Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-28 @ 2:07 AM
Study NCT ID:
NCT02258932
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2014-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CSII in Type 1 Diabetes: Diet, Quality of Life & Cardiometabolic Risks - A Longitudinal Study
Sponsor:
Liverpool John Moores University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: