Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

July 26, 2017 updated by: Jana Care

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Tustin, California, United States, 92780
        • Orange County Research Center
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02142
        • The Forsyth Institute
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy and Diabetic patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Each sample was measured in triplicate, twice per day, over the course of five days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jana Care

Collaborators

The Forsyth Institute
Orange County Research Center
ActivMed Practices & Research

Investigators

  • Principal Investigator: Hatice Hasturk, PhD, Forsyth Institute
  • Principal Investigator: Michael McCartney, MD, ActivMed Practices & Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2017

Primary Completion (Actual)

June 21, 2017

Study Completion (Actual)

June 21, 2017

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 28, 2017

Study Record Updates

Last Update Posted (Actual)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A1C-FI-001
  • A1C-OCRC-001 (Other Identifier: JanaCare)
  • A1C-AM-001 (Other Identifier: JanaCare)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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