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

This study is currently recruiting participants.
Verified December 2012 by GlucoVista
Sponsor:
Information provided by (Responsible Party):
GlucoVista
ClinicalTrials.gov Identifier:
NCT01508065
First received: January 9, 2012
Last updated: December 16, 2012
Last verified: December 2012
History of Changes
  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

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: Yes ]

    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
Estimated Primary Completion Date: March 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 clump 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 clump will be done and the results of blood glucose level reading from the non-invasive

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508065

Contacts
Contact: Hadas Lamberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Sponsors and Collaborators
GlucoVista
  More Information

No publications provided

Responsible Party: GlucoVista
ClinicalTrials.gov Identifier: NCT01508065     History of Changes
Other Study ID Numbers: gluco01
Study First Received: January 9, 2012
Last Updated: December 16, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013