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CSII in Type 1 Diabetes: Diet, Quality of Life & Cardiometabolic Risks - A Longitudinal Study

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ClinicalTrials.gov Identifier: NCT02258932
Recruitment Status : Completed
First Posted : October 8, 2014
Last Update Posted : February 19, 2016
Sponsor:
Collaborator:
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Information provided by (Responsible Party):
Mr Richard Webb, Liverpool John Moores University

Brief Summary:
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.

Condition or disease
Type 1 Diabetes

Detailed Description:

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.


Study Type : Observational [Patient Registry]
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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
Study Start Date : December 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort
Continuous subcutaneous insulin infusion
This group will consist of patients with Type 1 diabetes commencing continuous subcutaneous insulin infusion therapy.



Primary Outcome Measures :
  1. 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. ]
    The primary outcome will be measured for 12 months using a combination of food intake questionnaires and food diaries.


Secondary Outcome Measures :
  1. Quality of life of adults with Type 1 diabetes who are using insulin pump therapy. [ Time Frame: 12 months after commencement of the therapy ]
    Quality of life will be assessed using a combination of semi-structured interviews and quality of life questionnaires.

  2. Cardiometabolic risks of adult patients with Type 1 diabetes who are using insulin pump therapy. [ Time Frame: 12 months after commencement of the therapy ]
    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.


Biospecimen Retention:   Samples Without DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected from the Diabetes Centre from the Royal Liverpool and Broadgreen Hospital.
Criteria

Inclusion Criteria:

  • Patients must reside in Liverpool or the surrounding areas.
  • Patients must be ages over 18
  • Patients must have Type 1 diabetes
  • Patients must be using or pending the supply of an insulin pump.

Exclusion Criteria:

  • Patients must not live outside of Liverpool and the surrounding areas.
  • Patients must not be aged under 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258932


Locations
United Kingdom
Royal Liverpool and Broadgreen University Hospital
Liverpool, Merseyside, United Kingdom, L7 8XP
Sponsors and Collaborators
Liverpool John Moores University
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Investigators
Principal Investigator: Richard J Webb, BA Liverpool John Moores University

Responsible Party: Mr Richard Webb, Postgraduate Research Student, Liverpool John Moores University
ClinicalTrials.gov Identifier: NCT02258932     History of Changes
Other Study ID Numbers: 13/NW/0122-1
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: July 2015

Keywords provided by Mr Richard Webb, Liverpool John Moores University:
Type 1 diabetes
CSII
Continuous subcutaneous insulin infusion
Insulin pump
Nutrition
Eating behaviours
Quality of life
Cardiometabolic risks
Liverpool
NHS
Metabolomics
Observational
Lipoproteins
Lipids
Food
Food diary
Longitudinal

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs