Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 10:44 PM
Study NCT ID:
NCT00451334
Status:
UNKNOWN
Last Update Posted:
2007-03-23
First Post:
2007-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement
Sponsor:
Assaf-Harofeh Medical Center
Organization:
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:
False
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?: