Clinical trial NCT02258932: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
CSII
Continuous subcutaneous insulin infusion
Insulin pump
Nutrition
Eating behaviours
Quality of life
Cardiometabolic risks
Liverpool
NHS
Metabolomics
Observational
Lipoproteins
Lipids
Food
Food diary
Longitudinal
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Liverpool University Hospitals NHS Foundation Trust
First posted: 2014-10-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from the Diabetes Centre from the Royal Liverpool and Broadgreen Hospital.

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.

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

Primary outcomes:
measure: Eating behaviours of adult patients with Type 1 diabetes using continuous subcutaneous insulin infusion therapy measured using food diaries and food surveys.
timeFrame: 12 months after commencement of the therapy.
Secondary outcomes:
measure: Quality of life of adults with Type 1 diabetes who are using insulin pump therapy.
timeFrame: 12 months after commencement of the therapy
measure: Cardiometabolic risks of adult patients with Type 1 diabetes who are using insulin pump therapy.
timeFrame: 12 months after commencement of the therapy
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen University Hospital
state: Merseyside
Study officials:
affiliation: Liverpool John Moores University
name: Richard J Webb, BA
role: PRINCIPAL_INVESTIGATOR
References: