First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes

Diabetes Mellitus Clinical Trial

— VAARA  

Official title:

First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes: a Single-arm Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771090
• Other study ID #: VAARA study
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 16, 2023

Study information

• Verified date: June 2023
• Source: DCB Research AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Switzerland	Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) Inselspital, Universitätsspital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
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	Characteristics of volatile organic compound (VOC) signals measured by the Sokru device	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).	During the study procedure (approximately 5 hours)
Secondary	Volatile Organic Compound Signals	VOC signals measured by the Sokru device at different blood glucose levels	During the study procedure (approximately 5 hours)
Secondary	Blood glucose concentration	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	During the study procedure (approximately 5 hours)
Secondary	Time of onset of subjective symptoms of hypoglycemia	Self-reported onset of subjective symptoms of hypoglycemia	During the study procedure (approximately 5 hours)
Secondary	Heart rate	Heart rate is measured with a Mindray device	During the study procedure (approximately 5 hours)
Secondary	Oxygen saturation	Oxygen saturation is measured with a Mindray device	During the study procedure (approximately 5 hours)