<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/NCT04486183</url>
  </required_header>
  <id_info>
    <org_study_id>Eda ERGIN, PhD,RN</org_study_id>
    <secondary_id>Ayten Zaybak</secondary_id>
    <nct_id>NCT04486183</nct_id>
  </id_info>
  <brief_title>Effects of Different Methods Used to Take Blood Samples on Blood Glucose Measurements</brief_title>
  <official_title>Effects of Different Methods Used to Take Blood Samples on Blood Glucose Measurements</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Izmir Bakircay University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Izmir Bakircay University</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>
      Aims and Objectives: The purpose of this study is to compare whether or not there is a&#xD;
      difference between venous and capillary blood samples in blood glucose measurements and&#xD;
      investigate the effects of different aseptic methods used in skin cleaning before collecting&#xD;
      blood samples on measurement results.&#xD;
&#xD;
      Background: Capillary blood glucose measurement is a frequently used measurement method in&#xD;
      both clinical environments and the home environment. However, several different aseptic&#xD;
      techniques are used in collecting blood samples for glucose measurement.&#xD;
&#xD;
      Design and Methods: This was a quasi-experimental study that was conducted with 109 patients&#xD;
      who visited the blood collection unit of a University Hospital located in Western Turkey for&#xD;
      75 gr OGTT between November 2017 and April 2018. The capillary first and second blood drop&#xD;
      values taken from the patients after fasting and at two hours following OGTT and capillary&#xD;
      and venous blood glucose values were compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The data were collected by the researcher at the waiting room of the blood collection unit at&#xD;
      a close distance to the lavatory. A nurse working at the venous blood sample unit collected&#xD;
      fasting and 2 hours after OGTT venous blood samples from the individuals who arrived at the&#xD;
      blood collection unit for 75 gr OGTT. All venous blood and capillary blood samples were&#xD;
      obtained in a shorter time than 5 minutes. In this study, capillary blood samples were taken&#xD;
      from the same participant in four different ways:&#xD;
&#xD;
        -  As the first intervention, the middle finger of the individuals agreeing to participate&#xD;
           in the study was rubbed and wiped with a cotton infused with 70% alcohol, and 10 seconds&#xD;
           were given for it to dry. Afterwards, by perforating the finger with a lancet, firstly&#xD;
           the first blood drop glucose value and then the second blood drop glucose value were&#xD;
           measured.&#xD;
&#xD;
        -  As the second intervention, after ensuring that the individuals washed their hands with&#xD;
           soap at the lavatory of the blood collection unit and dried their hands with paper&#xD;
           towels, the middle finger of the right hand was rubbed, perforated with a lancet, and&#xD;
           firstly the first blood drop glucose value and then the second blood drop glucose value&#xD;
           were measured.&#xD;
&#xD;
        -  As the third intervention, for the individuals whose hands had been washed, the middle&#xD;
           finger of the left hand was rubbed and wiped with 70% alcohol-infused cotton, and 10&#xD;
           seconds were given for it to dry. The finger was perforated with a lancet and the first&#xD;
           and second blood drop glucose values were recorded.&#xD;
&#xD;
        -  As the fourth intervention, 2 hours after the individuals drank a beverage containing 75&#xD;
           gr of sugar for OGTT, in a state where their hands had been washed, the finger was wiped&#xD;
           with 70% alcohol, left to dry, perforated with a lancet, and the first and second blood&#xD;
           drop glucose values were measured and recorded&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 5, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This was a quasi-experimental study with a single group and simultaneous (matched) sample conducted with the purpose of examining whether or not there is a difference between venous and capillary blood samples in blood glucose level measurements and the effects of different methods used in skin cleaning before collecting blood samples on measurement results</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Information Form</measure>
    <time_frame>at 6-month</time_frame>
    <description>10 questions on the sociodemographic characteristics of the participants such as age, sex, height-weight, status of DM diagnosis in the family, status of having another chronic disease and status of smoking and alcohol consumption</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Data Record Form</measure>
    <time_frame>at 6-month</time_frame>
    <description>The individuals' venous blood glucose values, capillary fasting blood glucose first and second blood drop values measured with aseptic techniques and the first and second blood drop values of the venous and capillary blood glucose 2 hours after OGTT were recorded into a &quot;Data Record Form&quot;. As the glucometer device in the study, Roche's Accu-Chek® Performa Nano brand measurement device was used</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Blood Glucose, Low</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The data were collected by the researcher at the waiting room of the blood collection unit at a close distance to the lavatory. The capillary first and second blood drop values taken from the patients after fasting and at two hours following OGTT and capillary and venous blood glucose values were compared.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>capillary blood samples</intervention_name>
    <description>The patient's finger was wiped with alcohol, left to dry, and the first and second blood drops were read The patient was asked to wash their hands, their finger was perforated with a strip, and the first and second blood drops were read The finger of the patient whose hands had been washed was wiped with alcohol, left to dry, and the first and second blood drops were read Venous blood was collected for blood sugar measurement 2 hours after the patient had a beverage containing 75 gr sugar for OGTT The patient was ensured to wash their hands, their finger was wiped with alcohol, and the first and second blood drop glucose values were measured and recorded</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>capillary blood samples were taken from the same participant in four different ways</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  who had both upper extremities,&#xD;
&#xD;
          -  good capillary saturation,&#xD;
&#xD;
          -  blood glucose monitoring requests for OGTT,&#xD;
&#xD;
          -  who were fasting for 8-12 hours before giving blood,&#xD;
&#xD;
          -  who had requests for 75 gr sugar loading&#xD;
&#xD;
          -  who volunteered to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who refused to participate in the study,&#xD;
&#xD;
          -  whose capillary blood glucose could not be looked at after sugar loading.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>İzmir Bakırçay University</name>
      <address>
        <city>İzmir</city>
        <zip>35665</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Izmir Bakircay University</investigator_affiliation>
    <investigator_full_name>Eda Ergin</investigator_full_name>
    <investigator_title>Asistant Professor,Department of Fundamentals Nursing,</investigator_title>
  </responsible_party>
  <keyword>Blood Glucose Measurements</keyword>
  <keyword>Venous Blood</keyword>
  <keyword>Capillary Blood</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT04486183
org study id: Eda ERGIN, PhD,RN
secondary id: Ayten Zaybak
nct id: NCT04486183
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aims and Objectives: The purpose of this study is to compare whether or not there is a
      difference between venous and capillary blood samples in blood glucose measurements and
      investigate the effects of different aseptic methods used in skin cleaning before collecting
      blood samples on measurement results.

      Background: Capillary blood glucose measurement is a frequently used measurement method in
      both clinical environments and the home environment. However, several different aseptic
      techniques are used in collecting blood samples for glucose measurement.

      Design and Methods: This was a quasi-experimental study that was conducted with 109 patients
      who visited the blood collection unit of a University Hospital located in Western Turkey for
      75 gr OGTT between November 2017 and April 2018. The capillary first and second blood drop
      values taken from the patients after fasting and at two hours following OGTT and capillary
      and venous blood glucose values were compared.
The data were collected by the researcher at the waiting room of the blood collection unit at
      a close distance to the lavatory. A nurse working at the venous blood sample unit collected
      fasting and 2 hours after OGTT venous blood samples from the individuals who arrived at the
      blood collection unit for 75 gr OGTT. All venous blood and capillary blood samples were
      obtained in a shorter time than 5 minutes. In this study, capillary blood samples were taken
      from the same participant in four different ways:

        -  As the first intervention, the middle finger of the individuals agreeing to participate
           in the study was rubbed and wiped with a cotton infused with 70% alcohol, and 10 seconds
           were given for it to dry. Afterwards, by perforating the finger with a lancet, firstly
           the first blood drop glucose value and then the second blood drop glucose value were
           measured.

        -  As the second intervention, after ensuring that the individuals washed their hands with
           soap at the lavatory of the blood collection unit and dried their hands with paper
           towels, the middle finger of the right hand was rubbed, perforated with a lancet, and
           firstly the first blood drop glucose value and then the second blood drop glucose value
           were measured.

        -  As the third intervention, for the individuals whose hands had been washed, the middle
           finger of the left hand was rubbed and wiped with 70% alcohol-infused cotton, and 10
           seconds were given for it to dry. The finger was perforated with a lancet and the first
           and second blood drop glucose values were recorded.

        -  As the fourth intervention, 2 hours after the individuals drank a beverage containing 75
           gr of sugar for OGTT, in a state where their hands had been washed, the finger was wiped
           with 70% alcohol, left to dry, perforated with a lancet, and the first and second blood
           drop glucose values were measured and recorded
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This was a quasi-experimental study with a single group and simultaneous (matched) sample conducted with the purpose of examining whether or not there is a difference between venous and capillary blood samples in blood glucose level measurements and the effects of different methods used in skin cleaning before collecting blood samples on measurement results
primary purpose: Prevention
masking: None (Open Label)
measure: Patient Information Form
time frame: at 6-month
description: 10 questions on the sociodemographic characteristics of the participants such as age, sex, height-weight, status of DM diagnosis in the family, status of having another chronic disease and status of smoking and alcohol consumption
measure: Data Record Form
time frame: at 6-month
description: The individuals' venous blood glucose values, capillary fasting blood glucose first and second blood drop values measured with aseptic techniques and the first and second blood drop values of the venous and capillary blood glucose 2 hours after OGTT were recorded into a "Data Record Form". As the glucometer device in the study, Roche's Accu-Chek® Performa Nano brand measurement device was used
arm group label: Intervention
arm group type: Experimental
description: The data were collected by the researcher at the waiting room of the blood collection unit at a close distance to the lavatory. The capillary first and second blood drop values taken from the patients after fasting and at two hours following OGTT and capillary and venous blood glucose values were compared.
intervention type: Other
intervention name: capillary blood samples
description: The patient's finger was wiped with alcohol, left to dry, and the first and second blood drops were read The patient was asked to wash their hands, their finger was perforated with a strip, and the first and second blood drops were read The finger of the patient whose hands had been washed was wiped with alcohol, left to dry, and the first and second blood drops were read Venous blood was collected for blood sugar measurement 2 hours after the patient had a beverage containing 75 gr sugar for OGTT The patient was ensured to wash their hands, their finger was wiped with alcohol, and the first and second blood drop glucose values were measured and recorded
arm group label: Intervention
other name: capillary blood samples were taken from the same participant in four different ways
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Izmir Bakircay University
investigator full name: Eda Ergin
investigator title: Asistant Professor,Department of Fundamentals Nursing,
sharing ipd: No