None listed
Conditions
Brief summary
Type 1 diabetes is one of the most common life-long diseases in childhood. Management is intensive with frequent blood glucose management, insulin administration and monitoring of food intake and exercise and can affect most aspects of the life of the child. Insulin can be administered by multiple injections per day or with insulin pumps. There is growing evidence for improved glycaemic control by using insulin pumps. However, the optimal time to commence pump therapy is yet to be elucidated. Results of studies of pumps at diagnosis are conflicting and complicated by the inclusion of studies with pump therapy commencing at any time in the first year since diagnosis. This randomised controlled study intends to determine the optimal time to commence insulin pump therapy for type 1 diabetes in children. Children over 5 years will be randomised to either commence their pump within days of diagnosis compared to 3 months. The outcomes of interest will be whether an early pump start will result in improved diabetes control and preserve the function of the pancreatic beta cells. Secondary outcomes will include determining the effect on quality of life for the child and their parents and determining whether this approach is cost-effective.
Interventions
Insulin pump commencement at diagnosis. This will be prescribed by a paediatric endocrinologist, and education provided by a credentialed diabetes educator and paediatric dietitian. They will commence during the first admission for diabetes (within 7 days of diabetes diagnosis) and continue for 12 months. They will be reviewed by daily phone calls for the first week, weekly outpatient education for 1 months then 3 monthly outpatient clinic visits.
There are many different pumps available, and th
Insulin pump commencement at diagnosis. This will be prescribed by a paediatric endocrinologist, and education provided by a credentialed diabetes educator and paediatric dietitian. They will commence during the first admission for diabetes (within 7 days of diabetes diagnosis) and continue for 12 months. They will be reviewed by daily phone calls for the first week, weekly outpatient education for 1 months then 3 monthly outpatient clinic visits. There are many different pumps available, and the families can choose whichever pump is most suitable for them based on information provided by their endocrinologist and diabetes educator.
Sponsors
Dr Stephanie Johnson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
newly diagnosed T1DM age 5-15.9 years parent/guardian willing to provide consent ability to access insulin pump through private health or JDRF funding
Exclusion criteria
If the participant or carer has a diminished understanding or comprehension
Outcome results
None listed