<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/NCT01711385</url>
  </required_header>
  <id_info>
    <org_study_id>AAAD6446</org_study_id>
    <nct_id>NCT01711385</nct_id>
  </id_info>
  <brief_title>Undiagnosed Diabetes in a Dental Setting</brief_title>
  <official_title>Screening for Undiagnosed Diabetes in a Dental Setting - A New Paradigm for Dental Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Colgate Palmolive</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In an ongoing study new dental patients are screened to determine their risk of having&#xD;
      undiagnosed pre-diabetes or diabetes based on risk factors readily known by the patient and&#xD;
      signs of gum disease. Investigators further seek to assess if a post-identification&#xD;
      intervention leads to a greater likelihood of study participants identified as potentially&#xD;
      pre-diabetic or diabetic visiting their physician regarding their screening blood test&#xD;
      results, and to improved health outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 3% to 4% of the U.S. adult population has undiagnosed diabetes and the&#xD;
      prevalence is likely to be substantially higher among people with risk factors for diabetes.&#xD;
      Of note, many patients at the time of diagnosis of diabetes already have diabetic&#xD;
      complications. This indicates that there is a period of &quot;asymptomatic&quot; diabetes during which&#xD;
      hyperglycemia and other risk factors are present and complications are developing. This&#xD;
      substantial delay in clinical diagnosis of diabetes involves a period of about 10-12 years&#xD;
      that elapses between onset of diabetes and its diagnosis. Early diagnosis of diabetes, with&#xD;
      treatment aiming at strict control of blood glucose levels, is important in preventing or&#xD;
      mitigating its clinical complications and improving health outcomes.&#xD;
&#xD;
      Oral findings may offer an unrealized opportunity for the identification of affected&#xD;
      individuals unaware of their condition. Previous research suggests that oral healthcare&#xD;
      professionals have the opportunity to identify unrecognized diabetes and pre-diabetes in&#xD;
      dental patients and refer them to a physician for further evaluation and care.&#xD;
&#xD;
      Based on these findings, efforts to identify dental patients' risk of having undiagnosed&#xD;
      pre-diabetes or diabetes, using a new diagnostic blood test as the outcome (HPLC HbA1c),&#xD;
      continue. In addition, a subgroup of study subjects identified as potentially pre-diabetic or&#xD;
      diabetic are randomly assigned to either a group 1/basic-standard intervention arm or to a&#xD;
      group 2/enhanced intervention arm. The investigators seek to determine if a&#xD;
      post-identification intervention leads to a greater likelihood of study participants&#xD;
      identified as potentially pre-diabetic or diabetic visiting their physician regarding their&#xD;
      blood test results and to improved health outcomes. Results of this pilot study have the&#xD;
      potential to set in motion far ranging, changes in the practice of dentistry, leading to the&#xD;
      advancement of a new paradigm in dental practice that calls for the adoption of a more&#xD;
      holistic approach to patient care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of follow-up visit to physician regarding screening result</measure>
    <time_frame>Baseline up to six months</time_frame>
    <description>Investigators want to determine if the enhanced intervention increases the likelihood that study participants identified as potentially pre-diabetic or diabetic visit their physician to discuss the screening results of their and to receive advice from their physician, relative to participants in the standard practice group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in HbA1c</measure>
    <time_frame>Baseline up to six months</time_frame>
    <description>Investigators want to determine if study participants who receive the enhanced intervention have an improved HbA1c test result, relative to standard practice group participants, upon re-testing during a second study visit at 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improved periodontal measures</measure>
    <time_frame>Baseline up to six months</time_frame>
    <description>Investigators want to determine if the participants who receive the enhanced intervention are found to have improved periodontal findings, relative to standard practice group participants, upon re-examination during a second study visit at 6 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Prediabetic State</condition>
  <condition>Type 2 Diabetes Mellitus With Oral Complications</condition>
  <condition>Periodontal Pocket</condition>
  <condition>Tooth Loss</condition>
  <arm_group>
    <arm_group_label>Standard practice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Study patients are notified of their &quot;diagnostic&quot; test result within 72 hours. Those identified as potentially pre-diabetic or diabetic and randomized to the basic/control intervention, are informed that it is important to follow-up with their physician regarding their test results. They are contacted by phone once to schedule their 6-month recall visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study patients are notified of their &quot;diagnostic&quot; test result within 72 hours. Those identified as potentially pre-diabetic or diabetic and randomized to the enhanced group, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results. They are given a letter to take to their physician and receive a call at month two and then again at month four if necessary to inquire if they have followed-up with their physician and encouragement to do so, if they have not, prior to their six month follow-up study visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced intervention</intervention_name>
    <description>Study patients are notified of their blood test result within 72 hours. Those identified as potentially pre-diabetic or diabetic, and randomized to the enhanced intervention arm, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results or are provided with a referral to one. They are given a letter to take to their physician that specifies the risk factors identified, the tests carried out for the patient and the exact numeric results. They receive a call at month 2 to see if they have followed up with a physician regarding their test results. If they have not seen a physician regarding their results, they are advised again to do so and reminded of their individual risk factors. At month 4 they are asked again if they have seen a physician regarding their test results. If they still have not seen a physician at this time the message is reinforced. They are contacted again by phone to schedule the 6-month recall visit.</description>
    <arm_group_label>Enhanced intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who presents at the Columbia University College of Dental Medicine dental&#xD;
             clinic&#xD;
&#xD;
          -  Never been told that pre-diabetic or diabetic&#xD;
&#xD;
          -  40 years old or older, if white&#xD;
&#xD;
          -  30 years old or older, if non-white&#xD;
&#xD;
          -  If female, not pregnant&#xD;
&#xD;
          -  Not completely edentulous&#xD;
&#xD;
          -  Able to undergo a periodontal examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously told by physician that prediabetes or diabetes is present&#xD;
&#xD;
          -  &lt; 40 years of age if non-hispanic and white, and &lt; 30 years of age if hispanic or&#xD;
             non-white&#xD;
&#xD;
          -  For medical or other reasons cannot tolerate a periodontal exam&#xD;
&#xD;
          -  If female, pregnant&#xD;
&#xD;
          -  Fully edentulous&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ira B. Lamster, DDS, M.M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University College of Dental Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University College of Dental Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>August 13, 2021</last_update_submitted>
  <last_update_submitted_qc>August 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral Health</keyword>
  <keyword>Prediabetes</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Periodontitis</keyword>
  <keyword>Early Identification</keyword>
  <keyword>Prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Pocket</mesh_term>
    <mesh_term>Tooth Loss</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <!-- 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/NCT01711385
org study id: AAAD6446
nct id: NCT01711385
lead sponsor: 
collaborator: 
has dmc: No
In an ongoing study new dental patients are screened to determine their risk of having
      undiagnosed pre-diabetes or diabetes based on risk factors readily known by the patient and
      signs of gum disease. Investigators further seek to assess if a post-identification
      intervention leads to a greater likelihood of study participants identified as potentially
      pre-diabetic or diabetic visiting their physician regarding their screening blood test
      results, and to improved health outcomes.
