<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/NCT02258932</url>
  </required_header>
  <id_info>
    <org_study_id>13/NW/0122-1</org_study_id>
    <nct_id>NCT02258932</nct_id>
  </id_info>
  <brief_title>CSII in Type 1 Diabetes: Diet, Quality of Life &amp; Cardiometabolic Risks - A Longitudinal 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 Longitudinal 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 longitudinal investigatory literature is sparse. This&#xD;
      study will clarify whether adult CSII patients experience eating behaviour and quality of&#xD;
      life alterations over time after commencement of the therapy. This is important as changes&#xD;
      may be associated with cardiometabolic risk variations; which will also be investigated.&#xD;
&#xD;
      Participants will comprise of a convenience sample of adults with Type-1 diabetes invited&#xD;
      from diabetes clinics at the Royal Liverpool University Hospital who are due to commence&#xD;
      CSII.&#xD;
&#xD;
      Following ethical consent the participants who are due to commence CSII will be observed at 5&#xD;
      time points (every three months) over a year. It should be noted that the recruitment period&#xD;
      for the longitudinal arm of the study will be 9 months starting from the date the first&#xD;
      participant is recruited. At each time point each participant will be asked to complete a 5&#xD;
      day food diary, a food intake questionnaire (FIQ), a quality of life (QOL) questionnaire, a&#xD;
      semi-structured interview and give a 20ml sample of blood. This will be taken at the same&#xD;
      time and in addition to their regular diagnostic sample, however where this is unfeasible&#xD;
      extra occasional appointments may be needed. Results will be compared with existing patient&#xD;
      medical records, which will also be analysed during the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</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>12 months after commencement of the therapy.</time_frame>
    <description>The primary outcome will be measured for 12 months using a combination of food intake questionnaires and food diaries.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life of adults with Type 1 diabetes who are using insulin pump therapy.</measure>
    <time_frame>12 months after commencement of the therapy</time_frame>
    <description>Quality of life will be assessed 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>12 months after commencement of the therapy</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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5</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 commencing continuous subcutaneous insulin infusion 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>Non-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;
        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>July 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>Longitudinal</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/NCT02258932
org study id: 13/NW/0122-1
nct id: NCT02258932
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 longitudinal investigatory literature is sparse. This
      study will clarify whether adult CSII patients experience eating behaviour and quality of
      life alterations over time after commencement of the therapy. This is important as changes
      may be associated with cardiometabolic risk variations; which will also be investigated.

      Participants will comprise of a convenience sample of adults with Type-1 diabetes invited
      from diabetes clinics at the Royal Liverpool University Hospital who are due to commence
      CSII.

      Following ethical consent the participants who are due to commence CSII will be observed at 5
      time points (every three months) over a year. It should be noted that the recruitment period
      for the longitudinal arm of the study will be 9 months starting from the date the first
      participant is recruited. At each time point each participant will be asked to complete a 5
      day food diary, a food intake questionnaire (FIQ), a quality of life (QOL) questionnaire, a
      semi-structured interview and give a 20ml sample of blood. 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. Results will be compared with existing patient
      medical records, which will also be analysed during the study.
observational model: Cohort
time perspective: Prospective
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: 12 months after commencement of the therapy.
description: The primary outcome will be measured for 12 months using a combination of food intake questionnaires and food diaries.
measure: Quality of life of adults with Type 1 diabetes who are using insulin pump therapy.
time frame: 12 months after commencement of the therapy
description: Quality of life will be assessed 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: 12 months after commencement of the therapy
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.
arm group label: Continuous subcutaneous insulin infusion
description: This group will consist of patients with Type 1 diabetes commencing continuous subcutaneous insulin infusion 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: Non-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