<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/NCT02211235</url>
  </required_header>
  <id_info>
    <org_study_id>14-0960</org_study_id>
    <secondary_id>UL1TR001082</secondary_id>
    <nct_id>NCT02211235</nct_id>
  </id_info>
  <brief_title>Glycemic Monitoring in Cystic Fibrosis</brief_title>
  <acronym>GEM</acronym>
  <official_title>Characterization of Glucose Variability by Continuous Glucose Monitoring in Non-diabetic Youth With and Without Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</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>
      Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes&#xD;
      recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2&#xD;
      diabetes. Increasing evidence supports treating early glucose abnormalities in cystic&#xD;
      fibrosis patients to target CF specific outcomes, including lung function and nutrition&#xD;
      (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in&#xD;
      the 'prediabetic' state are unclear. A more accurate characterization of blood sugar&#xD;
      variability in youth with and without CF will help the investigators better interpret&#xD;
      continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and&#xD;
      more accurately identify those individuals at greatest risk for disease progression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 16, 2018</completion_date>
  <primary_completion_date type="Actual">May 16, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of time spent &gt; 140 mg/dl on CGM</measure>
    <time_frame>7 days</time_frame>
    <description>Percentage of time above normal glucose cut-point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of time spent &gt; 120 mg/dl on CGM</measure>
    <time_frame>7 days</time_frame>
    <description>Measures of glucose variability on CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of time spent &gt; 200 mg/dl on CGM</measure>
    <time_frame>7 days</time_frame>
    <description>Measures of glucose variability on CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of time spent &lt; 70 mg/dl on CGM</measure>
    <time_frame>7 days</time_frame>
    <description>Measures of glucose variability on CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of time spent &lt; 60 mg/dl on CGM</measure>
    <time_frame>7 days</time_frame>
    <description>Measures of glucose variability on CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of excursions &gt; 200mg/dl in 24 hours for one week</measure>
    <time_frame>7 days</time_frame>
    <description>Measures of glucose variability including peak glucose, mean glucose and measures of glucose variability on CGM.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in CGM variables and BMI</measure>
    <time_frame>3 years</time_frame>
    <description>To analyze in youth with CF the relationship between CGM variables and BMI Primary outcome: Change in BMI z-score collected at routine clinical visits over the preceding three years</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in CGM variables and lung function</measure>
    <time_frame>3 years</time_frame>
    <description>To analyze in youth with CF the relationship between CGM variables and lung function change in the preceding three years Secondary outcome: Change in forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) measures collected at routine clinical visits over the preceding three years</description>
  </other_outcome>
  <other_outcome>
    <measure>Characterize the relationships between markers of glycemia</measure>
    <time_frame>3 days</time_frame>
    <description>To characterize the relationships between alternative markers of glycemia (fructosamine, glycated albumin, and 1,5-anhydroglucitol) and CGM variables in non-diabetic CF youth and healthy controls</description>
  </other_outcome>
  <enrollment type="Actual">146</enrollment>
  <condition>Cystic Fibrosis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Alternative markers of glycemia, including fructosamine, glycated albumin, and&#xD;
      1,5-anhydroglucitol, Oral Glucose Tolerance Test (OGTT) derived markers of insulin secretion&#xD;
      and insulin sensitivity&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children and Adolescents ages 6-25, without diabetes. Out of 160 people, 45 will be healthy&#xD;
        controls, 45 with Cystic Fibrosis (normal glucose tolerance), and 70 with Cystic&#xD;
        Fibrosis-related diabetes or pre-diabetes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy controls (n=45) -&#xD;
&#xD;
          1. Age 10-25 years&#xD;
&#xD;
          2. BMI &lt;85th percentile&#xD;
&#xD;
          3. Baseline health at enrollment&#xD;
&#xD;
        CF controls (n=45) -&#xD;
&#xD;
          1. Age 10-25 years&#xD;
&#xD;
          2. Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic&#xD;
             testing)&#xD;
&#xD;
          3. Baseline health at enrollment (no inclusion/exclusion criteria for CF patients based&#xD;
             on lung function, BMI, pancreatic insufficiency, or genotype)&#xD;
&#xD;
        CF prediabetes &amp; CFRD (n=70)&#xD;
&#xD;
          1. Age 10-25 years&#xD;
&#xD;
          2. Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic&#xD;
             testing)&#xD;
&#xD;
          3. History of abnormal oral glucose tolerance testing (2h-glucose &gt;140, fasting plasma&#xD;
             glucose &gt;100,1hr glucose &gt;200)&#xD;
&#xD;
          4. If taking medication that affects glucose metabolism (ex. Insulin, insulin&#xD;
             sensitizers, glucocorticoids, atypical antipsychotics), should be on a stable dose&#xD;
             over the past 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Healthy controls -&#xD;
&#xD;
          1. Known diagnosis of diabetes or prediabetes (including type 1, type 2, MODY), abnormal&#xD;
             oral glucose tolerance test (OGTT) (ie. fasting plasma glucose ≥100 or 2hr ≥140 mg/dl)&#xD;
             or HbA1c ≥ 5.7%&#xD;
&#xD;
          2. BMI ≥85th percentile&#xD;
&#xD;
          3. Chronic disease that may affect glucose metabolism or use of medications affecting&#xD;
             glucose metabolism in the past 3 months (ex. Insulin, insulin sensitizers,&#xD;
             glucocorticoids, atypical antipsychotics)&#xD;
&#xD;
          4. Presence of type 1 diabetes auto-antibodies in any individuals with a first degree&#xD;
             relative with type 1 diabetes (will only include first degree relatives if they have&#xD;
             had previous negative auto-antibody screening performed as part of participation in&#xD;
             other studies such as the Trial Net studies at the Barbara Davis Center)&#xD;
&#xD;
          5. Acute illness (ex. Asthma exacerbation, gastroenteritis, febrile illness)&#xD;
&#xD;
          6. Pregnancy&#xD;
&#xD;
        CF participants -&#xD;
&#xD;
          1. Diagnosis of type 1 diabetes, type 2 diabetes, or MODY&#xD;
&#xD;
          2. Varying doses of medication affecting glucose metabolism in the past 3 months&#xD;
&#xD;
          3. Pulmonary exacerbation associated with hospitalization, or systemic steroid&#xD;
             requirement in the preceding 6 weeks&#xD;
&#xD;
          4. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine L Chan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado, University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>March 20, 2023</last_update_submitted>
  <last_update_submitted_qc>March 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cystic Fibrosis</keyword>
  <keyword>Healthy Controls</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Cystic Fibrosis Related Diabetes (CFRD)</keyword>
  <keyword>CFRD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT02211235
org study id: 14-0960
secondary id: UL1TR001082
nct id: NCT02211235
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes
      recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2
      diabetes. Increasing evidence supports treating early glucose abnormalities in cystic
      fibrosis patients to target CF specific outcomes, including lung function and nutrition
      (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in
      the 'prediabetic' state are unclear. A more accurate characterization of blood sugar
      variability in youth with and without CF will help the investigators better interpret
      continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and
      more accurately identify those individuals at greatest risk for disease progression.
observational model: Case-Control
time perspective: Prospective
measure: The percentage of time spent > 140 mg/dl on CGM
time frame: 7 days
description: Percentage of time above normal glucose cut-point.
measure: The percentage of time spent > 120 mg/dl on CGM
time frame: 7 days
description: Measures of glucose variability on CGM
measure: The percentage of time spent > 200 mg/dl on CGM
time frame: 7 days
description: Measures of glucose variability on CGM
measure: The percentage of time spent < 70 mg/dl on CGM
time frame: 7 days
description: Measures of glucose variability on CGM
measure: The percentage of time spent < 60 mg/dl on CGM
time frame: 7 days
description: Measures of glucose variability on CGM
measure: The number of excursions > 200mg/dl in 24 hours for one week
time frame: 7 days
description: Measures of glucose variability including peak glucose, mean glucose and measures of glucose variability on CGM.
measure: Change in CGM variables and BMI
time frame: 3 years
description: To analyze in youth with CF the relationship between CGM variables and BMI Primary outcome: Change in BMI z-score collected at routine clinical visits over the preceding three years
measure: Change in CGM variables and lung function
time frame: 3 years
description: To analyze in youth with CF the relationship between CGM variables and lung function change in the preceding three years Secondary outcome: Change in forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) measures collected at routine clinical visits over the preceding three years
measure: Characterize the relationships between markers of glycemia
time frame: 3 days
description: To characterize the relationships between alternative markers of glycemia (fructosamine, glycated albumin, and 1,5-anhydroglucitol) and CGM variables in non-diabetic CF youth and healthy controls
Alternative markers of glycemia, including fructosamine, glycated albumin, and
      1,5-anhydroglucitol, Oral Glucose Tolerance Test (OGTT) derived markers of insulin secretion
      and insulin sensitivity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christine L Chan, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis