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

University of Bern

Status: Completed

Conditions: Glucose Metabolism Disorders; Diabetes Mellitus; Metabolic Disease; Endocrine System Diseases

Treatments: Device: Device: Sokru device

Study type: Interventional

Funder types: Other

Identifiers

NCT05933616

VAARABreath

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

(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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Study Arm

Experimental group

Description:

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

Treatment:

Device: Device: Sokru device