EASD/ADA recommendations on automated insulin delivery launched
A recent paper in Diabetologia presents a review of the benefits and challenges of automated insulin delivery (AID), as these systems begin to enter mainstream diabetes care. The EASD/ADA Joint Diabetes Technology Working Group concludes with recommendations that will help drive the safe and successful use of this technology going forward. Dr Susan Aldridge reports.
Automated insulin delivery (AID) systems integrate data from a continuous glucose monitor (CGM), a control algorithm and an insulin pump, thereby automating subcutaneous insulin delivery. However, they are not completely automatic at the moment, because they still require user input for optimal prandial insulin dosing. Nevertheless, successful use of an AID does remove some of the daily burden for insulin users and may help optimise their glucose management.
However, AIDs are not without technical problems, which can affect any of their components, such as inaccurate sensor readings, occlusion of insulin infusion sets and inadequate adjustment of the control algorithm. The use of AIDs requires a certain degree of technical understanding and commitment on the part of both the person with diabetes and their healthcare provider. There is also an issue with access, for the relatively high cost of AID systems means they are not currently affordable for all who might benefit.
Despite these drawbacks – which can be addressed – it is likely that the use of AID systems will become more widespread in the not-too-distant future. Healthcare professionals and people with diabetes will need expert guidance on how to get the best out of these systems. To meet this need, the EASD/ADA Joint Diabetes Technology Working Group has reviewed the benefits, limitations and challenges of current AID systems, as well as looking at some key safety issues. Based on its findings, the Group has put together some recommendations to help all those concerned with the optimal and safe use of AID.
Benefits and limitations of AID
The development of AID systems goes back over 40 years, with the launch of the Biostator, which consisted of an algorithm on a microcomputer that could adjust intravenous insulin infusion rates in response to blood glucose measurements. Over the last 10 years, there has been massive growth in the development of AID. And there is ample evidence of benefit. These systems can improve both HbA1c and time in range. They also have a positive impact on quality of life, improving sleep, reducing anxiety and the daily burden of diabetes management.
However, there are a number of physiological, technical and behavioural limitations to be taken into account with the use of AID. CGM sensors are placed in interstitial fluid, so there is a time lag in their readout compared with blood glucose values. Sometimes CGM data is inaccurate or missing. Also, delivery of insulin from a pump into the subcutaneous space leads to a delay in its absorption.
Data management by people using AID systems, and their diabetes team, is essential to understand how effective the system is and the impact of meal bolusing and exercise. Although there has been an increase in cloud-based automatic data uploading, some AID systems still require manual data handling, which can be challenging. Then there is the problem of power outages and server failures, which can lead to data disruptions. And with smartphone control of AID, updates to operating systems or battery failure could impact insulin delivery. It is likely, however, that the next generation of AID systems will be improved with respect to these technical issues.
It’s also important for the person with diabetes to have realistic expectations of what AID can and cannot do for them. They still need to do meal announcements and accurate bolusing and be prepared to revert to basic diabetes management, should the AID fail at any time. And hypoglycaemia may be different with AID – users have reported that their system assumes they are still in hypoglycaemia, even after correction with rapid-acting glucose, with insulin delivery remaining suspended because of the glucose-sensor time lag. In short, there is a clear need for detailed education around AID systems before, during and after the person with diabetes makes the transition. This, of course, relies on the availability of a healthcare professional qualified to deliver it. There should also be 24/7 technical support available from the manufacturer, and both the user and their provider need to have ready access, in case of an urgent question.
Patient selection for AID systems
Some people with diabetes will do better on AID than others and it’s worth thinking about the individual factors influencing safe and successful use of a system.
First, there needs to be a level of technical capability – being familiar with insulin pump therapy, understanding carbohydrate counting, how the components of their AID work together and, most important, what to do when things go wrong. Then it should be established that they do have realistic expectations of the system, so they don’t get too frustrated with its limitations. They will also need to be able to be trained and supported – does their diabetes team have the time and resources for this?
The person with diabetes also needs to be mentally and psychologically able to cope with the requirements for successful AID use. This may rule out those with an eating disorder or severe psychiatric comorbidities and those who lack motivation to improve their diabetes management or who resist change in their routine. Finally, although there has been concern over whether AID is usable by those with diabetes complications, there are reports of improvements in glycaemia with AID use in people on haemodialysis and with gastroparesis. There are also some creative solutions to allow successful AID use for those with visual impairment.
The above groups of people with diabetes are mostly those who will be able to use AID safely. The dilemma is that they may not be those who have most to gain, at least in terms of glycaemic control (although they will enjoy a decrease in diabetes burden). People who are motivated and tech-savvy are likely to be near their glycaemic target already. But insulin pumps and CGM actually have most benefit – and therefore cost-effectiveness – in those with the highest HbA1c and most hypoglycaemia, whether due to poor self-management or diabetes burnout. So, the challenge moving forward is to find a way of including these people in the AID user community too. Selecting only those who can use these systems safely and easily is actually a form of health inequity.
The authors provide a detailed discussion of the safety aspects of AID, which need to be well understood by both users and providers. Both hypoglycaemic events and diabetic ketoacidosis may occur with either system malfunctioning or user error. It’s really important to know how to detect a malfunction or error and what to do about it. It is also vital to stay up to date with any product recalls or updates.
There are also concerns about cybersecurity, data privacy and data protection with the use of AID. In 2019, the FDA warned that an ‘unauthorised’ person (ie not the user, caregiver or healthcare professional) could potentially connect wirelessly to a nearby insulin pump if the connection was not secure and alter the pump’s settings to over- or under-deliver insulin. So ongoing vigilance and continuous testing of AID systems for cybersecurity are essential.
Usage of the large amounts of data generated by AID systems is also a critical issue. People with diabetes should feel comfortable about data privacy and data protection and know who has access to it. This is particularly relevant when data is being collected for real-world studies.
The Working Group authors have put together a detailed list of recommendations, which will hopefully guide the safe, successful and equitable use of AID systems in the future, as the technology continues to evolve. These are targeted at the various stakeholders. We provide just a few highlights here to stimulate discussion.
Regulatory agencies need to harmonise their activities. In the USA, the FDA has been very supportive of AID systems. In Europe, there is no single agency like the FDA and approval there imposes a bigger burden on manufacturers. As part of this, it would be useful to provide a common regulatory pathway with clear guidance on how to obtain approval.
Manufacturers should create readily available and accessible training modules to ensure their AID systems really do meet the needs of people with diabetes. And to improve health equity they should thoroughly assess the usability of device interfaces and create user-friendly platforms for all demographic groups. Users should be given the option to submit their data for real-world research, but should be assured of data security and patient confidentiality.
Professional organisations and charities/advocacy groups should lobby for more research into AID and work with healthcare professionals and people with diabetes to help set expectations and provide support for users. Meanwhile, research-funding bodies should provide funding for well-designed trials providing independent clinical evidence on the safety, effectiveness and outcomes of AID. Researchers and academics can contribute by developing and sharing appropriate patient-related outcome measures.
Healthcare professionals need to stay up to date with different AID systems and talk to people with diabetes about them, helping set realistic expectations. They will have access to the person’s data and this should be used to improve the quality of their care and health outcomes. And, finally, consumers of AID systems – that is, people with diabetes, family and caregivers – will need to be fully engaged in their diabetes care to get the most out of an AID system. Current and future systems do promise to improve glycaemic control – and, hopefully, long-term health outcomes – and reduce the daily burden of diabetes management, so it is important to do all we can to make AID as widely accessible as possible.
To read this paper, go to: Sherr JL, Heinemann L, Fleming GA, Bergenstal RM, Bruttomesso D, Hanaire H, Holl RW, Petrie JR, Peters AL, Evans M. Automated insulin delivery: benefits, challenges and recommendations. A consensus report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association. Diabetologia 6 October 2022.
For more on this topic, enrol on the following EASD e-Learning courses:
See also the following films on Horizons:
- Managing type 1 diabetes in adults: draft recommendations, Professor Pratik Choudhary and Dr Emma Wilmot in The long and the short of it
- Do novel diabetes technologies really lighten the load?, Professors Moshe Philip and Tadej Battelino
Any opinions expressed in this article are the responsibility of the EASD e-Learning Programme Director, Dr Eleanor D Kennedy.