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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01508065
First Posted: January 11, 2012
Last Update Posted: August 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlucoVista
  Purpose

Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that is difficult to achieve with current blood glucose monitoring technology. Home blood glucose monitoring (HBGM) technology, which requires finger pricking, 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 GM-205 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 GM-205 in evaluating blood glucose levels
  2. The accuracy of the Glucometer GM-205 in evaluating blood glucose levels

Condition Intervention
Diabetes Mellitus Type 1 Device: Glucometer GM-205

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device

Resource links provided by NLM:


Further study details as provided by GlucoVista:

Primary Outcome Measures:
  • assess the accuracy of the Glucometer GM-205 blood glucose [ Time Frame: the study is consist of two parts, each part lasts a few hours. ]

    To assess the accuracy of the Glucometer GM-205 blood glucose readings as evaluated by:

    • Mean relative error when compared to venous blood glucose measured by a laboratory device and SBGM (home use glucometer)
    • Correlation with values measured by glucose hexokinase based assay
    • Clark error grid with measurements of venous blood as the comparing value


Secondary Outcome Measures:
  • The safety of the Glucometer GM-205 in evaluating blood glucose levels [ Time Frame: the study is consist of two parts, each part lasts a few hours. ]

    Safety will be evaluated in a descriptive manner by recording all adverse events in the patient population by number and severity.

    The study will evaluate safety by assessing:

    1. Device related adverse events: local and systemic effects of the Glucometer GM-205 including: redness, burns, pain , or other complications.
    2. General adverse events: Adverse events not directly related to the Glucometer GM-205 device but are related to the study procedure (i.e clamping), such as: local infection, blood clot, bleeding, hypoglycemia.


Estimated Enrollment: 20
Study Start Date: September 2012
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
controlled type one diabetes mellitus. Device: Glucometer GM-205
The study procedure consists of two days trial. Each day consists of 4-6 hours, during which, hyper and hypoglycaemic clamp will be done. The first day will be used to calibrate the non-invasive Glucometer GM-205 for the specific patient.. The calibration will be done using the hexokinase assay (YSI 2300 STAT Plus) from the venous. During the second day, hyper and hypo glycemic clamp will be done and the results of blood glucose level reading from the non-invasive

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient population will include subjects with controlled type one diabetes mellitus.
Criteria

Inclusion Criteria:

  1. Ages: 18 to 65
  2. Males- not involved in active military duty.
  3. Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.

Exclusion Criteria:

  1. Active systemic or local infection.
  2. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508065


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
GlucoVista
  More Information

Responsible Party: GlucoVista
ClinicalTrials.gov Identifier: NCT01508065     History of Changes
Other Study ID Numbers: gluco01
First Submitted: January 9, 2012
First Posted: January 11, 2012
Last Update Posted: August 25, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases