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Trial registered on ANZCTR


Registration number
ACTRN12611000142932
Ethics application status
Not yet submitted
Date submitted
7/02/2011
Date registered
8/02/2011
Date last updated
8/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrated blood glucose monitoring with insulin pumps versus standard method - a randomised crossover trial
Scientific title
The impact on blood glucose measurement and metabolic control of an integrated blood glucose monitoring system with insulin pumps versus the standard manual system in children/adolescents with type 1 diabetes mellitus
Secondary ID [1] 253561 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes mellitus 261121 0
Condition category
Condition code
Metabolic and Endocrine 259269 259269 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257993 0
Treatment: Devices
Comparator / control treatment
Standard meters involve titrating insulin requirement to glucose measurements manually inputted into the pump memory. As above, participants use their pump for continual insulin infusion, mimicking physiological insulin delivery as much as possible. During the course of the trial, participants would be randomise to using their own insulin pump as the control for either the first or second six-month phase.
Control group
Active

Outcomes
Primary outcome [1] 262087 0
Mean Number of finger-prick blood glucose measurements entered into and recorded in participants' pump
Timepoint [1] 262087 0
6 months and 12 months (after each phase of trial)
Secondary outcome [1] 273128 0
Metabolic control as measured by HbA1c
Timepoint [1] 273128 0
3, 6, 9 and 12 months
Secondary outcome [2] 273129 0
User device satisfaction as measured by the Insulin Delivery System Rating Questionnaire (IDSRQ)
Timepoint [2] 273129 0
6 and 12 months
Secondary outcome [3] 273130 0
Information available to download from pump:
-total daily insulin dose
-number of boluses and percentage of dose given as a correction factor
-number of carbohydrate entries
-blood glucose variability
-% of insulin delivered as basal versus bolus
-% of blood glucose measurements within target range
Timepoint [3] 273130 0
3, 6, 9 and 12 months
Also assessed at 6 weeks after starting a new phase for assessment of novelty or carryover effect
Secondary outcome [4] 273131 0
Frequency of participants' contacts with the support team
Timepoint [4] 273131 0
6 and 12 months

Eligibility
Key inclusion criteria
Users due a pump upgrade within next 13 to 24 months
Minimum age
No limit
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pumps have a four-year duration of warranty, hence youth are automatically entitled to a pump upgrade after 4 years use. All youth due an upgrade in the next 13-24 months will be contacted by post, with telephone follow-up, for inclusion in the trial. Those who choose to participate will then be randomised to continued use of their own standard pump and BGL monitoring (arm A), or to use of the automated integrated pump and BGL monitoring device (arm B) for the first six months (1st phase). The study groups will cross-over after 6 months. The figure of 13 months prior to end of warranty is used as a starting point for recruitment to ensure that participants crossing back to their own pump in the second phase do not run out of warranty.
Individuals will be offered an opportunity to participate by post in the first instance, with telephone follow-up 3-4 weeks later, using contact details from the hospital system/medical records. Interested individuals can register their interest by returning the invitation by post, or by contacting the principal investigator directly by phone.
Participants will be randomly assigned to use of the integrated pump or to remain on their own pump, in the first phase.
A statistician not directly involved in the analysis of the study results will prepare the randomisation schedule using randomised block randomisation to maintain balance between treatment arms and ensure allocation concealment. This shall be done using sealed envelopes which shall be selected sequentially as participants are recruited by the principal investigator. By its nature, this trial cannot be blinded except to the analysing statistician. Data will be recorded and described in accordance with the CONSORT guidelines on randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258451 0
Hospital
Name [1] 258451 0
Royal Children's Hospital
Address [1] 258451 0
Flemington Rd
Parkville
VIC 3052
Country [1] 258451 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children's Research Institute
Address
Flemington Road
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 257595 0
None
Name [1] 257595 0
Address [1] 257595 0
Country [1] 257595 0
Other collaborator category [1] 251808 0
Commercial sector/Industry
Name [1] 251808 0
Roche Australia Pty Ltd
Address [1] 251808 0
Diabetes Care
Building E, Level 1
24-32 Lexington Drive
Bella Vista
NSW 2153
Country [1] 251808 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260433 0
HREC, Royal Children's Hospital
Ethics committee address [1] 260433 0
Flemington Road
Parkville
VIC 3052
Ethics committee country [1] 260433 0
Australia
Date submitted for ethics approval [1] 260433 0
07/02/2011
Approval date [1] 260433 0
Ethics approval number [1] 260433 0
Ethics committee name [2] 260434 0
Ethics committee address [2] 260434 0
Ethics committee country [2] 260434 0
Date submitted for ethics approval [2] 260434 0
07/02/2011
Approval date [2] 260434 0
Ethics approval number [2] 260434 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32184 0
Address 32184 0
Country 32184 0
Phone 32184 0
Fax 32184 0
Email 32184 0
Contact person for public queries
Name 15431 0
Dr Orla Neylon
Address 15431 0
c/o Dept of Endocrinology & Diabetes
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 15431 0
Australia
Phone 15431 0
+61 3 9345 5951
Fax 15431 0
Email 15431 0
orla.neylon@rch.org.au
Contact person for scientific queries
Name 6359 0
Dr Orla Neylon
Address 6359 0
c/o Dept of Endocrinology & Diabetes
Royal Children's Hospital
Flemington Road
Parkville
VIC 3052
Country 6359 0
Australia
Phone 6359 0
+61 3 9345 5951
Fax 6359 0
Email 6359 0
orla.neylon@rch.org.au

No information has been provided regarding IPD availability
Summary results
No Results