Plain English Summary
Background and study aims
Type 1 diabetes is a lifelong condition that occurs when the pancreas doesn't produce any insulin, the hormone that controls the amount of glucose (sugar) in the blood. This causes a person's blood glucose level to become too high. About 24,000 children and young people living in the UK have type 1 diabetes. Treatment requires adherence to a daily routine of multiple insulin injections and blood glucose tests. The effect of unplanned food, exercise, stress and illness on blood glucose levels also has to be anticipated and accommodated in the daily treatment plan. This routine and the symptoms of uncontrolled high or low blood glucose levels can adversely impact the quality of life of affected children and young people. In the longer term complications such as kidney failure, diseases of the heart and nervous system, sight loss and amputations also affect quality of life and reduce life expectancy by 20 years. Good blood glucose control and intensive insulin treatments minimise the risk of developing these complications. Blood glucose control is assessed from a blood test that measures glycosylated haemoglobin (HbA1c). There are two forms of intensive treatment: administration of insulin by multiple daily injections or using a pump. Pump therapy is 6 times more expensive than multiple daily injections. If HbA1c or quality of life is better during pump therapy this may be a good investment for the NHS. However, if pump therapy is no better than multiple daily injections, investment in diabetes care may be better directed elsewhere. This study aims to compare the outcomes of patients treated with multiple daily injections to those using pumps one and five years after diagnosis of type 1 diabetes.
Who can participate?
Children and young people (age 6 months to 15 years) with type 1 diabetes
What does the study involve?
Participants are randomly allocated to receive insulin either by multiple daily injections or pumps. All patients are educated to match insulin dose to carbohydrate intake, exercise and blood glucose readings. Patients receiving pumps are educated in their use. Patients are telephoned daily for 1 week, weekly for 1 month and monthly thereafter. Patients also have access to telephone advice. All contacts are logged. The following measurements are made at the start of the study and every 3 months for 1 year: HbA1c, body mass index, height, insulin dose and adverse events (uncontrolled high or low blood glucose levels). Quality of life is assessed at the start of the study and after 6 and 12 months using questionnaires. HbA1c is compared between the two groups at 1 year.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Alder Hey Children's NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2011 to June 2014
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
Dr Joanne Blair
Jo.Blair@alderhey.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Joanne Blair
ORCID ID
Contact details
Alder Hey Children's NHS Foundation Trust
Paediatric Diabetes & Endocrinology
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 252 5281
Jo.Blair@alderhey.nhs.uk
Additional identifiers
EudraCT number
2010-023792-25
ClinicalTrials.gov number
Protocol/serial number
HTA 08/14/39
Study information
Scientific title
A randomised controlled trial of continuous subcutaneous insulin infusion (CSII) compared to multiple daily injection (MDI) regimens in children and young people at diagnosis of type I diabetes mellitus (TIDM)
Acronym
SCIPI
Study hypothesis
This study is designed to provide an evidence base to inform future NHS investment in health care services for children and young people with TIDM. The role of intensive insulin therapy in optimizing glycaemic control and thereby reducing the risk of vascular complications of TIDM is unquestioned, however the optimal way in which to achieve this and the cost effectiveness of the tools currently available is unknown. This study will compare two methods of insulin delivery during childhood and adolescence to identify which facilitates superior glycaemic control, and examine the impact of treatment modalities on other predictors of vascular complications of TIDM, adverse events and quality of life (QoL).
More details can be found at http://www.nets.nihr.ac.uk/projects/hta/081439
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0005/52385/PRO-08-14-39.pdf
Ethics approval
Pending at time of registration
Study design
Open labelled two-arm randomised controlled trial with an inbuilt pilot
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not yet available in web format, please use contact details below to request a patient information sheet .
Condition
Children with Type 1 Diabetes Mellitus
Intervention
Participants will be randomised in a 1:1 ratio to either of the two treatments
1. Arm A (Multiple Dose Injection of Insulin (MDI) treatment): Insulin aspart and insulin glargine will be delivered subcutaneously using an insulin pen injection device
2. Arm B (Continuous Subcutaneous Insulin Infusion (CSII) treatment): Insulin aspart will be administered using CSII insulin pumps
The total duration for both the treatment arms is 1 year including and participants will be followed for the duration of the intervention.
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
Pilot study
Fifty percent or more subjects who are eligible and are invited to participate in the pilot study are successfully recruited.
Full study
Glycaemic control (HbA1c) 12 months after diagnosis
Secondary outcome measures
Pilot study
Demographic characteristics like age, gender and deprivation score are not significantly different in the group of subjects who are recruited compared to those who decline. These characteristics will be measured at the end of the pilot phase (at 6 months) before open the trial for full study.
Full study
1. Percentage of patients in each group with HbA1c <7.5%, measured at baseline, 3, 6, 9 and 12 months
2. Prevalence of adverse events (including severe hypoglycaemia) at 3, 6, 9 and 12 months
3. Change in Body Mass Index Standard Deviation Score (BMI SDS) at 3, 6, 9 and 12 months
4. Insulin requirements (units / kg /day) at 3, 6, 9 and 12 months
5. Quality of Life (QoL) assessed by PedsQL questionnaire at baseline, 6 and 12 months
6. Incremental cost per Quality-Adjusted Life-Year (QALY) gained at 12 months
Overall trial start date
03/01/2011
Overall trial end date
30/06/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Newly diagnosed TIDM using standard diagnostic practise (WHO Definition 2006)
2. Age 6 months - 15 years (inclusive)
3. Willing to give consent for the study
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
316
Participant exclusion criteria
1. Treated previously for diabetes
2. Haemoglobinopathy
3. Co-existing pathology conditions likely to affect glycaemic control, e.g. cystic fibrosis
4. Psychological or psychiatric disorders, e.g. eating disorder
5. Receipt of medication likely to affect glycaemic control, e.g. systemic or high dose topical corticosteroid or growth hormone therapy
6. Allergy to a component of insulin aspart or insulin glargine
7. Patient who have a first degree relative with existing TIDM
Patients previously diagnosed with coeliac disease or thyroid dysfunction will be eligible to join the study if they have maintained a gluten-free diet/been maintained in a euthyroid state for 3 months prior to the diagnosis of TIDM.
Recruitment start date
03/01/2011
Recruitment end date
30/06/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Alder Hey Children's NHS Foundation Trust
Liverpool
L12 2AP
United Kingdom
Sponsor information
Organisation
Alder Hey Children's NHS Foundation Trust (UK)
Sponsor details
c/o Dot Lambert
Mulberry House
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 2525673
dot.lambert@alderhey.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/02/2017
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25873144