Status:
COMPLETED
Accuracy and User Performance Evaluation of PixoTest HbA1c Measurement System
Lead Sponsor:
China Medical University Hospital
Conditions:
Diabetes
HbA1c
Eligibility:
All Genders
20+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 18 years or older.
- Willing to participate in the study, able to read and provide written informed consent form.
- HCT 25\~65%.
- Subjects including healthy subjects, outpatients and inpatients.
Exclusion
- An individual who does not meet the inclusion criteria will be excluded from enrollment.Taking prescription anticoagulants (such as Warfarin or Heparin) or have clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded.
- Hemophilia or any other bleeding disorder
- Reports having an infection with a blood borne pathogen (e.g. HIV, hepatitis)
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06575231
Start Date
July 1 2016
End Date
June 30 2017
Last Update
August 28 2024
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