Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

A Multicenter Study to Evaluate the External Precision of the Aina HbA1c Monitoring System in Quantitative Measurement of Glycosylated Hemoglobin (HbA1c)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03232437

Enrollment

Registered

2017-07-28

Start date

2017-06-14

Completion date

2017-06-21

Last updated

2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

HbA1c

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

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

Interventions

DEVICEAina HbA1c Monitoring System

Monitoring test for quantitative determination of HbA1c

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Precision (as measured by %CV) of HbA1c measurements	Each sample was measured in triplicate, twice per day, over the course of five days	HbA1c measured on 3 samples on the Aina HbA1c Monitoring System by 3 operators at each site.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026