CSII in Type 1 Diabetes: Diet, Quality of Life & Cardiometabolic Risks - A Longitudinal Study

NCT ID: NCT02258932

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-10-31

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.

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Continuous subcutaneous insulin infusion

This group will consist of patients with Type 1 diabetes commencing continuous subcutaneous insulin infusion therapy.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Liverpool John Moores University

OTHER

Sponsor Role: lead

Responsible Party

Mr Richard Webb

Postgraduate Research Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard J Webb, BA

Role: PRINCIPAL_INVESTIGATOR

Liverpool John Moores University

Locations

Royal Liverpool and Broadgreen University Hospital

Liverpool, Merseyside, United Kingdom

Countries

United Kingdom

Other Identifiers

13/NW/0122-1

Identifier Type: -

Identifier Source: org_study_id