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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614001330639
Ethics application status
Approved
Date submitted
24/11/2014
Date registered
18/12/2014
Date last updated
18/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
PumpTune computer recommended insulin pump settings compared to Doctor advised settings in children with Type 1 Diabetes: A randomised controlled trial
Scientific title
A randomised cross-over trial in children with Type 1 Diabetes to compare insulin pump settings set by PumpTune computerised algorithm to Doctor advised settings
Secondary ID [1] 285729 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 293614 0
Condition category
Condition code
Metabolic and Endocrine 293901 293901 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children have the settings controlling their insulin infusion pumps adjusted by a credentially diabetes educator using recommendations from PumpTune computer algorithm once and then are monitored with continuous glucose monitoring for a further six days. There was no washout period separating these six days from the comparison period.
Intervention code [1] 290683 0
Treatment: Devices
Comparator / control treatment
Children have the settings controlling their insulin infusion pumps adjusted once by a diabetes nurse educator using recommendations from a paediatric diabetes specialist doctor and then monitored with continuous glucose monitoring for 6 days.
Control group
Active

Outcomes
Primary outcome [1] 293674 0
percentage of time sensor glucose levels remain within range 3.9-10.0mmol/L as assessed by analysis of data exported from continous glucose sensor.
Timepoint [1] 293674 0
over 6 days observation
Secondary outcome [1] 311563 0
percentage time sensor glucose levels remain >=10mmo//L as assessed by analysis of data exported from continous glucose sensor.
Timepoint [1] 311563 0
over 6 days observation
Secondary outcome [2] 311564 0
percentage time sensor glucose levels remain <=3.9mmo//L as assessed by analysis of data exported from continous glucose sensor.
Timepoint [2] 311564 0
over 6 days observation
Secondary outcome [3] 311565 0
Number of times sensor glucose levels fall below 2.75mmol/L as assessed by analysis of data exported from continous glucose sensor.
Timepoint [3] 311565 0
over 6 days observation

Eligibility
Key inclusion criteria
HbA1c in range 6.5-9.5%
Diabetes was diagnosed at least 12 months previously
Performing >=4 finger prick blood glucose levels each day
Delivering at least six bolus doses of insulin each day
Minimum age
0 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not able to attend John Hunter Hospital for three consecutive weeks to have sensors inserted and pumps adjusted

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)
In this cross over trial the order the interventions were applied was randomised. An independant person used a randomisation table to allocate the order. Each set of pump adjustment instructions was placed into a sealed opaque envelope. The number 1 was written on the outside of the instructions to be used first and number 2 for those to be used second. The diabetes educator who entered the adjustments into the pumps was blinded as to the origin of the instructions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randmisation table based on permuted blocks was generated by a statistician using software package Stata v 13.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
The order the interventions were applied was randomised
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
NSW
Recruitment hospital [1] 3206 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 8986 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 290304 0
Charities/Societies/Foundations
Name [1] 290304 0
Hunter Medical Research Foundation
Address [1] 290304 0
1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country [1] 290304 0
Australia
Primary sponsor type
Individual
Name
Dr Donald Anderson
Address
Paediatric Endocrinology
John HUnter Children's Hospital
Locked Bag #1
Hunter Mail Centre NSW 2310
Country
Australia
Secondary sponsor category [1] 289015 0
Hospital
Name [1] 289015 0
John Hunter Children's Hospital
Address [1] 289015 0
Locked Bag #1
Hunter Mail Centre
NSW 2310
Country [1] 289015 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292010 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 292010 0
Locked Bag #1, Hunter Mail Centre, NSW 2310
Ethics committee country [1] 292010 0
Australia
Date submitted for ethics approval [1] 292010 0
Approval date [1] 292010 0
08/12/2011
Ethics approval number [1] 292010 0
11/11/16/4.02

Summary
Brief summary
Information from continuous glucose sensors is complicated. Insulin pumps can be set in many ways and the settings are complicated and may vary depending of the person making the changes. This study compares the results after insulin pumps are adjusted by a doctor or by a computer program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53038 0
Dr Donald G Anderson
Address 53038 0
Paediatric Endocrinology
John Hunter Children's Hospital
Locked Bag #1, Hunter Mail Centre, NSW 2310
Country 53038 0
Australia
Phone 53038 0
61249855634
Fax 53038 0
61249213599
Email 53038 0
donald.anderson@hnehealth.nsw.gov.au
Contact person for public queries
Name 53039 0
Dr Donald G Anderson
Address 53039 0
Paediatric Endocrinology
John Hunter Children's Hospital
Locked Bag #1, Hunter Mail Centre, NSW 2310
Country 53039 0
Australia
Phone 53039 0
61249855634
Fax 53039 0
61249213599
Email 53039 0
donald.anderson@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 53040 0
Dr Donald G Anderson
Address 53040 0
Paediatric Endocrinology
John Hunter Children's Hospital
Locked Bag #1, Hunter Mail Centre, NSW 2310
Country 53040 0
Australia
Phone 53040 0
61249855634
Fax 53040 0
61249213599
Email 53040 0
donald.anderson@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary