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)
3 other identifiers
observational
6
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2017
CompletedFirst Submitted
Initial submission to the registry
July 12, 2017
CompletedFirst Posted
Study publicly available on registry
July 28, 2017
CompletedJuly 28, 2017
July 1, 2017
7 days
July 12, 2017
July 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Monitoring test for quantitative determination of HbA1c
Eligibility Criteria
Healthy and Diabetic patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jana Carelead
- The Forsyth Institutecollaborator
- Orange County Research Centercollaborator
- ActivMed Practices & Researchcollaborator
Study Sites (3)
Orange County Research Center
Tustin, California, 92780, United States
The Forsyth Institute
Cambridge, Massachusetts, 02142, United States
ActivMed Practices & Research
Methuen, Massachusetts, 01844, United States
Biospecimen
Blood collected in EDTA vacutainers, aliquoted into smaller vials for shipment.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hatice Hasturk, PhD
Forsyth Institute
- PRINCIPAL INVESTIGATOR
Joel Neutel, MD
Orange County Research Center
- PRINCIPAL INVESTIGATOR
Michael McCartney, MD
ActivMed Practices & Research
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2017
First Posted
July 28, 2017
Study Start
June 14, 2017
Primary Completion
June 21, 2017
Study Completion
June 21, 2017
Last Updated
July 28, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share