<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/NCT02194608</url>
  </required_header>
  <id_info>
    <org_study_id>0000-347</org_study_id>
    <secondary_id>LCE#40378</secondary_id>
    <nct_id>NCT02194608</nct_id>
  </id_info>
  <brief_title>Telemonitoring System Study in Participants With Type 2 Diabetes Mellitus (MK-0000-347)</brief_title>
  <official_title>A Randomized Clinical Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Individuals With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal is to evaluate whether a home telehealth system that enables the participant&#xD;
      to monitor their body weight, blood glucose values and blood pressure values, associated with&#xD;
      remote educational support and feedback to the general practitioner, can improve metabolic&#xD;
      control and overall cardiovascular risk in individuals with type 2 diabetes mellitus (T2DM),&#xD;
      as compared to usual practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in blood glucose level</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in blood pressure</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in body mass index</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants who achieved hemoglobin A1c (HbA1c) &lt;7.0%</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants who achieved blood pressure &lt;130/80 mmHg</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants who achieved low-density lipoprotein (LDL) cholesterol &lt;100 mg/dL</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants requiring therapy modifications</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in total cholesterol</measure>
    <time_frame>Baseline, 6 months, and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in high-density lipoprotein (HDL) cholesterol</measure>
    <time_frame>Baseline, 6 months, and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in LDL cholesterol</measure>
    <time_frame>Baseline, 6 months, and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in triglycerides</measure>
    <time_frame>Baseline, 6 months, and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in cardiovascular risk score</measure>
    <time_frame>Baseline, 6 months, and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of emergency room visits and hospital admissions</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of office visits and home visits</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the number and doses of drugs for treatment of diabetes</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the number and doses of drugs for treatment of hypertension</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the number and doses of drugs for treatment of dyslipidemia</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant overall satisfaction level</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant compliance with protocol-provided devices</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who experienced hypoglycemia</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycemic episodes</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who experienced severe/symptomatic hypoglycemia</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of severe/symptomatic hypoglycemic episodes</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Telemedicine system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will self-test blood glucose level, weight, and blood pressure and results will be uploaded and transmitted directly via a hometelehealth system to a central location (HUB). Blood draws will be administered at baseline and follow-up visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will self-record their blood glucose levels, blood pressure and weight in a diary. Blood draws will be administered at baseline and follow-up visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Home telehealth system</intervention_name>
    <description>Participants will receive a weighing machine, glucometer, and a sphygmomanometer connected through a Bluetooth system from their home to the Telehealth center via a HUB.</description>
    <arm_group_label>Telemedicine system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  has type 2 diabetes&#xD;
&#xD;
          -  treated with oral agents in monotherapy or combined therapy ± basal insulin&#xD;
&#xD;
          -  previously educated to self-monitoring blood glucose (SMBG) use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has type 2 diabetes non-pharmacologically treated&#xD;
&#xD;
          -  has type 2 diabetes treated with multiple daily injections of insulin&#xD;
&#xD;
          -  is unable to use the telemedicine system&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  has major cardiovascular, cerebrovascular, or peripheral vascular event in the last 6&#xD;
             months&#xD;
&#xD;
          -  has any disease or condition, including alcohol or drugs abuse, that may interfere&#xD;
             with study completion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>June 23, 2015</last_update_submitted>
  <last_update_submitted_qc>June 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2015</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</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT02194608
org study id: 0000-347
secondary id: LCE#40378
nct id: NCT02194608
lead sponsor: 
has dmc: No
The primary goal is to evaluate whether a home telehealth system that enables the participant
      to monitor their body weight, blood glucose values and blood pressure values, associated with
      remote educational support and feedback to the general practitioner, can improve metabolic
      control and overall cardiovascular risk in individuals with type 2 diabetes mellitus (T2DM),
      as compared to usual practice.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Change from baseline in blood glucose level
time frame: Baseline and 12 months
measure: Change from baseline in blood pressure
time frame: Baseline and 12 months
measure: Change from baseline in body mass index
time frame: Baseline and 12 months
measure: Percentage of participants who achieved hemoglobin A1c (HbA1c) <7.0%
time frame: Up to 12 months
measure: Percentage of participants who achieved blood pressure <130/80 mmHg
time frame: Up to 12 months
measure: Percentage of participants who achieved low-density lipoprotein (LDL) cholesterol <100 mg/dL
time frame: Up to 12 months
measure: Percentage of participants requiring therapy modifications
time frame: Up to 12 months
measure: Change from baseline in total cholesterol
time frame: Baseline, 6 months, and 12 months
measure: Change from baseline in high-density lipoprotein (HDL) cholesterol
time frame: Baseline, 6 months, and 12 months
measure: Change from baseline in LDL cholesterol
time frame: Baseline, 6 months, and 12 months
measure: Change from baseline in triglycerides
time frame: Baseline, 6 months, and 12 months
measure: Change from baseline in cardiovascular risk score
time frame: Baseline, 6 months, and 12 months
measure: Number of emergency room visits and hospital admissions
time frame: Up to 12 months
measure: Number of office visits and home visits
time frame: Up to 12 months
measure: Change from baseline in the number and doses of drugs for treatment of diabetes
time frame: Baseline and 12 months
measure: Change from baseline in the number and doses of drugs for treatment of hypertension
time frame: Baseline and 12 months
measure: Change from baseline in the number and doses of drugs for treatment of dyslipidemia
time frame: Baseline and 12 months
measure: Participant overall satisfaction level
time frame: Up to 12 months
measure: Participant compliance with protocol-provided devices
time frame: Up to 12 months
measure: Number of participants who experienced hypoglycemia
time frame: Up to 12 months
measure: Number of hypoglycemic episodes
time frame: Up to 12 months
measure: Number of participants who experienced severe/symptomatic hypoglycemia
time frame: Up to 12 months
measure: Number of severe/symptomatic hypoglycemic episodes
time frame: Up to 12 months
arm group label: Telemedicine system
arm group type: Experimental
description: Participants will self-test blood glucose level, weight, and blood pressure and results will be uploaded and transmitted directly via a hometelehealth system to a central location (HUB). Blood draws will be administered at baseline and follow-up visits.
arm group label: Usual care
arm group type: No Intervention
description: Participants will self-record their blood glucose levels, blood pressure and weight in a diary. Blood draws will be administered at baseline and follow-up visits.
intervention type: Device
intervention name: Home telehealth system
description: Participants will receive a weighing machine, glucometer, and a sphygmomanometer connected through a Bluetooth system from their home to the Telehealth center via a HUB.
arm group label: Telemedicine system
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2