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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
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Scientific title
Advanced Diabetes Technology – A New Model of Care for Faster and More Equitable Access
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Secondary ID [1]
314097
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ADT_HRC_001
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Universal Trial Number (UTN)
U1111-1319-6229
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Trial acronym
ACCESS-AID
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes
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Condition category
Condition code
Metabolic and Endocrine
333350
333350
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0
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Diabetes
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Public Health
333651
333651
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330672
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Implementation effectiveness of the remote Hub - Cumulative incidence rates of new AID starts by the Hub
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Assessment method [1]
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Cumulative incidence rates of new AID starts by the Hub model will be calculated as the total number of AID starts delivered by the hub (numerator) divided by number of individuals with type 1 diabetes not on AID at the beginning of the study period (denominator). Where possible, incidence proportions will also be calculated stratified by region and for priority subpopulations (e.g. by ethnicity, urban/rural status and socioeconomic deprivation). The number of AID starts from the Hub will be collected from study records (i.e., the number who attend the AID start training + Aid commencement). The denominator populations will be estimated from population level data sources including the virtual diabetes register.
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Timepoint [1]
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At conclusion of the study
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Primary outcome [2]
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Implementation effectiveness of the remote Hub - Proportion of all new AID starts that were initiated by the Hub
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Assessment method [2]
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To determine the proportion of all new AID starts that were delivered by the hub, an individual will be considered to have started on AID on the date they are first dispensed a subsidised pump as recorded in national databases (e.g., PHARMS).
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Timepoint [2]
340929
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At conclusion of the study.
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Primary outcome [3]
341006
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Implementation effectiveness of the remote Hub - Rate of new AID starts
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Assessment method [3]
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The change over time in the number and incidence proportion of new AID starts whilst the hub is in operation, versus the 12 months prior. An individual will be considered to have started on AID on the date they are first dispensed a subsidised pump as recorded in national databases (e.g., PHARMS).
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Timepoint [3]
341006
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At conclusion of study
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Secondary outcome [1]
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Glycaemic control as measured by percentage of time in range 3.9 – 10mmol/L.
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Assessment method [1]
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By way of continuous glucose monitoring (CGM) data analysis.
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Timepoint [1]
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At baseline, and 3 and 6 months post intervention commencement.
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Secondary outcome [2]
445479
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Glycaemic control as measured by percentage of time below 3.9 mmol/L.
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Assessment method [2]
445479
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By way of CGM data analysis.
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Timepoint [2]
445479
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At baseline, and 3 and 6 months post-intervention commencement.
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Secondary outcome [3]
445480
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Glycaemic control as measured by percentage of time below 3.0 mmol/L.
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Assessment method [3]
445480
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By way of CGM data analysis.
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Timepoint [3]
445480
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At baseline, and 3 and 6 months post-intervention commencement.
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Secondary outcome [4]
445481
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Glycaemic control as measured by percentage of time above 10.0 mmol/L.
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Assessment method [4]
445481
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By way of CGM data analysis.
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Timepoint [4]
445481
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At baseline, and 3 and 6 months post-intervention commencement.
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Secondary outcome [5]
445482
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Glycaemic control as measured by percentage of time above 13.9 mmol/L.
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Assessment method [5]
445482
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By way of CGM data analysis.
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Timepoint [5]
445482
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At baseline, and 3 and 6 months post-intervention commencement.
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Secondary outcome [6]
445483
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Glycaemic control as measured by percentage of time in range 3.9 to 7.8 mmol/L.
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Assessment method [6]
445483
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By way of CGM data analysis.
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Timepoint [6]
445483
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At baseline, and 3 and 6 months post-intervention commencement.
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Secondary outcome [7]
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Glycaemic control as measured by glycated hemoglobin (HbA1c) from blood samples.
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Assessment method [7]
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Measured via point-of-care analyzer or diagnostics laboratory whole blood analysis.
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Timepoint [7]
445484
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At baseline and 3 months post intervention commencement.
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Secondary outcome [8]
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Glucose levels during the day (0600-2359 hours).
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Assessment method [8]
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By way of CGM data analysis.
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Timepoint [8]
445485
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At baseline and 3 and 6 months post intervetnion commencement.
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Secondary outcome [9]
445486
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Glucose levels during the night (0000 to 0559 hours).
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Assessment method [9]
445486
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By way of CGM data analysis.
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Timepoint [9]
445486
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At baseline and 3 and 6 months post intervention commencement
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Secondary outcome [10]
445487
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Glycaemic control as measured by coefficient of variation.
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Assessment method [10]
445487
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By way of CGM data analysis.
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Timepoint [10]
445487
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At baseline, 3 and 6 months post intervention
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Secondary outcome [11]
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Glycaemic control as measured by sensor glucose concentration.
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Assessment method [11]
445488
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By way of CGM data analysis.
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Timepoint [11]
445488
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At baseline and 3 and 6 months post intervention commencement
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Secondary outcome [12]
445489
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Glycaemic management index (GMI)
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Assessment method [12]
445489
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By way of CGM data analysis.
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Timepoint [12]
445489
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At baseline and 3 and 6 months post intervention commencement
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Secondary outcome [13]
445490
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Safety of AID - Hypoglycaemia
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Assessment method [13]
445490
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Determined by occurrence of episodes of severe hypoglycaemia defined as coma or convulsion requiring assistance from others, from participant self-reports and data linkage to medical records.
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Timepoint [13]
445490
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Continuously from start of baseline to end of study 12-week post-intervention commencement.
