<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/NCT01688778</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2011-158</org_study_id>
    <nct_id>NCT01688778</nct_id>
  </id_info>
  <brief_title>Telemedicine as a Means to Achieving Good Diabetes Control Among Patients With Type 2 Diabetes</brief_title>
  <official_title>The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Health and Care Committee, Copenhagen City Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate the effect of telemedicine among the group of&#xD;
      type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the&#xD;
      patients with regards to vulnerability and social resources and to determine wich groups&#xD;
      benefit the most from telemedicine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type-2-diabetes is a growing healthcare problem. Both because of the increasing amount of&#xD;
      patients and because of the complications of diabetes.&#xD;
&#xD;
      Non-pharmacological treatment is considered fundamental in the treatment of patients with&#xD;
      type-2-diabetes.&#xD;
&#xD;
      In the Community of Copenhagen, all patients diagnosed with diabetes receive rehabilitation.&#xD;
      The rehabilitation consists of counseling with regards to nutrition, physical activity,&#xD;
      smoking cessation and education about diabetes.&#xD;
&#xD;
      Some patients however, remain poorly regulated despite rehabilitation as well as&#xD;
      pharmacological treatment.&#xD;
&#xD;
      A total number of 165 patients will be randomized to intervention group or standard care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">April 28, 2015</completion_date>
  <primary_completion_date type="Actual">April 28, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in HbA1c</measure>
    <time_frame>Baseline, 16 weeks, 32 weeks, 6 months after intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting total cholesterol, LDL, HDL, triglycerides</measure>
    <time_frame>Baseline, 32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta-cell function test (HOMA)</measure>
    <time_frame>Baseline, 32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline, 32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bloodpressure</measure>
    <time_frame>Baseline, 32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Baseline, 32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Baseline, 32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Baseline, 32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip circumference</measure>
    <time_frame>Baseline, 32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>Baseline, 32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of medication</measure>
    <time_frame>Baseline, 32 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of hospital admissions</measure>
    <time_frame>32 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of visits at the emergency</measure>
    <time_frame>32 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of visits at the outpatient department</measure>
    <time_frame>32 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of visits at GP</measure>
    <time_frame>32-weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">165</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Poor Glycemic Control</condition>
  <condition>Medication Adherence</condition>
  <arm_group>
    <arm_group_label>Telemedicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monthly video consultations with a nurse as add-on to standard treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard diabetes control at a Diabetes Clinic or GP</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telemedicine</intervention_name>
    <description>Monthly video consultations with a nurse as add-on to standard treatment. The nurse has access to bloodsugar- bloodpressure and weight measurements uploaded by the participants to a tablet computer directly from the devices.&#xD;
Patients on Insulin measure bloodsugar twice a day (fasting and before their evening meal). Patients not on Insulin measure bloodsugar once a week (fasting and before their evening meal). All participants measure bloodpressure and weight once a week. The intervention lasts 32 weeks.</description>
    <arm_group_label>Telemedicine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HbA1c &gt; 7,5%&#xD;
&#xD;
          -  BMI &gt; 25&#xD;
&#xD;
          -  Spoken danish&#xD;
&#xD;
          -  Completed a rehabilitation program more than 6 months ago&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HbA1c &lt; 7,5%&#xD;
&#xD;
          -  BMI &lt; 25&#xD;
&#xD;
          -  Need of interpreter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Raun Hansen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <state>Copenhagen NV</state>
        <zip>DK-2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>September 18, 2018</last_update_submitted>
  <last_update_submitted_qc>September 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Caroline Raun Hansen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Lifestyle intervention</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Videoconference</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 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01688778
org study id: H-2-2011-158
nct id: NCT01688778
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate the effect of telemedicine among the group of
      type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the
      patients with regards to vulnerability and social resources and to determine wich groups
      benefit the most from telemedicine.
Type-2-diabetes is a growing healthcare problem. Both because of the increasing amount of
      patients and because of the complications of diabetes.

      Non-pharmacological treatment is considered fundamental in the treatment of patients with
      type-2-diabetes.

      In the Community of Copenhagen, all patients diagnosed with diabetes receive rehabilitation.
      The rehabilitation consists of counseling with regards to nutrition, physical activity,
      smoking cessation and education about diabetes.

      Some patients however, remain poorly regulated despite rehabilitation as well as
      pharmacological treatment.

      A total number of 165 patients will be randomized to intervention group or standard care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Changes in HbA1c
time frame: Baseline, 16 weeks, 32 weeks, 6 months after intervention
measure: Fasting total cholesterol, LDL, HDL, triglycerides
time frame: Baseline, 32 weeks
measure: Beta-cell function test (HOMA)
time frame: Baseline, 32 weeks
measure: Weight
time frame: Baseline, 32 weeks
measure: Bloodpressure
time frame: Baseline, 32 weeks
measure: Physical activity
time frame: Baseline, 32 weeks
measure: Change in quality of life
time frame: Baseline, 32 weeks
measure: Waist circumference
time frame: Baseline, 32 weeks
measure: Hip circumference
time frame: Baseline, 32 weeks
measure: Body mass index
time frame: Baseline, 32 weeks
measure: Use of medication
time frame: Baseline, 32 weeks
measure: Number of hospital admissions
time frame: 32 weeks
measure: Number of visits at the emergency
time frame: 32 weeks
measure: Number of visits at the outpatient department
time frame: 32 weeks
measure: Number of visits at GP
time frame: 32-weeks
arm group label: Telemedicine
arm group type: Experimental
description: Monthly video consultations with a nurse as add-on to standard treatment.
arm group label: Standard treatment
arm group type: No Intervention
description: Standard diabetes control at a Diabetes Clinic or GP
intervention type: Behavioral
intervention name: Telemedicine
description: Monthly video consultations with a nurse as add-on to standard treatment. The nurse has access to bloodsugar- bloodpressure and weight measurements uploaded by the participants to a tablet computer directly from the devices.
Patients on Insulin measure bloodsugar twice a day (fasting and before their evening meal). Patients not on Insulin measure bloodsugar once a week (fasting and before their evening meal). All participants measure bloodpressure and weight once a week. The intervention lasts 32 weeks.
arm group label: Telemedicine
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Caroline Raun Hansen, MD
role: Principal Investigator
affiliation: Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Caroline Raun Hansen
investigator title: MD
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No