Status:
COMPLETED
Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System
Lead Sponsor:
Jana Care
Collaborating Sponsors:
The Forsyth Institute
Orange County Research Center
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following sites: 1. Forsyth I...
Detailed Description
Each site tested three identical samples of HbA1c, at three different levels of HbA1c measurement. Samples were drawn at the Forsyth Institute, received and blinded by the Sponsor, and returned to For...
Eligibility Criteria
Inclusion
- Agree to the terms of this consent form
- Sign this consent form
- Be 18 years or older
- Have an HbA1c measured by a reference method within the last three months or based on medical history that is expected to fall in the range of 4 to 15%
- Provide blood samples from your arm and finger
- Come in in the morning of the study visit
Exclusion
- Not have a recent history of anemia or hemoglobin concentration above 20%
- Not be pregnant
- Not have previously given a blood sample to the Study Sponsor for a study
Key Trial Info
Start Date :
June 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03232437
Start Date
June 14 2017
End Date
June 21 2017
Last Update
July 28 2017
Active Locations (3)
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1
Orange County Research Center
Tustin, California, United States, 92780
2
The Forsyth Institute
Cambridge, Massachusetts, United States, 02142
3
ActivMed Practices & Research
Methuen, Massachusetts, United States, 01844