<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03232437</url>
  </required_header>
  <id_info>
    <org_study_id>A1C-FI-001</org_study_id>
    <secondary_id>A1C-OCRC-001</secondary_id>
    <secondary_id>A1C-AM-001</secondary_id>
    <nct_id>NCT03232437</nct_id>
  </id_info>
  <brief_title>Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System</brief_title>
  <official_title>A Multicenter Study to Evaluate the External Precision of the Aina HbA1c Monitoring System in Quantitative Measurement of Glycosylated Hemoglobin (HbA1c)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jana Care</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Forsyth Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Orange County Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ActivMed Practices &amp; Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jana Care</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in&#xD;
      quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following&#xD;
      sites:&#xD;
&#xD;
        1. Forsyth Institute in Cambridge, MA&#xD;
&#xD;
        2. Orange County Research Center in Tustin, CA&#xD;
&#xD;
        3. ActivMed Practices &amp; Research in Methuen, MA&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each site tested three identical samples of HbA1c, at three different levels of HbA1c&#xD;
      measurement. Samples were drawn at the Forsyth Institute, received and blinded by the&#xD;
      Sponsor, and returned to Forsyth Institute for testing. Samples were tested in triplicate,&#xD;
      twice per day, over the course of five days, by three trained operators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2017</start_date>
  <completion_date type="Actual">June 21, 2017</completion_date>
  <primary_completion_date type="Actual">June 21, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Precision (as measured by %CV) of HbA1c measurements</measure>
    <time_frame>Each sample was measured in triplicate, twice per day, over the course of five days</time_frame>
    <description>HbA1c measured on 3 samples on the Aina HbA1c Monitoring System by 3 operators at each site.</description>
  </primary_outcome>
  <enrollment type="Actual">6</enrollment>
  <condition>Diabetes</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aina HbA1c Monitoring System</intervention_name>
    <description>Monitoring test for quantitative determination of HbA1c</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood collected in EDTA vacutainers, aliquoted into smaller vials for shipment.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy and Diabetic patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Agree to the terms of this consent form&#xD;
&#xD;
          -  Sign this consent form&#xD;
&#xD;
          -  Be 18 years or older&#xD;
&#xD;
          -  Have an HbA1c measured by a reference method within the last three months or based on&#xD;
             medical history that is expected to fall in the range of 4 to 15%&#xD;
&#xD;
          -  Provide blood samples from your arm and finger&#xD;
&#xD;
          -  Come in in the morning of the study visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not have a recent history of anemia or hemoglobin concentration above 20%&#xD;
&#xD;
          -  Not be pregnant&#xD;
&#xD;
          -  Not have previously given a blood sample to the Study Sponsor for a study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hatice Hasturk, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Forsyth Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joel Neutel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orange County Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael McCartney, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ActivMed Practices &amp; Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orange County Research Center</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Forsyth Institute</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed Practices &amp; Research</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HbA1c</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03232437
org study id: A1C-FI-001
secondary id: A1C-OCRC-001
secondary id: A1C-AM-001
nct id: NCT03232437
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
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
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.
observational model: Other
time perspective: Cross-Sectional
measure: 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
description: HbA1c measured on 3 samples on the Aina HbA1c Monitoring System by 3 operators at each site.
intervention type: Device
intervention name: Aina HbA1c Monitoring System
description: Monitoring test for quantitative determination of HbA1c
Blood collected in EDTA vacutainers, aliquoted into smaller vials for shipment.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hatice Hasturk, PhD
role: Principal Investigator
affiliation: Forsyth Institute
last name: Joel Neutel, MD
role: Principal Investigator
affiliation: Orange County Research Center
last name: Michael McCartney, MD
role: Principal Investigator
affiliation: ActivMed Practices & Research
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No