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
|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 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|
|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|
Continuous subcutaneous insulin infusion
This group will consist of patients with Type 1 diabetes commencing continuous subcutaneous insulin infusion 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: 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.
- 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.
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): NCT02258932
|Royal Liverpool and Broadgreen University Hospital|
|Liverpool, Merseyside, United Kingdom, L7 8XP|
|Principal Investigator:||Richard J Webb, BA||Liverpool John Moores University|