Non Invasive Breath Based Acetone-meter- Easy Check
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes |
Device: Easy Check |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Assessing Feasibility of Non-invasive Breath Based Acetone Meter -Easy Check- Relative to Finger Capillary Blood Glucose and Beta Hydroxybutyrate Reference |
- correlation between the acetone values generated by study device and blood beta Hydroxybutyrate [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
- correlation between the acetone values generated by study device and blood glucose [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
- correlation between the acetone values generated by study device and HbA1c [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
- correlation between the acetone values generated by study device and oxygen [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
- Clarke Error Grid (segment 1 only) [ Time Frame: up to 30 weeks ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Easy Check versus reference glucometer and blood ketone meter
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
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT01530347 History of Changes |
| Other Study ID Numbers: | rmc006631ctil |
| Study First Received: | February 7, 2012 |
| Last Updated: | January 2, 2013 |
| Health Authority: | Israel: Clalit Health Services |
Keywords provided by Rabin Medical Center:
|
Glucose monitoring non-invasive glucometer Self glucose monitoring |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013