Non Invasive Breath Based Acetone-meter- Easy Check

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01530347
• Other study ID #: rmc006631ctil
• Status: Terminated
• Phase: Phase 1
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: May 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center	Petah- Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between the acetone values generated by study device and blood beta Hydroxybutyrate		up to 30 weeks
Primary	correlation between the acetone values generated by study device and blood glucose		up to 30 weeks
Primary	correlation between the acetone values generated by study device and HbA1c		up to 30 weeks
Primary	correlation between the acetone values generated by study device and oxygen		up to 30 weeks
Secondary	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