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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus Metabolic Disease Glucose Metabolism Disorders Endocrine System Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Study Arm

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

Group Type EXPERIMENTAL

Device: Sokru device

Intervention Type DEVICE

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

Interventions

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Device: Sokru device

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No