<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/NCT01713348</url>
  </required_header>
  <id_info>
    <org_study_id>ADC-PMR-APO-12015</org_study_id>
    <nct_id>NCT01713348</nct_id>
  </id_info>
  <brief_title>Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes</brief_title>
  <acronym>SIGN</acronym>
  <official_title>Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Diabetes Care</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Diabetes Care</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic&#xD;
      control by;&#xD;
&#xD;
        1. regularly checking and understanding Continuous Glucose data &amp; trend arrows at times&#xD;
           other than the standard pre-meal bolus calculation test times and&#xD;
&#xD;
        2. review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care&#xD;
           Professional (HCP) and adjusting behaviours &amp; therapy from interpretation of the&#xD;
           Continuous Glucose profiles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Phase 4</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time in Range</measure>
    <time_frame>Day 86 to 100 compared to Day 1 to 15</time_frame>
    <description>Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time in Range</measure>
    <time_frame>Days 86 to 100 intervention arm compared to control arm</time_frame>
    <description>Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Standard Deviation (SD)</measure>
    <time_frame>Day 86 to 100 compared to day 1 to 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c (mmol/Mol)</measure>
    <time_frame>Day 100 compared to day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Day 100 compared to day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>CGM - intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMBG - Control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FreeStyle Navigator</intervention_name>
    <description>Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
    <arm_group_label>CGM - intervention arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard SMBG</intervention_name>
    <description>Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
    <arm_group_label>SMBG - Control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and over&#xD;
&#xD;
          -  Type 1 diabetes on MDI with bolus injections for &gt;6 months prior to study enrolment or&#xD;
             Type 2 diabetes treated with 2 or more insulin injections daily.&#xD;
&#xD;
          -  In the investigator's opinion, thought technically capable of using FreeStyle&#xD;
             Navigator GM System device.&#xD;
&#xD;
          -  HbA1c between 7.5 and 12.0% (58 to 108 mmol/mol) for previous test obtained within 6&#xD;
             months prior to point of enrolment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant disease or condition that may compromise patient safety, including&#xD;
             unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any&#xD;
             uncontrolled chronic medical condition&#xD;
&#xD;
          -  Female subject is pregnant or planning to become pregnant within the planned study&#xD;
             duration. Subjects who become pregnant during the study will be discontinued from the&#xD;
             study.&#xD;
&#xD;
          -  Currently using / has previously used a Continuous Glucose Monitoring System within&#xD;
             the last 6 months.&#xD;
&#xD;
          -  Currently using Continuous Subcutaneous Insulin Infusion (CSII)&#xD;
&#xD;
          -  Currently using basal/long acting insulin only.&#xD;
&#xD;
          -  Participating in another study of a glucose monitoring device / drug that could affect&#xD;
             glucose measurements / management&#xD;
&#xD;
          -  Known allergy to medical grade adhesives&#xD;
&#xD;
          -  In the investigators opinion is unsuitable to participate due to any other&#xD;
             cause/reason.&#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>Ramzi Ajjan</last_name>
    <role>Principal Investigator</role>
    <affiliation>St James Hospital, Leeds</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ayr Hospital</name>
      <address>
        <city>Ayr</city>
        <state>Ayrshire</state>
        <zip>KA6 6DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tameside Hospital NHS Foundation Trust</name>
      <address>
        <city>Ashton-under-Lyne</city>
        <zip>OL6 9RW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal United Hospital</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Heartlands Hospital, Diabetes Clinic</name>
      <address>
        <city>City and Borough of Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Durham</name>
      <address>
        <city>Durham</city>
        <zip>DH1 5TW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ipswich Hospital NHS Trust</name>
      <address>
        <city>Ipswich</city>
        <zip>IP4 5PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James Hospital,</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rotherham General Hospital</name>
      <address>
        <city>Rotherham</city>
        <zip>S60 2UD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes Centre, New Cross Hospital,</name>
      <address>
        <city>Wolverhampton,</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <results_first_submitted>February 26, 2015</results_first_submitted>
  <results_first_submitted_qc>February 26, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 11, 2015</results_first_posted>
  <last_update_submitted>February 4, 2016</last_update_submitted>
  <last_update_submitted_qc>February 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CGM</keyword>
  <keyword>MDI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 105 subjects consented and enrolled into the study. Eighteen of these withdrew before randomisation or failed screening. Eighty-seven (87) subjects were randomised and 79 completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CGM - Intervention Arm - Type 1 Diabetes</title>
