xml: <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/NCT05976191</url>
    </required_header>
    <id_info>
      <org_study_id>2022/476</org_study_id>
      <nct_id>NCT05976191</nct_id>
    </id_info>
    <brief_title>Comparison of Fasting Blood Glucose Measurements From Fingertip and Intravenous on Patient Satisfaction in Patients With Diabetes Mellitus</brief_title>
    <official_title>Istanbul University Cerrahpaşa-IUC</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</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>
        The study was designed as a randomized controlled experimental study in order to compare the&#xD;
        fasting blood glucose values measured by puncturing the fingertips and using the intravenous&#xD;
        route of patients diagnosed with diabetes mellitus, and to determine the effect on patient&#xD;
        satisfaction. The blood glucose measurement via the intravenous catheter has an effect on&#xD;
        increasing the comfort of the patient compared to the fingertip measurement. It is thought&#xD;
        that information can be provided to increase patient satisfaction.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Crossover Assignment This research was designed in a pretest posttest randomized controlled experimental type</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Single (Participant) Identity information of the patients was concealed and verbal and written consents were obtained.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Blood Glucose Measurement Patient Satisfaction Form</measure>
      <time_frame>four months</time_frame>
      <description>Does intravenous blood glucose measurement have a positive effect on patient satisfaction compared to fingertip blood glucose measurement?</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Diabetes Mellitus</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients whose blood glucose is measured intravenously and from the fingertip</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients with fingertip blood glucose measurement</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Patients whose blood glucose is measured intravenously and from the fingertip</intervention_name>
      <description>A satisfaction survey will be conducted after these patients have previously examined their blood glucose via intravenous route, then fingertip blood glucose will be measured and a satisfaction survey will be applied.</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years and older&#xD;
  &#xD;
            -  No advanced hearing and vision problems&#xD;
  &#xD;
            -  Able to speak and understand Turkish&#xD;
  &#xD;
            -  Easy to communicate&#xD;
  &#xD;
            -  literate&#xD;
  &#xD;
            -  Agreeing to participate in the research voluntarily&#xD;
  &#xD;
            -  Patients who are hospitalized&#xD;
  &#xD;
            -  Regular finger blood sugar monitoring,&#xD;
  &#xD;
            -  Patients with an intravenous vascular access date within the first 24 hours&#xD;
  &#xD;
            -  Patients who had been diagnosed with Type 2 Diabetes Mellitus for at least one year&#xD;
               were.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who are treated with sedative drugs&#xD;
  &#xD;
            -  Patients using antipsychotic medication&#xD;
  &#xD;
            -  Patients with continuous drug infusion through the intravenous line&#xD;
  &#xD;
            -  Patients whose intravenous vascular access date has passed 24 hours&#xD;
  &#xD;
            -  Patients in unconscious, confused, apathetic state&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Istanbul University-Cerrahpaşa (IUC)</name>
        <address>
          <city>Istanbul</city>
          <state>Şişli</state>
          <zip>34381</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>AYSEGUL OZBAKAN</last_name>
        <phone>00905423047687</phone>
        <email>aysegulozbakan@icloud.com</email>
      </contact>
      <contact_backup>
        <last_name>ARZU ERKOC</last_name>
        <phone>00905552735500</phone>
        <email>arzu.erkochut@iuc.edu.tr</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Istanbul University-Cerrahpaşa (IUC)</name>
        <address>
          <city>Istanbul</city>
          <state>Şişli</state>
          <zip>34381</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>AYSEGUL OZBAKAN</last_name>
        <phone>05423047687</phone>
        <email>aysegulozbakan@icloud.com</email>
      </contact>
      <contact_backup>
        <last_name>ARZU ERKOÇ</last_name>
        <phone>05552735500</phone>
        <email>arzu.erkochut@iuc.edu.tr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>AYSEGUL</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <keyword>Diabetes mellitus</keyword>
    <keyword>Fear of finger piercing</keyword>
    <keyword>patient satisfaction</keyword>
    <keyword>blood glucose measurement</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976191
  org study id: 2022/476
  nct id: NCT05976191
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study was designed as a randomized controlled experimental study in order to compare the
        fasting blood glucose values measured by puncturing the fingertips and using the intravenous
        route of patients diagnosed with diabetes mellitus, and to determine the effect on patient
        satisfaction. The blood glucose measurement via the intravenous catheter has an effect on
        increasing the comfort of the patient compared to the fingertip measurement. It is thought
        that information can be provided to increase patient satisfaction.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Crossover Assignment This research was designed in a pretest posttest randomized controlled experimental type
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: Single (Participant) Identity information of the patients was concealed and verbal and written consents were obtained.
  measure: Blood Glucose Measurement Patient Satisfaction Form
  time frame: four months
  description: Does intravenous blood glucose measurement have a positive effect on patient satisfaction compared to fingertip blood glucose measurement?
  arm group label: experimental group
  arm group type: Experimental
  description: Patients whose blood glucose is measured intravenously and from the fingertip
  arm group label: control group
  arm group type: No Intervention
  description: Patients with fingertip blood glucose measurement
  intervention type: Behavioral
  intervention name: Patients whose blood glucose is measured intravenously and from the fingertip
  description: A satisfaction survey will be conducted after these patients have previously examined their blood glucose via intravenous route, then fingertip blood glucose will be measured and a satisfaction survey will be applied.
  arm group label: experimental group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: AYSEGUL
  investigator title: principal investigator
  mesh term: Diabetes Mellitus
  sharing ipd: No