Diabetes Mellitus
Conditions
Keywords
Volatile Organic Compounds, Hypoglycaemia
Brief summary
The primary aim of this clinical study is to find signal characteristics of VOCs detected by Sokru device during fasting, insulin injection and after glucose intake and to find the association with blood glucose variation in variant states of glycemia and hypoglycemia.
Interventions
DEVICESokru device
Different induced glycaemic states in people living with diabetes (PwD).
Sponsors
Insel Gruppe AG, University Hospital Bern
DCB Research AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Sokru device, prototype
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * T1D with MDI or CSII therapy \>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 breastfeeding * History of cardiovascular diseases * Diabetes-related comorbidities * HbA1c \>9 % * Epilepsy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristics of volatile organic compound (VOC) signals measured by the Sokru device | During the study procedure (approximately 5 hours) | The primary outcome are changes in VOC signals measured by the Sokru at low glucose levels (below 3.0 -3.9 mmol/L) or during the time when the blood glucose level is decreasing (from 10 and 3.9 mmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volatile Organic Compound Signals | During the study procedure (approximately 5 hours) | VOC signals measured by the Sokru device at different blood glucose levels |
| Blood glucose concentration | During the study procedure (approximately 5 hours) | Blood glucose levels are measured with the continuous glucose measurement system and in the venous blood at the time of the appearance of VOC signal peaks or drops |
| Time of onset of subjective symptoms of hypoglycemia | During the study procedure (approximately 5 hours) | Self-reported onset of subjective symptoms of hypoglycemia |
| Heart rate | During the study procedure (approximately 5 hours) | Heart rate is measured with a Mindray device |
| Oxygen saturation | During the study procedure (approximately 5 hours) | Oxygen saturation is measured with a Mindray device |
Countries
Switzerland
Outcome results
None listed