Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT01511861
Status:
UNKNOWN
Last Update Posted:
2020-02-19
First Post:
2012-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device
Sponsor:
GlucoVista
Organization:
Study Overview
Official Title:
Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that is difficult to achieve with current blood glucose monitoring technology. Home blood glucose monitoring (HBGM) technology, which requires finger pricking, 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 GM-205 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. Assessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels compare to the standard glucose blood test
2. Creating database of glucose levels readings utilizing the Glucometer GM-205.
The Glucometer GM-205 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. Assessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels compare to the standard glucose blood test
2. Creating database of glucose levels readings utilizing the Glucometer GM-205.
Detailed Description:
None
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?: