- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02258945
CSII in Type 1 Diabetes: Diet, Quality of Life & Cardiometabolic Risks - A Cross-Sectional Study
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 Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Merseyside
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Liverpool, Merseyside, United Kingdom, L7 8XP
- Royal Liverpool and Broadgreen University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Continuous Subcutaneous Insulin Infusion
This group will consist of patients with Type 1 diabetes using continuous subcutaneous insulin infusion therapy.
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Multiple Daily Injections
This group will consist of patients with Type 1 diabetes using multiple daily injection therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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0 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life of adults with Type 1 diabetes who are using insulin pump therapy.
Time Frame: 0 Months
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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.
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0 Months
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Cardiometabolic risks of adult patients with Type 1 diabetes who are using insulin pump therapy.
Time Frame: 0 Months
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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).
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0 Months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard J Webb, BA, Liverpool John Moores University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/NW/0122-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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