Objective
The overall objective is to equip diabetes healthcare professionals with the knowledge, skills, and attitudes to provide islet cell therapy for patients with type 1 diabetes safely and effectively. This will be achieved by 1) Developing a comprehensive curriculum and 2) Creating an engaging e-learning course. These will cover key aspects of care learned over the last 25 years in clinical islet transplantation and use the most effective teaching and learning strategies designed for health care practioners with expertise in type 1 diabetes, but who do not have experience in taking care of transplant patients.
Background Rationale
Enabling new cell therapies that are approved for treatment of T1D clinical trials to be arpidly adopted and deployed is vital if we wish to avoid the slow uptake in novel therapies that have been seen with insulin pump therapy and automated insulin delivery systems. Recent reports from clinical trials have shown insulin independence in people with longstanding T1D after treatment with zimislecel (stem cell derived islet cells developed by Vertex) in combination with anti-rejection drugs. The next phase of trials is underway, with the expectation that the results will be presented to regulators in 2026, requesting approval for use in clinical practice.
This begs the question as to who will provide treatment with these cell therapies and look after the recipients. We believe that this would best be provided by a cohort of appropriately trained healthcare professionals who can integrate expertise in T1D management with management of anti-rejection drugs.
Current expertise is limited to a few centres and a small number of individuals. Much knowledge is based on experience and not all of the knowledge is accessible – there are no text books. Curating this knowledge and packaging it in a way that it can be easily shared and applied in different countries is important. We don’t have anywhere need sufficient capacity for people to visit established centres to learn. Learning by experience is important, to help people develop skills in problem solving and adapting to individual patient needs and unexpected situations are key, rather than merely learning a series of facts.
Currently, no courses exist which have been specifically designed to train diabetes clinicians to manage people receiving cell therapies. By using proven instructional strategies with the most effective learning tools we believe that we can deliver an educational program to develop skills and competencies efficiently and at an appropriate scale to facilitate delivery of cell therapies in clinic.
Description of Project
Despite advances in technology to support insulin delivery, self-management of type 1 diabetes is associated with significant burdens, challenges to mental well being and does not fully resolve substantial risks for short-term (hypoglycemia) and long-term health impacts (diabetes complications and premature mortality. Over the last 25 years, islet cell transplantation has shown the potential to replace insulin producing beta cells as an alternative to insulin therapy, enabling recipients to reach glucose targets without hypoglycemia, offering a prospect of preventing progression of diabetes complications. This is not a scalable solution because of the limited number of deceased pancreas organ donors and the need for anti-rejection drugs which have side effects.
Recent clinical trials have shown that islet cells made from stem cells (potentially an unlimited supply ) can normalize glucose levels in recipients without the need to take insulin injections. These stem cell islet treatments require people to take anti-rejection drugs, (although the long term goal would be to eliminate the need for this). In order for cell therapies to be delivered to people with type 1 diabetes in clinical practice it will be necessary to have health care professionals who have sufficient knowledge and training to confidently deliver safe and skilled care. Only a small number of doctors have experience in islet transplantation, many of who are experts in transplant surgery. There is an urgent need to build capacity among diabetes clinicians and equip them with key skills to identify which patients can benefit the most from these new treatments, the ability to explain the benefits and risks of cell therapies, and training in how to use anti-rejection drugs and monitor and manage any side effects. This proposal seeks to address this key gap by developing a curriculum and e-learning course to equip healthcare professionals to deliver sc-islet cell therapies to people with T1D.
Drawing on expertise from international clinicians who specialise in managing type 1 diabetes and who also are experts in islet transplantation, we propose to develop a curriculum which will identify the key knowledge, skills and competencies required to deliver cell therapies in the clinic. To help develop learn, understand and then be able to apply this in practice we will develop an e-learning course. By incorporating video, animation, case studies and interactive problem solving we will equip participants with confidence and skills, not merely knowledge of facts. To allow people from around the world to access the course it will be delivered online. Much of the learning will be done at the learners own pace, but it will be augmented by group-learning sessions by video conference. Practitioners who have complete the course will be encouraged to continue as members of a community of practice who will continue to learn from each other, using bulletin boards, chat forums and online meetings to share best practice in this rapidly evolving field.
Anticipated Outcome
We anticipate that this work will generate a comprehensive curriculum to train healthcare providers to safely and confidently manage people with T1D who receive novel cell therapies. The content of the curriculum will be available online in a wiki-style format that can be update and which will serve as a resource for practitioners. The modular e-learning course will become a sought after training and certification program that we anticipate will be required for staff to work in approved cell therapy centres. Modules from the course will also be of value for a wider range of practitioners who may be involved in part of the procedure (e.g. interventional radiologists) or general physicians or nurse practitioners who care for people with T1D and would like to better understand whom should be referred. We anticipate that in time, this training will be incorporated in standard training for practitioners in diabetes and endocrinology.
The major outcome, however, is to facilitate the rapid deployment of cell therapies into routine clinical practice, and not restricted to highly specialised transplant centres without T1D expertise.
Relevance to T1D
Despite advanced technologies and automated insulin delivery, T1D is burdensome and the need for a treatment beyond exogenous insulin is clear to people and families living with T1D. Progress in islet cell replacement has been relatively slow – limited by the availability of donor organs and the need for anti-rejection drugs. Diabetes clinicians are not familiar with these drugs and are anxious about using them. Kidney transplant doctors use these drugs routinely – but don’t have the capacity to look after all the people with T1D who might benefit from cell therapies. A potential risk is that we could have a “functional cure for diabetes” but no means to provide it to people with T1D. A further risk is that the anxiety and worry of diabetes providers could become a barrier to recommending cell therapies. There is an unfortunate history of gatekeeping when it comes to new therapies for T1D (#wearenotwaiting). Providing diabetes practitioners with the knowledge, skills and confidence to begin cell therapies is thus vital if these treatments are to reach the clinic and the people who need them most. A robust training program will give people with T1D the confidence that they will be getting the best and safest care.