<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/NCT01718522</url>
  </required_header>
  <id_info>
    <org_study_id>CEN_G_DB_1</org_study_id>
    <nct_id>NCT01718522</nct_id>
  </id_info>
  <brief_title>Registry of Use and Application of Sensor Augmented Pump (SAP) Therapy Under Daily Life Conditions</brief_title>
  <acronym>RANSuP</acronym>
  <official_title>The Application and Advantage of Sensor Augmented Pump (SAP) Therapy Under Daily Conditions (Registerstudie Zur Anwendung Und Nutzen Der Sensorunterstützten Pumpentherapie (SuP) Unter Alltagsbedingungen)(RANSuP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Diabetes</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Diabetes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this registry is to collect the real life data on Sensor Augmented pump (SAP)&#xD;
      therapy usage in type 1 Diabetes mellitus (DM) patients treated with Medtronic Insulin pumps&#xD;
      and continuous glucose monitoring systems in Germany.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this registry is to reflect the daily practice with Sensor Augmented Pump&#xD;
      (SAP) therapy usage in Type 1 Diabetes Mellitus (DM) patients treated with Medtronic insulin&#xD;
      pumps (Paradigm VEO®) and continuous glucose monitoring systems in Germany. In addition, the&#xD;
      aim is of this registry is to support:&#xD;
&#xD;
        -  obtain reimbursement for SAP therapy in Germany&#xD;
&#xD;
        -  building a platform (advisory committee) for discussion of SAP data.&#xD;
&#xD;
        -  looking for deficits with implementation of glucose sensor data in diabetes therapy&#xD;
           management and development of &quot;follow-up education&quot; materials.&#xD;
&#xD;
      This is a national multi-center, post-market non-interventional prospective study with CE&#xD;
      marked and commercially available devices and consumables.&#xD;
&#xD;
      The study will be conducted from March 2012 to April 2013 in Germany. The duration of&#xD;
      individual patient participation is 3 to 6 months.&#xD;
&#xD;
      Health outcomes will be measured in approximately 75 patients between 6-65 years old&#xD;
      diagnosed with Type 1 DM over a period of at least 3 months in approximately 15 centers. The&#xD;
      patients are under treatment of Paradigm VEO® without any additional insulin injections and&#xD;
      use continuous glucose monitoring, or patients that are not using continuous glucose&#xD;
      monitoring, but that are willing to start with SAP. The enrolled subjects have a first visit&#xD;
      inquiring the status data (including upload of device data in CareLink software, Hemoglobin&#xD;
      A1c (HbA1c) value measurement) without any intervention. Thereafter, the SAP therapy is&#xD;
      optimized based on individual continuous glucose monitoring (CGM) data during a second visit&#xD;
      one month later and then a last visit like the first visit in which the status will be&#xD;
      determined.&#xD;
&#xD;
      Parameters of glycemic control will be measured, such as the frequency of hypoglycemia&#xD;
      (glucose values ≤ 70 mg/dl), over a period of 30 days after the first patient's visit (Visit&#xD;
      1) and after the visit 2 when an adjustment of the therapy has been discussed with the&#xD;
      patient based on the collected CGM results between the two first visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number (n) of Excursions &lt;70 mg/dl Per Sensor Day at Baseline and 3 Months</measure>
    <time_frame>baseline and 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number (n) of Excursions &lt;40 mg/dl Per Sensor Day at Baseline and 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve (AUC) in Hypoglycemic Region (&lt; 70mg/dl) at Baseline and 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Area under the curve (AUC) in hypoglycemic region (&lt; 70mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve (AUC) in Hyperglycemic Region (&gt;140mg/dl) at Baseline and 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Area under the curve (AUC) in hyperglycemic region (&gt;140mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">75</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sensor augmented pump (SAP)</intervention_name>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Diabetes mellitus, type 1&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with signed informed consent&#xD;
&#xD;
          -  Type 1 DM and has been on insulin pump therapy for at least 3 months prior to&#xD;
             signature of the informed consent&#xD;
&#xD;
          -  patients use CGM component as part as part of the continuous subcutaneous insulin&#xD;
             infusion (CSII) therapy for a minimum of 1 month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participation in any other trial&#xD;
&#xD;
          -  any disease or drug treatment that can interfere with the outcome of sensor usage&#xD;
&#xD;
          -  using CGM in CSII &lt; 3 days/week&#xD;
&#xD;
          -  patients not willing to sign informed consent&#xD;
&#xD;
          -  abuse of alcohol or drugs (exception of nicotine consumption)&#xD;
&#xD;
          -  eating disorder, anorexia, bulimia or other mental disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Tsioli C, Danne T für die RANSuP-Studiengruppe. RANSuP-Registerstudie: Anwendung der Sensorunterstützten Pumpentherapie unter Alltagsbedingungen. Diabetologie und Stoffwechsel 2013; 8: S62</citation>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <results_first_submitted>February 16, 2016</results_first_submitted>
  <results_first_submitted_qc>January 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2019</results_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group</title>
          <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention Group</title>
          <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="75"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="33.88" spread="16.56"/>
                  </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="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number (n) of Excursions &lt;70 mg/dl Per Sensor Day at Baseline and 3 Months</title>
        <time_frame>baseline and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).</description>
          </group>
        </group_list>
        <measure>
          <title>Number (n) of Excursions &lt;70 mg/dl Per Sensor Day at Baseline and 3 Months</title>
          <units>excursions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.26" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number (n) of Excursions &lt;40 mg/dl Per Sensor Day at Baseline and 3 Months</title>
