Lotty

One hot Saturday in June, I sat with my nine-year-old at our local NHS walk-in centre. His toe was very swollen following a minor injury a few days before, and we’d been advised by a pharmacist to get it checked out. The waiting room was packed and it was a couple of hours before we were seen by the nurse. She gestured at the bed while she sat and finished her notes from the last patient—apparently the IT system hadn’t been playing ball. When she eventually took a look at my son’s foot, she grimaced, but didn’t say much. Her bedside manner wasn’t the best, but I figured that was OK as long as my son was treated well. I was trying hard to appear cheerful and in control, as he was quite nervous by this point. But I began to feel uneasy as the nurse prepared to make a hole in his toenail. She said nothing about what she was doing, and it looked very much like she wasn’t going to disinfect his nail before proceeding. I didn’t get the impression she wanted my thoughts on the whole process, so I subtly mentioned that his toe might be a bit on the dirty side, so probably needed a wipe down. Without speaking, she grabbed a bottle of disinfectant and did as I’d hinted. Once it was over, he seemed to be in a lot of pain, so I asked whether she was sure it wasn’t infected. I was taken aback by her response. “Are you questioning my clinical judgement?” she demanded. Feeling I needed to justify my question, I assured her that I wasn’t and explained that he had had an infected nail before, so I just wanted to be sure. “Well, you may have experienced infections, but that doesn’t mean you know anything about this case.” I decided to shut up and just get through the rest of the appointment so we could be on our way. Sadly, from speaking with friends, and from my own history, I know our experience wasn’t a one-off. There is an irritation that surfaces in some healthcare professionals when you ask questions as a patient or parent. For some it may be grounded in pride or insecurity. For others, it is probably just about wanting to get through the patient list as quickly as possible. The strain that healthcare professionals are under at the moment is immense; I know that the frustrations of the poor IT system and obvious understaffing are likely to have affected the way this nurse responded to me. But there can be catastrophic consequences for patients when they and their parents, families and carers feel unable to raise concerns—or are ignored when they do. A few weeks after our experience at the walk-in centre, I read an article by journalist Merope Mills about the tragic and avoidable death of her 13-year-old daughter Martha. Martha died because doctors repeatedly missed signs of sepsis following a bike accident that caused pancreatic trauma. A striking feature of Merope’s account is the way her concerns and questions were repeatedly dismissed or minimised by nurses and doctors. She was told on multiple occasions that she was overreacting and should defer to the doctors. The inquest into Martha’s death vindicated many of Merope’s concerns and demonstrated that a string of serious errors had been made in Martha’s care. She writes, “Something that’s obvious but doesn’t get said enough [is] our trust in doctors should have limits.”[1] But so often, parents feel that when they push these limits and ask questions, they are seen as interfering, or wanting to have too much information. Interactions like my son and I had with the nurse at the walk-in centre back up the idea that as patients, we have no right to ask questions. These experiences aren't just unpleasant—they have the potential to cause serious harm. For my son, nothing bad happened. But in Martha’s case, it was deadly. We were asked to return to the walk-in centre a few days later to have the dressing removed and the toe checked. Fortunately, we had an entirely different experience with a much friendlier nurse who was happy to answer my questions and reassure my son. She actively invited us to share the smallest concern and be part of the decision-making process. She smiled. She explained what she was doing. She wished us well. The nurse in this second appointment had the opposite effect to the nurse in the first—we felt safe. References 1 Merope Mills. ‘We had such trust, we feel such fools’: how shocking hospital mistakes led to our daughter’s death. The Guardian, 3 September 2022

For people with diabetes (PWD), hospitals can feel like unsafe places. As a result, many are afraid of having to access emergency care or stay in hospital as an inpatient. This is partly because PWD are experts at self-management, with intricate knowledge of their own bodies. I have personal experience of this, having had type 1 diabetes myself for nearly two decades. As PWD, although we can't always predict how our diabetes will behave, our decisions on how to react to every situation become instinctive. When control is taken from our hands it feels terrifying; how could anyone else make a safe decision on our behalf? It feels like handing your baby over to a stranger! Harm in hospital - a reality for people with diabetes Sadly, all too often these fears are based in reality. When appropriately trained, healthcare professionals can make safe medication decisions for PWD, but research reveals a shockingly high prevalence of harm due to diabetes-related medication and treatment errors.[2] A recent blog on the hub looked at safety concerns raised by the Healthcare Safety Investigation Branch (HSIB) about insulin administration errors in hospitals. In HSIB’s reference case, the husband of the patient in question (who was in hospital for reasons other than diabetes) had raised concerns about the potential for a dosing error on two separate occasions, but he had not been listened to by staff. As a result, the patient was given five times her prescribed dose of insulin, in what could have been a fatal incident. These concerns go back years, with various organisations including Diabetes UK highlighting the need for action to make hospitals safer for people with diabetes.[1] The Getting It Right First Time (GIRFT) report on Diabetes published in November 2020 outlined some serious patient safety issues, including the fact that many hospitals have no effective system to identify patients with diabetes and have not trained ward staff in the safe use of insulin.[2] It also highlighted inconsistent timings and content of hospital food as an issue for PWD. According to GIRFT, the risk of developing diabetic ketoacidosis (DKA)—a life-threatening complication of type 1 diabetes—is between 40-60 times higher in hospital than the background incidence rate of the type 1 population. Most people with diabetes who have stayed in hospital will have their own tale to tell about issues with the care they received. My own experience bears out this concern that many healthcare professionals simply don’t know enough about the condition to look after people with diabetes safely and respectfully. Six years ago I had a planned caesarean section and my diabetes team warned me, “Whatever happens, don’t let them take your insulin pump. They’ll try, but you keep hold of it!” As diabetes specialists, they knew that as long as I was able to, I was the best person to administer my insulin and monitor my blood sugar levels. Type 1 diabetes is a balancing act, and being put unnecessarily on a sliding scale (a glucose and insulin drip often given to PWD when they are in hospital) can damage the equilibrium we work so hard to achieve, and can cause many issues. Of course, sometimes your medical situation may mean that the best course of action is being put on a sliding scale or someone else taking over your diabetes control. But there is a tendency for doctors to see it as the safe option, when it can be unnecessary and less safe than letting an inpatient look after their own insulin needs. Unfortunately, my diabetes team was right—as soon as the anaesthetist saw my pump he was insistent he should take it from me, and I had to be incredibly assertive to be allowed to keep it on. In the end, I did keep it connected and managed excellent control throughout my three days in hospital. Despite the excellent care I received from many other healthcare professionals, the incident left me feeling on edge and like I couldn’t fully trust the staff. What people with diabetes fear most about staying in hospital It’s wrong that the very setting supposedly designed to bring us back to health is a place that seems unsafe to many people with diabetes. Wanting to better understand the issues, I recently asked the diabetes online community on Twitter why going to hospital was scary—and their responses were horrifying. I received Tweets from people in different countries, demonstrating that the problem is not confined to the NHS—people from around the world all told similar stories and raised similar concerns to people in the UK. Here are some of the issues they raised: Lack of healthcare professional knowledge about diabetes A number of people reported nurses not understanding the difference between type 1 and type 2 diabetes, with sometimes dangerous consequences. There were numerous reports of people with type 1 diabetes being denied insulin. One person said they had been denied insulin because they were over 50 and it was assumed they “must have type 2.” Another person described how an A&E consultant did not realise they needed insulin all the time, and refused to administer any more once they were out of DKA. This resulted in them going back into DKA and needing further treatment which could have been avoided with the right knowledge. Many PWD talked about the fact that healthcare professionals in inpatient settings did not know anything about how insulin pumps and continuous glucose monitors (CGM) worked. Some had never even seen them before. With these devices becoming more and more common in the UK, it seems important that all healthcare professionals are trained to understand what they are, and the basics of how they work. No one would expect an intricate knowledge of how they work, but being able to recognise them, knowing where to look for more information and seeking to facilitate their use in inpatient settings would be a good start. Treating hypoglycaemia (low blood sugar) in hospital was also described by many as being very difficult. One person said, “I told them on a few occasions I felt ‘low’. Finally Lucozade got wheeled out but it was almost an inconvenience.” Having diabetes technology and equipment taken away Many PWD reported a fear of devices amongst medical professionals, describing how their monitors and pumps were taken and “locked away.” In one particularly worrying account, someone described being sedated when they protested against having their pump taken away. Many people described intense fear and the feeling of having all power taken away from them as a patient when their devices were removed. Healthcare professionals not listening to or trusting people with diabetes Most people were understanding that healthcare professionals can’t be expected to know everything about diabetes. However, the most commonly expressed frustration was about not being listened to when sharing information about their diabetes. This is the issue that was raised in the HSIB investigation. There was a perception that some healthcare professionals are “arrogant” and assume their knowledge is superior to that of their patient. Some people reported receiving sarcastic and disparaging remarks from healthcare professionals, which heightened their sense of being unsafe. One person said, “It’s dead hard to have to fight your corner while feeling so unwell.” Another person who had type 1 for many years reported being ‘diagnosed with type 1’ while in hospital, despite repeatedly telling staff she already had the condition. Lack of systems to support safety There were numerous reports of insulin drips running out and people being left without any insulin for hours. The reason often given for this was that no doctor was available to sign off the prescription. People also reported a lack of checks in places, for example, in nurse administration of insulin via a sliding scale. One person said, “The nurse left the glucose drip on but turned off the insulin. It terrifies me to think how bad this could have been.” One person reported a fellow patient having to fetch a nurse from the nurses station because no one was responding to their call button when they needed hypo treatment. This kind of scenario is doubtless linked to NHS staffing shortages that are currently causing many safety issues for staff and patients. Alongside these horror stories, I did come across examples of good practice which left PWD feeling confident that the care they were receiving was safe. One Twitter user described being able to keep her pump and continuous glucose monitor on during brain surgery, and was told by the medical team looking after her, “You are the expert on your condition, you advise us.” Another said, “In recent years [I have] been really impressed with how all staff just leave me to my own devices.” Another said that, “most HCP listened to me as T1 myself and welcomed my input.” However, most of these positive experiences were qualified with a ‘but’ followed by a story of a negative or dangerous experience of emergency or inpatient care. You can read more of the comments I received from PWD in this community thread on the hub. Improving safety: policy, training and staff attitudes This lack of consistency across services is a major problem—we can never plan where or when we will need hospital treatment, so it is important that issues are addressed across all trusts and settings. The GIRFT report highlights this issue, recognising that “there is still a large degree of variation in the quality and availability of targeted inpatient services, and in the frequency of hospital-acquired harm resulting from poor diabetes care.”[2] The National Diabetes Inpatient Audit (NaDIA) has been carried out across 81% hospitals over the past few years and is a useful tool in providing data to help specialities and trusts identify and overcome diabetes-related safety issues. For example, its 2021 report highlighted an increased prevalence of DKA among patients in surgical specialties and recommended “the establishment of processes to ensure that insulin is not stopped in people with type 1 diabetes.”[3] The information provided by NaDIA and the GIRFT recommendations are good steps forward, but whether services will have the resources and capacity to take action, is another question. People with diabetes tend to be great educators on the condition they live with, and some reported using their hospital stay as an opportunity to educate healthcare professionals looking after them about diabetes. But it shouldn’t be down to them. Diabetes is a complex condition that requires attention to detail and accurate knowledge to manage safely. Not everyone can be an expert, but helping staff identify when to ask for help from someone who is—and having the humility to do it—should be a priority. The GIRFT report observed that having an increased presence of diabetes specialists in inpatient settings can hugely reduce the number of diabetes medication errors. It recommends the presence of a seven-day multidisciplinary diabetes inpatient team in every hospital to ensure appropriate planning and support for patients with diabetes, whatever they are in hospital for.[2] Perhaps most importantly, hospital staff need to be trained to ask people with diabetes about their management and have a degree of trust in their judgement. Only then will PWD feel confident about going to hospital, whether in an emergency or for elective treatment—shared decision making shouldn’t stop at the hospital door. References 1 Making hospitals safe for people with diabetes. Diabetes UK, 2017 2 Rayman G, Kar, P. Diabetes GIRFT Programme National Specialty Report. NHS England & NHS Improvement. November 2020 3 National Diabetes Inpatient Audit (NaDIA) Harms 2020, England. Healthcare Quality Improvement Partnership. 2021

A few weeks ago, a painful and rapidly-swelling elbow forced me to pick up the phone and ask for help. I have rheumatoid arthritis, treated by immunosuppressive biologic drugs and complicated by other health issues. In ‘normal times' I am supposed to see my consultant every six months. But due to Covid-19, I had not seen her in two years and was muddling along by myself. So I wrote myself a script, made sure I had all the information I needed and psyched myself up to fight for an appointment with whoever I reached after navigating the hospital switchboard. Amazingly, I got through to my rheumatologist’s secretary at the first attempt. I explained my situation and, if I’m honest, was shocked by the compassion and understanding she showed me. “That sounds really difficult, I’ll get you an appointment as soon as I can.” She found me a phone appointment in six weeks time, apologised for the wait and the fact that it wasn't in person, and gave me the number of the rheumatology nurse helpline in case they could offer me anything else in the meantime. I couldn’t have felt better served or more cared for. It left me wondering why I hadn’t called before. And then I remembered the reasons - and realised this pleasant interaction felt like an anomaly. Why patients don’t ask for help There are so many reasons that stop patients proactively seeking the care they know they need, including: lack of clarity about who to contact or difficulty getting through. difficult past interactions that left you feeling dismissed and belittled. lack of follow-up when you have been in touch before. believing there are others worse off, that your needs aren’t important enough. previous harm or treatment mistakes. believing you will be ‘adding to the problem’ of the Covid-19 elective care backlog. Most patients, particularly those with a long-term condition, will identify with some of these reasons. But central to most of them is the idea of damaged trust, and it is many separate experiences that contribute to this erosion of patient confidence. Trust in the NHS, or any healthcare system, is a nuanced picture for each individual patient. But it warrants attention, as lack of trust has a huge impact on patients’ ability and willingness to access the healthcare system that, after all, exists to look after them. That in turn negatively affects their health outcomes and safety.[1] Two years into this pandemic, trust is more important now that it has ever been, but I fear that with every strained conversation and cancelled appointment, it is gradually ebbing away from patients. Patients and the NHS - it’s complicated In a healthcare setting, relationships are complex as they are not just about individuals, but a whole system. When I sit on the phone to a locum GP, both of us come to the consultation with loaded preconceptions - she of the thousands of patients she has seen, and I of the many doctors I have sat opposite before. The weight of the system sits heavy. The impact this has on experiences of care should not be underestimated. Increasing trust between patients and clinicians is key to patient safety, and for patients with long-term conditions, lack of trust can have a particularly profound effect. A good example of this is the UK Government’s vaccine rollout in Spring 2021. The universal public message was “Don’t contact us, we won’t forget you.” While I understand where this message came from - the need to protect immensely stretched NHS services - I wonder whether anyone in that comms meeting considered how that would be heard by some of the people it was aimed at. People who had been told they were ‘clinically extremely vulnerable’, who in some cases had spent months at home, alone. People for whom the vaccine meant freedom. People who are more likely than most to have experienced ‘being forgotten’ by the NHS before. In the end, anxiety about this led many, myself included, to call their GP to find out if they were ‘on the list’. In my case, I was accused of trying to ‘queue-jump’ while a friend at another GP surgery was told they were being ‘a nuisance’. My purpose in sharing this is not to have a go at individual staff, who were undoubtedly under huge pressure, but to highlight the impact that even brief interactions can have on a patient’s trust in their health services. I have certainly noticed that I am more reluctant to contact my GP since that incident. It was lack of trust that the system would look after me that made me call, and the call itself that further eroded my faith in the compassion and competence of the health system. Better communication builds trust People are often at their most vulnerable and anxious in healthcare settings, meaning that interactions have a particularly profound effect on how they view their treatment and the people involved. As a patient, here are four observations about how improving NHS communication could increase patient trust in the healthcare system. None of them are novel suggestions, but the need to prioritise them feels particularly important at the moment. Increase understanding of shared decision making Patients and clinicians alike need to really understand shared decision making and the role that patients have in ensuring their treatment is right for them. Shared decision making takes longer,[2] but it has proven benefits in reducing harm and improving outcomes.