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Trial record 9 of 456 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

Tracking Information
First Submitted Date October 3, 2014
First Posted Date October 8, 2014
Last Update Posted Date February 19, 2016
Study Start Date December 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 3, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02258932 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 3, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CSII in Type 1 Diabetes: Diet, Quality of Life & Cardiometabolic Risks - A Longitudinal Study
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
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.
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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Retention:   Samples Without DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Patients will be selected from the Diabetes Centre from the Royal Liverpool and Broadgreen Hospital.
Condition Type 1 Diabetes
Intervention Not Provided
Study Groups/Cohorts Continuous subcutaneous insulin infusion
This group will consist of patients with Type 1 diabetes commencing continuous subcutaneous insulin infusion therapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 18, 2016)
5
Original Estimated Enrollment
 (submitted: October 3, 2014)
25
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02258932
Other Study ID Numbers 13/NW/0122-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mr Richard Webb, Liverpool John Moores University
Study Sponsor Liverpool John Moores University
Collaborators Royal Liverpool and Broadgreen University Hospitals NHS Trust
Investigators
Principal Investigator: Richard J Webb, BA Liverpool John Moores University
PRS Account Liverpool John Moores University
Verification Date July 2015