<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/NCT03253237</url>
  </required_header>
  <id_info>
    <org_study_id>DNOOM1072014</org_study_id>
    <nct_id>NCT03253237</nct_id>
  </id_info>
  <brief_title>Primary Care - Continuous Glucose Monitoring</brief_title>
  <acronym>PC-COSMO</acronym>
  <official_title>Continuous Glucose Monitoring in Patients With Diabetes Mellitus Type 2 in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zagreb</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Association of teachers in general practice / family medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zagreb</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>
      Introduction and objective: The key to optimal diabetes management is tight glucose control.&#xD;
      Hemoglobin A1c is the gold standard to assess glycemic control but in cases of unrecognized&#xD;
      hypoglycemia, confusing nighttime events or in cases of large variations in blood glucose, a&#xD;
      haemoglobin A1c can not detect specific movement of blood glucose. Continuous glucose&#xD;
      monitoring (CGM) provides informations of glucose levels in a real-time format and may be&#xD;
      helpful for making the personalized therapy decisions desired in the era of precision&#xD;
      medicine. Our aim is to analyse the benefit of tracking patterns of glucose values by using&#xD;
      continuous glucose monitoring (CGM) in patients with T2DM in family medicine office.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY DESIGN: An observational, multicenter, cross-sectional study. A total of 20 GPs from&#xD;
      four Croatian regions will recruit up to five subjects of both sexes from August 2017 till&#xD;
      the end of September 2017, diagnosed with type 2 diabetes mellitus at least one year prior to&#xD;
      study entry, aged ≥40 years, with no insulin in therapy and with clinical suspicion of&#xD;
      hypoglycemia or with disproportion in actual glycemia na haemoglobin A1c findings.&#xD;
      Sociodemographic, laboratory (HbA1c, fasting and postprandial glucose, total cholesterol,&#xD;
      high density cholesterol, low density cholesterol, triglyceride and serum creatinine) and&#xD;
      habits data will be collected. SETTING: Totally 100 of patients will be included. At primary&#xD;
      care office each patient wear the device (iPro™2 Medtronic) subcutaneously for up to 7-days&#xD;
      and return it to the office for download. Patients do not receive glucose alerts and only see&#xD;
      the CGM data after it's been analyzed by the healthcare professional. A CGM device is to be&#xD;
      set and take of by the GP. Before the study start all GPs will have a short education on CGM&#xD;
      device by the diabetologist who use CGM on a daily base. Study period is seven days and&#xD;
      includes screening before study entry and two visits. On Day 1, after screening and signing&#xD;
      the informed consent, the CGM device is applied. Patient is instructed to keep a 7 day diary&#xD;
      with four daily standard home blood glucose monitoring (SHBGM) along with the data on eating,&#xD;
      physical exercise, drugs. Bayer's Contour® glucometer is used for the SHBGM. On Day 7, CGM&#xD;
      device is took of and the data from iPro2 is uploaded to PC. At the end, each patient fill a&#xD;
      short query on satisfaction while wearing CGM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">October 7, 2017</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2017</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>Glycemic variability in individuals with type 2 diabetes mellitus in primary care measured by continuous glucose monitor device</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Continuous Glucose Monitoring</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>continuous glucose monitoring (CGM)</intervention_name>
    <description>A CGM device is to be set and take of by the GP. Before the study start all GPs will have a short education on CGM device by the diabetologist who use CGM on a daily base. Study period is seven days and includes screening before study entry and two visits. On Day 1, after screening and signing the informed consent, the CGM device is applied. Patient is instructed to keep a 7 day diary with four daily standard home blood glucose monitoring (SHBGM) along with the data on eating, physical exercise, drugs. Bayer's Contour® glucometer is used for the SHBGM. On Day 7, CGM device is took of and the data from iPro2 is uploaded to PC. At the end, each patient fill a short query on satisfaction while wearing CGM.</description>
    <other_name>iPro™2 Medtronic</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Totally 100 of patients with type 2 diabetes mellitus diagnosed at least one year prior to&#xD;
        study entry, aged ≥40 years, both sexes, treated in primary care, with no isulin in therapy&#xD;
        and with clinical suspicion of hypoglycemia or with disproprtion in actual glycemia na&#xD;
        haemoglobin A1c findings will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  T2DM diagnosed at least one year prior to study entry&#xD;
&#xD;
          -  no insulin in therapy&#xD;
&#xD;
          -  patients' ability to understand and answer the questionnaire by themselves&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known coagulopathy&#xD;
&#xD;
          -  oral anticoagulants in therapy&#xD;
&#xD;
          -  skin disease that enables continuous glucose monitor device application&#xD;
&#xD;
          -  febrile illness&#xD;
&#xD;
          -  patient's inability to physically visit a general practitioners office&#xD;
&#xD;
          -  patient's inability to answer the questionnaire by themselves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valerija Lang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Association of teachers in general practice / family medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Valerija Lang, PhD</last_name>
    <phone>+385915202230</phone>
    <email>valerija.bralic.lang@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Association of teachers in general practice / family medicine</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valerija Lang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zagreb</investigator_affiliation>
    <investigator_full_name>Valerija Bralic Lang</investigator_full_name>
    <investigator_title>Valerija Bralic Lang, MD, FP, PhD</investigator_title>
  </responsible_party>
  <keyword>Glycemic variability</keyword>
  <keyword>Hypoglycemia</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>Undecided</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/NCT03253237
org study id: DNOOM1072014
nct id: NCT03253237
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction and objective: The key to optimal diabetes management is tight glucose control.
