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

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ClinicalTrials.gov Identifier: NCT01508065
Recruitment Status : Recruiting
First Posted : January 11, 2012
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
GlucoVista

Brief 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

Condition or disease Intervention/treatment
Diabetes Mellitus Type 1 Device: Glucometer CGM-305

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
Study Start Date : September 2012
Actual Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Group/Cohort Intervention/treatment
controlled type one diabetes mellitus. 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.




Primary Outcome Measures :
  1. Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by mean relative error when compared to venous blood glucose measured by a laboratory device. [ Time Frame: will be assessed after second experimental day ]
  2. Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by correlation with values measured by glucose hexokinase based assay [ Time Frame: will be assessed after second experimental day ]
  3. Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by Clark error grid with measurements of venous blood as the comparing value [ Time Frame: will be assessed after second experimental day ]

Secondary Outcome Measures :
  1. The safety of the Glucometer CGM-305 in evaluating blood glucose levels [ Time Frame: The study consists of three days trial, first day lasts an 8-10 hours, second and third days last 4-6 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 CGM-305 including: redness, burns, pain , or other complications.
    2. General adverse events: Adverse events not directly related to the Glucometer CGM-305 device but are related to the study procedure (i.e clamping), such as: local infection, blood clot, bleeding, hypoglycemia.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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:

  • Type 1 Diabetic patient.
  • Ages: 18 to 65.
  • Signed informed consent.
  • HbA1c of 6%-9% at screening.
  • Males- not involved in active military duty.
  • Females-non-child bearing potential or females of child-bearing potential who have a negative pregnancy test (HCG in blood or urine) within 72 hours of informed consent.

Exclusion criteria:

  • Active systemic or local infection.
  • Any medical condition that, by the investigator judgment, will increase the risk from Hyper and Hypo-Glycemic experiment: seizures, heart disease, hypoglycemia unawareness etc.
  • History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)

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


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

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

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Responsible Party: GlucoVista
ClinicalTrials.gov Identifier: NCT01508065     History of Changes
Other Study ID Numbers: gluco01
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases