<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/NCT03020069</url>
  </required_header>
  <id_info>
    <org_study_id>16-01011</org_study_id>
    <nct_id>NCT03020069</nct_id>
  </id_info>
  <brief_title>Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes</brief_title>
  <official_title>Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine that continuous glucose monitoring systems (CGMS)&#xD;
      with intensive real time feedback about diabetes management from medical staff to the patient&#xD;
      will affect motivation and/or behavior, in adolescents with poorly controlled type 1&#xD;
      diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack&#xD;
      thereof) and patients' sense of self-efficacy will influence their stage of change and&#xD;
      potentially glucose levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty adolescents, ages 13-19 years, with type 1 diabetes and an HbA1c &gt; = 8 % who are also&#xD;
      naive to CGMS use will be recruited from the diabetes outpatient population followed at&#xD;
      Bellevue Hospital, Lutheran Hospital, Woodhull Hospital, and the NYU Fink Pediatric&#xD;
      Ambulatory Care Center. Forty subjects will be randomly assigned to the CGMS group and 20&#xD;
      subjects will be assigned to the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">July 13, 2018</completion_date>
  <primary_completion_date type="Actual">July 13, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months</measure>
    <time_frame>Baseline, 3 Months</time_frame>
    <description>The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months</measure>
    <time_frame>Baseline, 3 Months</time_frame>
    <description>HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months</measure>
    <time_frame>Baseline, 3 Months</time_frame>
    <description>Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Glucose Meter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuing Glucose Monitoring Device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Glucose Meter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Average Blood glucose measure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CGMS Device</intervention_name>
    <arm_group_label>Glucose Meter</arm_group_label>
    <other_name>Continuing Glucose Monitoring Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Device</intervention_name>
    <arm_group_label>No Glucose Meter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type 1 diabetes&#xD;
&#xD;
          -  HbA1c &gt; = 8 %&#xD;
&#xD;
          -  naive to CGMS use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with developmental delay&#xD;
&#xD;
          -  Patients who do not use a glucose meter to test capillary blood glucose level&#xD;
&#xD;
          -  Patients without access to a telephone will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bonita Franklin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>February 6, 2020</results_first_submitted>
  <results_first_submitted_qc>March 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2020</results_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 Diabetes</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Glucose Monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03020069/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Glucose Meter</title>
          <description>Continuing Glucose Monitoring Device&#xD;
CGMS Device</description>
        </group>
        <group group_id="P2">
          <title>No Glucose Meter</title>
          <description>Average Blood glucose measure&#xD;
No Device</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Glucose Meter</title>
          <description>Continuing Glucose Monitoring Device&#xD;
CGMS Device</description>
        </group>
        <group group_id="B2">
          <title>No Glucose Meter</title>
          <description>Average Blood glucose measure&#xD;
No Device</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16" lower_limit="14" upper_limit="18"/>
                    <measurement group_id="B2" value="17" lower_limit="16" upper_limit="18"/>
                    <measurement group_id="B3" value="16" lower_limit="14" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months</title>
        <description>The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.</description>
        <time_frame>Baseline, 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Glucose Meter</title>
            <description>Continuing Glucose Monitoring Device&#xD;
CGMS Device</description>
          </group>
          <group group_id="O2">
            <title>No Glucose Meter</title>
            <description>Average Blood glucose measure&#xD;
No Device</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months</title>
          <description>The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" lower_limit="-11.4" upper_limit="15.9"/>
                    <measurement group_id="O2" value="-3.8" lower_limit="-21.2" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months</title>
        <description>HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change.</description>
        <time_frame>Baseline, 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Glucose Meter</title>
            <description>Continuing Glucose Monitoring Device&#xD;
CGMS Device</description>
          </group>
          <group group_id="O2">
            <title>No Glucose Meter</title>
            <description>Average Blood glucose measure&#xD;
No Device</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months</title>
          <description>HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change.</description>
          <units>mmol/mol</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.4" lower_limit="-132" upper_limit="67"/>
                    <measurement group_id="O2" value="-36" lower_limit="-194" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months</title>
        <description>Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.</description>
        <time_frame>Baseline, 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Glucose Meter</title>
            <description>Continuing Glucose Monitoring Device&#xD;
CGMS Device</description>
          </group>
          <group group_id="O2">
            <title>No Glucose Meter</title>
            <description>Average Blood glucose measure&#xD;
No Device</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months</title>
          <description>Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.</description>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-18.3" upper_limit="0.7"/>
                    <measurement group_id="O2" value="0" lower_limit="-0.1" upper_limit="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months</title>
        <description>There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.</description>
        <time_frame>Baseline, 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Glucose Meter</title>
            <description>Continuing Glucose Monitoring Device&#xD;
CGMS Device</description>
          </group>
          <group group_id="O2">
            <title>No Glucose Meter</title>
            <description>Average Blood glucose measure&#xD;
No Device</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months</title>
          <description>There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.375" lower_limit="-.375" upper_limit="0.875"/>
                    <measurement group_id="O2" value="-0.25" lower_limit="-0.625" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>For 3 months after randomization</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Glucose Meter</title>
          <description>Continuing Glucose Monitoring Device&#xD;
CGMS Device</description>
        </group>
        <group group_id="E2">
          <title>No Glucose Meter</title>
          <description>Average Blood glucose measure&#xD;
No Device</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jeniece Ilkowitz RN, MA, CDE</name_or_title>
      <organization>NYU Langone Health</organization>
      <phone>212-263-9910</phone>
      <email>Jeniece.ilkowitz@nyulangone.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03020069
org study id: 16-01011
nct id: NCT03020069
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine that continuous glucose monitoring systems (CGMS)
      with intensive real time feedback about diabetes management from medical staff to the patient
      will affect motivation and/or behavior, in adolescents with poorly controlled type 1
      diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack
      thereof) and patients' sense of self-efficacy will influence their stage of change and
      potentially glucose levels.
Sixty adolescents, ages 13-19 years, with type 1 diabetes and an HbA1c > = 8 % who are also
      naive to CGMS use will be recruited from the diabetes outpatient population followed at
      Bellevue Hospital, Lutheran Hospital, Woodhull Hospital, and the NYU Fink Pediatric
      Ambulatory Care Center. Forty subjects will be randomly assigned to the CGMS group and 20
      subjects will be assigned to the control group.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months
time frame: Baseline, 3 Months
description: The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.
measure: Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months
time frame: Baseline, 3 Months
description: HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change.
measure: Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months
time frame: Baseline, 3 Months
description: Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.
measure: Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months
time frame: Baseline, 3 months
description: There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.
arm group label: Glucose Meter
arm group type: Experimental
description: Continuing Glucose Monitoring Device
arm group label: No Glucose Meter
arm group type: Active Comparator
description: Average Blood glucose measure
intervention type: Device
intervention name: CGMS Device
arm group label: Glucose Meter
other name: Continuing Glucose Monitoring Device
intervention type: Other
intervention name: No Device
arm group label: No Glucose Meter
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: No
last name: Bonita Franklin, MD
role: Principal Investigator
affiliation: NYU School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 