None listed
Conditions
Brief summary
Good control of diabetes is essential to reduce the risk of developing diabetes-associated complications such as blindness, amputations or kidney failure. Intensive management of diabetes ensures better control and this is pursued in our population by multiple daily injections, or use of an insulin pump (~30% of population). Insulin pumps better mimic natural insulin delivery, being infused on a constant basis at varying adjustable rates throughout the day. Extra insulin is bolused for meals, or if blood glucose recordings are above target range. Good control on a pump is directly related to the number of blood glucose readings tested so insulin can be titrated to requirement. These glucose readings are optimally used when inputted into the pump, a step which must be done manually by the user. This is suboptimal in our population relative to international data, recently established as a mean of 3.1 readings per day versus 4.8 per day in other centres. A novel blood glucose meter has been developed which automatically inputs the measurement into the pump via bluetooth shortly after it is taken. This device is TGA approved for use in the paediatric population and widely used in Europe. We wish to examine whether or not it significantly increases the number of blood glucose measurements in a patient’s pump and if this has an overall effect on diabetes control, as measured by HbA1c. We aim to randomise 50 users to either using their own regular insulin pump, or the new integrated pump system for the first six months. After the first six months, participants will 'crossover' i.e. people using their own pump will then have the opportunity to use the new pump for six months and those who had the new pump would revert back to using their own pump. We intend to examine the effects of the different pumps, if any, on the number of blood glucose tests recorded and on overall metabolic control.
Interventions
Insulin pumps have been used since the 70s and involve infusion of short-acting insulin from a reservoir in the pump into the subcutaneous tissue via a ‘giving set’ at preselected programmed rates.This delivers a continuous basal rate of small amounts of rapid-acting insulin throughout the 24 hour period, with larger user-activated ‘bolus’ doses at meal or snack times. The basal rate can be programmed to change at various intervals throughout the day, which is particularly useful in regulating
Insulin pumps have been used since the 70s and involve infusion of short-acting insulin from a reservoir in the pump into the subcutaneous tissue via a ‘giving set’ at preselected programmed rates.This delivers a continuous basal rate of small amounts of rapid-acting insulin throughout the 24 hour period, with larger user-activated ‘bolus’ doses at meal or snack times. The basal rate can be programmed to change at various intervals throughout the day, which is particularly useful in regulating overnight blood glucose levels. Bolus doses are given before meals based on self monitored blood glucose level, carbohydrate content of the meal and anticipated exercise after the meal. Further ‘correctional’ bolus doses can be given at any time if the random blood glucose is higher than the target range and there is a need for additional insulin. All activity is recorded in the pump device which can then be downloaded to a computer to demonstrate a log-book view of various different parameters e.g. time and values of self-monitored blood glucose (SMBG), time and amount of carbohydrate consumed and amount of insulin delivered. This allows for critical analysis of glucose control and enables identification of areas for adjustment to improve control. A novel blood glucose meter has been developed which automatically inputs the recorded BGL measurement into a compatible insulin pump via bluetooth shortly after it is taken. It is recommended that pump users check their blood glucose several times a day to enable insulin titration to requirement. The number of glucose values inputted in the pump device has been shown to correlate with an improvement in diabetes control. The primary outcome is therefore the mean number of glucose readings over a six month period. This trial is planned to comprise two phases, each lasting six months. Participants will be randomised to using either their own pump or the new integrated pump for the first six months. At the end of the first phase, participants will have a clinic appointment where they will be assigned to the second phase. Where they were randomised to using their own pump, they will be introduced to the integrated pump and vice versa, where they started on the integrated device, it will be taken back, stored and they will use their own pump as the standard pump for the second phase. After 12 months, the participant's duration in the trial is complete and they progress to pump upgrade, as is normal practice. They may upgrade to the integrated pump, or another pump of their choosing.
Sponsors
Murdoch Children's Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No
Inclusion criteria
Users due a pump upgrade within next 13 to 24 months
Exclusion criteria
1) Have previously experienced significant skin reactions to pump giving sets, or other reactions which may mean that changing to a different pump may result in similar reaction and/or study withdrawal 2) Non-English speaking users
Outcome results
None listed