Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
NCT ID: NCT01508065
Last Updated: 2019-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2012-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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controlled type one diabetes mellitus.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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GlucoVista
INDUSTRY
Responsible Party
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Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Central Contacts
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Other Identifiers
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gluco01
Identifier Type: -
Identifier Source: org_study_id
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