Clinical trial NCT01508065: Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
Official title: Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus Type 1
Lead sponsor: GlucoVista
Sponsor class: INDUSTRY
First posted: 2012-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient population will include subjects with controlled type one diabetes mellitus.

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


Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: will be assessed after second experimental day
measure: Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by correlation with values measured by glucose hexokinase based assay
timeFrame: will be assessed after second experimental day
measure: Accuracy of the Glucometer CGM-305 blood glucose readings as evaluated by Clark error grid with measurements of venous blood as the comparing value
timeFrame: will be assessed after second experimental day
Secondary outcomes:
measure: The safety of the Glucometer CGM-305 in evaluating blood glucose levels
timeFrame: The study consists of three days trial, first day lasts an 8-10 hours, second and third days last 4-6 hours.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References: