- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01508065
Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
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:
- The safety of the Glucometer CGM-305 in evaluating blood glucose levels
- The accuracy of the Glucometer CGM-305 in evaluating blood glucose levels
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hadas Lamberg, PhD
- Phone Number: 00 972 2 6777572
- Email: lhadas@hadassah.org.il
Study Locations
-
-
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Jerusalem, Israel, 91120
- Recruiting
- Hadassah Medical Organization
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Jerusalem, Israel
- Not yet recruiting
- Hadassah Medical Organization
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
controlled type one diabetes mellitus.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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will be assessed after second experimental day
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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
|
will be assessed after second experimental day
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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
|
will be assessed after second experimental day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
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The study consists of three days trial, first day lasts an 8-10 hours, second and third days last 4-6 hours.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- gluco01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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