<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/NCT04460092</url>
  </required_header>
  <id_info>
    <org_study_id>IR.BMSU.BAQ.REC.1398.059</org_study_id>
    <nct_id>NCT04460092</nct_id>
  </id_info>
  <brief_title>Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose</brief_title>
  <official_title>The Effect of Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose Control in Type - II Diabetic Patients in Baqiyatollah Hospital and Clinic, Tehran, 2019 -2020</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baqiyatallah Medical Sciences University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baqiyatallah Medical Sciences University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes&#xD;
      will be selected based on entry and exit criteria, then randomly divided into two equal&#xD;
      groups (group &quot;A&quot; and group &quot;B&quot;).In the first three days of the first week of&#xD;
      hospitalization, in group &quot;A&quot; insulin injection with a 90-degree angle and using Nidel&#xD;
      32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree&#xD;
      angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in&#xD;
      another three days, the types of needles used in the two groups are moved together. After a&#xD;
      one-day break, in another three days, the types of needles used in the two groups are&#xD;
      replaced together. Then the VAS scale will be used to assess post-injection pain; the amount&#xD;
      of leakage after the injection will be measured in two ways Yes/No, according to the&#xD;
      researcher's observation. And to check the effect of Needles on controlling patients' blood&#xD;
      sugar, their blood sugar levels will be measured based on the routine of hospital units.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes&#xD;
      will be selected based on entry and exit criteria, then randomly divided into two equal&#xD;
      groups (group &quot;A&quot; and group &quot;B&quot;).In the first three days of the first week of&#xD;
      hospitalization, in group &quot;A&quot; insulin injection with a 90-degree angle and using Nidel&#xD;
      32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree&#xD;
      angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in&#xD;
      another three days, the types of needles used in the two groups are moved together. After a&#xD;
      one-day break, in another three days, the types of needles used in the two groups are&#xD;
      replaced together. Then the VAS scale will be used to assess post-injection pain; the amount&#xD;
      of leakage after the injection will be measured in two ways Yes/No, according to the&#xD;
      researcher's observation. And to check the effect of Needles on controlling patients' blood&#xD;
      sugar, their blood sugar levels will be measured based on the routine of hospital units.&#xD;
&#xD;
      After entering the data in SPSS20 software, the collected data will be analyzed using&#xD;
      descriptive statistics (frequency, percentage, mean, standard deviation) and statistical&#xD;
      tests (t-test, chi-square).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">September 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 29, 2020</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma glucose</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Laboratory check the Plasma glucose according to the routine of the hospital units</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insulin leakage</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>The rate of insulin leakage after injection is observational</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain when insulin injection</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Survey severity pain when insulin injection by Visual Analogue Scale (VAS). This is a numerical scale that tells the patient the severity of their pain from one to ten. The larger the number, the more pain there is.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Group &quot;A&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the first three days, participants in group &quot;A&quot; will inject 90-degree insulin injections using 5-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 8 mm to inject insulin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group&quot;B&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the first three days, participants in group &quot;B&quot; will inject 90-degree insulin injections using 8-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 5mm to inject insulin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>5-mm 32-gauge Insulin needles in the first three days of Intervention</intervention_name>
    <description>32-gauge needles with a length of 5mm to inject insulin in first three days</description>
    <arm_group_label>Group &quot;A&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>8-mm 32-gauge Insulin needles in the first three days of Intervention</intervention_name>
    <description>32-gauge needles with a length of 8mm to inject insulin in first three days</description>
    <arm_group_label>Group&quot;B&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>5-mm 32-gauge Insulin needles in the last three days of Intervention</intervention_name>
    <description>32-gauge needles with a length of 5mm to inject insulin in second three days</description>
    <arm_group_label>Group&quot;B&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>8-mm 32-gauge Insulin needles in the last three days of Intervention</intervention_name>
    <description>32-gauge needles with a length of 8mm to inject insulin in second three days</description>
    <arm_group_label>Group &quot;A&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having type II diabetes&#xD;
&#xD;
          -  Use injectable insulin for at least two years&#xD;
&#xD;
          -  BMI &gt;18&#xD;
&#xD;
          -  Lack of mental illness and mental retardation&#xD;
&#xD;
          -  Use insulin pen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of desire to participate in the study&#xD;
&#xD;
          -  Having a skin problem in the injection site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esmail Heidaranlu</last_name>
    <role>Study Chair</role>
    <affiliation>Baqiyatallah university of medical sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammad Sadegh Bagheri Baghdasht</last_name>
    <phone>0098 936 8214509</phone>
    <email>hiasdasd0@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mohammad Sadegh Bagheri Baghdasht</name>
      <address>
        <city>Tehran</city>
        <zip>0</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad Sadegh Bagheri Baghdasht</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 5, 2020</last_update_submitted>
  <last_update_submitted_qc>July 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baqiyatallah Medical Sciences University</investigator_affiliation>
    <investigator_full_name>Mohammad Sadegh Bagheri Baghdasht</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus, Type 2</keyword>
  <keyword>Blood Glucose</keyword>
  <keyword>Pain</keyword>
  <keyword>leakage</keyword>
  <keyword>insulin injections</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
  </intervention_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/NCT04460092
org study id: IR.BMSU.BAQ.REC.1398.059
nct id: NCT04460092
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes
      will be selected based on entry and exit criteria, then randomly divided into two equal
      groups (group "A" and group "B").In the first three days of the first week of
      hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel
      32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree
      angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in
      another three days, the types of needles used in the two groups are moved together. After a
      one-day break, in another three days, the types of needles used in the two groups are
      replaced together. Then the VAS scale will be used to assess post-injection pain; the amount
      of leakage after the injection will be measured in two ways Yes/No, according to the
      researcher's observation. And to check the effect of Needles on controlling patients' blood
      sugar, their blood sugar levels will be measured based on the routine of hospital units.
This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes
      will be selected based on entry and exit criteria, then randomly divided into two equal
      groups (group "A" and group "B").In the first three days of the first week of
      hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel
      32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree
      angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in
      another three days, the types of needles used in the two groups are moved together. After a
      one-day break, in another three days, the types of needles used in the two groups are
      replaced together. Then the VAS scale will be used to assess post-injection pain; the amount
      of leakage after the injection will be measured in two ways Yes/No, according to the
      researcher's observation. And to check the effect of Needles on controlling patients' blood
      sugar, their blood sugar levels will be measured based on the routine of hospital units.

      After entering the data in SPSS20 software, the collected data will be analyzed using
      descriptive statistics (frequency, percentage, mean, standard deviation) and statistical
      tests (t-test, chi-square).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Plasma glucose
time frame: Up to 7 days
description: Laboratory check the Plasma glucose according to the routine of the hospital units
measure: Insulin leakage
time frame: Up to 7 days
description: The rate of insulin leakage after injection is observational
measure: Pain when insulin injection
time frame: Up to 7 days
description: Survey severity pain when insulin injection by Visual Analogue Scale (VAS). This is a numerical scale that tells the patient the severity of their pain from one to ten. The larger the number, the more pain there is.
arm group label: Group "A"
arm group type: Experimental
description: In the first three days, participants in group "A" will inject 90-degree insulin injections using 5-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 8 mm to inject insulin.
arm group label: Group"B"
arm group type: Experimental
description: In the first three days, participants in group "B" will inject 90-degree insulin injections using 8-mm 32-gauge needles. Then, with an interval of one day, in the second three days, they will use 32-gauge needles with a length of 5mm to inject insulin.
intervention type: Device
intervention name: 5-mm 32-gauge Insulin needles in the first three days of Intervention
description: 32-gauge needles with a length of 5mm to inject insulin in first three days
arm group label: Group "A"
intervention type: Device
intervention name: 8-mm 32-gauge Insulin needles in the first three days of Intervention
description: 32-gauge needles with a length of 8mm to inject insulin in first three days
arm group label: Group"B"
intervention type: Device
intervention name: 5-mm 32-gauge Insulin needles in the last three days of Intervention
description: 32-gauge needles with a length of 5mm to inject insulin in second three days
arm group label: Group"B"
intervention type: Device
intervention name: 8-mm 32-gauge Insulin needles in the last three days of Intervention
description: 32-gauge needles with a length of 8mm to inject insulin in second three days
arm group label: Group "A"
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Esmail Heidaranlu
role: Study Chair
affiliation: Baqiyatallah university of medical sciences
last name: Mohammad Sadegh Bagheri Baghdasht
phone: 0098 936 8214509
email: hiasdasd0@gmail.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Baqiyatallah Medical Sciences University
investigator full name: Mohammad Sadegh Bagheri Baghdasht
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin, Globin Zinc