Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000440426p
Ethics application status
Submitted, not yet approved
Date submitted
14/04/2025
Date registered
12/05/2025
Date last updated
12/05/2025
Date data sharing statement initially provided
12/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
ACCESS-AID Study – Accelerating Care, Capacity & Equity in Automated Insulin Delivery (AID) Systems for New Zealanders with Type 1 Diabetes
Scientific title
Advanced Diabetes Technology – A New Model of Care for Faster and More Equitable Access
Secondary ID [1] 314097 0
ADT_HRC_001
Universal Trial Number (UTN)
U1111-1319-6229
Trial acronym
ACCESS-AID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 336877 0
Condition category
Condition code
Metabolic and Endocrine 333350 333350 0 0
Diabetes
Public Health 333651 333651 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a quasi-experimental, single-arm study. A remote national Hub model will be deployed to provide prioritized national AID set up and support, before transferring participants back to their usual care teams when stable. AID systems link an insulin pump, glucose sensor and computer algorithm to automate insulin delivery. The systems continuously adjusts insulin to help keep blood sugars more stable. This study will use fully funded and commercially available insulin pumps in New Zealand.

The ACCESS-AID remote hub will be staffed by a multidisciplinary Clinical Team and supported by the wider research team (who all support individuals with T1D) which includes Adult and Paediatric Endocrinologists, Nurse Practitioners, Diabetes Nurse Specialists, Dietitians and experienced Diabetes Research Staff.

Key roles within the Clinical Team include a Remote Hub Manager, Medical Lead, Nursing Lead, Clinical Staff and Dietitian. Clinical staff will be registered Allied Health Professionals, mostly nurses, diabetes nurse specialists, dietitians and/or pharmacists. The day to day running of the Hub will be led by the Hub Manager. Interactions with participants enrolled in the Hub to provide clinical support and follow up will be led by the Nursing Lead and Clinical Staff. The Medical Lead will provide medical oversight to the Clinical Team. The Dietitian(s) will provide nutrition related oversight and carbohydrate awareness/counting education as required. Care provided by the Clinical Staff wil be differ from that provided by usual health care providers. Rather, this model of care will streamline the process so provide quicker and more equitable access to AID systems.

For this study, a participants usual care team refers to the health professionals which usually oversee their diabetes related care (e.g., diabetes clinic, GP, etc.). Any member of the participants usual care team will be able to refer them to the ACCESS-AID hub. During enrolment in the ACCES-AID Hub, participants usual care teams will be invited to attend study visits (e.g. the Telehealth consult), however this is optional. At the end of participants enrolment in the Hub, usual care teams will continue with diabetes related care.

The duration from enrolment in the Hub, until transfer back to usual care teams is expected to be 4-months, but can vary based on need. Glycaemic data will be reviewed remotely at 6-months (after participants have been transferred back to usual care teams), to monitor sustained improvements in glycaemic control, after which point participants will be removed from the study's online diabetes management accounts (i.e., after this point study staff can no longer access participant data). The duration from referral to enrolment may vary depending on participants prioritisation score.

Referral to Hub: Data included in referral will be used to calculate prioritisation score, which will determine time to enrolment in Hub.

Day -28 (+ 14 days): Enrolment in Hub
- Informed consent: participant provided with electronic participant information sheet or physical copy via post if online unavailable. Team member to phone participant to explain study and answer any questions. Link sent to obtain electronic consent.
- Commence collection of biochemical data including: HbA1c and traditional CGM metrics. If participants have not had biochemical tests completed as a part of a Diabetes Health Screen in the previous 12-months from enrolment, urinary albumin:creatinine ratio, renal function and lipid studies may also be completed. Completion of baseline questionnaires including Diabetes Treatment Satisfaction Questionnaire (DTSQ) and EQ-5D (a measure of health status) and an only carbohydrate counting assessment tool. A referral to an optional group or individual carbohydrate counting/awareness education session with study dietitian will be completed if the score from carbohydrate counting assessment indicates need for additional support.
- Telehealth Consult with Hub staff to confirm selection of AID system (funded systems commercially available in NZ) and commencement of appropriate CGM (if not already using). Hub team to confirm initial pump settings determined from at least 2 weeks of CGM data and baseline biochemical and physical data. Arrange pump start with supplier Initial settings to be sent to company representative in advance of AID training.

Day 0: Commencement of AID following in-person AID training provided by an external company (device distributer who are trained to provide pump specific training).

Day 0 to 12-weeks: Remote review by Hub staff daily for the first three days, then twice weekly for a week, weekly for three weeks and then monthly ending at 12-weeks.

12-weeks: Collection of biochemical data including: HbA1c and traditional CGM metrics; completion of online questionnaires including: DTSQ and EQ-5D. End of enrolment in Hub and transfer back to usual care teams.

12-16 weeks: A sub-group of enrolled participants, and health professionals from their usual care teams, will be invited to participate in semi-structured, face to face qualitative interviews to explore acceptability of the remote hub as a new model of care, as well as experience using AID.

6 months: Remote review of CGM data.

Note: Timeline from enrolment to AID start will vary depending on prioritised capacity and previous CGM data use/availability. We anticipate a maximum of 4 weeks from pump selection to AID start.
Intervention code [1] 330672 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340927 0
Implementation effectiveness of the remote Hub - Cumulative incidence rates of new AID starts by the Hub
Timepoint [1] 340927 0
At conclusion of the study
Primary outcome [2] 340929 0
Implementation effectiveness of the remote Hub - Proportion of all new AID starts that were initiated by the Hub
Timepoint [2] 340929 0
At conclusion of the study.
Primary outcome [3] 341006 0
Implementation effectiveness of the remote Hub - Rate of new AID starts
Timepoint [3] 341006 0
At conclusion of study
Secondary outcome [1] 445478 0
Glycaemic control as measured by percentage of time in range 3.9 – 10mmol/L.
Timepoint [1] 445478 0
At baseline, and 3 and 6 months post intervention commencement.
Secondary outcome [2] 445479 0
Glycaemic control as measured by percentage of time below 3.9 mmol/L.
Timepoint [2] 445479 0
At baseline, and 3 and 6 months post-intervention commencement.
Secondary outcome [3] 445480 0
Glycaemic control as measured by percentage of time below 3.0 mmol/L.
Timepoint [3] 445480 0
At baseline, and 3 and 6 months post-intervention commencement.
Secondary outcome [4] 445481 0
Glycaemic control as measured by percentage of time above 10.0 mmol/L.
Timepoint [4] 445481 0
At baseline, and 3 and 6 months post-intervention commencement.
Secondary outcome [5] 445482 0
Glycaemic control as measured by percentage of time above 13.9 mmol/L.
Timepoint [5] 445482 0
At baseline, and 3 and 6 months post-intervention commencement.
Secondary outcome [6] 445483 0
Glycaemic control as measured by percentage of time in range 3.9 to 7.8 mmol/L.
Timepoint [6] 445483 0
At baseline, and 3 and 6 months post-intervention commencement.
Secondary outcome [7] 445484 0
Glycaemic control as measured by glycated hemoglobin (HbA1c) from blood samples.
Timepoint [7] 445484 0
At baseline and 3 months post intervention commencement.
Secondary outcome [8] 445485 0
Glucose levels during the day (0600-2359 hours).
Timepoint [8] 445485 0
At baseline and 3 and 6 months post intervetnion commencement.
Secondary outcome [9] 445486 0
Glucose levels during the night (0000 to 0559 hours).
Timepoint [9] 445486 0
At baseline and 3 and 6 months post intervention commencement
Secondary outcome [10] 445487 0
Glycaemic control as measured by coefficient of variation.
Timepoint [10] 445487 0
At baseline, 3 and 6 months post intervention
Secondary outcome [11] 445488 0
Glycaemic control as measured by sensor glucose concentration.
Timepoint [11] 445488 0
At baseline and 3 and 6 months post intervention commencement
Secondary outcome [12] 445489 0
Glycaemic management index (GMI)
Timepoint [12] 445489 0
At baseline and 3 and 6 months post intervention commencement
Secondary outcome [13] 445490 0
Safety of AID - Hypoglycaemia
Timepoint [13] 445490 0
Continuously from start of baseline to end of study 12-week post-intervention commencement.
Secondary outcome [14] 445491 0
Safety of AID - DKA
Timepoint [14] 445491 0
Continuously from start of baseline to end of study 12-week post-intervention commencement.
Secondary outcome [15] 445493 0
The change in diabetes treatment satisfaction.
Timepoint [15] 445493 0
At baseline and at the end of the study 3 months post-intervention commencement.
Secondary outcome [16] 445494 0
The change in health status.
Timepoint [16] 445494 0
At baseline, and at the end of the study 3 months post-intervention commencement.
Secondary outcome [17] 445495 0
Change in self efficacy of clinical staff
Timepoint [17] 445495 0
At baseline, and at the end of staff employment with Hub (likely to be 6-months)
Secondary outcome [18] 445496 0
Cost-effectiveness of remote Hub
Timepoint [18] 445496 0
Baseline and at the end of the study period.
Secondary outcome [19] 446020 0
Impact of Dietetic Input
Timepoint [19] 446020 0
Baseline and 12-weeks post commencement of AID.
Secondary outcome [20] 446021 0
Acceptability of Hub Model as new model of care - Participants
Timepoint [20] 446021 0
12-16 weeks post AID start.
Secondary outcome [21] 446022 0
Acceptability of Hub model as new model of care - Clinical Staff
Timepoint [21] 446022 0
Within 4 weeks of end of employment with Hub
Secondary outcome [22] 446219 0
Acceptability of Hub Model as new model of care - Participants
Timepoint [22] 446219 0
At baseline, and at the end of the study 3 months post-intervention commencement.

