Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

Jana Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Aina HbA1c Monitoring System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03232437

A1C-FI-001

A1C-OCRC-001 (Other Identifier)

A1C-AM-001 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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