Approximately 3% to 4% of the U.S. adult population has undiagnosed diabetes and the
      prevalence is likely to be substantially higher among people with risk factors for diabetes.
      Of note, many patients at the time of diagnosis of diabetes already have diabetic
      complications. This indicates that there is a period of "asymptomatic" diabetes during which
      hyperglycemia and other risk factors are present and complications are developing. This
      substantial delay in clinical diagnosis of diabetes involves a period of about 10-12 years
      that elapses between onset of diabetes and its diagnosis. Early diagnosis of diabetes, with
      treatment aiming at strict control of blood glucose levels, is important in preventing or
      mitigating its clinical complications and improving health outcomes.

      Oral findings may offer an unrealized opportunity for the identification of affected
      individuals unaware of their condition. Previous research suggests that oral healthcare
      professionals have the opportunity to identify unrecognized diabetes and pre-diabetes in
      dental patients and refer them to a physician for further evaluation and care.

      Based on these findings, efforts to identify dental patients' risk of having undiagnosed
      pre-diabetes or diabetes, using a new diagnostic blood test as the outcome (HPLC HbA1c),
      continue. In addition, a subgroup of study subjects identified as potentially pre-diabetic or
      diabetic are randomly assigned to either a group 1/basic-standard intervention arm or to a
      group 2/enhanced intervention arm. The investigators seek to determine if a
      post-identification intervention leads to a greater likelihood of study participants
      identified as potentially pre-diabetic or diabetic visiting their physician regarding their
      blood test results and to improved health outcomes. Results of this pilot study have the
      potential to set in motion far ranging, changes in the practice of dentistry, leading to the
      advancement of a new paradigm in dental practice that calls for the adoption of a more
      holistic approach to patient care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Occurrence of follow-up visit to physician regarding screening result
time frame: Baseline up to six months
description: Investigators want to determine if the enhanced intervention increases the likelihood that study participants identified as potentially pre-diabetic or diabetic visit their physician to discuss the screening results of their and to receive advice from their physician, relative to participants in the standard practice group.
measure: Decrease in HbA1c
time frame: Baseline up to six months
description: Investigators want to determine if study participants who receive the enhanced intervention have an improved HbA1c test result, relative to standard practice group participants, upon re-testing during a second study visit at 6 months.
measure: Improved periodontal measures
time frame: Baseline up to six months
description: Investigators want to determine if the participants who receive the enhanced intervention are found to have improved periodontal findings, relative to standard practice group participants, upon re-examination during a second study visit at 6 months.
arm group label: Standard practice
arm group type: No Intervention
description: Study patients are notified of their "diagnostic" test result within 72 hours. Those identified as potentially pre-diabetic or diabetic and randomized to the basic/control intervention, are informed that it is important to follow-up with their physician regarding their test results. They are contacted by phone once to schedule their 6-month recall visit.
arm group label: Enhanced intervention
arm group type: Experimental
description: Study patients are notified of their "diagnostic" test result within 72 hours. Those identified as potentially pre-diabetic or diabetic and randomized to the enhanced group, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results. They are given a letter to take to their physician and receive a call at month two and then again at month four if necessary to inquire if they have followed-up with their physician and encouragement to do so, if they have not, prior to their six month follow-up study visit.
intervention type: Behavioral
intervention name: Enhanced intervention
description: Study patients are notified of their blood test result within 72 hours. Those identified as potentially pre-diabetic or diabetic, and randomized to the enhanced intervention arm, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results or are provided with a referral to one. They are given a letter to take to their physician that specifies the risk factors identified, the tests carried out for the patient and the exact numeric results. They receive a call at month 2 to see if they have followed up with a physician regarding their test results. If they have not seen a physician regarding their results, they are advised again to do so and reminded of their individual risk factors. At month 4 they are asked again if they have seen a physician regarding their test results. If they still have not seen a physician at this time the message is reinforced. They are contacted again by phone to schedule the 6-month recall visit.
arm group label: Enhanced intervention
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Ira B. Lamster, DDS, M.M.Sc.
role: Principal Investigator
affiliation: Columbia University College of Dental Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Periodontal Pocket
mesh term: Tooth Loss
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State