Non Invasive Breath Based Acetone-meter- Easy Check

Clalit Health Services

Status and phase: Terminated; Phase 1

Conditions: Type 1 Diabetes

Treatments: Device: Easy Check

Study type: Interventional

Funder types: Other

Identifiers

NCT01530347

rmc006631ctil

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Easy Check versus reference glucometer and blood ketone meter

Experimental group

Description:

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

Treatment:

Device: Easy Check