<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/NCT03028220</url>
  </required_header>
  <id_info>
    <org_study_id>15HH2875</org_study_id>
    <nct_id>NCT03028220</nct_id>
  </id_info>
  <brief_title>Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data</brief_title>
  <acronym>IHART-CGM</acronym>
  <official_title>Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study proposes to assess the impact of Libre on frequency, duration and&#xD;
      severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people&#xD;
      with impaired awareness of hypoglycaemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes&#xD;
      complications and self monitoring of glucose levels is an important component of achieving&#xD;
      and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose&#xD;
      control in all age groups when used continuously, and reduces the incidence of low blood&#xD;
      glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the&#xD;
      commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can&#xD;
      become less aware of it. This reduced aware of hypoglycaemia has significant risks including&#xD;
      seizures, coma and even death, and has an impact on people's ability to drive and function.&#xD;
&#xD;
      The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of&#xD;
      retrospective continuous glucose monitoring data to users when the monitor is waved in&#xD;
      proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14&#xD;
      days and is non-adjunctive (does not require calibration to capillary blood glucose).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% Time Spent in Hypoglycaemia (&lt;3.3mmol/L, 60mg/dL)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Percentage time spent in hypoglycaemia (&lt;3.3mmol/L, 60mg/dL) change from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>% Time Spent in Hypoglycaemia (&lt;2.8mmol/L, 50mg/dL)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Percentage time spent in hypoglycaemia (&lt;2.8mmol/L, 50mg/dL) change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Time Spent in Hypoglycaemia (&lt;3.9mmol/L, 70mg/dL)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Percentage time spent in hypoglycaemia (&lt;3.9mmol/L, 70mg/dL) change in baseline to endpint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Time Spent in Hyperglycaemia (&gt;10mmol/L, 180mg/dL)</measure>
    <time_frame>10 weeks</time_frame>
    <description>Percentage time spent in hyperglycaemia (&gt;10mmol/L, 180mg/dL) change in baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Time Spent in Hyperglycaemia (&gt;15mmol/L, 270mg/dL)</measure>
    <time_frame>10 weeks</time_frame>
    <description>% time spent in hyperglycaemia (&gt;15mmol/L, 270mg/dL) change in baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of participants with hypoglycemic excursions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Hypoglycaemia</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of participants with episodes of severe hypoglycaemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Glucose Variability Measured</measure>
    <time_frame>8 weeks</time_frame>
    <description>Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Variability Measured by MAGE</measure>
    <time_frame>8 weeks</time_frame>
    <description>Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Variability Measured by CONGA</measure>
    <time_frame>8 weeks</time_frame>
    <description>Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Type 1 Diabetes Mellitus With Hypoglycemia</condition>
  <condition>Impaired Awareness of Hypoglycemia</condition>
  <condition>Type1diabetes</condition>
  <arm_group>
    <arm_group_label>Real time continuous glucose monitoring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of Dexcom G5 continuous glucose monitoring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flash glucose monitoring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of Abbott FreeStyle Libre flash glucose monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom G5 Continuous Glucose Monitor</intervention_name>
    <description>Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
    <arm_group_label>Real time continuous glucose monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Abbott Freestyle Libre</intervention_name>
    <description>Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
    <arm_group_label>Flash glucose monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults over 18 years of age&#xD;
&#xD;
          -  Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide&#xD;
             &lt;200 pmol/L&#xD;
&#xD;
          -  Severe hypoglycaemic event in the last 12 months requiring third party assistance OR a&#xD;
             Gold Score ≥ 4&#xD;
&#xD;
          -  Type 1 diabetes for greater than 3 years&#xD;
&#xD;
          -  On an intensified multiple dose insulin injection regimen for &gt; 6 months (MDI)&#xD;
&#xD;
          -  Previous type 1 diabetes structured education (either group or 1:1)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of CGM or Libre device within the last 6 months (except short periods of&#xD;
             diagnostic blinded use under clinic supervision)&#xD;
&#xD;
          -  Use of regular paracetamol&#xD;
&#xD;
          -  Pregnant or planning pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  Enrolled in other clinical trials, except at the discretion of the chief investigator&#xD;
&#xD;
          -  Have active malignancy or under investigation for malignancy&#xD;
&#xD;
          -  Severe visual impairment&#xD;
&#xD;
          -  Reduced manual dexterity&#xD;
&#xD;
          -  Unable to participate due to other factors, as assessed by the Chief Investigators&#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>Nick Oliver, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>August 10, 2018</results_first_submitted>
  <results_first_submitted_qc>April 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 16, 2019</results_first_posted>
  <last_update_submitted>October 23, 2019</last_update_submitted>
  <last_update_submitted_qc>October 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 1 Diabetes</keyword>
  <keyword>Hypoglycemia</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>
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>August 30, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03028220/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Real Time Continuous Glucose Monitoring</title>
          <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
        </group>
        <group group_id="P2">
          <title>Flash Glucose Monitoring</title>
