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

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

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.

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