Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

Completed

Conditions studied: Diabetes

In brief

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 Institute in Cambridge, MA 2. Orange County Research Center in Tustin, CA 3. ActivMed Practices \& Research in Methuen, MA

Key facts

Study ID

NCT03232437

Run by

Jana Care

People needed

6

Starts

2017-06-14

Expected to finish

2017-06-21

Last updated by the study team

2017-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orange County Research Center — Tustin, California, United States
• The Forsyth Institute — Cambridge, Massachusetts, United States
• ActivMed Practices & Research — Methuen, Massachusetts, United States

Full record on ClinicalTrials.gov

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