or blood glucose level, its dynamics, and interindividual differences [During the study procedure (approximately 5 hours)]
To find possible association between the onset of change in glucose, vital signs and VOC spectra [During the study procedure (approximately 5 hours)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

(as in VAARA study, NCT05771090)

Inclusion Criteria:

Written informed consent.
Type 1 Diabetes with Multiple daily insulin injection (MDI) or Continuous subcutaneous insulin infusion therapy (CSII) >1 year
Age 18 - 50 (inclusive)
Caucasian ethnicity
BMI between 18.5 and 24.9 kg/m2 (inclusive)
Usage of a continuous glucose monitoring (CGM)

Exclusion Criteria:

Pregnancy or lactation period
History of cardiovascular diseases
Diabetes-related comorbidities
HbA1c >9 %
Epilepsy
Smoking (last cigarette within past 6 months)
Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome.
Known sensitivity to Latex.
Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation.