<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/NCT01694758</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-CME-XXX-2012/1</org_study_id>
    <nct_id>NCT01694758</nct_id>
  </id_info>
  <brief_title>OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA</brief_title>
  <acronym>OPTIMISE</acronym>
  <official_title>OPtimal Type 2 dIabetes Management Including Benchmarking and Standard Treatment in CEEMEA (OPTIMISE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <brief_summary>
    <textblock>
      OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which will&#xD;
      include patients suffering from diabetes type 2, treated or untreated, insulin dependent or&#xD;
      not insulin dependent.&#xD;
&#xD;
      In this study we aim to explore at a primary care level whether the use of benchmarking&#xD;
      against a set of guideline-based reference values on a patient basis, may improve quality of&#xD;
      patient care, in particular control of diabetes, lipids and blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1</measure>
    <time_frame>after 12 months of follow-up</time_frame>
    <description>To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure, expressed as the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of patient care improvement, in particular the control of diabetes, lipids and blood pressure</measure>
    <time_frame>after 12 months of follow-up versus baseline</time_frame>
    <description>To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of preventive screening</measure>
    <time_frame>after 12 months of follow-up versus baseline</time_frame>
    <description>To follow up evolution markers of preventive screening; retinopathy, neuropathy, dietary counseling, smoking habits, BMI, waist circumference, physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines</measure>
    <time_frame>after 12 months of follow-up versus baseline</time_frame>
    <description>To investigate the LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">733</enrollment>
  <condition>Diabetes Mellitus, Non-Insulin-Dependent</condition>
  <arm_group>
    <arm_group_label>Patients with diabetes type 2</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diabetes type 2&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects suffering from diabetes type 2,&#xD;
&#xD;
          -  treated or untreated,&#xD;
&#xD;
          -  insulin dependent or not insulin dependent Able to read and send SMS (if SMS&#xD;
             applicable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes Pregnancy diabetes&#xD;
&#xD;
          -  Hospitalization at the moment of enrollment in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dan Isacoff, ASSOC. PROF.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Medicine and Pharmacy Carol Davila, Bucharest, Romania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Blagoevgrad</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pleven</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alexandria</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brasov</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bucuresti</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cluj</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Constanta</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Craiova</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Galati</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Giurgiu</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iasi</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oradea</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pitesti</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ploiesti</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Satu Mare</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tg Jiu</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tg Mures</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Timisoara</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Romania</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Benchmarking could improve quality of patient care</keyword>
  <keyword>ESC and ATP III Guidelines</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>
  <!-- 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/NCT01694758
org study id: NIS-CME-XXX-2012/1
nct id: NCT01694758
lead sponsor: 
OPTIMISE-CEEMEA is a multinational, multi-centre, observational, prospective study which will
      include patients suffering from diabetes type 2, treated or untreated, insulin dependent or
      not insulin dependent.

      In this study we aim to explore at a primary care level whether the use of benchmarking
      against a set of guideline-based reference values on a patient basis, may improve quality of
      patient care, in particular control of diabetes, lipids and blood pressure.
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1
time frame: after 12 months of follow-up
description: To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure, expressed as the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c1
measure: Quality of patient care improvement, in particular the control of diabetes, lipids and blood pressure
time frame: after 12 months of follow-up versus baseline
description: To investigate whether the use of benchmarking could improve quality of patient care, in particular the control of diabetes, lipids and blood pressure
measure: Markers of preventive screening
time frame: after 12 months of follow-up versus baseline
description: To follow up evolution markers of preventive screening; retinopathy, neuropathy, dietary counseling, smoking habits, BMI, waist circumference, physical activity
measure: The LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines
time frame: after 12 months of follow-up versus baseline
description: To investigate the LDL cholesterol parameter of the primary and secondary objectives according to ATP III guidelines
arm group label: Patients with diabetes type 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dan Isacoff, ASSOC. PROF.
role: Principal Investigator
affiliation: University of Medicine and Pharmacy Carol Davila, Bucharest, Romania
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country: Bulgaria
country: Romania
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2