        <time_frame>Baseline and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)</description>
          </group>
        </group_list>
        <measure>
          <title>Number (n) of Excursions &lt;40 mg/dl Per Sensor Day at Baseline and 3 Months</title>
          <units>excursions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.12</p_value>
            <method>Wilcoxon Signed-Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months</title>
        <time_frame>Baseline and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with Sensor-augmented pump therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).</description>
          </group>
        </group_list>
        <measure>
          <title>Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months</title>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.96" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.90" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.30</p_value>
            <method>Wilcoxon Signed-Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months</title>
        <time_frame>Baseline and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)</description>
          </group>
        </group_list>
        <measure>
          <title>Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months</title>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.80" spread="24.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159.06" spread="25.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months</title>
        <time_frame>Baseline and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).&#xD;
sensor augmented pump (SaP)</description>
          </group>
        </group_list>
        <measure>
          <title>Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months</title>
          <units>sensor days/calendar week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.01" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.04</p_value>
            <method>Wilcoxon Signed-Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Curve (AUC) in Hypoglycemic Region (&lt; 70mg/dl) at Baseline and 3 Months</title>
        <description>Area under the curve (AUC) in hypoglycemic region (&lt; 70mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.</description>
        <time_frame>Baseline and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC) in Hypoglycemic Region (&lt; 70mg/dl) at Baseline and 3 Months</title>
          <description>Area under the curve (AUC) in hypoglycemic region (&lt; 70mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.</description>
          <units>mg/dl*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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.028" spread="0.026"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.35</p_value>
            <method>Wilcoxon Signed-Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Curve (AUC) in Hyperglycemic Region (&gt;140mg/dl) at Baseline and 3 Months</title>
        <description>Area under the curve (AUC) in hyperglycemic region (&gt;140mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.</description>
        <time_frame>Baseline and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC) in Hyperglycemic Region (&gt;140mg/dl) at Baseline and 3 Months</title>
          <description>Area under the curve (AUC) in hyperglycemic region (&gt;140mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.</description>
          <units>mg/dl*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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.79" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Wilcoxon Signed-Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months</title>
        <time_frame>Baseline and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months</title>
          <units>min/sensor 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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="737.62" spread="232.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="771.00" spread="426.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.61</p_value>
            <method>Wilcoxon Signed-Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months</title>
        <time_frame>Baseline and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months</title>
          <units>activations/patient/sensor 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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1</p_value>
            <method>Wilcoxon Signed-Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months</title>
        <time_frame>Baseline and 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months</title>
          <units>activations/patient/sensor 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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.22</p_value>
            <method>Wilcoxon Signed-Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months</title>
        <time_frame>Baseline and 3 months</time_frame>
        <population>Meals were not adequately documented, so that a meaningful analysis was not possible</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM)</description>
          </group>
        </group_list>
        <measure>
          <title>Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months</title>
          <population>Meals were not adequately documented, so that a meaningful analysis was not possible</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group</title>
          <description>Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="75"/>
              </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="75"/>
              </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>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. Dr. Thomas Danne</name_or_title>
      <organization>Kinder- und Jugendkrankenhaus Auf der Bult</organization>
      <phone>0511-8115-3331</phone>
      <email>danne@hka.de</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/NCT01718522
org study id: CEN_G_DB_1
nct id: NCT01718522
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this registry is to collect the real life data on Sensor Augmented pump (SAP)
      therapy usage in type 1 Diabetes mellitus (DM) patients treated with Medtronic Insulin pumps
      and continuous glucose monitoring systems in Germany.
The purpose of this registry is to reflect the daily practice with Sensor Augmented Pump
      (SAP) therapy usage in Type 1 Diabetes Mellitus (DM) patients treated with Medtronic insulin
      pumps (Paradigm VEO®) and continuous glucose monitoring systems in Germany. In addition, the
      aim is of this registry is to support:

        -  obtain reimbursement for SAP therapy in Germany

        -  building a platform (advisory committee) for discussion of SAP data.

        -  looking for deficits with implementation of glucose sensor data in diabetes therapy
           management and development of "follow-up education" materials.

      This is a national multi-center, post-market non-interventional prospective study with CE
      marked and commercially available devices and consumables.

      The study will be conducted from March 2012 to April 2013 in Germany. The duration of
      individual patient participation is 3 to 6 months.

      Health outcomes will be measured in approximately 75 patients between 6-65 years old
      diagnosed with Type 1 DM over a period of at least 3 months in approximately 15 centers. The
      patients are under treatment of Paradigm VEO® without any additional insulin injections and
      use continuous glucose monitoring, or patients that are not using continuous glucose
      monitoring, but that are willing to start with SAP. The enrolled subjects have a first visit
      inquiring the status data (including upload of device data in CareLink software, Hemoglobin
      A1c (HbA1c) value measurement) without any intervention. Thereafter, the SAP therapy is
      optimized based on individual continuous glucose monitoring (CGM) data during a second visit
      one month later and then a last visit like the first visit in which the status will be
      determined.

      Parameters of glycemic control will be measured, such as the frequency of hypoglycemia
      (glucose values ≤ 70 mg/dl), over a period of 30 days after the first patient's visit (Visit
      1) and after the visit 2 when an adjustment of the therapy has been discussed with the
      patient based on the collected CGM results between the two first visits.
observational model: Cohort
time perspective: Prospective
measure: Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months
time frame: baseline and 3 months
measure: Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months
time frame: Baseline and 3 months
measure: Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months
time frame: Baseline and 3 months
measure: Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months
time frame: Baseline and 3 months
measure: Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months
time frame: Baseline and 3 months
measure: Area Under the Curve (AUC) in Hypoglycemic Region (< 70mg/dl) at Baseline and 3 Months
time frame: Baseline and 3 months
description: Area under the curve (AUC) in hypoglycemic region (< 70mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.
measure: Area Under the Curve (AUC) in Hyperglycemic Region (>140mg/dl) at Baseline and 3 Months
time frame: Baseline and 3 months
description: Area under the curve (AUC) in hyperglycemic region (>140mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.
measure: Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months
time frame: Baseline and 3 months
measure: Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months
time frame: Baseline and 3 months
measure: Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months
time frame: Baseline and 3 months
measure: Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months
time frame: Baseline and 3 months
arm group label: Intervention Group
description: Patients treated with sensor augmented pump (SAP) therapy with insulin pump Paradigm VEO® and use continuous glucose monitoring (CGM).
intervention type: Device
intervention name: sensor augmented pump (SAP)
arm group label: Intervention Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 65 Years
healthy volunteers: No
citation: Tsioli C, Danne T für die RANSuP-Studiengruppe. RANSuP-Registerstudie: Anwendung der Sensorunterstützten Pumpentherapie unter Alltagsbedingungen. Diabetologie und Stoffwechsel 2013; 8: S62
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 