CSII in Type 1 Diabetes: Diet, Quality of Life & Cardiometabolic Risks - A Cross-Sectional Study
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|ClinicalTrials.gov Identifier: NCT02258945|
Recruitment Status : Completed
First Posted : October 8, 2014
Last Update Posted : February 19, 2016
|Condition or disease|
|Type 1 Diabetes|
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|
|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|
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.
- 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.
- 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.
- 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
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
|Royal Liverpool and Broadgreen University Hospital|
|Liverpool, Merseyside, United Kingdom, L7 8XP|
|Principal Investigator:||Richard J Webb, BA||Liverpool John Moores University|