<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/NCT03227094</url>
  </required_header>
  <id_info>
    <org_study_id>AtHome</org_study_id>
    <nct_id>NCT03227094</nct_id>
  </id_info>
  <brief_title>Simplification of CF-related Diabetes Screening at Home</brief_title>
  <acronym>AtHome</acronym>
  <official_title>Simplification of CF-related Diabetes Screening by the Use of a Home-based Oral Glucose Tolerance Test (OGTT): A Pilot Study to Evaluate the Validity and Patients' Perceptions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherches Cliniques de Montreal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vertex Pharmaceuticals Incorporated</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Recherches Cliniques de Montreal</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cystic fibrosis (CF)-related diabetes (CFRD) is the most common complication after pulmonary&#xD;
      complications. This specific form of diabetes is associated with an increased morbidity and&#xD;
      mortality. CFRD prevalence at the age of 10 is 10% and reaches 40 to 50% in adulthood, while&#xD;
      another 35% of adult patients presents impaired glucose tolerance.&#xD;
&#xD;
      In order to identify patients at risk and to implement early therapeutic measures, an annual&#xD;
      CFRD screening test should therefore be undertaken for CF patients after 10 years of age. The&#xD;
      2-hour oral glucose tolerance test (OGTT) with a sweet beverage is the recommended screening&#xD;
      test. However, participation rates for screening tests are far from optimal. For examples, in&#xD;
      2015, the investigators observed that only 47% of non-diabetic patients attended to planned&#xD;
      screening despite large availability and advertisement (unpublished data). Comparable low&#xD;
      levels of screening for CFRD, usually below 33%, have been reported by various teams. Several&#xD;
      reasons could explain these low adherence rates. Some factors are related to patients&#xD;
      perceptions and experience: OGTT is perceived as an additional medical burden requiring a&#xD;
      scheduled appointment (several weeks after the last exacerbation); overnight fasting followed&#xD;
      by the intake of a large glucose load within 5 minutes can lead to nausea, headache, bloating&#xD;
      and fatigue; some patients fear multiple blood sampling, etc. In addition, in case of CFRD&#xD;
      diagnosis, recommended capillary blood glucose monitoring, nutritional advice and treatment&#xD;
      (insulin) are perceived as extremely invasive and complex, thus some patients prefer avoiding&#xD;
      screening test. To date, no alternative screening method has demonstrated its effectiveness&#xD;
      to screen for CFRD. The investigators of this study believe that a simplified version of the&#xD;
      OGTT would be more attractive, would make it more acceptable for patients and has the&#xD;
      potential to improve their adherence to screening tests, simplify CF-team works and reduce&#xD;
      costs. By allowing appropriate education and introduction of treatment in a timely manner,&#xD;
      improved adherence to annual screening for dysglycemia has the potential to minimize or&#xD;
      prevent clinical deterioration observed in years preceding CFRD onset.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a pilot study to evaluate the validity and the acceptability of a&#xD;
      home-based OGTT by comparing, in patients with CF:&#xD;
&#xD;
        -  Standard hospital-based OGTT with measures of plasma glucose and the use of 75g glucose&#xD;
           beverage;&#xD;
&#xD;
        -  Home-based OGTT with measures of glucose using a continuous glucose monitoring system&#xD;
           (CGMS; without blood sample collection) and the 75g glucose beverage;&#xD;
&#xD;
        -  Home-based OGTT with measures of glucose using CGMS and 75g of glucose from candies as a&#xD;
           substitute to this poorly appreciate beverage.&#xD;
&#xD;
      Specific objectives are to determine i) the internal validity (specificity, sensitivity) of&#xD;
      both home-based OGTTs versus a standard OGTT in controlled setting, and ii) the predictive&#xD;
      value (positive and negative). The investigators will also iii) investigate patient's&#xD;
      perception and likelihood that the proposed method improves adherence to annual screening,&#xD;
      and iv) evaluate potential cost reduction associated with proposed simplified screening&#xD;
      tests.&#xD;
&#xD;
      On the day of the OGTT, and after obtaining informed consent, a CGMS will be installed.&#xD;
      Patients will receive the very simple training required to use it as well as a pre-packed&#xD;
      Jelly Beans bag containing 75g of glucose and a standard 75g glucose beverage bottle. This&#xD;
      CGMS will provide interstitial glucose values each 15 min over the next 14 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Internal validity</measure>
    <time_frame>OGTTs performed within 14 days</time_frame>
    <description>Specificity and sensitivity of both home-based OGTTs versus a standard OGTT in controlled setting</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictive value (positive and negative)</measure>
    <time_frame>OGTTs performed within 14 days</time_frame>
    <description>Both home-based OGTTs versus a standard OGTT in controlled setting</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's perception</measure>
    <time_frame>OGTTs performed within 14 days</time_frame>
    <description>Visual analog scale questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost evaluation of methods</measure>
    <time_frame>OGTTs performed within 14 days</time_frame>
    <description>Estimated cost of each methods</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Cystic Fibrosis</condition>
  <condition>Cystic Fibrosis-related Diabetes</condition>
  <arm_group>
    <arm_group_label>Standard OGTT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>OGTT standard test at hospital (75g glucose beverage; 2-h test with plasma glucose collection)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home-based OGTT (Beverage)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Home-based OGTT with CGM device, without glucose collection (75g glucose beverage; 2-h test: glycemia measured by CGM)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home-based OGTT (Candy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Home-based OGTT with CGM device, without glucose collection (75g of glucose (Jelly Beans); 2-h test: glycemia measured by CGM)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standard OGTT</intervention_name>
    <description>Standard-OGTT Plasma glucose : 0, 30, 60, 90, 120 minutes Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.) Questionnaires CGMS training &amp; delivery of Jelly-Bean/75g glucose beverage</description>
    <arm_group_label>Standard OGTT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Home-based OGTT (Beverage)</intervention_name>
    <description>In a random order Candy-OGTT (Jelly-Bean) or 75 g glucose beverage Glycemia every 15 minutes from CGMS collection; standardized condition (fasting + rest) Questionnaires</description>
    <arm_group_label>Home-based OGTT (Beverage)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Home-based OGTT (Candy)</intervention_name>
    <description>In a random order Candy-OGTT (Jelly-Bean) or 75 g glucose beverage Glycemia every 15 minutes from CGMS collection; standardized condition (fasting + rest) Questionnaires</description>
    <arm_group_label>Home-based OGTT (Candy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult CF-patient without known diabetes&#xD;
&#xD;
          -  In stable condition at least 1-month apart from the last exacerbation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known CFRD&#xD;
&#xD;
          -  Recent exacerbation&#xD;
&#xD;
          -  Use medications known to interfere with glucose metabolism such as oral steroids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rémi Rabasa-Lhoret, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montreal Research Clinical Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHUM</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2W1R7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Clinical Research Institute (IRCM)</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2W 1R7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut de Recherches Cliniques de Montreal</investigator_affiliation>
    <investigator_full_name>Rémi Rabasa-Lhoret</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Screening test</keyword>
  <keyword>Continuous glucose monitoring</keyword>
  <keyword>Oral glucose tolerance test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <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/NCT03227094
org study id: AtHome
nct id: NCT03227094
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cystic fibrosis (CF)-related diabetes (CFRD) is the most common complication after pulmonary
      complications. This specific form of diabetes is associated with an increased morbidity and
      mortality. CFRD prevalence at the age of 10 is 10% and reaches 40 to 50% in adulthood, while
      another 35% of adult patients presents impaired glucose tolerance.

      In order to identify patients at risk and to implement early therapeutic measures, an annual
      CFRD screening test should therefore be undertaken for CF patients after 10 years of age. The
      2-hour oral glucose tolerance test (OGTT) with a sweet beverage is the recommended screening
      test. However, participation rates for screening tests are far from optimal. For examples, in
      2015, the investigators observed that only 47% of non-diabetic patients attended to planned
      screening despite large availability and advertisement (unpublished data). Comparable low
      levels of screening for CFRD, usually below 33%, have been reported by various teams. Several
      reasons could explain these low adherence rates. Some factors are related to patients
      perceptions and experience: OGTT is perceived as an additional medical burden requiring a
      scheduled appointment (several weeks after the last exacerbation); overnight fasting followed
      by the intake of a large glucose load within 5 minutes can lead to nausea, headache, bloating
      and fatigue; some patients fear multiple blood sampling, etc. In addition, in case of CFRD
      diagnosis, recommended capillary blood glucose monitoring, nutritional advice and treatment
      (insulin) are perceived as extremely invasive and complex, thus some patients prefer avoiding
      screening test. To date, no alternative screening method has demonstrated its effectiveness
      to screen for CFRD. The investigators of this study believe that a simplified version of the
      OGTT would be more attractive, would make it more acceptable for patients and has the
      potential to improve their adherence to screening tests, simplify CF-team works and reduce
      costs. By allowing appropriate education and introduction of treatment in a timely manner,
      improved adherence to annual screening for dysglycemia has the potential to minimize or
      prevent clinical deterioration observed in years preceding CFRD onset.
The investigators propose a pilot study to evaluate the validity and the acceptability of a
      home-based OGTT by comparing, in patients with CF:

