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Non Invasive Breath Based Acetone-meter- Easy Check

NCT01530347 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-05-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Moshe Phillip, Prof · Rabin Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01530347 on ClinicalTrials.gov