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Trial registered on ANZCTR


Registration number
ACTRN12625000054415
Ethics application status
Approved
Date submitted
16/12/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of early automated insulin delivery on equity in young Maori and/or Pacific Peoples with type 1 diabetes (Early AID Study)
Scientific title
Effect of early automated insulin delivery on HbA1c and equity in young Maori and/or Pacific Peoples with type 1 diabetes (Early AID Study)
Secondary ID [1] 313509 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 335938 0
Condition category
Condition code
Metabolic and Endocrine 332525 332525 0 0
Diabetes
Public Health 332740 332740 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants newly diagnosed with type 1 diabetes will be enrolled in the study and begin their diabetes journey using evidence-based intensive management strategies. These include multiple daily injections (with flexible dosing according to carbohydrate intake and glucose level) and continuous glucose monitoring (CGM). Early transition onto Automated Insulin Delivery (AID) will occur within 3
months of diagnosis. Participants will use an YpsoPump compatible CGM and an YpsoPump running in AID utilizing the CamAPS FX algorithm. During the first 7 days of using AID, daily electronic review will occur to ensure safety. Investigators will adjust settings if the participants’ time spent <3.5mmol/L is not less than 4%, and time spent >15mmol/L is not less than 30%, or if the investigator has any other safety concerns.
Participant involvement will include the wearing of a compatible continuous glucose monitor (CGM) and insulin pump. Both the CGM and insulin pump used are available for full Pharmac funding as of the 1-Oct-2024. The algorithm used in this system will be the CamAPS FX closed loop system, also fully funded through PHARMAC.
Initial pump settings will be determined by the study Endocrinologist.
AID use will commence in the first 3 months post diagnosis and continue from initiation, up to 12 months post diagnosis.
Follow-up appointments following pump initiation will align with normal clinical appointments at 3, 6, 9, and 12 months.
System settings will be reviewed by the study doctor and changed as needed. With glucose control reviewed remotely to monitor adherence and need for changes. Data from the CGM and pump will be automatically uploaded to a cloud based server every 24 hours to enable review of data by the study doctor.
Intervention code [1] 330081 0
Treatment: Devices
Comparator / control treatment
Historical data from the national diabetes database DPMS will be used to compare HbA1c outcomes up to 12 months post diagnosis, Data collected from 01-Jan-2020 to 31-Dec-2024 will be used to provide the comparison.
Control group
Historical

Outcomes
Primary outcome [1] 340164 0
The primary outcome to be measured will be the percentage of Maori and/or Pacific Peoples attaining HbA1c below the international recommended target of <53mmol/mol at 6- and 12-months post diagnosis.
Timepoint [1] 340164 0
Baseline, 3 months, 6 months, 9 months and 12 months post diagnosis.
This outcome will be evaluated at the conclusion of the study.
Secondary outcome [1] 443065 0
Qualitative measures using kaupapa Maori methodology. The aim of the interviews is to assess the impact of AID technology use by young Maori and whanau.
The objectives are to:
- create an indigenous, safe space for Maori participants to freely tell their stories, share their
diabetes journey and generate discussion.
- Explore the experiences of whanau in initiating and maintaining AID technology.
-Provide an understanding of the challenges and issues to accessing timely and quality diabetes
care.

These will be assessed as a single composite outcome.
Timepoint [1] 443065 0
1st interview within 2 weeks of Baseline/ diagnosis.
2nd interview within 2 weeks of pump initiation.
3rd interview at 12 months post diagnosis.
Secondary outcome [2] 443545 0
Technology use at 12 months post diagnosis
Timepoint [2] 443545 0
12 Months post Diagnosis
Secondary outcome [3] 443546 0
Clinic attendance or lack of contact with health care providers (HCP)
Timepoint [3] 443546 0
3 months, 6 months, 9 months, and 12 months post diagnosis
Secondary outcome [4] 443547 0
Episodes of hospital attendance, diabetes or non-diabetes related
Timepoint [4] 443547 0
3 months, 6 months, 9 months, 12 months post diagnosis with Type 1 Diabetes

Eligibility
Key inclusion criteria
Inclusion Criteria: 1. Maori and/or Pacific Peoples aged 25 years and under
2. Type 1 diabetes as per the American Diabetes Association Classification.
3. Willing and able to adhere to the study protocol.
4. Access to the internet and a computer system that meets requirements for uploading the pump.
Minimum age
0 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
Allergic or intolerant Humalog® and NovoRapid® insulin

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/01/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26783 0
New Zealand
State/province [1] 26783 0

Funding & Sponsors
Funding source category [1] 317578 0
Charities/Societies/Foundations
Name [1] 317578 0
CureKids
Country [1] 317578 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
Country
New Zealand
Secondary sponsor category [1] 320392 0
None
Name [1] 320392 0
Address [1] 320392 0
Country [1] 320392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316284 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 316284 0
Ethics committee country [1] 316284 0
New Zealand
Date submitted for ethics approval [1] 316284 0
30/10/2024
Approval date [1] 316284 0
12/11/2024
Ethics approval number [1] 316284 0

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

Contacts
Principal investigator
Name 137394 0
A/Prof Martin de Bock
Address 137394 0
University of Otago, Christchurch, Department of Paediatrics, Level 3, 4 Oxford Terrace, 8011, Christchurch Central, Christchurch
Country 137394 0
New Zealand
Phone 137394 0
+64 211956579
Fax 137394 0
Email 137394 0
martin.debock@otago.ac.nz
Contact person for public queries
Name 137395 0
Martin de Bock
Address 137395 0
University of Otago, Christchurch, Department of Paediatrics, Level 3, 4 Oxford Terrace, 8011, Christchurch Central, Christchurch
Country 137395 0
New Zealand
Phone 137395 0
+64 211956579
Fax 137395 0
Email 137395 0
martin.debock@otago.ac.nz
Contact person for scientific queries
Name 137396 0
Martin de Bock
Address 137396 0
University of Otago, Christchurch, Department of Paediatrics, Level 3, 4 Oxford Terrace, 8011, Christchurch Central, Christchurch
Country 137396 0
New Zealand
Phone 137396 0
+64 211956579
Fax 137396 0
Email 137396 0
martin.debock@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24404Ethical approval2024   388584-(Uploaded-16-12-2024-12-21-58)-Letter FULL Approval.pdf
24406Informed consent form2024   388584-(Uploaded-16-12-2024-12-22-43)-PICF Adult - Early AID_Version 1.2_CLEAN.pdf



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.