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

• Conditions: Diabetes Mellitus Type 1
• Interventions: Device: Glucometer CGM-305

• Registration Number: NCT01508065
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-11
• Study Start: 2012-09
• Primary Completion: 2014-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
controlled type one diabetes mellitus.	Glucometer CGM-305	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
The safety of the Glucometer CGM-305 in evaluating blood glucose levels	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.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel