Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000500752p
Ethics application status
Submitted, not yet approved
Date submitted
27/02/2022
Date registered
29/03/2022
Date last updated
16/03/2023
Date data sharing statement initially provided
29/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Insulin Pumps at Diagnosis (IPAD) in children study
Scientific title
Randomised controlled trial of insulin pumps of the effectiveness of insulin pumps in children diagnosed with Type 1 diabetes
Secondary ID [1] 306549 0
none
Universal Trial Number (UTN)
Trial acronym
IPAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 325441 0
Condition category
Condition code
Metabolic and Endocrine 322822 322822 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322974 0
Treatment: Other
Intervention code [2] 323114 0
Treatment: Devices
Comparator / control treatment
The control group will commence an insulin pump as an outpatient at 3 months post diagnosis
This will be prescribed by a paediatric endocrinologist, and education provided by a credentialed diabetes educator and paediatric dietitian. They will commence as an outpatient and be followed until 12 months post diagnosis. After commencing the pump they will be reviewed by daily phone calls for the first week and as required thereafter in addition to standard 3 monthly outpatient visits
Control group
Active

Outcomes
Primary outcome [1] 330605 0
metabolic control as assessed by HbA1c
Timepoint [1] 330605 0
12 months post diagnosis of diabetes
Primary outcome [2] 330606 0
Time in range from continuous glucose monitor download
Timepoint [2] 330606 0
12 months after diagnosis of diabetes
Secondary outcome [1] 406924 0
incremental cost effectiveness ratio as determined by EQ-ED-Y, questionnaire of parental expenses (designed specifically for this study) and staff report of patient contact
Timepoint [1] 406924 0
12 months after diabetes diagnosis
Secondary outcome [2] 406925 0
quality of life as determined by ED-5D-Y
Timepoint [2] 406925 0
12 months after diabetes diagnosis
Secondary outcome [3] 408045 0
diabetes-specific quality of life as determined by Peds Qol - diabetes module
Timepoint [3] 408045 0
12 months after diabetes diagnosis

Eligibility
Key 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
Minimum age
5 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If the participant or carer has a diminished understanding or comprehension

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
• The study will recruit 80 participants over 24 months and continue to follow them for 1 year
• QCH current has 120 newly diagnosed children per year
– 60% of whom commence insulin pump therapy within the first year (and is increasing every year)
– Based on 50% participation rate we may expect approx. 40 participants per year
• A sample size of 80 final participants is calculated based on
– a clinically significant difference in HbA1c of 0.5% (recognised as a threshold used by IS FDA and pharmaceutical industry to determine effectiveness)
– SD of 0.8 (based on HbA1c data from 2018-2019) and
– a power of 80%

T-tests will be used to compare normally distributed measures, including the primary outcomes (CGM time in range, HbA1c and estimated C-peptide). Where outcomes are non-normally distributed, Mann-Whitney-Wilcoxon U tests will be used to compare groups. To analyse counts of events, Poisson or negative binomial regression (in the case of overdispersion) will be used. The project team is highly skilled in the management of T1D and the use and interpretation of CGM data, both in clinical and research contexts .

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2023
Actual
Date of last participant enrolment
Anticipated
20/03/2025
Actual
Date of last data collection
Anticipated
20/03/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21847 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 36904 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 310884 0
Charities/Societies/Foundations
Name [1] 310884 0
Children's Hospital Foundation
Country [1] 310884 0
Australia
Primary sponsor type
Individual
Name
Dr Stephanie Johnson
Address
Department of Endocrinology
Queensland Children's Hospital
501 Stanley St
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 312159 0
None
Name [1] 312159 0
Address [1] 312159 0
Country [1] 312159 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310444 0
Children's Health Queensland Hospital and Health Service HREC
Ethics committee address [1] 310444 0
Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 310444 0
Australia
Date submitted for ethics approval [1] 310444 0
28/02/2022
Approval date [1] 310444 0
Ethics approval number [1] 310444 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117690 0
Dr Stephanie Johnson
Address 117690 0
Department of Endocrinology and Diabetes
Queensland Children's Hospital
501 Stanley St
South Brisbane
QLD 4101
Country 117690 0
Australia
Phone 117690 0
+61 7 30685264
Fax 117690 0
Email 117690 0
stephanie.johnson@health.qld.gov.au
Contact person for public queries
Name 117691 0
Dr Stephanie Johnson
Address 117691 0
Department of Endocrinology and Diabetes
Queensland Children's Hospital
501 Stanley St
South Brisbane
QLD 4101
Country 117691 0
Australia
Phone 117691 0
+61 7 30685264
Fax 117691 0
Email 117691 0
stephanie.johnson@health.qld.gov.au
Contact person for scientific queries
Name 117692 0
Dr Stephanie Johnson
Address 117692 0
Department of Endocrinology and Diabetes
Queensland Children's Hospital
501 Stanley St
South Brisbane
QLD 4101
Country 117692 0
Australia
Phone 117692 0
+61 7 30685264
Fax 117692 0
Email 117692 0
stephanie.johnson@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual deidentified participant data - all collected data
When will data be available (start and end dates)?
02/05/2025-02/05/2027
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal, including metaanalyses of pump at diagnosis studeies
How or where can data be obtained?
by approval of the PI Stephanie.johnson@health.qld.gov.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.