Eligibility
Key inclusion criteria
Individuals diagnosed with type 1 diabetes.
Suitable health care team available for transfer of care at the end of enrolment in study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are pregnant will not be eligible to be enrolled in the Hub (these individuals will be able to access an insulin pump through existing health delivery pathways). Additionally, those who have non-diabetes moderate-severe health / mental health issues that are active, would be referred to appropriate health care providers first for support and management, before transitioning to diabetes technology. There is no age restriction, however the Clinical Team will ensure suitability of commencement of AID in younger individuals on a case-by-case basis.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 26928 0
New Zealand
State/province [1] 26928 0

Funding & Sponsors
Funding source category [1] 318605 0
Government body
Name [1] 318605 0
Health Research Council of New Zealand
Country [1] 318605 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 321157 0
None
Name [1] 321157 0
Address [1] 321157 0
Country [1] 321157 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317207 0
Health and Disability Ethics Committee 
Ethics committee address [1] 317207 0
Ethics committee country [1] 317207 0
New Zealand
Date submitted for ethics approval [1] 317207 0
10/04/2025
Approval date [1] 317207 0
Ethics approval number [1] 317207 0

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

Contacts
Principal investigator
Name 140346 0
Prof Benjamin Wheeler
Address 140346 0
Department of Paediatric and Child Health ,Dunedin School of Medicine, Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 140346 0
New Zealand
Phone 140346 0
+64 274701980
Fax 140346 0
Email 140346 0
[email protected]
Contact person for public queries
Name 140347 0
Benjamin Wheeler
Address 140347 0
Department of Paediatric and Child Health ,Dunedin School of Medicine, Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 140347 0
New Zealand
Phone 140347 0
+64 274701980
Fax 140347 0
Email 140347 0
[email protected]
Contact person for scientific queries
Name 140348 0
Benjamin Wheeler
Address 140348 0
Department of Paediatric and Child Health ,Dunedin School of Medicine, Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 140348 0
New Zealand
Phone 140348 0
+64 274701980
Fax 140348 0
Email 140348 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.