Non Invasive Breath Based Acetone-meter- Easy Check

NCT01530347 | Terminated Phase 1

• 1 other identifier: rmc006631ctil
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Glucose monitoring; non-invasive glucometer; Self glucose monitoring

Outcome Measures

Primary Outcomes (4)

• correlation between the acetone values generated by study device and blood beta Hydroxybutyrate

  up to 30 weeks

• correlation between the acetone values generated by study device and blood glucose

  up to 30 weeks

• correlation between the acetone values generated by study device and HbA1c

  up to 30 weeks

• correlation between the acetone values generated by study device and oxygen

  up to 30 weeks

Secondary Outcomes (1)

• Clarke Error Grid (segment 1 only)

  up to 30 weeks

Study Arms (1)

Easy Check versus reference glucometer and blood ketone meter

EXPERIMENTAL

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

Interventions

Easy Check DEVICE

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.

Easy Check versus reference glucometer and blood ketone meter

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing an inform consent form
• Males aged \> 18 years old
• \< BMI \< 28 (segment 1 only)
• Treatment with insulin pump (segment 2 only)
• Willing to perform all study related procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Moshe Phillip, Prof

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 9, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

IL (1)