<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/NCT02214017</url>
  </required_header>
  <id_info>
    <org_study_id>Telemedicine in type 2 DM</org_study_id>
    <nct_id>NCT02214017</nct_id>
  </id_info>
  <brief_title>Telemedicine Strategy With Home Treatment Save Resources</brief_title>
  <official_title>Can a Telemedicine Strategy With Home Treatment Save Resources in Acute Medical Conditions While Maintaining Quality of Care?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kolding Sygehus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kolding Sygehus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Progress in technology has made telemedicine-based solutions with video consultations&#xD;
      available in the management and treatment of chronic diseases like diabetes, heart failure&#xD;
      and lung insufficiency at home. However, no direct comparisons on health outcomes of&#xD;
      telemedicine using video consultations versus usual outpatient treatment are available.&#xD;
&#xD;
      We wanted to implement a model of telemedicine and to evaluate health indicators in type 2&#xD;
      diabetes patients treated by video consultations or the standard outpatient treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic illnesses, such as asthma, diabetes, heart failure, and hypertension, represent a&#xD;
      significant burden of disease Chronic diseases also impose huge costs on the health care&#xD;
      systems responsible for managing them as well as their significance for those affected.&#xD;
&#xD;
      Non-pharmacological treatment is mandatory for type 2 diabetes patients characterized by&#xD;
      central obesity, sedentary lifestyle, and overeating (1). Secondary failure to reach&#xD;
      treatment goals despite an extensive National diabetes rehabilitation program in Denmark is&#xD;
      often seen (2). Outpatient control shows positive effects on outpatient rehabilitation (3)&#xD;
      reducing HbA1c, weight, and blood pressure. However, some patients never accomplish good&#xD;
      diabetes regulation and in others regulation deteriorates over time. New approaches are&#xD;
      required and need testing to motivate and give feedback to the patients at home. Telemedicine&#xD;
      has the capacity to achieve this, where a diabetic nurse may optimize motivation, treatment,&#xD;
      and diet through direct feedback adapted to milieu of the patient in accordance with a&#xD;
      potential spouse.&#xD;
&#xD;
      Good metabolic control is important as diabetes is inevitable a factor for increased risk of&#xD;
      cardiovascular disease, neuropathy, and nephropathy (4). The quality of life and reduction in&#xD;
      work ability is affected, thus, life expectancy is shortened by 6-8 years. Multi-factorial&#xD;
      intervention may delay this (5).&#xD;
&#xD;
      The high incidence of the serious implications strengthens the importance of achieving good&#xD;
      metabolic control through lifestyle changes. Health education shows reduction in&#xD;
      cardiovascular risk factors (6-8), which often disappears after the end of the intervention&#xD;
      (6-8). Good self-care and compliance improve the outcome and reduces diabetes complications&#xD;
      (9) and we need new tools to achieve higher attendance to the National diabetes program.&#xD;
      Telemedicine represents a novel tool of educating and controlling chronic diseases. It&#xD;
      reduced HbA1c for five years with in trials designed to test video-conferencing, clinical&#xD;
      data entry and review, web-based education materials, and monitored chat groups (10). Home&#xD;
      telemonitoring was compared with telephone calls reducing the HbA1c levels in type 2 diabetes&#xD;
      (11) and the technology confer a statistically significant reduction in HbA1c of 0.5 % when&#xD;
      applied as add-on to standard treatment. It was used adjunctively to a broader telemedicine&#xD;
      initiative for adults with diabetes. The largest telemedicine study initiated by the Ministry&#xD;
      of Health in England (Whole Systems Demonstrator) randomized 3320 patients [12] with heart&#xD;
      failure and diabetes to telemedicine care. It showed that the telemedicine intervention as&#xD;
      add-on therapy resulted a statistically significant reduction in mortality from 8.3% versus&#xD;
      4.6%. Similarly, it showed a reduction of number of inpatients and the number of bed days by&#xD;
      11% and 14%, respectively. The patients' health-related quality of life was unchanged. The&#xD;
      savings was less than the additional cost of using telemedicine and overall it cost 15% more&#xD;
      per patient. This point at two important factors when applying telemedicine solutions: First,&#xD;
      it should preferably replace the standard care and not add-on and, second, be based on the&#xD;
      patient's own computer, tablet or smartphone, all of which will reduce the cost&#xD;
      substantially. Telemedicine is available for 98-99% of all inhabitants in Denmark by&#xD;
      broadband, which allows video conference at home. A few randomized trials with this&#xD;
      technology are available at present. We aimed at implementing a telemedicine model in our&#xD;
      setting and the design and method should evaluate the quality of treatment as well as&#xD;
      technical problems and replace the standard treatment.&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      We compared clinical data from a telemedicine group with a standard care group treated by the&#xD;
      same medical algorithm. We wanted to reduce the barriers for the use of a home monitoring and&#xD;
      -treatment among elderly, type 2 diabetes patients&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Treatment by telemedicine or standard care in type 2 diabetes patients results in similar&#xD;
      clinical HbA1c, blood pressure, and lipids.&#xD;
&#xD;
      Materials and methods:&#xD;
&#xD;
      Individually visits at the outpatient clinic to plan improvement of glycemic control were&#xD;
      made before information of the study was given. Individual goals of the treatment and the&#xD;
      drugs needed to fulfil the objectives were agreed on. The patients received the information&#xD;
      for the study, and if they wanted to participate, they signed an approval of participation&#xD;
      and randomization was performed. All medical treatment, control of blood glucose, blood&#xD;
      pressure, lipids, and education was executed via videotelephone in the telemedicine group In&#xD;
      the control group patients attended usual procedure in the outpatient clinic with regular&#xD;
      visits. Summary of recommendations for glycemic, blood pressure, and lipid control for the&#xD;
      participants were: HbA1c 6.5-7.5% (48-58 mmol/L) , fasting blood glucose 6.5-7.5 mmol/l,&#xD;
      diurnal blood pressure &lt; 130/80 mmHg, LDL-cholesterol &lt;100 mg/dL (&lt;2.5 mmol/L) and start of&#xD;
      medication with elevated urinary albumin/creatinine excretion ≥30 (μg/mg). The treatment&#xD;
      algorithm was lifestyle adjustment plus antidiabetic drugs described elsewhere. When the&#xD;
      goals were reached within 3 weeks, the videotelephone was disconnected and patients were&#xD;
      encouraged to continue glycemic control at their general practitioner. However, the trial&#xD;
      went on with a follow-up and evaluation after six month according to the 'intention-to-treat'&#xD;
      principle to see if a difference in the initial care mattered significantly.&#xD;
&#xD;
      A videotelephone in the telemedicine group was delivered and serviced by the Danish Tele&#xD;
      Company. The trial included type 2 diabetes patients allocated from October 2011 until July&#xD;
      2012 referred to the outpatient clinic from general practitioners. At entry, all patients&#xD;
      were screened by albumin/creatinine excretion rate, blood pressure, and electrocardiogram,&#xD;
      lipid profile, diabetic food control, and arteriosclerotic symptoms (angina pectoris,&#xD;
      claudication, and fatigue). Diurnal blood pressure was measured by monitors. All measurements&#xD;
      were repeated six months after inclusion in all participants&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemia</measure>
    <time_frame>Six months of treatment</time_frame>
    <description>Percent of glycosylated hemoglobin, HbA1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipids</measure>
    <time_frame>Six months of treatment</time_frame>
    <description>Total-cholesterol</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>Six months of treatment</time_frame>
    <description>Diurnal blood pressure measured by Spacelab monitor, Spacelab 90207</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diabetic patients attended usual procedure in the outpatient clinic with regular visits</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telemedicine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>A videotelephone, TandBerg E20,</intervention_name>
    <arm_group_label>Telemedicine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral motivation</intervention_name>
    <description>Optimization of medical care in diabetes</description>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_label>Telemedicine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The participants had to live at home, be able to communicate by videotelephone, had no&#xD;
        psychiatric disorders, an age between 40 and 85 years and be able to administer medication.&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria were type 1 diabetes, speech disabilities, non-Danish speakers or with&#xD;
        severe chronic disease like renal failure (GFR&lt;30 ml/min), liver insufficiency or in cancer&#xD;
        treatment.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ole W Rasmussen, Dr.Med.Scie</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kolding Sygehus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endrinology Dept, Kolding Hospital</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://biotech-health.com/en/articles/57649.html</url>
    <description>publication of results</description>
  </link>
  <reference>
    <citation>Bower P, Cartwright M, Hirani SP, Barlow J, Hendy J, Knapp M, Henderson C, Rogers A, Sanders C, Bardsley M, Steventon A, Fitzpatrick R, Doll H, Newman S. A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial. BMC Health Serv Res. 2011 Aug 5;11:184. doi: 10.1186/1472-6963-11-184.</citation>
    <PMID>21819569</PMID>
  </reference>
  <reference>
    <citation>Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.</citation>
    <PMID>19390093</PMID>
  </reference>
  <reference>
    <citation>Stone RA, Rao RH, Sevick MA, Cheng C, Hough LJ, Macpherson DS, Franko CM, Anglin RA, Obrosky DS, Derubertis FR. Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial. Diabetes Care. 2010 Mar;33(3):478-84. doi: 10.2337/dc09-1012. Epub 2009 Dec 15.</citation>
    <PMID>20009091</PMID>
  </reference>
  <reference>
    <citation>Wootton R. Twenty years of telemedicine in chronic disease management--an evidence synthesis. J Telemed Telecare. 2012 Jun;18(4):211-20. doi: 10.1258/jtt.2012.120219.</citation>
    <PMID>22674020</PMID>
  </reference>
  <results_reference>
    <citation>Rasmussen OW, Lauszus FF, Loekke M. Telemedicine compared with standard care in type 2 diabetes mellitus: A randomized trial in an outpatient clinic. J Telemed Telecare. 2016 Sep;22(6):363-8. doi: 10.1177/1357633X15608984. Epub 2015 Oct 14.</citation>
    <PMID>26468213</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <results_first_submitted>August 21, 2017</results_first_submitted>
  <results_first_submitted_qc>November 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 19, 2018</results_first_posted>
  <last_update_submitted>November 15, 2018</last_update_submitted>
  <last_update_submitted_qc>November 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kolding Sygehus</investigator_affiliation>
    <investigator_full_name>Ole Winther Rasmussen</investigator_full_name>
    <investigator_title>Senior Consultant, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>diabetes</keyword>
  <keyword>telemedicine</keyword>
  <keyword>glycemia</keyword>
  <keyword>lipids</keyword>
  <keyword>blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <study_docs>
    <study_doc>
      <doc_id>doi: 10.1177/1357633X15608984</doc_id>
      <doc_type>publication</doc_type>
      <doc_url>https://www.ncbi.nlm.nih.gov/pubmed/26468213</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard Care</title>
          <description>Diabetic patients attended usual procedure in the outpatient clinic with regular visits&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
        </group>
        <group group_id="P2">
          <title>Telemedicine Group</title>
          <description>After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.&#xD;
A videotelephone, TandBerg E20,&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard Care</title>
          <description>Diabetic patients attended usual procedure in the outpatient clinic with regular visits&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
        </group>
        <group group_id="B2">
          <title>Telemedicine Group</title>
          <description>After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.&#xD;
A videotelephone, TandBerg E20,&#xD;
Behavioral motivation: Optimization of medical care in diabetes</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="22"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68" lower_limit="36" upper_limit="80"/>
                    <measurement group_id="B2" value="59" lower_limit="46" upper_limit="83"/>
                    <measurement group_id="B3" value="64" lower_limit="36" upper_limit="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Denmark</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg / m^2</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" lower_limit="23" upper_limit="43"/>
                    <measurement group_id="B2" value="32.7" lower_limit="26" upper_limit="67"/>
                    <measurement group_id="B3" value="31.8" lower_limit="23" upper_limit="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>duration of type 2 diabetes</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.5" lower_limit="0" upper_limit="22"/>
                    <measurement group_id="B2" value="11.5" lower_limit="2" upper_limit="21"/>
                    <measurement group_id="B3" value="11" lower_limit="0" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>insulin treatment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Glycemia</title>
        <description>Percent of glycosylated hemoglobin, HbA1c</description>
        <time_frame>Six months of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Diabetic patients attended usual procedure in the outpatient clinic with regular visits&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
          </group>
          <group group_id="O2">
            <title>Telemedicine Group</title>
            <description>After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.&#xD;
A videotelephone, TandBerg E20,&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemia</title>
          <description>Percent of glycosylated hemoglobin, HbA1c</description>
          <units>percent of glycosylated hemoglobin</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="5.8" upper_limit="9.6"/>
                    <measurement group_id="O2" value="7.6" lower_limit="6.2" upper_limit="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lipids</title>
        <description>Total-cholesterol</description>
        <time_frame>Six months of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Diabetic patients attended usual procedure in the outpatient clinic with regular visits&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
          </group>
          <group group_id="O2">
            <title>Telemedicine Group</title>
            <description>After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.&#xD;
A videotelephone, TandBerg E20,&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
          </group>
        </group_list>
        <measure>
          <title>Lipids</title>
          <description>Total-cholesterol</description>
          <units>milli mols/l</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" lower_limit="2.7" upper_limit="4.9"/>
                    <measurement group_id="O2" value="3.6" lower_limit="2.4" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Blood Pressure</title>
        <description>Diurnal blood pressure measured by Spacelab monitor, Spacelab 90207</description>
        <time_frame>Six months of treatment</time_frame>
        <population>diastolic blood pressure</population>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>Diabetic patients attended usual procedure in the outpatient clinic with regular visits&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
          </group>
          <group group_id="O2">
            <title>Telemedicine Group</title>
            <description>After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.&#xD;
A videotelephone, TandBerg E20,&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure</title>
          <description>Diurnal blood pressure measured by Spacelab monitor, Spacelab 90207</description>
          <population>diastolic blood pressure</population>
          <units>mmHg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" lower_limit="50" upper_limit="92"/>
                    <measurement group_id="O2" value="80" lower_limit="58" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Standard Care</title>
          <description>Diabetic patients attended usual procedure in the outpatient clinic with regular visits&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
        </group>
        <group group_id="E2">
          <title>Telemedicine Group</title>
          <description>After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.&#xD;
A videotelephone, TandBerg E20,&#xD;
Behavioral motivation: Optimization of medical care in diabetes</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </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>Finn Lauszus</name_or_title>
      <organization>Herning Hospital</organization>
      <phone>+45 78434614</phone>
      <email>finlau@rm.dk</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/NCT02214017
org study id: Telemedicine in type 2 DM
nct id: NCT02214017
lead sponsor: 
has dmc: No
Progress in technology has made telemedicine-based solutions with video consultations
      available in the management and treatment of chronic diseases like diabetes, heart failure
      and lung insufficiency at home. However, no direct comparisons on health outcomes of
      telemedicine using video consultations versus usual outpatient treatment are available.

      We wanted to implement a model of telemedicine and to evaluate health indicators in type 2
      diabetes patients treated by video consultations or the standard outpatient treatment
Chronic illnesses, such as asthma, diabetes, heart failure, and hypertension, represent a
      significant burden of disease Chronic diseases also impose huge costs on the health care
      systems responsible for managing them as well as their significance for those affected.

      Non-pharmacological treatment is mandatory for type 2 diabetes patients characterized by
      central obesity, sedentary lifestyle, and overeating (1). Secondary failure to reach
      treatment goals despite an extensive National diabetes rehabilitation program in Denmark is
      often seen (2). Outpatient control shows positive effects on outpatient rehabilitation (3)
      reducing HbA1c, weight, and blood pressure. However, some patients never accomplish good
      diabetes regulation and in others regulation deteriorates over time. New approaches are
      required and need testing to motivate and give feedback to the patients at home. Telemedicine
      has the capacity to achieve this, where a diabetic nurse may optimize motivation, treatment,
      and diet through direct feedback adapted to milieu of the patient in accordance with a
      potential spouse.

      Good metabolic control is important as diabetes is inevitable a factor for increased risk of
      cardiovascular disease, neuropathy, and nephropathy (4). The quality of life and reduction in
      work ability is affected, thus, life expectancy is shortened by 6-8 years. Multi-factorial
      intervention may delay this (5).

      The high incidence of the serious implications strengthens the importance of achieving good
      metabolic control through lifestyle changes. Health education shows reduction in
      cardiovascular risk factors (6-8), which often disappears after the end of the intervention
      (6-8). Good self-care and compliance improve the outcome and reduces diabetes complications
      (9) and we need new tools to achieve higher attendance to the National diabetes program.
      Telemedicine represents a novel tool of educating and controlling chronic diseases. It
      reduced HbA1c for five years with in trials designed to test video-conferencing, clinical
      data entry and review, web-based education materials, and monitored chat groups (10). Home
      telemonitoring was compared with telephone calls reducing the HbA1c levels in type 2 diabetes
      (11) and the technology confer a statistically significant reduction in HbA1c of 0.5 % when
      applied as add-on to standard treatment. It was used adjunctively to a broader telemedicine
      initiative for adults with diabetes. The largest telemedicine study initiated by the Ministry
      of Health in England (Whole Systems Demonstrator) randomized 3320 patients [12] with heart
      failure and diabetes to telemedicine care. It showed that the telemedicine intervention as
      add-on therapy resulted a statistically significant reduction in mortality from 8.3% versus
      4.6%. Similarly, it showed a reduction of number of inpatients and the number of bed days by
      11% and 14%, respectively. The patients' health-related quality of life was unchanged. The
      savings was less than the additional cost of using telemedicine and overall it cost 15% more
      per patient. This point at two important factors when applying telemedicine solutions: First,
      it should preferably replace the standard care and not add-on and, second, be based on the
      patient's own computer, tablet or smartphone, all of which will reduce the cost
      substantially. Telemedicine is available for 98-99% of all inhabitants in Denmark by
      broadband, which allows video conference at home. A few randomized trials with this
      technology are available at present. We aimed at implementing a telemedicine model in our
      setting and the design and method should evaluate the quality of treatment as well as
      technical problems and replace the standard treatment.

      Aim:

      We compared clinical data from a telemedicine group with a standard care group treated by the
      same medical algorithm. We wanted to reduce the barriers for the use of a home monitoring and
      -treatment among elderly, type 2 diabetes patients

      Hypothesis:

      Treatment by telemedicine or standard care in type 2 diabetes patients results in similar
      clinical HbA1c, blood pressure, and lipids.

      Materials and methods:

      Individually visits at the outpatient clinic to plan improvement of glycemic control were
      made before information of the study was given. Individual goals of the treatment and the
      drugs needed to fulfil the objectives were agreed on. The patients received the information
      for the study, and if they wanted to participate, they signed an approval of participation
      and randomization was performed. All medical treatment, control of blood glucose, blood
      pressure, lipids, and education was executed via videotelephone in the telemedicine group In
      the control group patients attended usual procedure in the outpatient clinic with regular
      visits. Summary of recommendations for glycemic, blood pressure, and lipid control for the
      participants were: HbA1c 6.5-7.5% (48-58 mmol/L) , fasting blood glucose 6.5-7.5 mmol/l,
      diurnal blood pressure < 130/80 mmHg, LDL-cholesterol <100 mg/dL (<2.5 mmol/L) and start of
      medication with elevated urinary albumin/creatinine excretion ≥30 (μg/mg). The treatment
      algorithm was lifestyle adjustment plus antidiabetic drugs described elsewhere. When the
      goals were reached within 3 weeks, the videotelephone was disconnected and patients were
      encouraged to continue glycemic control at their general practitioner. However, the trial
      went on with a follow-up and evaluation after six month according to the 'intention-to-treat'
      principle to see if a difference in the initial care mattered significantly.

      A videotelephone in the telemedicine group was delivered and serviced by the Danish Tele
      Company. The trial included type 2 diabetes patients allocated from October 2011 until July
      2012 referred to the outpatient clinic from general practitioners. At entry, all patients
      were screened by albumin/creatinine excretion rate, blood pressure, and electrocardiogram,
      lipid profile, diabetic food control, and arteriosclerotic symptoms (angina pectoris,
      claudication, and fatigue). Diurnal blood pressure was measured by monitors. All measurements
      were repeated six months after inclusion in all participants
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Glycemia
time frame: Six months of treatment
description: Percent of glycosylated hemoglobin, HbA1c
measure: Lipids
time frame: Six months of treatment
description: Total-cholesterol
measure: Blood Pressure
time frame: Six months of treatment
description: Diurnal blood pressure measured by Spacelab monitor, Spacelab 90207
arm group label: Standard care
arm group type: Active Comparator
description: Diabetic patients attended usual procedure in the outpatient clinic with regular visits
arm group label: Telemedicine group
arm group type: Experimental
description: After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.
intervention type: Device
intervention name: A videotelephone, TandBerg E20,
arm group label: Telemedicine group
intervention type: Behavioral
intervention name: Behavioral motivation
description: Optimization of medical care in diabetes
arm group label: Standard care
arm group label: Telemedicine group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ole W Rasmussen, Dr.Med.Scie
role: Principal Investigator
affiliation: Kolding Sygehus
facility: 
country: Denmark
url: http://biotech-health.com/en/articles/57649.html
description: publication of results
citation: Bower P, Cartwright M, Hirani SP, Barlow J, Hendy J, Knapp M, Henderson C, Rogers A, Sanders C, Bardsley M, Steventon A, Fitzpatrick R, Doll H, Newman S. A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial. BMC Health Serv Res. 2011 Aug 5;11:184. doi: 10.1186/1472-6963-11-184.
PMID: 21819569
citation: Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.
PMID: 19390093
citation: Stone RA, Rao RH, Sevick MA, Cheng C, Hough LJ, Macpherson DS, Franko CM, Anglin RA, Obrosky DS, Derubertis FR. Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial. Diabetes Care. 2010 Mar;33(3):478-84. doi: 10.2337/dc09-1012. Epub 2009 Dec 15.
PMID: 20009091
citation: Wootton R. Twenty years of telemedicine in chronic disease management--an evidence synthesis. J Telemed Telecare. 2012 Jun;18(4):211-20. doi: 10.1258/jtt.2012.120219.
PMID: 22674020
citation: Rasmussen OW, Lauszus FF, Loekke M. Telemedicine compared with standard care in type 2 diabetes mellitus: A randomized trial in an outpatient clinic. J Telemed Telecare. 2016 Sep;22(6):363-8. doi: 10.1177/1357633X15608984. Epub 2015 Oct 14.
PMID: 26468213
responsible party type: Principal Investigator
investigator affiliation: Kolding Sygehus
investigator full name: Ole Winther Rasmussen
investigator title: Senior Consultant, Associate Professor
mesh term: Diabetes Mellitus, Type 2
study doc: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 