Type 1 DiabetesNCT02258945
CSII in Type 1 Diabetes: Diet, Quality of Life & Cardiometabolic Risks - A Cross-Sectional Study
An observational study of Type 1 Diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Aug 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from the Diabetes Centre from the Royal Liverpool and Broadgreen Hospital.
Who may be able to join
- 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.
Who cannot join
- Patients must not live outside of Liverpool and the surrounding areas.
- Patients must not be aged under 18
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool and Broadgreen University Hospital
Liverpool, Merseyside, L7 8XP
About this study
Official title: Eating Behaviours, Quality of Life and Cardiometabolic Risks in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion Therapy - A Cross-Sectional Study
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.
Read the 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 investigatory literature is sparse. This study will clarify whether adult CSII patients experience eating behaviour and quality of life alterations compared to patients using multiple daily injection (MDI) therapy. This is important as differences may be associated with cardiometabolic risk variations; which will also be investigated.
Participants will be a combination of adults with Type-1 diabetes invited from diabetes clinics at the Royal Liverpool University Hospital who are a) have been using CSII for over 1 year or b) have Type 1 diabetes but have never used CSII, have no current plans to use CSII and are presently using MDI therapy.
Following ethical consent participants will be asked to complete one food frequency questionnaire (FFQ) and one quality of life (QOL) questionnaire. A subgroup of these participants (approximately 10 CSII users and 10 MDI users) will then be asked to take part in one interview to investigate quality of life and complete a food diary to explore eating behaviours. All participants consenting to the cross-sectional arm of the study will also be asked to provide an extra volume of blood for analysis. 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. (Please be aware that the interview, food diary and blood sample are all optional and that the minimum requirement for participation in the study is the completion of the FFQ and the QOL questionnaires). Results will be compared with existing patient medical records, which will also be analysed during the study.
- 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, Cross-Sectional
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 Months
Secondary outcomes (2)
Quality of life of adults with Type 1 diabetes who are using insulin pump therapy.
Quality of life will be assessed at one time point only (due to the nature of the cross-sectional study design) using a combination of semi-structured interviews and quality of life questionnaires.
Measured: 0 Months
Cardiometabolic risks of adult patients with Type 1 diabetes who are using insulin pump 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. Data will be collected at one time point only (due to the nature of the cross-sectional study design).
Measured: 0 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Mr Richard Webb, Liverpool John Moores University
- Investigators
- Richard J Webb, BA, Principal investigator, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258945
- Sponsor's protocol ID
- 13/NW/0122-2
- Status last verified
- Apr 2015
- First submitted
- 3 Oct 2014
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Behaviours, Quality of Life and Cardiometabolic Risks in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion Therapy - A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT02258945
- Acronym / sponsor ID
- 13/NW/0122-2
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, CSII, Continuous subcutaneous insulin infusion, Insulin pump, Nutrition, Eating behaviours, Quality of life, Cardiometabolic risks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 investigatory literature is sparse. This study will clarify whether adult CSII patients experience eating behaviour and quality of life alterations compared to patients using multiple daily injection (MDI) therapy. This is important as differences may be associated with cardiometabolic risk variations; which will also be investigated.
Participants will be a combination of adults with Type-1 diabetes invited from diabetes clinics at the Royal Liverpool University Hospital who are a) have been using CSII for over 1 year or b) have Type 1 diabetes but have never used CSII, have no current plans to use CSII and are presently using MDI therapy.
Following ethical consent participants will be asked to complete one food frequency questionnaire (FFQ) and one quality of life (QOL) questionnaire. A subgroup of these participants (approximately 10 CSII users and 10 MDI users) will then be asked to take part in one interview to investigate quality of life and complete a food diary to explore eating behaviours. All participants consenting to the cross-sectional arm of the study will also be asked to provide an extra volume of blood for analysis. 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. (Please be aware that the interview, food diary and blood sample are all optional and that the minimum requirement for participation in the study is the completion of the FFQ and the QOL questionnaires). Results will be compared with existing patient medical records, which will also be analysed during the study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from the Diabetes Centre from the Royal Liverpool and Broadgreen Hospital.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients must not live outside of Liverpool and the surrounding areas.
- Patients must not be aged under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eating behaviours of adult patients with Type 1 diabetes using continuous subcutaneous insulin infusion therapy measured using food diaries and food surveys.
Time frame: 0 Months
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.
2 secondary outcomes
Quality of life of adults with Type 1 diabetes who are using insulin pump therapy.
Time frame: 0 Months
Cardiometabolic risks of adult patients with Type 1 diabetes who are using insulin pump therapy.
Time frame: 0 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J Webb, BA principal investigator
Liverpool John Moores University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating behaviours of adult patients with Type 1 diabetes using continuous subcutaneous insulin infusion therapy measured using food diaries and food surveys. (time frame: 0 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.