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Secondary outcome [14]
445491
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Safety of AID - DKA
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Assessment method [14]
445491
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Determined by occurrence of episodes of diabetic ketoacidosis from participant self-reports and data linkage to medical records.
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Timepoint [14]
445491
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Continuously from start of baseline to end of study 12-week post-intervention commencement.
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Secondary outcome [15]
445493
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The change in diabetes treatment satisfaction.
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Assessment method [15]
445493
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Measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
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Timepoint [15]
445493
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At baseline and at the end of the study 3 months post-intervention commencement.
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Secondary outcome [16]
445494
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The change in health status.
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Assessment method [16]
445494
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Measured by the EQ-5D questionnaires.
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Timepoint [16]
445494
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At baseline, and at the end of the study 3 months post-intervention commencement.
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Secondary outcome [17]
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Change in self efficacy of clinical staff
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Assessment method [17]
445495
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Measured by the self-efficacy questionnaire (an independently reviewed questionnaire designed specifically for this study)..
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Timepoint [17]
445495
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At baseline, and at the end of staff employment with Hub (likely to be 6-months)
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Secondary outcome [18]
445496
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Cost-effectiveness of remote Hub
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Assessment method [18]
445496
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Markov model will be used for the cost-effectiveness analysis (cost per quality adjusted life years). A control group will be used as comparison, comprised of individuals who initiate AID through their usual care providers (an individual will be considered to have started on AID on the date they are first dispensed a subsidised pump as recorded in national databases e.g., PHARMS). This study will be from the perspective of the health service in New Zealand, and only direct medical costs will be considered.
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Timepoint [18]
445496
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Baseline and at the end of the study period.
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Secondary outcome [19]
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Impact of Dietetic Input
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Assessment method [19]
446020
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Glycemic metrics will be compared for those who attended a carbohydrate counting/awareness education session versus those who do not attend.
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Timepoint [19]
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Baseline and 12-weeks post commencement of AID.
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Secondary outcome [20]
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Acceptability of Hub Model as new model of care - Participants
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Assessment method [20]
446021
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Semi-structured, face to face interviews will be conducted by a member of the research team with up to 45 participants: 10-15 Maori, 10-15 Pacific and 10-15 non-maori, non-pacific. Interviews may be up to 60 minutes in duration. Interview will be audio recorded and transcribed verbatim. Transcripts will be analysed using thematic analysis.
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Timepoint [20]
446021
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12-16 weeks post AID start.
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Secondary outcome [21]
446022
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Acceptability of Hub model as new model of care - Clinical Staff
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Assessment method [21]
446022
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Semi-structured, face to face interviews with clinical staff will be conducted by a member of the research team. Interviews may be up to 60 minutes in duration. Interview will be audio recorded and transcribed verbatim. Transcripts will be analysed using thematic analysis.
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Timepoint [21]
446022
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Within 4 weeks of end of employment with Hub
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Secondary outcome [22]
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Acceptability of Hub Model as new model of care - Participants
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Assessment method [22]
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Acceptability/experience questionnaire (an independently reviewed questionnaire designed specifically for this study).
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Timepoint [22]
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At baseline, and at the end of the study 3 months post-intervention commencement.
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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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
26928
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Funding & Sponsors
Funding source category [1]
318605
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Government body
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Name [1]
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Health Research Council of New Zealand
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Address [1]
318605
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Country [1]
318605
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
321157
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Address [1]
321157
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Country [1]
321157
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317207
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Health and Disability Ethics Committee
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Ethics committee address [1]
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [1]
317207
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New Zealand
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Date submitted for ethics approval [1]
317207
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10/04/2025
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Approval date [1]
317207
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Ethics approval number [1]
317207
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Summary
Brief summary
Automated insulin delivery (AID) is the recognised best treatment for managing glucose in people with Type 1 Diabetes (T1D) and has been shown to greatly improve glucose outcomes. These systems link a pump, glucose sensor and computer algorithm to automate insulin delivery. The systems continuously adjusts insulin to help keep your glucose more stable. Despite this, access to these technologies is slow and not always available to those who need them most. Now that this technology is fully funded for people living with T1D in Aotearoa New Zealand, an estimated 10,000 people are expected to want to transition on to insulin pumps in the next year. However, no way near this number are currently being given access to insulin pumps each year in NZ. The purpose of this study is to provide a remote ‘Hub’, as a new model for health delivery, to assist the healthcare system successfully transition individuals with T1D onto AID. We anticipate this will allow individuals in regions struggling with staffing to allow pump starts earlier access to pumps than they would normally receive.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Benjamin Wheeler
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Address
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Department of Paediatric and Child Health ,Dunedin School of Medicine, Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
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Country
140346
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New Zealand
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Phone
140346
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+64 274701980
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Fax
140346
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Email
140346
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[email protected]
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Contact person for public queries
Name
140347
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Benjamin Wheeler
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Address
140347
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Department of Paediatric and Child Health ,Dunedin School of Medicine, Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
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Country
140347
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New Zealand
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Phone
140347
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+64 274701980
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Fax
140347
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Email
140347
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[email protected]
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Contact person for scientific queries
Name
140348
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Benjamin Wheeler
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Address
140348
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Department of Paediatric and Child Health ,Dunedin School of Medicine, Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
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Country
140348
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New Zealand
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Phone
140348
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+64 274701980
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Fax
140348
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Email
140348
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[email protected]
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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.
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