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:

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus Type 1
• Intervention / Treatment: Device: Glucometer CGM-305

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Organization
  • Jerusalem, Israel
    • Not yet recruiting
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient population will include subjects with controlled type one diabetes mellitus.

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

controlled type one diabetes mellitus.

Device: 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.

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.	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

Outcome Measure	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: Device related adverse events: local and systemic effects of the Glucometer CGM-305 including: redness, burns, pain , or other complications.; 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.	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: GlucoVista

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 10, 2012
• First Posted (Estimate): January 11, 2012

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: gluco01