Objective
Our aims are to
1. To evaluate the delivery of care for early type 1 diabetes in different centres and States across Australia
2. To characterise the demographics of the children (and their families) who are monitored
3. To determine the barriers to monitoring early type 1 diabetes for families and people with early type diabetes
4. To measure fidelity to international guidelines as presented and updated from 2024 onwards
5. To determine equity of access to therapy to delay onset of insulin therapy and to preserve insulin production
6. To develop a fit for purpose data registry for early type 1 diabetes in Australia to evaluate the monitoring program and service delivery
Background Rationale
Key advances have shifted the approach to the management of type 1 diabetes. These centre around the recognition that the early stages of type 1 diabetes before symptoms have developed are crucial to detect and monitor. This is first to prevent the life-threatening complication of presenting with diabetic ketoacidosis, second to allow time for support and education before insulin is required, and third to enable individuals with early type 1 diabetes to access trials of disease modifying therapy. The presence of blood autoantibodies to the insulin producing cells defines early type 1 diabetes. Multiple autoantibodies predict a lifetime risk of close to 100% of insulin requiring type 1 diabetes. In this application we will include all children and adults in Australia with one of more islet autoantibodies, confirmed on repeat testing, who therefore require some monitoring, as being part of the early type 1 diabetes care program in Australia. In 2024 two sets of international guidelines for the management of early type 1 diabetes were developed with input from our team. The guidelines are consistent and reflect the need for implementation of guidelines to prevent diabetic ketoacidosis and allow access to disease modifying therapy for as many eligible individuals as possible.
Here we establish seven paediatric monitoring centres for early type 1 diabetes in conjunction with one adult monitoring centre to capture all regions of Australia, including use of telehealth, so that there can be increasing equity of access to disease modifying therapy, education and support.
Work is progressing towards a general population screening program in Australia; this combined with the increasing success of disease modifying therapy, makes the establishment of feasible, acceptable, effective and scalable monitoring of early type 1 diabetes essential. Thus we will prepare the health workforce and health system in Australia for universal general population screenng.
Description of Project
The overriding aim of this proposal is to implement the international guidelines for the management of early type 1 diabetes in a rapidly changing landscape of disease modifying therapy for children and adults with early type 1 diabetes. We require information to prepare the health workforce and health system in Australia for the future impact of a national general population screening program.
Key advances have shifted the approach to the management of type 1 diabetes. These centre around the recognition that the early (pre-symptomatic) stages of type 1 diabetes are crucial to detect and monitor. This is first to prevent diabetic ketoacidosis, second to allow time for support and education more slowly before insulin is required, and third to enable access to increasingly available trials of disease modifying (immune modulation) therapy. The presence of autoantibodies to the insulin producing cells (islet autoantibodies) is the hallmark of early type 1 diabetes. Multiple autoantibodies predict a lifetime risk of close to 100% of insulin requiring type 1 diabetes.
In this application we include all children and adults in Australia with one of more islet autoantibodies, confirmed on repeat testing, as being part of the early type 1 diabetes care program in Australia.
The majority of Australian children and young adults known to have early type 1 diabetes (⁓400) have been screened and monitored through several screening initiatives. While the numbers of people who have been identified are relatively small in early 2025, the combination of a proposed RCT in general population screening and the likely availability of a prevention trial in 2026 to slow down or halt the need for insulin therapy will dramatically increase screening uptake and require delivery of care for early type 1 diabetes that is acceptable, feasible, scalable, affordable and able to be integrated into the health system of each State in Australia.
In 2024 two sets of consistent international guidelines for the management of early type 1 diabetes were developed with input and leadership of subgroups from four of the investigators on this application. They endorse the need for implementation of guidelines to prevent diabetic ketoacidosis and allow access to disease modifying therapy for as many eligible individuals as possible.
Seven pediatric early type 1 diabetes monitoring centres and one adult monitoring centre are part of this application. At present these centres follow some children or adults with early type 1 diabetes and most recruit to disease modifying therapy trials. Considerable discussion with families and between the centres has occurred to optimise the pathway from screening to laboratory testing to delivery of results to families and to their closest providers. Lessons learnt from our previous cohorts will be implemented.
An evaluation framework will be developed to evaluate the monitoring program and allow alignment with international programs. The monitoring Centres are linked also to the disease modifying therapy trials in early type 1 diabetes in Australia and qualitative studies of children and family experiences and continuous glucose monitoring.
Anticipated Outcome
We anticipate that the numbers of children identified with early type 1 diabetes in Australia will increase three old in the next three years in response to availability of disease modifying therapy trials for early type 1 diabetes and increased screening, including the general population trial (Project A).
Implementation and evaluation frameworks will be designed with implementation scientists [CI Shepherd, CI Rankin - Project A], to explain factors that are barriers or enablers to implementation and to evaluate the program. The evaluation framework will consider sociodemographic representation, experiences of families (with ongoing contributions from the separate QuEST study analysis leading to co-design of clinics); equity of access to trials and access to education and support prior to insulin initiation; take- up of the monitoring program once a child is found to be islet autoantibody positive; staff capacity building; the extent to which the monitoring is implemented faithful to the guidelines across the monitoring centres; the extent to which the monitoring becomes part of routine health care in the centres; and the elements that are critical for this integration of the program into the health service.
Thereby we will develop the best model of care that can be integrated into the Australia health care system.
Relevance to T1D
The proposal will develop the best health service delivery for the monitoring of early type 1 diabetes. This will lead to the prevention of diabetic ketoacidosis, which presently occurs in about 33 % of children with type 1 diabetes in Australia. The proposal will also enable for a smoother landing with more education and support for families in which a child is approaching insulin requirements and for adults approaching insulin therapy. Finally, as the availability of disease modifying therapy increases it will ensure as many children and adults as possible have equity of access to these therapies, including enrollment in trials to delay the onset of insulin therapy and preserve insulin production from the body.
By determining the best model of care we will prepare the health workforce and health system in Australia for the future impact of a universal national general population screening program.