<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/NCT02232698</url>
  </required_header>
  <id_info>
    <org_study_id>ADC-CI-APO-13019</org_study_id>
    <nct_id>NCT02232698</nct_id>
  </id_info>
  <brief_title>An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)</brief_title>
  <acronym>IMPACT</acronym>
  <official_title>Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 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>
      The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose&#xD;
      Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing&#xD;
      using a randomised controlled study design in adults with Type 1 diabetes using insulin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time Spent &lt;70 mg/dL</measure>
    <time_frame>Baseline and Days 194 to 208</time_frame>
    <description>Difference in time &lt;70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c at 6 Months</measure>
    <time_frame>Baseline and Day 208</time_frame>
    <description>Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Spent &lt;55 mg/dL and &lt;40 mg/dL</measure>
    <time_frame>Baseline and Days 194 to 208</time_frame>
    <description>Difference in time &lt;55 mg/dL &amp; &lt;40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Episodes &lt;70 mg/dL, &lt;55 mg/dL and &lt;40 mg/dL</measure>
    <time_frame>Baseline and Days 194-208</time_frame>
    <description>Difference in frequency of episodes &lt;70 mg/dL, &lt;55 mg/dL and &lt;40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Spent &gt;180 mg/dL and &gt;240 mg/dL</measure>
    <time_frame>Baseline and Days 194 to 208</time_frame>
    <description>Difference in time &gt;180 mg/dL and &gt;240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Range</measure>
    <time_frame>Baseline and Days 194 to 208</time_frame>
    <description>Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Glucose Measurements Performed</measure>
    <time_frame>Days 1 to 208</time_frame>
    <description>Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>System Utilisation</measure>
    <time_frame>Days 15 to 208</time_frame>
    <description>System utilisation assessed by percentage of sensor glucose data collected by the intervention group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208</measure>
    <time_frame>Baseline and Day 208</time_frame>
    <description>The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).&#xD;
There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).&#xD;
The ANCOVA adjusts for baseline DTSQs (status version).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">328</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Sensor Based Glucose Monitoring System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard sensing system use for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Blood Glucose Monitoring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sensor Based Glucose Monitoring System</intervention_name>
    <description>Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
    <arm_group_label>Sensor Based Glucose Monitoring System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Blood Glucose Monitoring</intervention_name>
    <description>Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
    <arm_group_label>Standard Blood Glucose Monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with Type 1 diabetes for ≥ 5 years&#xD;
&#xD;
          2. On their current insulin regimen for ≥ 3 months prior to study entry&#xD;
&#xD;
          3. Screening HbA1c result ≤ 7.5% (58 mmol/mol)&#xD;
&#xD;
          4. Reports self testing of blood glucose levels on a regular basis equivalent to a&#xD;
             minimum of 3 times daily for at least 2 months prior to study entry&#xD;
&#xD;
          5. In the investigator's opinion the subject is considered technically capable of using&#xD;
             the Abbott Sensor Based Glucose Monitoring System&#xD;
&#xD;
          6. Aged 18 years or over.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a&#xD;
             diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in&#xD;
             the investigator's opinion the subject currently experiences less than minimal warning&#xD;
             symptoms for impending hypoglycaemia)&#xD;
&#xD;
          2. Subject is currently prescribed animal insulin&#xD;
&#xD;
          3. Subject is currently prescribed oral steroid therapy or is likely to require oral&#xD;
             steroid therapy for any acute or chronic condition during the study&#xD;
&#xD;
          4. Has known allergy to medical grade adhesives&#xD;
&#xD;
          5. Currently participating in another device or drug study that could affect glucose&#xD;
             measurements or glucose management&#xD;
&#xD;
          6. Currently using a Continuous Glucose Monitoring (CGM) device or has used one within&#xD;
             the previous 4 months&#xD;
&#xD;
          7. Currently using Sensor augmented pump therapy&#xD;
&#xD;
          8. Is planning to use a CGM device at any time during the study&#xD;
&#xD;
          9. A female subject who is pregnant or planning to become pregnant within the study&#xD;
             duration&#xD;
&#xD;
         10. A breast feeding mother&#xD;
&#xD;
         11. Currently receiving dialysis treatment or planning to receive dialysis during the&#xD;
             study&#xD;
&#xD;
         12. Has a pacemaker&#xD;
&#xD;
         13. Has experienced an acute myocardial infarction within previous 6 months&#xD;
&#xD;
         14. Has a concomitant disease or condition that may compromise subject safety including;&#xD;
             unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any&#xD;
             other uncontrolled medical condition&#xD;
&#xD;
         15. Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in&#xD;
             the previous 6 months&#xD;
&#xD;
         16. In the investigator's opinion, the subject is considered unsuitable for inclusion in&#xD;
             the study for any other 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>Stephan Matthaei</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diabetes Center Quakenbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie</name>
      <address>
        <city>Feldkirch</city>
        <zip>6807</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Graz Abteilung für Innere Medizin, Klin. Abteilung für Endokrinologie und Stoffwechsel</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diakonissen-Krankenhaus Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik fuer Innere Medizin III Medizinische Universitaet Wien</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital Medzin 5</name>
