Type 1 Diabetes
Conditions
Keywords
Glucose monitoring, non-invasive glucometer, Self glucose monitoring
Brief summary
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.
Interventions
DEVICEEasy Check
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.
Sponsors
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Clarke Error Grid (segment 1 only) | up to 30 weeks | 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. |
Countries
Israel
Outcome results
None listed