Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451334
Status:
UNKNOWN
Last Update Posted:
2007-03-23
First Post:
2007-03-22
Brief Title:
Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GS
Brief Summary:
This study is a prospective open label controlled single center study 40 patients will be recruited for the study according to patients inflow and meeting eligibility criteria
Primary Goal
To evaluate the safety of the GlucoSat technology as a non-invasive blood glucose level measurement technology
Secondary Goal
To assess the efficacy of the GlucoSat technology as a non-invasive blood glucose level measurement technology
Primary Goal
To evaluate the safety of the GlucoSat technology as a non-invasive blood glucose level measurement technology
Secondary Goal
To assess the efficacy of the GlucoSat technology as a non-invasive blood glucose level measurement technology
Detailed Description:
Primary Endpoint Parameter
Primary study endpoint will be to establish the safety of using the GlucoSat technology as a non-invasive glucose level measurement technology Safety will be established by paucity of adverse events Adverse Events occurrence will be documented throughout the study
Secondary Endpoint Parameters
Efficacy of the GlucoSat technology will be assessed by
Proving the accuracy and precision of the GlucoSat technology by comparing the glucose level measured by the GlucoSat device to the glucose level observed by any certified for clinics invasive device Inter device variability should be within 15
Patient satisfaction questionnaire
Physician satisfaction will be assessed by questionnaire
Primary study endpoint will be to establish the safety of using the GlucoSat technology as a non-invasive glucose level measurement technology Safety will be established by paucity of adverse events Adverse Events occurrence will be documented throughout the study
Secondary Endpoint Parameters
Efficacy of the GlucoSat technology will be assessed by
Proving the accuracy and precision of the GlucoSat technology by comparing the glucose level measured by the GlucoSat device to the glucose level observed by any certified for clinics invasive device Inter device variability should be within 15
Patient satisfaction questionnaire
Physician satisfaction will be assessed by questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None