      Hemoglobin A1c is the gold standard to assess glycemic control but in cases of unrecognized
      hypoglycemia, confusing nighttime events or in cases of large variations in blood glucose, a
      haemoglobin A1c can not detect specific movement of blood glucose. Continuous glucose
      monitoring (CGM) provides informations of glucose levels in a real-time format and may be
      helpful for making the personalized therapy decisions desired in the era of precision
      medicine. Our aim is to analyse the benefit of tracking patterns of glucose values by using
      continuous glucose monitoring (CGM) in patients with T2DM in family medicine office.
STUDY DESIGN: An observational, multicenter, cross-sectional study. A total of 20 GPs from
      four Croatian regions will recruit up to five subjects of both sexes from August 2017 till
      the end of September 2017, diagnosed with type 2 diabetes mellitus at least one year prior to
      study entry, aged ≥40 years, with no insulin in therapy and with clinical suspicion of
      hypoglycemia or with disproportion in actual glycemia na haemoglobin A1c findings.
      Sociodemographic, laboratory (HbA1c, fasting and postprandial glucose, total cholesterol,
      high density cholesterol, low density cholesterol, triglyceride and serum creatinine) and
      habits data will be collected. SETTING: Totally 100 of patients will be included. At primary
      care office each patient wear the device (iPro™2 Medtronic) subcutaneously for up to 7-days
      and return it to the office for download. Patients do not receive glucose alerts and only see
      the CGM data after it's been analyzed by the healthcare professional. A CGM device is to be
      set and take of by the GP. Before the study start all GPs will have a short education on CGM
      device by the diabetologist who use CGM on a daily base. Study period is seven days and
      includes screening before study entry and two visits. On Day 1, after screening and signing
      the informed consent, the CGM device is applied. Patient is instructed to keep a 7 day diary
      with four daily standard home blood glucose monitoring (SHBGM) along with the data on eating,
      physical exercise, drugs. Bayer's Contour® glucometer is used for the SHBGM. On Day 7, CGM
      device is took of and the data from iPro2 is uploaded to PC. At the end, each patient fill a
      short query on satisfaction while wearing CGM.
observational model: Cohort
time perspective: Prospective
measure: Glycemic variability in individuals with type 2 diabetes mellitus in primary care measured by continuous glucose monitor device
time frame: 7 days
intervention type: Device
intervention name: continuous glucose monitoring (CGM)
description: A CGM device is to be set and take of by the GP. Before the study start all GPs will have a short education on CGM device by the diabetologist who use CGM on a daily base. Study period is seven days and includes screening before study entry and two visits. On Day 1, after screening and signing the informed consent, the CGM device is applied. Patient is instructed to keep a 7 day diary with four daily standard home blood glucose monitoring (SHBGM) along with the data on eating, physical exercise, drugs. Bayer's Contour® glucometer is used for the SHBGM. On Day 7, CGM device is took of and the data from iPro2 is uploaded to PC. At the end, each patient fill a short query on satisfaction while wearing CGM.
other name: iPro™2 Medtronic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Valerija Lang
role: Principal Investigator
affiliation: Association of teachers in general practice / family medicine
last name: Valerija Lang, PhD
phone: +385915202230
email: valerija.bralic.lang@gmail.com
facility: 
status: Recruiting
contact: 
country: Croatia
responsible party type: Principal Investigator
investigator affiliation: University of Zagreb
investigator full name: Valerija Bralic Lang
investigator title: Valerija Bralic Lang, MD, FP, PhD
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided