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Trial registered on ANZCTR


Registration number
ACTRN12625000356460p
Ethics application status
Submitted, not yet approved
Date submitted
31/01/2025
Date registered
24/04/2025
Date last updated
24/04/2025
Date data sharing statement initially provided
24/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
PODx Trial: A randomised-controlled trial of Omnipod®5 automated insulin delivery system commenced within 7 days of diagnosis of type 1 diabetes mellitus in children, and adolescents and adults.
Scientific title
PODx Trial: A randomised-controlled trial of Omnipod®5 automated insulin delivery system commenced within 7 days of diagnosis of type 1 diabetes mellitus in children, and adolescents and adults.
Secondary ID [1] 313940 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 336511 0
Condition category
Condition code
Metabolic and Endocrine 333020 333020 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a randomized controlled trial including children (2-16 years of age) and adults (>16 years of age) with newly diagnosis type 1 diabetes (< 7 days). Participants will be randomized 2 : 1 to Omnipod®5 automated insulin delivery system OR flexible bolus multiple daily insulin injections (MDI) and continuous glucose monitoring (CGM).
The Omnipod 5 is a tubeless automated insulin pump that is worn on the body and changed every 3 days. It automatically varies insulin delivery based on sensor (CGM) glucose levels. The total duration of the intervention in both arms will be 12 weeks. Both arms will be wearing CGM and data from this is automatically uploaded to cloud based data management systems which will be reviewed for adherence and data analysis.
Intervention code [1] 330437 0
Treatment: Devices
Comparator / control treatment
The control group will receive standard care consisting of flexible bolus multiple daily insulin injections (MDI) and continuous glucose monitoring (CGM).
Control group
Active

Outcomes
Primary outcome [1] 340559 0
Percentage time in range (3.9-10mmol/L)
Timepoint [1] 340559 0
Assessed weekly for 12 weeks post intervention commencement.
Secondary outcome [1] 446633 0
Insulin delivery satisfication
Timepoint [1] 446633 0
4 weeks after intervention 12 weeks after intervention (completion of study)
Secondary outcome [2] 444829 0
Costs to health system and participants/carers
Timepoint [2] 444829 0
Baseline (just EQ-5D-5L) 4 weeks after intervention 12 weeks after intervention (completion of study)
Secondary outcome [3] 446634 0
Feeding practices
Timepoint [3] 446634 0
4 weeks after intervention 12 weeks after intervention (completion of study)
Secondary outcome [4] 444828 0
Glycaemic outcome
Timepoint [4] 444828 0
Baseline 4 weeks after intervention 12 weeks after intervention (completion of study)
Secondary outcome [5] 444473 0
Diabetes distress
Timepoint [5] 444473 0
4 weeks after intervention 12 weeks after intervention (completion of study)
Secondary outcome [6] 446632 0
Sleep quality
Timepoint [6] 446632 0
4 weeks after intervention 12 weeks after intervention (completion of study)
Secondary outcome [7] 446631 0
Fear of hypoglycaemia
Timepoint [7] 446631 0
4 weeks after intervention 12 weeks after intervention (completion of study)

Eligibility
Key inclusion criteria
- Diagnosis of clinical T1D within last 7 days
- For participants 16 years of age at least 1 diabetes antibody needs to be positive.
- Body weight greater than or equal to 10 kg or estimated TDD of greater than or equal to > 10 units
- Ongoing care to be at RNSH or SCH Randwick
- Willing to wear study device/s
- Willing to dose insulin according to carbohydrate counting
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Serious skin diseases precluding use of CGM and insulin pump
- Unable to count carbohydrates
- Unable to use required technology
- Requires diluted insulin due to low total daily insulin dose
- Paediatric participants to be excluded from the study after randomisation if all diabetes autoantibodies are negative, as a diagnosis of Type 1 diabetes cannot be confirmed.
- Participants or carers of participants <16 years of age from non-English speaking background. This has been included due to the intensive education process that is required as part of this study.


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)
Yes by central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Adaptive randomisation stratified by site and age
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
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
5/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318432 0
Hospital
Name [1] 318432 0
Sydney Children's Hospital Randwick
Country [1] 318432 0
Australia
Funding source category [2] 318319 0
Hospital
Name [2] 318319 0
Royal North Shore Hospital
Country [2] 318319 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Country
Australia
Secondary sponsor category [1] 320712 0
Hospital
Name [1] 320712 0
Sydney Children's Hospital Randwick
Address [1] 320712 0
Country [1] 320712 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316954 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 316954 0
Ethics committee country [1] 316954 0
Australia
Date submitted for ethics approval [1] 316954 0
03/02/2025
Approval date [1] 316954 0
Ethics approval number [1] 316954 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139550 0
Dr Amy Wanaguru
Address 139550 0
Department of Paediatric Diabetes and Endocrinology, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 139550 0
Australia
Phone 139550 0
+61 294632166
Fax 139550 0
Email 139550 0
[email protected]
Contact person for public queries
Name 139551 0
Amy Wanaguru
Address 139551 0
Department of Paediatric Diabetes and Endocrinology, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 139551 0
Australia
Phone 139551 0
+61 294632166
Fax 139551 0
Email 139551 0
[email protected]
Contact person for scientific queries
Name 139552 0
Amy Wanaguru
Address 139552 0
Department of Paediatric Diabetes and Endocrinology, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Country 139552 0
Australia
Phone 139552 0
+61 294632166
Fax 139552 0
Email 139552 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.