          <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
        </group>
        <group group_id="P2">
          <title>SMBG - Control Arm - Type 1 Diabetes</title>
          <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
        </group>
        <group group_id="P3">
          <title>CGM - Intervention Arm - Type 2 Diabetes</title>
          <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
        </group>
        <group group_id="P4">
          <title>SMBG - Control Arm - Type 2 Diabetes</title>
          <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CGM - Intervention Arm - Type 1 Diabetes</title>
          <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
        </group>
        <group group_id="B2">
          <title>SMBG - Control Arm - Type 1 Diabetes</title>
          <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
        </group>
        <group group_id="B3">
          <title>CGM - Intervention Arm - Type 2 Diabetes</title>
          <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
        </group>
        <group group_id="B4">
          <title>SMBG - Control Arm - Type 2 Diabetes</title>
          <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
        </group>
        <group group_id="B5">
          <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="29"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="15"/>
            <count group_id="B5" value="87"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.0" spread="11.5"/>
                    <measurement group_id="B2" value="43.7" spread="9.9"/>
                    <measurement group_id="B3" value="57.8" spread="8.8"/>
                    <measurement group_id="B4" value="55.5" spread="10.9"/>
                    <measurement group_id="B5" value="49.0" spread="13.2"/>
                  </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="14"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="51"/>
                  </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 Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline HbA1c</title>
          <units>mmol/mol</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.4" spread="14.1"/>
                    <measurement group_id="B2" value="74.8" spread="13.9"/>
                    <measurement group_id="B3" value="76.5" spread="15.0"/>
                    <measurement group_id="B4" value="77.4" spread="13.7"/>
                    <measurement group_id="B5" value="76.4" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline HbA1c</title>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.2" spread="1.3"/>
                    <measurement group_id="B2" value="9.0" spread="1.3"/>
                    <measurement group_id="B3" value="9.2" spread="1.4"/>
                    <measurement group_id="B4" value="9.2" spread="1.3"/>
                    <measurement group_id="B5" value="9.1" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time in Range</title>
        <description>Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.</description>
        <time_frame>Day 86 to 100 compared to Day 1 to 15</time_frame>
        <population>All analyses were performed according to the intention-to-treat principle.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM - Intervention Arm - Type 1 Diabetes</title>
            <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
          </group>
          <group group_id="O2">
            <title>SMBG - Control Arm - Type 1 Diabetes</title>
            <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
          </group>
          <group group_id="O3">
            <title>CGM - Intervention Arm - Type 2 Diabetes</title>
            <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
          </group>
          <group group_id="O4">
            <title>SMBG - Control Arm - Type 2 Diabetes</title>
            <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Range</title>
          <description>Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.</description>
          <population>All analyses were performed according to the intention-to-treat principle.</population>
          <units>hours per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="3.0"/>
                    <measurement group_id="O2" value="11.5" spread="4.6"/>
                    <measurement group_id="O3" value="13.3" spread="5.2"/>
                    <measurement group_id="O4" value="12.3" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="3.9"/>
                    <measurement group_id="O2" value="11.5" spread="4.2"/>
                    <measurement group_id="O3" value="14.7" spread="5.8"/>
                    <measurement group_id="O4" value="13.3" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9345</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>3.3</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.29</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0427</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.4</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>3.5</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.05</ci_lower_limit>
            <ci_upper_limit>2.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Range</title>
        <description>Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.</description>
        <time_frame>Days 86 to 100 intervention arm compared to control arm</time_frame>
        <population>All analyses were performed according to the intention-to-treat principle.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM - Intervention Arm - Type 1 Diabetes</title>
            <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
          </group>
          <group group_id="O2">
            <title>SMBG - Control Arm - Type 1 Diabetes</title>
            <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
          </group>
          <group group_id="O3">
            <title>CGM - Intervention Arm - Type 2 Diabetes</title>
            <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
          </group>
          <group group_id="O4">
            <title>SMBG - Control Arm - Type 2 Diabetes</title>
            <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Range</title>
          <description>Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.</description>
          <population>All analyses were performed according to the intention-to-treat principle.</population>
          <units>hours per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="3.0"/>
                    <measurement group_id="O2" value="11.5" spread="4.6"/>
                    <measurement group_id="O3" value="13.3" spread="5.2"/>
                    <measurement group_id="O4" value="12.3" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="3.9"/>
                    <measurement group_id="O2" value="11.5" spread="4.2"/>
                    <measurement group_id="O3" value="14.7" spread="5.8"/>
                    <measurement group_id="O4" value="13.3" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.8367</p_value>
            <method>ANCOVA</method>
            <method_desc>Performed for each type of Diabetes and adjusted for baseline Time in Range.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.25</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.65</ci_lower_limit>
            <ci_upper_limit>2.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7969</p_value>
            <method>ANCOVA</method>
            <method_desc>Performed for each type of Diabetes and adjusted for baseline Time in Range.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.27</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.05</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.86</ci_lower_limit>
            <ci_upper_limit>2.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucose Standard Deviation (SD)</title>
        <time_frame>Day 86 to 100 compared to day 1 to 15</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CGM - Intervention Arm - Type 1 Diabetes</title>
            <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
          </group>
          <group group_id="O2">
            <title>SMBG - Control Arm - Type 1 Diabetes</title>
            <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
          </group>
          <group group_id="O3">
            <title>CGM - Intervention Arm - Type 2 Diabetes</title>
            <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
          </group>
          <group group_id="O4">
            <title>SMBG - Control Arm - Type 2 Diabetes</title>
            <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose Standard Deviation (SD)</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.8"/>
                    <measurement group_id="O2" value="3.7" spread="0.8"/>
                    <measurement group_id="O3" value="3.0" spread="0.7"/>
                    <measurement group_id="O4" value="3.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="0.7"/>
                    <measurement group_id="O2" value="3.8" spread="0.6"/>
                    <measurement group_id="O3" value="2.8" spread="0.7"/>
                    <measurement group_id="O4" value="3.0" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0352</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.6</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.51</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0506</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.7</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.54</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HbA1c (mmol/Mol)</title>
        <time_frame>Day 100 compared to day 1</time_frame>
        <population>Analysis performed according to the intention-to-treat principle. Analysis in the Type 1 population is after removal of 1 outlier.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM - Intervention Arm - Type 1 Diabetes</title>
            <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
          </group>
          <group group_id="O2">
            <title>SMBG - Control Arm - Type 1 Diabetes</title>
            <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
          </group>
          <group group_id="O3">
            <title>CGM - Intervention Arm - Type 2 Diabetes</title>
            <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
          </group>
          <group group_id="O4">
            <title>SMBG - Control Arm - Type 2 Diabetes</title>
            <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
          </group>
        </group_list>
        <measure>
          <title>HbA1c (mmol/Mol)</title>
          <population>Analysis performed according to the intention-to-treat principle. Analysis in the Type 1 population is after removal of 1 outlier.</population>
          <units>mmol/mol</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="10"/>
                    <measurement group_id="O2" value="75" spread="14"/>
                    <measurement group_id="O3" value="77" spread="15"/>
                    <measurement group_id="O4" value="77" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72" spread="8"/>
                    <measurement group_id="O2" value="74" spread="14"/>
                    <measurement group_id="O3" value="67" spread="13"/>
                    <measurement group_id="O4" value="72" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0580</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>8</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-9</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.6</ci_lower_limit>
            <ci_upper_limit>-4.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HbA1c</title>
        <time_frame>Day 100 compared to day 1</time_frame>
        <population>Analysis performed according to the intention-to-treat principle.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM - Intervention Arm - Type 1 Diabetes</title>
            <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
          </group>
          <group group_id="O2">
            <title>SMBG - Control Arm - Type 1 Diabetes</title>
            <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
          </group>
          <group group_id="O3">
            <title>CGM - Intervention Arm - Type 2 Diabetes</title>
            <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
          </group>
          <group group_id="O4">
            <title>SMBG - Control Arm - Type 2 Diabetes</title>
            <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100</description>
          </group>
        </group_list>
        <measure>
          <title>HbA1c</title>
          <population>Analysis performed according to the intention-to-treat principle.</population>
          <units>Percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="0.9"/>
                    <measurement group_id="O2" value="9.0" spread="1.3"/>
                    <measurement group_id="O3" value="9.2" spread="1.4"/>
                    <measurement group_id="O4" value="9.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="0.7"/>
                    <measurement group_id="O2" value="8.9" spread="1.3"/>
                    <measurement group_id="O3" value="8.3" spread="1.2"/>
                    <measurement group_id="O4" value="8.8" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0580</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.8</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.59</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.8</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.1</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.24</ci_lower_limit>
            <ci_upper_limit>-0.45</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events collected from enrollment to completion by last subject (8 months)</time_frame>
      <desc>In addition to the adverse events listed below, one subject who withdrew from the study before randomisation reported Menieres disease.</desc>
      <group_list>
        <group group_id="E1">
          <title>CGM - Intervention Arm - Type 1 Diabetes</title>
          <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
        </group>
        <group group_id="E2">
          <title>SMBG - Control Arm - Type 1 Diabetes</title>
          <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100.</description>
        </group>
        <group group_id="E3">
          <title>CGM - Intervention Arm - Type 2 Diabetes</title>
          <description>Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.&#xD;
FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100</description>
        </group>
        <group group_id="E4">
          <title>SMBG - Control Arm - Type 2 Diabetes</title>
          <description>Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.&#xD;
Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Severe hypoglycaemia</sub_title>
                <description>Not device or study related.</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <description>Not device or study related.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Sickness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infection - general</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dental</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Joint pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Foot pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Infection - renal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cold</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="29"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E3" events="11" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" events="9" subjects_affected="6" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sensor tip</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Snr Director, Clinical Development &amp; Regulatory Affairs</name_or_title>
      <organization>Abbott Diabetes Care</organization>
      <phone>01993863164</phone>
      <email>joe.bugler@abbott.com</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/NCT01713348
org study id: ADC-PMR-APO-12015
nct id: NCT01713348
lead sponsor: 
has dmc: No
To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic
      control by;

        1. regularly checking and understanding Continuous Glucose data & trend arrows at times
           other than the standard pre-meal bolus calculation test times and

        2. review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care
           Professional (HCP) and adjusting behaviours & therapy from interpretation of the
           Continuous Glucose profiles.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Time in Range
time frame: Day 86 to 100 compared to Day 1 to 15
description: Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.
measure: Time in Range
time frame: Days 86 to 100 intervention arm compared to control arm
description: Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.
measure: Glucose Standard Deviation (SD)
time frame: Day 86 to 100 compared to day 1 to 15
measure: HbA1c (mmol/Mol)
time frame: Day 100 compared to day 1
measure: HbA1c
time frame: Day 100 compared to day 1
arm group label: CGM - intervention arm
arm group type: Experimental
description: Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.
arm group label: SMBG - Control arm
arm group type: Active Comparator
description: Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.
intervention type: Device
intervention name: FreeStyle Navigator
description: Masked CGM day 1 to 15, unmasked CGM days 15 to 100
arm group label: CGM - intervention arm
intervention type: Device
intervention name: Standard SMBG
description: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
arm group label: SMBG - Control arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ramzi Ajjan
role: Principal Investigator
affiliation: St James Hospital, Leeds
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes Mellitus
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 