<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/NCT02258945</url>
  </required_header>
  <id_info>
    <org_study_id>13/NW/0122-2</org_study_id>
    <nct_id>NCT02258945</nct_id>
  </id_info>
  <brief_title>CSII in Type 1 Diabetes: Diet, Quality of Life &amp; Cardiometabolic Risks - A Cross-Sectional Study</brief_title>
  <official_title>Eating Behaviours, Quality of Life and Cardiometabolic Risks in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion Therapy - A Cross-Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool John Moores University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Liverpool University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Liverpool John Moores University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glycaemic control is an important aspect of Type 1 diabetes (T1D) management for&#xD;
      diabetologists and patients alike. Evidence suggests continuous subcutaneous insulin infusion&#xD;
      (CSII) is an effective method of achieving this. Among the advantages of CSII is the&#xD;
      opportunity for patients to potentially discard relatively inflexible mealtimes and&#xD;
      carbohydrate requirements imposed by other regimes such as multiple daily injections (MDI).&#xD;
      There are also reported improvements in quality of life. Furthermore, in patients with good&#xD;
      glycaemic control, such as those often assisted by CSII, various qualitative atherogenic&#xD;
      lipid abnormalities may exist, despite the presence of a normal quantitative lipid profile;&#xD;
      potentially leading to increased cardiometabolic risks. Literature examining the eating&#xD;
      behaviours, quality of life and cardiometabolic risks of CSII patients over time after&#xD;
      commencement of the therapy is sparse, frequently dated and worthy of further research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Continuous subcutaneous insulin infusion (CSII) is a therapy for patients with Type-1&#xD;
      diabetes mellitus involving insulin administration via electronic pump. CSII has been shown&#xD;
      to reduce HbA1c levels and improve blood sugar control and the continuous, unobtrusive&#xD;
      insulin delivery may potentially allow patients increased dietary flexibility and quality of&#xD;
      life. However, despite these claims investigatory literature is sparse. This study will&#xD;
      clarify whether adult CSII patients experience eating behaviour and quality of life&#xD;
      alterations compared to patients using multiple daily injection (MDI) therapy. This is&#xD;
      important as differences may be associated with cardiometabolic risk variations; which will&#xD;
      also be investigated.&#xD;
&#xD;
      Participants will be a combination of adults with Type-1 diabetes invited from diabetes&#xD;
      clinics at the Royal Liverpool University Hospital who are a) have been using CSII for over 1&#xD;
      year or b) have Type 1 diabetes but have never used CSII, have no current plans to use CSII&#xD;
      and are presently using MDI therapy.&#xD;
&#xD;
      Following ethical consent participants will be asked to complete one food frequency&#xD;
      questionnaire (FFQ) and one quality of life (QOL) questionnaire. A subgroup of these&#xD;
      participants (approximately 10 CSII users and 10 MDI users) will then be asked to take part&#xD;
      in one interview to investigate quality of life and complete a food diary to explore eating&#xD;
      behaviours. All participants consenting to the cross-sectional arm of the study will also be&#xD;
      asked to provide an extra volume of blood for analysis. This will be taken at the same time&#xD;
      and in addition to their regular diagnostic sample, however where this is unfeasible extra&#xD;
      occasional appointments may be needed. (Please be aware that the interview, food diary and&#xD;
      blood sample are all optional and that the minimum requirement for participation in the study&#xD;
      is the completion of the FFQ and the QOL questionnaires). Results will be compared with&#xD;
      existing patient medical records, which will also be analysed during the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Eating behaviours of adult patients with Type 1 diabetes using continuous subcutaneous insulin infusion therapy measured using food diaries and food surveys.</measure>
    <time_frame>0 Months</time_frame>
    <description>The primary outcome will be measured at one time point only (due to the cross-sectional nature of the study) using a combination of food frequency questionnaires and food diaries. It is anticipated that all measurements will be taken between April 2014 and December 2014.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life of adults with Type 1 diabetes who are using insulin pump therapy.</measure>
    <time_frame>0 Months</time_frame>
    <description>Quality of life will be assessed at one time point only (due to the nature of the cross-sectional study design) using a combination of semi-structured interviews and quality of life questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiometabolic risks of adult patients with Type 1 diabetes who are using insulin pump therapy.</measure>
    <time_frame>0 Months</time_frame>
    <description>Cardiometabolic risks will be measured by accessing patient's medical records and taking a sample blood which will be analysed for lipoprotein subfractions, apolipoproteins (A1, A2 and B), HDL, LDL, NEFA, triglycerides and total cholesterol. Metabolomics analysis will also be carried out on collected plasma samples with a focus on both previously identified markers of cardiovascular disease and novel biomarkers. Data will be collected at one time point only (due to the nature of the cross-sectional study design).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Continuous Subcutaneous Insulin Infusion</arm_group_label>
    <description>This group will consist of patients with Type 1 diabetes using continuous subcutaneous insulin infusion therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Daily Injections</arm_group_label>
    <description>This group will consist of patients with Type 1 diabetes using multiple daily injection therapy.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma will be retained for use by the research team during the study. After the study&#xD;
      remaining samples will be destroyed in accordance with the Human Tissue Authority Code of&#xD;
      Practice.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be selected from the Diabetes Centre from the Royal Liverpool and Broadgreen&#xD;
        Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must reside in Liverpool or the surrounding areas.&#xD;
&#xD;
          -  Patients must be ages over 18&#xD;
&#xD;
          -  Patients must have Type 1 diabetes&#xD;
&#xD;
          -  Patients must be using or pending the supply of an insulin pump.&#xD;
&#xD;
          -  Patients who have been using either continuous subcutaneous insulin infusion or&#xD;
             multiple daily injections for over a year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients must not live outside of Liverpool and the surrounding areas.&#xD;
&#xD;
          -  Patients must not be aged under 18&#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>Richard J Webb, BA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liverpool John Moores University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Liverpool and Broadgreen University Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>February 18, 2016</last_update_submitted>
  <last_update_submitted_qc>February 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Liverpool John Moores University</investigator_affiliation>
    <investigator_full_name>Mr Richard Webb</investigator_full_name>
    <investigator_title>Postgraduate Research Student</investigator_title>
  </responsible_party>
  <keyword>Type 1 diabetes</keyword>
  <keyword>CSII</keyword>
  <keyword>Continuous subcutaneous insulin infusion</keyword>
  <keyword>Insulin pump</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Eating behaviours</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Cardiometabolic risks</keyword>
  <keyword>Liverpool</keyword>
  <keyword>NHS</keyword>
  <keyword>Metabolomics</keyword>
  <keyword>Observational</keyword>
  <keyword>Lipoproteins</keyword>
  <keyword>Lipids</keyword>
  <keyword>Food</keyword>
  <keyword>Food diary</keyword>
  <keyword>Cross-Sectional</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 1</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/NCT02258945
org study id: 13/NW/0122-2
nct id: NCT02258945
lead sponsor: 
collaborator: 
has dmc: No
Glycaemic control is an important aspect of Type 1 diabetes (T1D) management for
      diabetologists and patients alike. Evidence suggests continuous subcutaneous insulin infusion
      (CSII) is an effective method of achieving this. Among the advantages of CSII is the
      opportunity for patients to potentially discard relatively inflexible mealtimes and
      carbohydrate requirements imposed by other regimes such as multiple daily injections (MDI).
      There are also reported improvements in quality of life. Furthermore, in patients with good
      glycaemic control, such as those often assisted by CSII, various qualitative atherogenic
      lipid abnormalities may exist, despite the presence of a normal quantitative lipid profile;
      potentially leading to increased cardiometabolic risks. Literature examining the eating
      behaviours, quality of life and cardiometabolic risks of CSII patients over time after
      commencement of the therapy is sparse, frequently dated and worthy of further research.
Continuous subcutaneous insulin infusion (CSII) is a therapy for patients with Type-1
      diabetes mellitus involving insulin administration via electronic pump. CSII has been shown
      to reduce HbA1c levels and improve blood sugar control and the continuous, unobtrusive
      insulin delivery may potentially allow patients increased dietary flexibility and quality of
      life. However, despite these claims investigatory literature is sparse. This study will
      clarify whether adult CSII patients experience eating behaviour and quality of life
      alterations compared to patients using multiple daily injection (MDI) therapy. This is
      important as differences may be associated with cardiometabolic risk variations; which will
      also be investigated.

      Participants will be a combination of adults with Type-1 diabetes invited from diabetes
      clinics at the Royal Liverpool University Hospital who are a) have been using CSII for over 1
      year or b) have Type 1 diabetes but have never used CSII, have no current plans to use CSII
      and are presently using MDI therapy.

      Following ethical consent participants will be asked to complete one food frequency
      questionnaire (FFQ) and one quality of life (QOL) questionnaire. A subgroup of these
      participants (approximately 10 CSII users and 10 MDI users) will then be asked to take part
      in one interview to investigate quality of life and complete a food diary to explore eating
      behaviours. All participants consenting to the cross-sectional arm of the study will also be
      asked to provide an extra volume of blood for analysis. This will be taken at the same time
      and in addition to their regular diagnostic sample, however where this is unfeasible extra
      occasional appointments may be needed. (Please be aware that the interview, food diary and
      blood sample are all optional and that the minimum requirement for participation in the study
      is the completion of the FFQ and the QOL questionnaires). Results will be compared with
      existing patient medical records, which will also be analysed during the study.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Eating behaviours of adult patients with Type 1 diabetes using continuous subcutaneous insulin infusion therapy measured using food diaries and food surveys.
time frame: 0 Months
description: The primary outcome will be measured at one time point only (due to the cross-sectional nature of the study) using a combination of food frequency questionnaires and food diaries. It is anticipated that all measurements will be taken between April 2014 and December 2014.
measure: Quality of life of adults with Type 1 diabetes who are using insulin pump therapy.
time frame: 0 Months
description: Quality of life will be assessed at one time point only (due to the nature of the cross-sectional study design) using a combination of semi-structured interviews and quality of life questionnaires.
measure: Cardiometabolic risks of adult patients with Type 1 diabetes who are using insulin pump therapy.
time frame: 0 Months
description: Cardiometabolic risks will be measured by accessing patient's medical records and taking a sample blood which will be analysed for lipoprotein subfractions, apolipoproteins (A1, A2 and B), HDL, LDL, NEFA, triglycerides and total cholesterol. Metabolomics analysis will also be carried out on collected plasma samples with a focus on both previously identified markers of cardiovascular disease and novel biomarkers. Data will be collected at one time point only (due to the nature of the cross-sectional study design).
arm group label: Continuous Subcutaneous Insulin Infusion
description: This group will consist of patients with Type 1 diabetes using continuous subcutaneous insulin infusion therapy.
arm group label: Multiple Daily Injections
description: This group will consist of patients with Type 1 diabetes using multiple daily injection therapy.
Plasma will be retained for use by the research team during the study. After the study
      remaining samples will be destroyed in accordance with the Human Tissue Authority Code of
      Practice.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard J Webb, BA
role: Principal Investigator
affiliation: Liverpool John Moores University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Liverpool John Moores University
investigator full name: Mr Richard Webb
investigator title: Postgraduate Research Student
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1