Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT05933616
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2023-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes VOC Patterns over time as gallery plots', 'timeFrame': 'During the study procedure (approximately 5 hours)', 'description': 'Difference in gallery plots (3D visualization of retention index, drift time, ion current) from selected VOC peaks over time.'}, {'measure': 'Changes VOC Patterns over time as boxplots', 'timeFrame': 'During the study procedure (approximately 5 hours)', 'description': 'Difference in box plots from selected VOC peaks over time.'}, {'measure': 'Correlation between blood glucose and patterns', 'timeFrame': 'During the study procedure (approximately 5 hours)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Time lag', 'timeFrame': 'During the study procedure (approximately 5 hours)', 'description': 'The time lag between hypoglycaemia onset and change in VOCs will be calculated-'}, {'measure': 'Association between the onset of change in glucose, vital signs and VOC spectra', 'timeFrame': 'During the study procedure (approximately 5 hours)', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Volatile Organic Compounds', 'Hypoglycaemia'], 'conditions': ['Diabetes Mellitus', 'Metabolic Disease', 'Glucose Metabolism Disorders', 'Endocrine System Diseases']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '(as in VAARA study, NCT05771090)\n\nInclusion Criteria:\n\n* Written informed consent.\n* Type 1 Diabetes with Multiple daily insulin injection (MDI) or Continuous subcutaneous insulin infusion therapy (CSII) \\>1 year\n* Age 18 - 50 (inclusive)\n* Caucasian ethnicity\n* BMI between 18.5 and 24.9 kg/m2 (inclusive)\n* Usage of a continuous glucose monitoring (CGM)\n\nExclusion Criteria:\n\n* Pregnancy or lactation period\n* History of cardiovascular diseases\n* Diabetes-related comorbidities\n* HbA1c \\>9 %\n* Epilepsy\n* Smoking (last cigarette within past 6 months)\n* Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome.\n* Known sensitivity to Latex.\n* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation.'}, 'identificationModule': {'nctId': 'NCT05933616', 'acronym': 'VAARABreath', 'briefTitle': 'Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser', 'orgStudyIdInfo': {'id': 'VAARABreath'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Arm', 'description': 'Participants in the study arm will undergo the study procedure which are different induced glycaemic states.', 'interventionNames': ['Device: Device: Sokru device']}], 'interventions': [{'name': 'Device: Sokru device', 'type': 'DEVICE', 'description': 'Different induced glycaemic states in people living with diabetes (PwD).', 'armGroupLabels': ['Study Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Witthauer Lilian, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'DCB Research AG', 'class': 'OTHER'}, {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}