      <address>
        <city>Wien</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes Klinik Bad Mergentheim</name>
      <address>
        <city>Bad Mergentheim</city>
        <zip>97980</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum für Diabetologie Hamburg Bergedorf</name>
      <address>
        <city>Hamburg</city>
        <zip>21029</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes-Zentrum Hannover-Nord</name>
      <address>
        <city>Hannover</city>
        <zip>30165</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes Center Quakenbruck</name>
      <address>
        <city>Quakenbrück</city>
        <zip>49610</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Versdias GmbH</name>
      <address>
        <city>Sūlzbach-Rosenberg</city>
        <zip>92237</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vrije Universiteit Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <zip>1007 MB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouwe gasthuis ( OLVG)</name>
      <address>
        <city>Amsterdam</city>
        <zip>1090 HM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Ziekenhuis</name>
      <address>
        <city>Breda</city>
        <zip>4800 RK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Haaglanden</name>
      <address>
        <city>Den Haag</city>
        <zip>2512 VA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethesda Diabetes Research Center</name>
      <address>
        <city>Hoogeveen</city>
        <zip>7909 AA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Utrecht</city>
        <zip>3543 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>8916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Diabetologica</name>
      <address>
        <city>Gijon</city>
        <zip>33206</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servicio de Endocrinología Hospital Unversitario Cruces</name>
      <address>
        <city>Vizcaya</city>
        <zip>48903</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Falu Lasarett</name>
      <address>
        <city>Falun</city>
        <zip>SE-791 29</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset Solna</name>
      <address>
        <city>Solna</city>
        <zip>SE-171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhuset Huddinge</name>
      <address>
        <city>Stockholm</city>
        <zip>SE-141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <results_first_submitted>January 6, 2017</results_first_submitted>
  <results_first_submitted_qc>February 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 10, 2017</results_first_posted>
  <last_update_submitted>February 27, 2017</last_update_submitted>
  <last_update_submitted_qc>February 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sensing Technology</keyword>
  <keyword>Type 1 Diabetes,</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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 328 subjects consented and enrolled into the study. Eighty-seven (87) of these failed screening or withdrew before randomisation. Two hundred and forty-one (241) subjects were randomised and 211 completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sensor Based Glucose Monitoring System</title>
          <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
        </group>
        <group group_id="P2">
          <title>Standard Blood Glucose Monitoring</title>
          <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="121"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Met exclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Had device-associated symptoms</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with study device</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Allocated to control group</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>2 pregnant subjects (1 in each group) were excluded from all efficacy analysis (as stated in the protocol).</population>
      <group_list>
        <group group_id="B1">
          <title>Sensor Based Glucose Monitoring System</title>
          <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
        </group>
        <group group_id="B2">
          <title>Standard Blood Glucose Monitoring</title>
          <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</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="119"/>
            <count group_id="B2" value="120"/>
            <count group_id="B3" value="239"/>
          </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="42.4" spread="13.1"/>
                    <measurement group_id="B2" value="45.0" spread="14.6"/>
                    <measurement group_id="B3" value="43.7" spread="13.9"/>
                  </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="42"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Screening HbA1c</title>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.73" spread="0.52"/>
                    <measurement group_id="B2" value="6.74" spread="0.59"/>
                    <measurement group_id="B3" value="6.74" spread="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Screening 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="50.1" spread="5.7"/>
                    <measurement group_id="B2" value="50.2" spread="6.5"/>
                    <measurement group_id="B3" value="50.1" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time Spent &lt;70 mg/dL</title>
        <description>Difference in time &lt;70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
        <time_frame>Baseline and Days 194 to 208</time_frame>
        <population>1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.</population>
        <group_list>
          <group group_id="O1">
            <title>Sensor Based Glucose Monitoring System</title>
            <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
          <group group_id="O2">
            <title>Standard Blood Glucose Monitoring</title>
            <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
        </group_list>
        <measure>
          <title>Time Spent &lt;70 mg/dL</title>
          <description>Difference in time &lt;70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
          <population>1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.</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="119"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.38" spread="2.31"/>
                    <measurement group_id="O2" value="3.44" spread="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 194-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.03" spread="1.93"/>
                    <measurement group_id="O2" value="3.27" spread="2.58"/>
                  </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>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.239</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HbA1c at 6 Months</title>
        <description>Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1</description>
        <time_frame>Baseline and Day 208</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sensor Based Glucose Monitoring System</title>
            <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
          <group group_id="O2">
            <title>Standard Blood Glucose Monitoring</title>
            <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
        </group_list>
        <measure>
          <title>HbA1c at 6 Months</title>
          <description>Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1</description>
          <units>percentage of Glycated Haemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.79" spread="0.52"/>
                    <measurement group_id="O2" value="6.78" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.94" spread="0.65"/>
                    <measurement group_id="O2" value="6.95" spread="0.66"/>
                  </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>0.9556</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.059</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Spent &lt;55 mg/dL and &lt;40 mg/dL</title>
        <description>Difference in time &lt;55 mg/dL &amp; &lt;40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
        <time_frame>Baseline and Days 194 to 208</time_frame>
        <population>1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.</population>
        <group_list>
          <group group_id="O1">
            <title>Sensor Based Glucose Monitoring System</title>
            <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
          <group group_id="O2">
            <title>Standard Blood Glucose Monitoring</title>
            <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
        </group_list>
        <measure>
          <title>Time Spent &lt;55 mg/dL and &lt;40 mg/dL</title>
          <description>Difference in time &lt;55 mg/dL &amp; &lt;40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
          <population>1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.</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="119"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time spent &lt;55 mg/dL, Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.59" spread="1.42"/>
                    <measurement group_id="O2" value="1.77" spread="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time spent &lt;55 mg/dL, Days 194-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="0.96"/>
                    <measurement group_id="O2" value="1.65" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time spent &lt;40 mg/dL, Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.59" spread="0.85"/>
                    <measurement group_id="O2" value="0.75" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time spent &lt;40 mg/dL, Days 194-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="0.47"/>
                    <measurement group_id="O2" value="0.73" spread="1.41"/>
                  </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>&lt;0.0001</p_value>
            <p_value_desc>Statistical analysis of time spent &lt;55 mg/dL</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.82</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.175</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <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>0.0003</p_value>
            <p_value_desc>Statistical analysis of time spent &lt;40 mg/dL</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.122</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Episodes &lt;70 mg/dL, &lt;55 mg/dL and &lt;40 mg/dL</title>
        <description>Difference in frequency of episodes &lt;70 mg/dL, &lt;55 mg/dL and &lt;40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
        <time_frame>Baseline and Days 194-208</time_frame>
        <population>1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.</population>
        <group_list>
          <group group_id="O1">
            <title>Sensor Based Glucose Monitoring System</title>
            <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
          <group group_id="O2">
            <title>Standard Blood Glucose Monitoring</title>
            <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Episodes &lt;70 mg/dL, &lt;55 mg/dL and &lt;40 mg/dL</title>
          <description>Difference in frequency of episodes &lt;70 mg/dL, &lt;55 mg/dL and &lt;40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
          <population>1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.</population>
          <units>number of episodes 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="119"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Frequency of episodes &lt;70 mg/dL, Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.81" spread="0.90"/>
                    <measurement group_id="O2" value="1.67" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frequency of episodes &lt;70 mg/dL, Days 194-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" spread="0.81"/>
                    <measurement group_id="O2" value="1.69" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frequency of episodes &lt;55 mg/dL, Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="0.65"/>
                    <measurement group_id="O2" value="0.92" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frequency of episodes &lt;55 mg/dL, Days 194-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="0.55"/>
                    <measurement group_id="O2" value="0.92" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frequency of episodes &lt;40 mg/dL, Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" spread="0.43"/>
                    <measurement group_id="O2" value="0.44" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frequency of episodes &lt;40 mg/dL, Days 194-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.29"/>
                    <measurement group_id="O2" value="0.43" spread="0.55"/>
                  </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>
            <groups_desc>Statistical analysis of frequency of episodes &lt;70 mg/dL</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.45</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.089</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis of frequency of episodes &lt;55 mg/dL</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.074</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis of frequency of episodes &lt;40 mg/dL</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.050</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Spent &gt;180 mg/dL and &gt;240 mg/dL</title>
        <description>Difference in time &gt;180 mg/dL and &gt;240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
        <time_frame>Baseline and Days 194 to 208</time_frame>
        <population>1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.</population>
        <group_list>
          <group group_id="O1">
            <title>Sensor Based Glucose Monitoring System</title>
            <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
          <group group_id="O2">
            <title>Standard Blood Glucose Monitoring</title>
            <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
        </group_list>
        <measure>
          <title>Time Spent &gt;180 mg/dL and &gt;240 mg/dL</title>
          <description>Difference in time &gt;180 mg/dL and &gt;240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).</description>
          <population>1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.</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="119"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time spent &gt;180 mg/dL, Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.62" spread="2.48"/>
                    <measurement group_id="O2" value="5.80" spread="3.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time spent &gt;180 mg/dL, Days 194-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.16" spread="3.05"/>
                    <measurement group_id="O2" value="6.08" spread="3.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time spent &gt;240 mg/dL, Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" spread="1.44"/>
                    <measurement group_id="O2" value="1.91" spread="1.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time spent &gt;240 mg/dL, Days 194-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.67" spread="1.36"/>
                    <measurement group_id="O2" value="2.06" spread="1.61"/>
                  </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>
            <groups_desc>Statistical analysis of time spent &gt;180 mg/dL</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5623</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.19</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.329</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for time spent &gt;240 mg/dL</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0247</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.163</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Range</title>
        <description>Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).</description>
        <time_frame>Baseline and Days 194 to 208</time_frame>
        <population>1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.</population>
        <group_list>
          <group group_id="O1">
            <title>Sensor Based Glucose Monitoring System</title>
            <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
          <group group_id="O2">
            <title>Standard Blood Glucose Monitoring</title>
            <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Range</title>
          <description>Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).</description>
          <population>1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.</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="119"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" spread="2.5"/>
                    <measurement group_id="O2" value="14.8" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Days 194-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8" spread="2.9"/>
                    <measurement group_id="O2" value="14.6" spread="2.9"/>
                  </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>0.0006</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.30</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Glucose Measurements Performed</title>
        <description>Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.</description>
        <time_frame>Days 1 to 208</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sensor Based Glucose Monitoring System</title>
            <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
          <group group_id="O2">
            <title>Standard Blood Glucose Monitoring</title>
            <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Glucose Measurements Performed</title>
          <description>Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.</description>
          <units>number of measurements 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="106"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of fingerstick tests, Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="2.0"/>
                    <measurement group_id="O2" value="5.8" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of fingerstick tests, Days 194-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.0"/>
                    <measurement group_id="O2" value="5.6" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of sensor scans, Days 15-208</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1" spread="6.9"/>
                    <measurement group_id="O2" value="NA" spread="NA">Number of sensor scans does not apply to this group as they did not use the sensor to self-manage their glucose levels.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>System Utilisation</title>
        <description>System utilisation assessed by percentage of sensor glucose data collected by the intervention group</description>
        <time_frame>Days 15 to 208</time_frame>
        <population>112 subjects included in the analysis, 7 were not included due to missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Sensor Based Glucose Monitoring System</title>
            <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
        </group_list>
        <measure>
          <title>System Utilisation</title>
          <description>System utilisation assessed by percentage of sensor glucose data collected by the intervention group</description>
          <population>112 subjects included in the analysis, 7 were not included due to missing data.</population>
          <units>percentage of sensor glucose collected</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.8" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208</title>
        <description>The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).&#xD;
There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).&#xD;
The ANCOVA adjusts for baseline DTSQs (status version).</description>
        <time_frame>Baseline and Day 208</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sensor Based Glucose Monitoring System</title>
            <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
          <group group_id="O2">
            <title>Standard Blood Glucose Monitoring</title>
            <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208</title>
          <description>The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).&#xD;
There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).&#xD;
The ANCOVA adjusts for baseline DTSQs (status version).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hyperglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.6"/>
                    <measurement group_id="O2" value="0.5" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="1.6"/>
                    <measurement group_id="O2" value="0.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Satisfaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4" spread="5.5"/>
                    <measurement group_id="O2" value="7.2" spread="6.2"/>
                  </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>
            <groups_desc>Statistical analysis of perceived frequency of hyperglycaemia</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.22</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis of perceived frequency of hypoglycaemia</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0713</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.22</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis of total treatment satisfaction score</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.84</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events collected from enrolment (6 months)</time_frame>
      <desc>In addition to the serious adverse events listed below, 1 subject reported a serious adverse event of hypoglycaemia during the baseline phase (prior to randomisation), this subject was subsequently randomised to the Sensor Based Glucose Monitoring group.&#xD;
No serious adverse events were related to the study device.</desc>
      <group_list>
        <group group_id="E1">
          <title>Sensor Based Glucose Monitoring System</title>
          <description>Standard sensing system use for 6 months.&#xD;
Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
        </group>
        <group group_id="E2">
          <title>Standard Blood Glucose Monitoring</title>
          <description>Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.&#xD;
Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).&#xD;
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <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="4" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>retroperitoneal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>hypoglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <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="33" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>medical device site reaction</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="120"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>influenza</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="120"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>nasopharyngitis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="19" subjects_at_risk="120"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="121"/>
              </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>01993 863164</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/NCT02232698
org study id: ADC-CI-APO-13019
nct id: NCT02232698
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose
      Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing
      using a randomised controlled study design in adults with Type 1 diabetes using insulin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Time Spent <70 mg/dL
time frame: Baseline and Days 194 to 208
description: Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
measure: HbA1c at 6 Months
time frame: Baseline and Day 208
description: Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1
measure: Time Spent <55 mg/dL and <40 mg/dL
time frame: Baseline and Days 194 to 208
description: Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
measure: Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL
time frame: Baseline and Days 194-208
description: Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
measure: Time Spent >180 mg/dL and >240 mg/dL
time frame: Baseline and Days 194 to 208
description: Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).
measure: Time in Range
time frame: Baseline and Days 194 to 208
description: Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).
measure: Number of Glucose Measurements Performed
time frame: Days 1 to 208
description: Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.
measure: System Utilisation
time frame: Days 15 to 208
description: System utilisation assessed by percentage of sensor glucose data collected by the intervention group
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208
time frame: Baseline and Day 208
description: The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).
There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).
The ANCOVA adjusts for baseline DTSQs (status version).
arm group label: Sensor Based Glucose Monitoring System
arm group type: Experimental
description: Standard sensing system use for 6 months.
arm group label: Standard Blood Glucose Monitoring
arm group type: Active Comparator
description: Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.
intervention type: Device
intervention name: Sensor Based Glucose Monitoring System
description: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
arm group label: Sensor Based Glucose Monitoring System
intervention type: Device
intervention name: Standard Blood Glucose Monitoring
description: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time).
arm group label: Standard Blood Glucose Monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephan Matthaei
role: Principal Investigator
affiliation: Diabetes Center Quakenbruck
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Germany
country: Netherlands
country: Spain
country: Sweden
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Hypoglycemia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 