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

Diabetes Mellitus Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01508065
• Other study ID #: gluco01
• Status: Recruiting
• Start date: September 2012

Study information

• Verified date: February 2019
• Source: GlucoVista
• Contact: Hadas Lamberg, PhD
• Phone: 00 972 2 6777572
• Email: lhadas[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
GlucoVista

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.