Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05933616
Other study ID # VAARABreath
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date April 30, 2024

Study information

Verified date December 2023
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility (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.

Study Design


Intervention

Device:
Device: Sokru device
Different induced glycaemic states in people living with diabetes (PwD).

Locations

Country Name City State
Switzerland University of Bern Bern

Sponsors (3)

Lead Sponsor Collaborator
University of Bern DCB Research AG, Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes VOC Patterns over time as gallery plots Difference in gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time. During the study procedure (approximately 5 hours)
Primary Changes VOC Patterns over time as boxplots Difference in box plots from selected VOC peaks over time. During the study procedure (approximately 5 hours)
Primary Correlation between blood glucose and patterns 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. During the study procedure (approximately 5 hours)
Secondary Time lag The time lag between hypoglycaemia onset and change in VOCs will be calculated- During the study procedure (approximately 5 hours)
Secondary Association between the onset of change in glucose, vital signs and VOC spectra 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. During the study procedure (approximately 5 hours)
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A