Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

Jana Care6 enrolled

Overview

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

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 Forsyth Institute for testing. Samples were tested in triplicate, twice per day, over the course of five days, by three trained operators.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetes

Interventions

Aina HbA1c Monitoring SystemDEVICE

Monitoring test for quantitative determination of HbA1c

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Locations (3)

Orange County Research Center

Tustin, California, United States

The Forsyth Institute

Cambridge, Massachusetts, United States

ActivMed Practices & Research

Methuen, Massachusetts, United States

Outcomes

Primary Outcomes

Precision (as measured by %CV) of HbA1c measurements

HbA1c measured on 3 samples on the Aina HbA1c Monitoring System by 3 operators at each site.

Time frame: Each sample was measured in triplicate, twice per day, over the course of five days

Data from ClinicalTrials.gov

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