NCT02258945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 19, 2016

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

October 3, 2014

Last Update Submit

February 18, 2016

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesCSIIContinuous subcutaneous insulin infusionInsulin pumpNutritionEating behavioursQuality of lifeCardiometabolic risksLiverpoolNHSMetabolomicsObservationalLipoproteinsLipidsFoodFood diaryCross-Sectional

Outcome Measures

Primary Outcomes (1)

  • Eating behaviours of adult patients with Type 1 diabetes using continuous subcutaneous insulin infusion therapy measured using food diaries and food surveys.

    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.

    0 Months

Secondary Outcomes (2)

  • Quality of life of adults with Type 1 diabetes who are using insulin pump therapy.

    0 Months

  • Cardiometabolic risks of adult patients with Type 1 diabetes who are using insulin pump therapy.

    0 Months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be selected from the Diabetes Centre from the Royal Liverpool and Broadgreen Hospital.

You may qualify if:

  • 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.
  • Patients who have been using either continuous subcutaneous insulin infusion or multiple daily injections for over a year.

You may not qualify if:

  • Patients must not live outside of Liverpool and the surrounding areas.
  • Patients must not be aged under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Liverpool and Broadgreen University Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma will be retained for use by the research team during the study. After the study remaining samples will be destroyed in accordance with the Human Tissue Authority Code of Practice.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Richard J Webb, BA

    Liverpool John Moores University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Research Student

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 8, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2015

Study Completion

August 1, 2015

Last Updated

February 19, 2016

Record last verified: 2015-04

Locations

GB(1)