          <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>1 participant in the CGM group was randomised and completed the trial but the CGM data could not be analysed due to an uploading error. All other data was analysed for this participant.</population>
      <group_list>
        <group group_id="B1">
          <title>Real Time Continuous Glucose Monitoring</title>
          <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
        </group>
        <group group_id="B2">
          <title>Flash Glucose Monitoring</title>
          <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.5" lower_limit="45" upper_limit="64.5"/>
                    <measurement group_id="B2" value="48.5" lower_limit="34" upper_limit="63"/>
                    <measurement group_id="B3" value="49.5" lower_limit="37.5" upper_limit="63.5"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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>Count of Participants</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>% Time Spent in Hypoglycaemia (&lt;3.3mmol/L, 60mg/dL)</title>
        <description>Percentage time spent in hypoglycaemia (&lt;3.3mmol/L, 60mg/dL) change from baseline</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>% Time Spent in Hypoglycaemia (&lt;3.3mmol/L, 60mg/dL)</title>
          <description>Percentage time spent in hypoglycaemia (&lt;3.3mmol/L, 60mg/dL) change from baseline</description>
          <units>percentage of time &lt;3.3mmol/l</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" lower_limit="-5.0" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="1.3" lower_limit="-1.4" upper_limit="3.6"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Time Spent in Hypoglycaemia (&lt;2.8mmol/L, 50mg/dL)</title>
        <description>Percentage time spent in hypoglycaemia (&lt;2.8mmol/L, 50mg/dL) change from baseline</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>% Time Spent in Hypoglycaemia (&lt;2.8mmol/L, 50mg/dL)</title>
          <description>Percentage time spent in hypoglycaemia (&lt;2.8mmol/L, 50mg/dL) change from baseline</description>
          <units>percentage of time &lt;2.8mmol/l</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" lower_limit="-4.3" upper_limit="-0.5"/>
                    <measurement group_id="O2" value="1.3" lower_limit="-1.0" upper_limit="2.4"/>
                  </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>Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Time Spent in Hypoglycaemia (&lt;3.9mmol/L, 70mg/dL)</title>
        <description>Percentage time spent in hypoglycaemia (&lt;3.9mmol/L, 70mg/dL) change in baseline to endpint</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>% Time Spent in Hypoglycaemia (&lt;3.9mmol/L, 70mg/dL)</title>
          <description>Percentage time spent in hypoglycaemia (&lt;3.9mmol/L, 70mg/dL) change in baseline to endpint</description>
          <units>percentage of time &lt;3.9mmol/l</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" lower_limit="-6.1" upper_limit="-0.1"/>
                    <measurement group_id="O2" value="0.6" lower_limit="-2.1" upper_limit="5.4"/>
                  </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>Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)</title>
        <description>Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)</title>
          <description>Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint</description>
          <units>percentage of time &gt;3.9&lt;7.8 mmol/l</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="3.3" upper_limit="14.4"/>
                    <measurement group_id="O2" value="5.9" lower_limit="-2.4" upper_limit="9.0"/>
                  </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>Other</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)</title>
        <description>Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)</title>
          <description>Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint</description>
          <units>percentage of time &gt;3.9&lt;10 mmol/l</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" lower_limit="7.2" upper_limit="15.8"/>
                    <measurement group_id="O2" value="5.3" lower_limit="1.1" upper_limit="11.7"/>
                  </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>Other</non_inferiority_type>
            <p_value>1</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Time Spent in Hyperglycaemia (&gt;10mmol/L, 180mg/dL)</title>
        <description>Percentage time spent in hyperglycaemia (&gt;10mmol/L, 180mg/dL) change in baseline to endpoint</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>% Time Spent in Hyperglycaemia (&gt;10mmol/L, 180mg/dL)</title>
          <description>Percentage time spent in hyperglycaemia (&gt;10mmol/L, 180mg/dL) change in baseline to endpoint</description>
          <units>percentage of time &gt;10mmol/L</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.6" lower_limit="-13.0" upper_limit="-1.1"/>
                    <measurement group_id="O2" value="-7.0" lower_limit="-16.9" upper_limit="1.7"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.820</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Time Spent in Hyperglycaemia (&gt;15mmol/L, 270mg/dL)</title>
        <description>% time spent in hyperglycaemia (&gt;15mmol/L, 270mg/dL) change in baseline to endpoint</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>% Time Spent in Hyperglycaemia (&gt;15mmol/L, 270mg/dL)</title>
          <description>% time spent in hyperglycaemia (&gt;15mmol/L, 270mg/dL) change in baseline to endpoint</description>
          <units>percentage of time &gt;15 mmol/l</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" lower_limit="-8.6" upper_limit="-0.7"/>
                    <measurement group_id="O2" value="-3.1" lower_limit="-5.3" upper_limit="-0.4"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.820</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hypoglycemia</title>
        <description>Number of participants with hypoglycemic excursions</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>Hypoglycemia</title>
          <description>Number of participants with hypoglycemic excursions</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.570</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severe Hypoglycaemia</title>
        <description>Number of participants with episodes of severe hypoglycaemia</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>Severe Hypoglycaemia</title>
          <description>Number of participants with episodes of severe hypoglycaemia</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </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>Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Glucose Variability Measured</title>
        <description>Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Glucose Variability Measured</title>
          <description>Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1</description>
          <units>percent</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-0.1" upper_limit="0.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="-0.1" upper_limit="0.0"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.910</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucose Variability Measured by MAGE</title>
        <description>Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose Variability Measured by MAGE</title>
          <description>Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)</description>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" lower_limit="-2.9" upper_limit="-0.5"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-1.6" upper_limit="0.1"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.460</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glucose Variability Measured by CONGA</title>
        <description>Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Continuous Glucose Monitoring</title>
            <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
          </group>
          <group group_id="O2">
            <title>Flash Glucose Monitoring</title>
            <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</description>
          </group>
        </group_list>
        <measure>
          <title>Glucose Variability Measured by CONGA</title>
          <description>Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)</description>
          <units>mmol/l</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" lower_limit="-0.5" upper_limit="0.2"/>
                    <measurement group_id="O2" value="0.1" lower_limit="-0.1" upper_limit="0.2"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.191</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Real Time Continuous Glucose Monitoring</title>
          <description>Use of Dexcom G5 continuous glucose monitoring&#xD;
Dexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values</description>
        </group>
        <group group_id="E2">
          <title>Flash Glucose Monitoring</title>
          <description>Use of Abbott FreeStyle Libre flash glucose monitoring&#xD;
Abbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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>Prof Nick Oliver</name_or_title>
      <organization>Imperial College London</organization>
      <phone>02075942460</phone>
      <email>nick.oliver@imperial.ac.uk</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/NCT03028220
org study id: 15HH2875
nct id: NCT03028220
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical study proposes to assess the impact of Libre on frequency, duration and
      severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people
      with impaired awareness of hypoglycaemia.
Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes
      complications and self monitoring of glucose levels is an important component of achieving
      and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose
      control in all age groups when used continuously, and reduces the incidence of low blood
      glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the
      commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can
      become less aware of it. This reduced aware of hypoglycaemia has significant risks including
      seizures, coma and even death, and has an impact on people's ability to drive and function.

      The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of
      retrospective continuous glucose monitoring data to users when the monitor is waved in
      proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14
      days and is non-adjunctive (does not require calibration to capillary blood glucose).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
time frame: 10 weeks
description: Percentage time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) change from baseline
measure: % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)
time frame: 10 weeks
description: Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline
measure: % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)
time frame: 10 weeks
description: Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) change in baseline to endpint
measure: % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
time frame: 10 weeks
description: Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint
measure: % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)
time frame: 10 weeks
description: Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint
measure: % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)
time frame: 10 weeks
description: Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint
measure: % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)
time frame: 10 weeks
description: % time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint
measure: Hypoglycemia
time frame: 8 weeks
description: Number of participants with hypoglycemic excursions
measure: Severe Hypoglycaemia
time frame: 8 weeks
description: Number of participants with episodes of severe hypoglycaemia
measure: Changes in Glucose Variability Measured
time frame: 8 weeks
description: Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1
measure: Glucose Variability Measured by MAGE
time frame: 8 weeks
description: Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)
measure: Glucose Variability Measured by CONGA
time frame: 8 weeks
description: Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)
arm group label: Real time continuous glucose monitoring
arm group type: Active Comparator
description: Use of Dexcom G5 continuous glucose monitoring
arm group label: Flash glucose monitoring
arm group type: Active Comparator
description: Use of Abbott FreeStyle Libre flash glucose monitoring
intervention type: Device
intervention name: Dexcom G5 Continuous Glucose Monitor
description: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values
arm group label: Real time continuous glucose monitoring
intervention type: Device
intervention name: Abbott Freestyle Libre
description: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data
arm group label: Flash glucose monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nick Oliver, FRCP
role: Principal Investigator
affiliation: Imperial College London
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Hypoglycemia
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 