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Completed

NCT Number: NCT05933616

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

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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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

(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.

Treatment and study plan

Device: Sokru device

Device

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

Primary outcomes

  1. Changes VOC Patterns over time as gallery plots

    Time frame: During the study procedure (approximately 5 hours)

    Difference in gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.

  2. Changes VOC Patterns over time as boxplots

    Time frame: During the study procedure (approximately 5 hours)

    Difference in box plots from selected VOC peaks over time.

  3. Correlation between blood glucose and patterns

    Time frame: During the study procedure (approximately 5 hours)

    Signals will be classified into euglycemic (between 4 and 10 mmol/l), hypoglycaemic (smaller than 4 mmol/l) and hyperglycaemic (above 10 mmol/l) phases or stable and changing phases. A principal component analysis (PCA) of the data will be performed to identify which VOCs are characteristic for certain glucose levels. A partial least squares discriminant analysis (PLS-DA) will be used to further identify important features of the VOC fingerprints.

Secondary outcomes

  1. Time lag

    Time frame: During the study procedure (approximately 5 hours)

    The time lag between hypoglycaemia onset and change in VOCs will be calculated-

  2. Association between the onset of change in glucose, vital signs and VOC spectra

    Time frame: During the study procedure (approximately 5 hours)

    Associations between changes in VOCs and perceived hypoglycaemic symptoms, heart rate, ECG, and oxygen saturation will be evaluated using correlation coefficients and mixed effects models.

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • DCB Research AG
  • Insel Gruppe AG, University Hospital Bern

Registry information

Acronym: VAARABreath

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 6, 2023
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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