<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/NCT03235492</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00076395</org_study_id>
    <nct_id>NCT03235492</nct_id>
  </id_info>
  <brief_title>Salivary Glycated Albumin</brief_title>
  <official_title>Clinical Study of Salivary Glycated Albumin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      (1) to determine whether the ratio of glycated albumin and total albumin in saliva is&#xD;
      equivalent to blood and (2) to investigate whether the non-invasive SmartAlbu portable&#xD;
      salivary sensor is as accurate as standard tests that measure glycosylated hemoglobin&#xD;
      (HbA1c).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Anticipated">February 15, 2025</completion_date>
  <primary_completion_date type="Anticipated">February 15, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Salivary glycated albumin vs. blood glycated albumin</measure>
    <time_frame>30 min</time_frame>
    <description>Whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Salivary glycated albumin vs. glycosylated hemoglobin (HbA1c)</measure>
    <time_frame>30 min</time_frame>
    <description>To investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure HbA1c.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">176</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>SmartAlbu</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If a participant agrees, after obtaining informed consent, the investigator will measure and record temperature, blood pressure, heart rate, height and weight. The participant will be given detailed instruction on how to hold the container and will be asked to spit (or deposit) their saliva up to the indicated line. The procedure will be performed twice to study the reproducibility of the test. The participant will then be asked to have a standard blood draw of 2-3 mls of blood into a vacutainer tube for analysis of HbA1c at the central lab and 1-2 mls of blood for glycated albumin for assay analysis, and a finger stick for point of care HbA1c measurement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SmartAlbu</intervention_name>
    <description>Plan:&#xD;
Consent an individual&#xD;
Measure and record temperature, blood pressure, heart rate, height and weight&#xD;
Obtain two samples of saliva for the SmartAlbu portable salivary sensor&#xD;
Take a venous blood sample for HbA1c and&#xD;
Glycated albumin&#xD;
Obtain blood sample from a finger stick for point of care HbA1c device</description>
    <arm_group_label>SmartAlbu</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  123 individuals with type 1 or type 2 diabetes&#xD;
&#xD;
          -  53 non diabetic controls&#xD;
&#xD;
          -  Age: 18 to 80&#xD;
&#xD;
          -  Body mass index &gt;18.5kg / m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute illness (within 7 days) - respiratory infection, fever above 38 °C, sinusitis&#xD;
             infection, severe allergies.&#xD;
&#xD;
          -  Individuals with known sickle cell, pregnancy, hemoglobinopathies, renal failure&#xD;
&#xD;
          -  Subjects unable to give voluntary informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen N Davis, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland, Baltimore</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maka Siamashvili, MD</last_name>
    <phone>410-706-5623</phone>
    <email>msiamashvili@som.umaryland.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maka Siamashvili, MD</last_name>
      <phone>410-706-5623</phone>
      <email>msiamashvili@som.umaryland.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Stephen N. Davis, MBBS</investigator_full_name>
    <investigator_title>Chairman of Medicine</investigator_title>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>salivary glycated albumin</keyword>
  <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/NCT03235492
org study id: HP-00076395
nct id: NCT03235492
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
(1) to determine whether the ratio of glycated albumin and total albumin in saliva is
      equivalent to blood and (2) to investigate whether the non-invasive SmartAlbu portable
      salivary sensor is as accurate as standard tests that measure glycosylated hemoglobin
      (HbA1c).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Salivary glycated albumin vs. blood glycated albumin
time frame: 30 min
description: Whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood.
measure: Salivary glycated albumin vs. glycosylated hemoglobin (HbA1c)
time frame: 30 min
description: To investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure HbA1c.
arm group label: SmartAlbu
arm group type: Experimental
description: If a participant agrees, after obtaining informed consent, the investigator will measure and record temperature, blood pressure, heart rate, height and weight. The participant will be given detailed instruction on how to hold the container and will be asked to spit (or deposit) their saliva up to the indicated line. The procedure will be performed twice to study the reproducibility of the test. The participant will then be asked to have a standard blood draw of 2-3 mls of blood into a vacutainer tube for analysis of HbA1c at the central lab and 1-2 mls of blood for glycated albumin for assay analysis, and a finger stick for point of care HbA1c measurement.
intervention type: Device
intervention name: SmartAlbu
description: Plan:
Consent an individual
Measure and record temperature, blood pressure, heart rate, height and weight
Obtain two samples of saliva for the SmartAlbu portable salivary sensor
Take a venous blood sample for HbA1c and
Glycated albumin
Obtain blood sample from a finger stick for point of care HbA1c device
arm group label: SmartAlbu
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen N Davis, MBBS
role: Principal Investigator
affiliation: University of Maryland, Baltimore
last name: Maka Siamashvili, MD
phone: 410-706-5623
email: msiamashvili@som.umaryland.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Stephen N. Davis, MBBS
investigator title: Chairman of Medicine
sharing ipd: No