[3] We need better education for all parties about shared decision making if it is to become the norm for healthcare in the UK. It is encouraging to see organisations developing tools that can help patients prepare for consultations and understand which information will be useful to share, but we need to make sure all patients can access them. Address concerns and past harm A consultation needs to be about more than just the symptoms a patient is experiencing at that moment. Doctors who take time to understand where a patient’s hesitations come from are able to instil trust and help deal with those concerns. Allowing space for patients to talk about difficult healthcare experiences and feel heard can make a huge difference. This takes time, but those additional minutes are an investment in the patient’s health and future healthcare interactions. Trust works both ways, and as a patient I feel more relaxed and able to listen to a doctor’s expertise when they take my lived experience seriously. Identify and train the gatekeepers Clinicians understandably can’t be accessible to all patients at all times, so receptionists and other staff act as the gatekeepers to treatment. That’s why it is so important that these individuals communicate well with patients. A conversation that leaves a patient feeling unimportant and dismissed, even if it is polite, results in frustration and resentment, not just towards the gatekeeper but perhaps the whole department, hospital or NHS. Their role is vital in building patient trust and confidence, as my phone call with the rheumatology secretary demonstrates. Training and good systems that allow gatekeepers to offer the right information and support will help ensure patients don’t feel they are being denied access to the care they need. Maintain contact and foster transparency Many patients recognise the limitations placed on the NHS because of the ongoing impact of Covid-19; they just want to be kept in the loop. I have heard very little about my ongoing treatment from either hospital specialty I am under since January 2020. I have no idea whether anyone is looking at my regular blood test results or whether I’m even still ‘on the books’. I don’t know what I should do if I need support, and when I’m likely to be contacted next. Contact takes a bit of time, but it means patients don’t feel forgotten and gives them license to seek help when they really need it. Perhaps it’s time to invest in systems that make it easy to contact patients and bridge the gap between now sparse appointments. A question of resources Sadly, each of these solutions require something NHS services are very short of at the moment - time. NHS staff are under immense pressure every day, with record numbers leaving the NHS under the strain of Covid-related PTSD or simply having ‘had enough’. As staff become fewer, the pressure on remaining staff builds. Patients feel this strain and sense the pressure, and doubts about whether the system really has their back can grow. The issue of trust is a complex one with no easy fixes, but the more we can facilitate positive interactions and relationships, the more confidence all parties will have in our healthcare system. If trust can be built and maintained, patients like me will feel safer and more at ease when they need to access care. Of course, whether the government sees enough value in building trust in the NHS to properly invest in it, is another question altogether. References [1] F Chipidza, Rachel Wallwork and Theodore Stern. 'Impact of the doctor-patient relationship'. Prim Care Companion CNS Disord. 2015:17(5):10 [2] S Lenzen, R Daniëls, M Amantia van Bokhoven et al. 'What makes it so difficult for nurses to coach patients in shared decision making? A process evaluation'. International Journal of Nursing Studies. 2018:80:1-11 [3] C Okoli, G Brough, B Allan et al. 'Shared decision making between patients and healthcare providers and its association with favorable health outcomes among people living with HIV'. AIDS and Behavior. 2021:25:1384–1395

