Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232437
• Other study ID #: A1C-FI-001
• Secondary ID: A1C-OCRC-001A1C-
• Status: Completed
• Phase: N/A
• First received: July 12, 2017
• Last updated: July 26, 2017
• Start date: June 14, 2017
• Est. completion date: June 21, 2017

Study information

• Verified date: July 2017
• Source: Jana Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 21, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Aina HbA1c Monitoring System
Monitoring test for quantitative determination of HbA1c

Locations

Country	Name	City	State
United States	The Forsyth Institute	Cambridge	Massachusetts
United States	ActivMed Practices & Research	Methuen	Massachusetts
United States	Orange County Research Center	Tustin	California

Sponsors (4)

Lead Sponsor	Collaborator
Jana Care	ActivMed Practices & Research, Orange County Research Center, The Forsyth Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precision (as measured by %CV) of HbA1c measurements	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