Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-14

Study Completion Date

2017-06-21

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Aina HbA1c Monitoring System

Monitoring test for quantitative determination of HbA1c

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes