Type 1 Diabetes Clinical Trial
— EBECAOfficial title:
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents (EBECA)
This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.
Status | Recruiting |
Enrollment | 3600 |
Est. completion date | July 2030 |
Est. primary completion date | July 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 22 Years |
Eligibility | Inclusion Criteria: - Age 0 = 22 years at study entry and signed informed consent Additional inclusion criteria for respiratory disease population: - Acute disease: - Acute signs for a respiratory disease, indicated by e.g. increased work of breathing (e.g. dyspnea, increased respiratory rate), cough or wheezing. - Chronic disease: - Suspected or confirmed chronic airway disease (e.g. asthma). Additional inclusion criteria for neurological disease population: - Acute disease: - Acute presentation or report within 24 hours of any signs of neurological deficit (motor function, sensoneural, or verbal). - Chronic disease: - Confirmed chronic neurologic disease (e.g. childhood epilepsy). Additional inclusion criteria for T1D disease population: - Acute disease: - Hyperglycemia and/or pH (venous) <7.3, bicarbonate >10 mmol/L, increased levels of acetone in blood or urine in the context of newly diagnosed or known T1D. - Chronic disease: - Confirmed diagnosis of T1D Exclusion Criteria: - Physical or intellectual impairment precluding protocol adherence. Additional exclusion criteria for respiratory disease population: - Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical and/or pharmacological treatment and is associated with an inflammatory response, relevant congenital defects Additional exclusion criteria for neurological disease population: - Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical and/or pharmacological treatment and is associated with an inflammatory response, relevant congenital defects. Additional exclusion criteria for T1D population: - Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), relevant congenital defects. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Children's Hospital Basel (UKBB) | Basel |
Lead Sponsor | Collaborator |
---|---|
University Children's Hospital Basel | Fondation Botnar (Switzerland), Swiss National Science Foundation |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days of hospitalization | In the presentation of an acute disease the primary outcome will be days of hospitalization and its association with the exhaled breath pattern. | approx 30 days (from beginn hospitalisation to discharge date) | |
Primary | Change in Mass spectrometric profile of exhaled breath patterns | In the chronic presentation of the diseases, the mass spectrometric profile of exhaled breath patterns is analyzed | Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10) | |
Primary | Change in Concentration of exhaled metabolites of pharmacotherapy | Concentration of exhaled metabolites of pharmacotherapy (breath metabolomics data) | Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10) | |
Secondary | Identification of chemical structure of exhaled molecules (acetone, glucose) | Identification of chemical structure of exhaled molecules (acetone, glucose) | approx 30 days (from begin hospitalisation to discharge date) | |
Secondary | Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l) | Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l) | 0h, 2h, 4h, 6h, 8h, 12h, 18h, 24h, 36h, 48h, 72h (h =hours after hospital admission) | |
Secondary | Change in clinical endpoint lung function (Forced Expiratory Pressure in 1 Second FEV1 l/s) for correlation between clinical endpoint and the abundance of exhaled metabolites | Change in clinical endpoint lung function (Forced Expiratory Pressure in 1 Second FEV1 l/s) for correlation between clinical endpoint and the abundance of exhaled metabolites | approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits) | |
Secondary | Change in clinical endpoint (body temperature, Celsius) for correlation between clinical endpoint and the abundance of exhaled metabolites | Change in clinical endpoint (body temperature) for correlation between clinical endpoint and the abundance of exhaled metabolites | approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits) | |
Secondary | Change in clinical endpoint (blood pressure, mmHg) for correlation between clinical endpoint and the abundance of exhaled metabolites | Change in clinical endpoint (blood pressure) for correlation between clinical endpoint and the abundance of exhaled metabolites | approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02897557 -
Insulet Artificial Pancreas Early Feasibility Study
|
N/A | |
Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 |