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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| controlled type one diabetes mellitus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucometer CGM-305 | Device | 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. |
| Measure | Description | 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. | will be assessed after second experimental day | |
| Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by correlation with values measured by glucose hexokinase based assay | will be assessed after second experimental day | |
| Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by Clark error grid with measurements of venous blood as the comparing value | will be assessed after second experimental day |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of the Glucometer CGM-305 in evaluating blood glucose levels | 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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Inclusion criteria:
Exclusion criteria:
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The patient population will include subjects with controlled type one diabetes mellitus.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadas Lamberg, PhD | Contact | 00 972 2 6777572 | lhadas@hadassah.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Recruiting | Jerusalem | 91120 | Israel | ||
| Hadassah Medical Organization |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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. |
| Not yet recruiting |
| Jerusalem |
| Israel |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |