Non Invasive Breath Based Acetone-meter- Easy Check

Study Overview
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Brief Summary
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Segment 1- this segment will include two main steps: Step 1-Calibration: During this step we plan to collect paired measurements of capillary blood glucose using reference method and data generated by the non invasive study device. Samples will be obtained at specific time points during 4 hours: at fasting, and after consuming standard liquid meal at 60, 120, 180 and 240 minutes. At each time point capillary blood glucose will be measured using the invasive reference method. The paired reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will convert the acetone values measured by study device to blood glucose values. step 2-Validation: During this segment the second step of this segment we plan to evaluate the validity and reliability of the non-invasive breath-based glucometer compared to standard invasive reference glucometer. Results will be compared using a Clark error grid. Segment 2- During this segment we plan to collect paired measurements of capillary blood glucose beta Hydroxybutyrate using reference method and acetone values generated by the non invasive breath based study device. Samples will be obtained at specific time points during 4 hours after overnight fasting, while basal insulin will be suspended, which is accepted to produce ketosis.

Official Title
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Assessing Feasibility of Non-invasive Breath Based Acetone Meter -Easy Check- Relative to Finger Capillary Blood Glucose and Beta Hydroxybutyrate Reference

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Easy Check


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signing an inform consent form Type 1 diabetes diagnosed at least 12 months prior to study inclusion Males aged > 18 years old 23< BMI < 28 (segment 1 only) Treatment with insulin pump (segment 2 only) Willing to perform all study related procedures Exclusion Criteria: Psychiatric disorder Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease Patients who are not willing or are not capable of performing the protocol requirements Participating in another study that includes investigational drug or investigational equipment Patients who are under low carbohydrate diet Patients who are known as heavy alcohol drinkers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Easy Check versus reference glucometer and blood ketone meter<br>Collection of paired measurements of capillary blood glucose using reference method (approved glucometer)and blood beta Hydroxybutyrate (approved ketone meter) and data generated by the non invasive study device | Device: Easy Check<br>* Collection of paired measurements of capillary blood glucose using reference method and data generated by the non invasive study device. Samples will be obtained at specific time points during 4 hours: at fasting, and after consuming standard liquid meal at 60, 120, 180 and 240 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between the acetone values generated by study device and blood beta Hydroxybutyrate |  | up to 30 weeks | 
| correlation between the acetone values generated by study device and blood glucose |  | up to 30 weeks | 
| correlation between the acetone values generated by study device and HbA1c |  | up to 30 weeks | 
| correlation between the acetone values generated by study device and oxygen |  | up to 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clarke Error Grid (segment 1 only) | The Clarke Error Gride breaks down a scatter plot of a reference glucose meter and an evaluated glucose meter into five regions: values within 20% of the reference meter, values outside of 20% but would not lead to inappropriate treatment,points leading to unnecessary treatment,points indicating a potentially dangerous failure to detect hypoglycemia or hyperglycemia and points that would confuse treatment of hypoglycemia for hyperglycemia and vice-versa. | up to 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose monitoring, non-invasive glucometer, Self glucose monitoring