        -  Standard hospital-based OGTT with measures of plasma glucose and the use of 75g glucose
           beverage;

        -  Home-based OGTT with measures of glucose using a continuous glucose monitoring system
           (CGMS; without blood sample collection) and the 75g glucose beverage;

        -  Home-based OGTT with measures of glucose using CGMS and 75g of glucose from candies as a
           substitute to this poorly appreciate beverage.

      Specific objectives are to determine i) the internal validity (specificity, sensitivity) of
      both home-based OGTTs versus a standard OGTT in controlled setting, and ii) the predictive
      value (positive and negative). The investigators will also iii) investigate patient's
      perception and likelihood that the proposed method improves adherence to annual screening,
      and iv) evaluate potential cost reduction associated with proposed simplified screening
      tests.

      On the day of the OGTT, and after obtaining informed consent, a CGMS will be installed.
      Patients will receive the very simple training required to use it as well as a pre-packed
      Jelly Beans bag containing 75g of glucose and a standard 75g glucose beverage bottle. This
      CGMS will provide interstitial glucose values each 15 min over the next 14 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Internal validity
time frame: OGTTs performed within 14 days
description: Specificity and sensitivity of both home-based OGTTs versus a standard OGTT in controlled setting
measure: Predictive value (positive and negative)
time frame: OGTTs performed within 14 days
description: Both home-based OGTTs versus a standard OGTT in controlled setting
measure: Patient's perception
time frame: OGTTs performed within 14 days
description: Visual analog scale questionnaire
measure: Cost evaluation of methods
time frame: OGTTs performed within 14 days
description: Estimated cost of each methods
arm group label: Standard OGTT
arm group type: Other
description: OGTT standard test at hospital (75g glucose beverage; 2-h test with plasma glucose collection)
arm group label: Home-based OGTT (Beverage)
arm group type: Experimental
description: Home-based OGTT with CGM device, without glucose collection (75g glucose beverage; 2-h test: glycemia measured by CGM)
arm group label: Home-based OGTT (Candy)
arm group type: Experimental
description: Home-based OGTT with CGM device, without glucose collection (75g of glucose (Jelly Beans); 2-h test: glycemia measured by CGM)
intervention type: Diagnostic Test
intervention name: Standard OGTT
description: Standard-OGTT Plasma glucose : 0, 30, 60, 90, 120 minutes Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.) Questionnaires CGMS training & delivery of Jelly-Bean/75g glucose beverage
arm group label: Standard OGTT
intervention type: Diagnostic Test
intervention name: Home-based OGTT (Beverage)
description: In a random order Candy-OGTT (Jelly-Bean) or 75 g glucose beverage Glycemia every 15 minutes from CGMS collection; standardized condition (fasting + rest) Questionnaires
arm group label: Home-based OGTT (Beverage)
intervention type: Diagnostic Test
intervention name: Home-based OGTT (Candy)
description: In a random order Candy-OGTT (Jelly-Bean) or 75 g glucose beverage Glycemia every 15 minutes from CGMS collection; standardized condition (fasting + rest) Questionnaires
arm group label: Home-based OGTT (Candy)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rémi Rabasa-Lhoret, MD, PhD
role: Principal Investigator
affiliation: Montreal Research Clinical Institute
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Institut de Recherches Cliniques de Montreal
investigator full name: Rémi Rabasa-Lhoret
investigator title: Associate Professor of Medicine
mesh term: Cystic Fibrosis
mesh term: Diabetes Mellitus
mesh term: Fibrosis
sharing ipd: No