Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575231
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Accuracy and User Performance Evaluation of PixoTest HbA1c Measurement System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accuracy and User Performance Evaluation of PixoTest HbA1c Measurement System
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the accuracy user performance of PixoTest HbAc1 measurement system and to collect feedback from subjects
Detailed Description:
According to WHO report the number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014 Diabetes is a major cause of blindness kidney failure heart attacks stroke and lower limb amputation In 2012 alone diabetes caused 15 million death Tight glucose control is essential for prevention of complications in people with diabetes The Diabetes Control and Complications Trial DCCT provided direct evidence the relationship between HbA1c level and risks for diabetic complications in diabetes Based on the results of the DCCT the American Diabetes Association ADA has published recommendations for HbA1c and plasma glucose levels that are widely used HbA1c testing can be performed at any time of day and without special patient preparation it is more convenient for patients and even measuring fasting plasma glucose
The ADA recommends measurement of HbA1c typically 3-4 times per year for type 1 and poorly controlled type 2 diabetic patients and 2 times per year for well-controlled type 2 diabetic patients to determine whether a patients metabolic control has remained continuously within the target range Most diabetes patients will go to hospital to measurement HbA1c but should wait few days for test result Most diabetes patient maybe not measurement HbA1c so many time per year The PixoTest HbA1c measurement system can give result for a few minutes at home The diabetes patient can measure HbA1c at home dont need go to hospital
The PixoTest HbA1c measurement system is defined as the respective reagent system and the corresponding smartphone It is intended for quantitative measurement of HbA1c in capillary whole blood and use in the home by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control
This study is designed to test the accuracy and user performance of the Pixotest HbA1c measurement system
The ADA recommends measurement of HbA1c typically 3-4 times per year for type 1 and poorly controlled type 2 diabetic patients and 2 times per year for well-controlled type 2 diabetic patients to determine whether a patients metabolic control has remained continuously within the target range Most diabetes patients will go to hospital to measurement HbA1c but should wait few days for test result Most diabetes patient maybe not measurement HbA1c so many time per year The PixoTest HbA1c measurement system can give result for a few minutes at home The diabetes patient can measure HbA1c at home dont need go to hospital
The PixoTest HbA1c measurement system is defined as the respective reagent system and the corresponding smartphone It is intended for quantitative measurement of HbA1c in capillary whole blood and use in the home by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control
This study is designed to test the accuracy and user performance of the Pixotest HbA1c measurement system
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