What is closed-loop insulin delivery? ‘Closed-loop’ insulin delivery, also known as an artificial pancreas system (APS), is a self-regulating system for administering insulin to patients with type 1 diabetes. An insulin pump is connected to a continuous glucose monitor (CGM) via a smartphone app or minicomputer - in some systems, this is built into the insulin pump. The app or pump uses an algorithm to respond to blood glucose data from the CGM, automatically adjusting insulin delivery from the pump. The CGM then picks up resulting changes in blood glucose levels and relays this information back to the app, which will again adjust insulin delivery. This cycle is a ‘closed loop’, automatically adjusting insulin to keep blood glucose levels within a target range, without human input. A game-changer for diabetes care The system has major benefits for people living with type 1 diabetes. Most users report drastic improvements to glycaemic control, both in HbA1c (a long-term measure of blood glucose) and blood glucose ‘time in target’.[1] Closed-loop systems can alleviate the strain of constant decision making for people with diabetes and their families.[2] Traditional treatment with multiple daily injections or an insulin pump relies on the person with diabetes (or a carer) to constantly make decisions to try and keep blood glucose levels stable and safe. Awareness of the long- and short-term consequences of poor control [3] adds to the significant mental burden of living with type 1 diabetes.[4] Using an APS can reduce safety fears for patients and their families. Hypoglycaemia (low blood sugar) caused by insulin treatment causes unpleasant symptoms and can lead to seizures, passing out and even death. It is a particular concern for parents of young children, as overnight hypos can be hard to detect and dangerous if left untreated. One parent of a toddler using an APS said the system means they can finally sleep without anxiety: “No worry if my child will be alive the next morning, not jumping out of bed due to a car alarm out on the street and thinking that it was the pump’s alarm, nothing; just sleep, for us and our child.”[5] There are currently three commercial hybrid closed-loop systems available in the UK - the Medtronic 670G/780G, Tandem t:slim X2 Control IQ and CamAPS FX systems [6] and the earliest has been available since 2019. Although the technology has huge benefits for people with diabetes, limited funding means that it is only available to a very small number of NHS patients. The DIY artificial pancreas and #WeAreNotWaiting But there is another way to access closed-loop technology - by building your own artificial pancreas. Long before the first commercial closed-loop system was licensed for UK use, people with diabetes were writing their own algorithms and making them available to others within the diabetes community. Over the past six years, several patients and family members have developed code to allow anyone to build their own artificial pancreas. Known as ‘loopers’, this motivated group has developed an extensive range of open-source programmes, resources and training. There are an estimated 8-10,000 people worldwide using one of the three major open source algorithms, Loop, OpenAPS and AndroidAPS.[7] The hashtag ‘#WeAreNotWaiting’ was adopted on social media as patients began taking action to speed up the development of diabetes technologies. This patient movement uses Twitter and Facebook to share resources, issues and fixes with anyone who wants to build a DIY APS. Setting one up requires time, the right kit and a degree of technological ability, and an increasing number of people are doing it for themselves. Jazz Sethi, Founder of The Diabesties Foundation and the first known person in India to set up a DIY APS, says: “I had heard of the DIY loop and the #WeAreNotWaiting movement a while back. Getting genuinely tired of fluctuating sugars, I decided to take the plunge. The process was not as difficult as I had anticipated - if you are a little tech-savvy, setting up the loop is just following instructions and using common sense. As soon as I started using the loop, I could see that it had increased my basal rate to correct my high sugar. It was... magic! My quality of life has seen a drastic improvement. Being in range 90-95% of the time has meant I’m not constantly exhausted from correcting for either a high or a low. My eating patterns have regulated now that I’m not snacking for lows and my anxiety and fear of hypos have reduced.” DIY APS developers say that the DIY approach allows a more personalised experience for users, with their systems able to do more than commercial options thanks to years of customisation and constant development.[8] One recent research study even demonstrated that DIY systems provide better time-in-range outcomes than one of the commercially available systems.