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Completed

NCT Number: NCT03232437

Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

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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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orange County Research Center, Tustin, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aina HbA1c Monitoring System

Device

Monitoring test for quantitative determination of HbA1c

Primary outcomes

  1. Precision (as measured by %CV) of HbA1c measurements

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jana Care

Industry

Collaborators

  • ActivMed Practices & Research
  • Orange County Research Center
  • The Forsyth Institute

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2017
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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