ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 2857 for:    Type 1 Diabetes

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02258945
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 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.


Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
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
Study Start Date : April 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin
U.S. FDA Resources

Group/Cohort
Continuous Subcutaneous Insulin Infusion
This group will consist of patients with Type 1 diabetes using continuous subcutaneous insulin infusion therapy.
Multiple Daily Injections
This group will consist of patients with Type 1 diabetes using multiple daily injection 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: 0 Months ]
    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.


Secondary Outcome Measures :
  1. Quality of life of adults with Type 1 diabetes who are using insulin pump therapy. [ Time Frame: 0 Months ]
    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.

  2. Cardiometabolic risks of adult patients with Type 1 diabetes who are using insulin pump therapy. [ Time Frame: 0 Months ]
    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).


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   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.
  • Patients who have been using either continuous subcutaneous insulin infusion or multiple daily injections for over a year.

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): NCT02258945


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: NCT02258945     History of Changes
Other Study ID Numbers: 13/NW/0122-2
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: April 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
Cross-Sectional

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