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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Sokru device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Sokru device, prototype
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Participants in the study arm will undergo the study procedure which are different induced glycaemic states. | Device: Sokru device<br>* Different induced glycaemic states in people living with diabetes (PwD).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volatile Organic Compound Signals | VOC signals measured by the Sokru device at different blood glucose levels | During the study procedure (approximately 5 hours) | 
| 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) | 
| Time of onset of subjective symptoms of hypoglycemia | Self-reported onset of subjective symptoms of hypoglycemia | During the study procedure (approximately 5 hours) | 
| Heart rate | Heart rate is measured with a Mindray device | During the study procedure (approximately 5 hours) | 
| Oxygen saturation | Oxygen saturation is measured with a Mindray device | During the study procedure (approximately 5 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volatile Organic Compounds, Hypoglycaemia