Clinical trial NCT01530347: Non Invasive Breath Based Acetone-meter- Easy Check
Official title: Assessing Feasibility of Non-invasive Breath Based Acetone Meter -Easy Check- Relative to Finger Capillary Blood Glucose and Beta Hydroxybutyrate Reference
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 1 Diabetes
Keywords: Glucose monitoring
non-invasive glucometer
Self glucose monitoring
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: correlation between the acetone values generated by study device and blood beta Hydroxybutyrate
timeFrame: up to 30 weeks
measure: correlation between the acetone values generated by study device and blood glucose
timeFrame: up to 30 weeks
measure: correlation between the acetone values generated by study device and HbA1c
timeFrame: up to 30 weeks
measure: correlation between the acetone values generated by study device and oxygen
timeFrame: up to 30 weeks
Secondary outcomes:
measure: Clarke Error Grid (segment 1 only)
timeFrame: up to 30 weeks
Other outcomes:
Locations:
city: Petah- Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References: