<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/NCT02225691</url>
  </required_header>
  <id_info>
    <org_study_id>2014-32</org_study_id>
    <nct_id>NCT02225691</nct_id>
  </id_info>
  <brief_title>Effect of Paired Testing to Poorly Controlled Chinese Diabetes on Glycemic Control and Self Care</brief_title>
  <official_title>Effect of Introducing Daily Paired Testing to Poorly Controlled Chinese Diabetes Patients on Glycemic Control and Self Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai 6th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai 6th People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims is to evaluate the effect of introducing paired testing on actual testing&#xD;
      frequency, glycemic control, psychosocial and behavioural aspects of poorly controlled&#xD;
      diabetes patients in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Self monitoring of blood glucose (SMBG) in insulin treated type 1 and type 2 diabetics has&#xD;
      consistently been demonstrated to confer benefits, and is considered an essential part in the&#xD;
      management of diabetes. In China, utilization of SMBG among diabetes patients is low. Even&#xD;
      among those who perform SMBG regularly, the daily testing frequency falls short of those&#xD;
      recommended in international and national clinical guidelines. There is thus a need to create&#xD;
      the awareness of the benefits of SMBG and at the same time establish a SMBG regimen that is&#xD;
      deemed practically feasible and cost effective for diabetes patients.&#xD;
&#xD;
      Paired testing entails the act of measuring glucose level before and after an event that may&#xD;
      impact the glucose level in a patient, e.g. meals, exercise, medication adjustment, and&#xD;
      thereafter responding to any abnormal glucose levels/patterns by modifying lifestyle and/or&#xD;
      medication.&#xD;
&#xD;
      This study aims is to evaluate the effect of introducing paired testing on actual testing&#xD;
      frequency, glycemic control, psychosocial and behavioral aspects of poorly controlled&#xD;
      diabetes patients in China.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">September 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>Baseline change in HbA1c at month 3 and 6 between paired testing and control arms for each of the 3 patient segments.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who achieve good glycemic control (HbA1c≤7%)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Baseline change in quality of life score (based on Chinese Normal Audit of Diabetes-Dependent Quality of Life Questionnaire)</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Baseline change in self-care scores (based on Diabetes Self-Efficacy Scale Questionnaire)</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>paired testing of blood glucose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Paired testing arm will undergo paired testing of blood glucose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Non-insulin patients will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Patients in the control arms will not undergo paired testing and will be managed as before.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paired testing of blood glucose Accu-Chek®</intervention_name>
    <description>Patients in the paired testing arms will undergo training on paired testing with Accu-Chek® Active blood glucose meters. The paired testing training would include (1) how and when (testing regimen) to perform paired testing, and (2) how to respond to paired testing readings via lifestyle modifications, self-adjustment of insulin dose and additional testing, if applicable. Please refer to Annex A for further details of the training.</description>
    <arm_group_label>paired testing of blood glucose</arm_group_label>
    <other_name>Accu-Chek® Active blood glucose meters</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with diabetes mellitus&#xD;
&#xD;
          -  HbA1c ≥ 8% measured within the a month prior to enrolment&#xD;
&#xD;
          -  Have not been performing SMBG on a regular (daily) basis within the 3 months prior to&#xD;
             enrolment&#xD;
&#xD;
          -  Willing and able to use Accu-Chek® Active blood glucose meter to perform daily SMBG&#xD;
&#xD;
          -  Willing and able to complete participant questionnaires&#xD;
&#xD;
          -  Willing and able to visit the physician at month 3 and month 6&#xD;
&#xD;
          -  Provide informed consent prior to enrolling in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any retinopathy that required photocoagulation or retinal surgery in the 6 months&#xD;
             prior to enrolment or that may require photocoagulation or retinal surgery during the&#xD;
             study&#xD;
&#xD;
          -  Any clinically significant condition that required hospitalization in the last 2&#xD;
             months prior to enrolment or that may require hospitalization (e.g. elective surgery)&#xD;
             during the study&#xD;
&#xD;
          -  Any clinically significant psychosis or cognitive impairment&#xD;
&#xD;
          -  Unlikelihood to comply or complete the study&#xD;
&#xD;
          -  Women who are pregnant, lactating or planning to become pregnant during the study&#xD;
             period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weiping Jia, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai 6th People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weiping Jia, MD,PHD</last_name>
    <phone>＋8602164369181</phone>
    <email>wpjia@sjtu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Weiping Jia</name>
      <address>
        <city>Shanghai</city>
        <zip>200233</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Weiping Jia, MD,PHD</last_name>
      <phone>+8602164369181</phone>
      <email>wpjia@sjtu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Weiping Jia, MD,PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>November 19, 2014</last_update_submitted>
  <last_update_submitted_qc>November 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai 6th People's Hospital</investigator_affiliation>
    <investigator_full_name>Weiping Jia</investigator_full_name>
    <investigator_title>The director of the endocrinology and metabolism department of the Shanghai 6th People's Hospital</investigator_title>
  </responsible_party>
  <keyword>type 1 diabetes</keyword>
  <keyword>type 2 diabetes</keyword>
  <keyword>paired testing</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>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 3, 2017</submitted>
    <returned>September 22, 2017</returned>
  </pending_results>
  <!-- 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/NCT02225691
org study id: 2014-32
nct id: NCT02225691
lead sponsor: 
has dmc: Yes
This study aims is to evaluate the effect of introducing paired testing on actual testing
      frequency, glycemic control, psychosocial and behavioural aspects of poorly controlled
      diabetes patients in China.
Self monitoring of blood glucose (SMBG) in insulin treated type 1 and type 2 diabetics has
      consistently been demonstrated to confer benefits, and is considered an essential part in the
      management of diabetes. In China, utilization of SMBG among diabetes patients is low. Even
      among those who perform SMBG regularly, the daily testing frequency falls short of those
      recommended in international and national clinical guidelines. There is thus a need to create
      the awareness of the benefits of SMBG and at the same time establish a SMBG regimen that is
      deemed practically feasible and cost effective for diabetes patients.

      Paired testing entails the act of measuring glucose level before and after an event that may
      impact the glucose level in a patient, e.g. meals, exercise, medication adjustment, and
      thereafter responding to any abnormal glucose levels/patterns by modifying lifestyle and/or
      medication.

      This study aims is to evaluate the effect of introducing paired testing on actual testing
      frequency, glycemic control, psychosocial and behavioral aspects of poorly controlled
      diabetes patients in China.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Baseline change in HbA1c at month 3 and 6 between paired testing and control arms for each of the 3 patient segments.
time frame: 6 months
measure: Proportion of patients who achieve good glycemic control (HbA1c≤7%)
time frame: 6 months
measure: Baseline change in quality of life score (based on Chinese Normal Audit of Diabetes-Dependent Quality of Life Questionnaire)
time frame: 6 months
measure: Baseline change in self-care scores (based on Diabetes Self-Efficacy Scale Questionnaire)
time frame: 6 months
arm group label: paired testing of blood glucose
arm group type: Experimental
description: Patient will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Paired testing arm will undergo paired testing of blood glucose.
arm group label: control arm
arm group type: No Intervention
description: Non-insulin patients will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Patients in the control arms will not undergo paired testing and will be managed as before.
intervention type: Device
intervention name: Paired testing of blood glucose Accu-Chek®
description: Patients in the paired testing arms will undergo training on paired testing with Accu-Chek® Active blood glucose meters. The paired testing training would include (1) how and when (testing regimen) to perform paired testing, and (2) how to respond to paired testing readings via lifestyle modifications, self-adjustment of insulin dose and additional testing, if applicable. Please refer to Annex A for further details of the training.
arm group label: paired testing of blood glucose
other name: Accu-Chek® Active blood glucose meters
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Weiping Jia, MD, PHD
role: Principal Investigator
affiliation: Shanghai 6th People's Hospital
last name: Weiping Jia, MD,PHD
phone: ＋8602164369181
email: wpjia@sjtu.edu.cn
facility: 
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai 6th People's Hospital
investigator full name: Weiping Jia
investigator title: The director of the endocrinology and metabolism department of the Shanghai 6th People's Hospital
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Mellitus, Type 1
submitted: May 3, 2017
returned: September 22, 2017