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Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device

NCT01508065 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2019-02-20

No results posted yet for this study

Summary

Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that can be achieved with a true non-invasive device offering the likelihood of continuous glucose monitoring. Currently, glucose is best monitored by measuring capillary blood from the fingertips, from venous/arterial line blood samples and from a daily calibrated Subcutaneous Blood Glucose Monitor (SBGM) which is a source of severe inconvenience and hence, a lack of compliance.

Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized.

The Glucometer CGM-305 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements.

The primary objectives of the trial are to determine:

1. The safety of the Glucometer CGM-305 in evaluating blood glucose levels
2. The accuracy of the Glucometer CGM-305 in evaluating blood glucose levels

Conditions

  • Diabetes Mellitus Type 1

Interventions

DEVICE

Glucometer CGM-305

The study procedure consists of three days trial. After each experimental day the results of blood glucose level reading from the non-invasive Glucometer CGM-305 will be compared to the reading from several devices, as following: Abbott Freestyle Libre, the hexokinase assay (YSI 2300 STAT Plus) from the venous and the laboratory blood measurements. First day of trial consists of 8-10 hours and is used to calibrate the non-invasive Glucometer CGM-305 for the specific patient. During the second and third days a fasting experiment is performed and consists of 4-6 hours.

Sponsors & Collaborators

  • GlucoVista

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-07-31

Countries

  • Israel

Study Locations

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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 NCT01508065 on ClinicalTrials.gov