Non Invasive Breath Based Acetone-meter- Easy Check

This study has suspended participant recruitment.
(sponsor wish to amend the protocol before proceeding to segment 2 of the study)
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01530347
First received: February 7, 2012
Last updated: January 2, 2013
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530347

Locations
Israel
Schneider Children's Medical Center
Petah- Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, Prof Rabin Medical Center
  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 April 16, 2014