[9] What are the patient safety issues with closed-loop insulin delivery systems? There are many benefits to APS, but there are undoubtedly patient safety issues associated with their use: Over-reliance on technology No technology is perfect and sometimes insulin pumps break and CGMs malfunction. Although technology can relieve the burden of diabetes care, patients should never discount the value of their own human instinct and input in the processes that keep them healthy. To mitigate this risk, DIY APS documentation contains clear and extensive warnings about the need to ensure people take responsibility for their own wellbeing while using the system, and patients using commercial systems must undergo training to ensure they understand their role. Patients being ‘left behind’ Most people with type 1 diabetes are not able to access an APS, whether commercially-produced or DIY. It is expensive to self-fund a commercial APS, and building a DIY APS also involves substantial cost as it requires multiple tech components. Many patients cannot access funding for insulin pumps and CGMs [10] to use in a DIY system and the cost to buy these component devices is considerable. In addition, social media has helped a huge number of people access DIY APS programmes, but there are plenty of people with type 1 diabetes who have never even heard of looping. Considering the safety advantages of this technology for people with type 1 diabetes, there is still much work to do to ensure those who could most benefit are able to access it. There are also a few safety issues specifically related to open-source DIY APS: Use of old technology Due to the cost of self-funding CGMs and insulin pumps, DIY APS users sometimes buy second-hand, out-of-warranty components from unregulated sources. There is a risk that these devices will be damaged or more susceptible to faults. Creating wider access to these technologies within the NHS would reduce this risk and allow a wider group of patients to try out DIY looping. Lack of regulation While DIY closed loops have been shown to be safe and effective in improving outcomes, there is an extent to which users must accept the risks of using a DIY system. No regulatory body has yet approved their use.[11] Organisations that monitor medical tech also urge caution when using apps to support diabetes management. Liz Ashall-Payne, CEO of ORCHA says, "Such systems highlight the life changing role technology can play in people's lives. But given its essential role, upholding safety standards is paramount. ORCHA continuously scans the market for smartphone apps that better manage living with diabetes, then rigorously assesses these products. We encourage anyone who is looking to develop or use such products, to make sure there is independent verification of safety standards." But as Tim Street, Founder of diabetes tech blog Diabettech highlights, “All of the open source options follow a rigorous development and testing process that is very similar to that undertaken by commercial offerings. The developers are all users or carers for users, so a safety first approach is taken and the testing is very controlled.” The personal investment that users have in these systems is an additional safety motivation that commercial biotech companies don’t have. Liability issues If DIY looping goes wrong, there is a big question mark over who could be held liable,[12] with suggestions that programmers, distributors, loopers themselves and even NHS staff could be held responsible in legal terms. This creates a nervousness around looping that has caused some clinicians to avoid involvement with DIY APS. Partha Kar, NHS England’s National Specialty Advisor for Diabetes, recognises the significance of this issue: “Clinicians are worried about DIY systems as they aren’t sure whether the GMC would support them should something go wrong.” A recent article in Medical Law International also highlighted that this problem is restricting access to DIY APS: “Practically speaking, this has led to clinicians adopting a precautionary approach in the clinic. Generally, even clinicians who are aware of the existence of DIY systems do not discuss them as an option unless the patient raises the issue themselves.”[11] The authors of this article call for clearer guidance for clinicians and highlight that “there is nothing in [the GMC guidance] which ought to be interpreted as requiring clinicians to refrain from discussing DIY APS with, or recommending them to, their patients.”[11] An international consensus paper on the issue of APS liability is in the pipeline and should help mitigate concerns and allow clinicians to feel more able to get involved in supporting patients using APS.[7] In spite of these issues, a number of research studies have now demonstrated the relative safety of DIY APS systems.[2][13][14] It is also important to consider safety issues related to looping within the context of wider safety issues faced by people with type 1 diabetes. As Dana Lewis, an early developer and champion of DIY APS puts it, “...a net risk safety perspective should be used, considering the almost constant risk of insulin management for people living with diabetes.”[15] The future of artificial pancreas technology So where will closed loop artificial pancreas systems go from here? As more and more people make use of DIY APS, the biotech industry is catching up. Several manufacturers have released closed-loop systems in the UK, but these are likely to be limited to a small number of NHS patients for several years, due to their cost. But progress is being made as the evidence around the benefits of APS is better understood, as Partha Kar outlines: “We are working with NICE to assess how best to use commercial systems going forward and are currently collecting data to inform future guidance.” The parallel development of ‘ultra-rapid acting insulins’ is likely to make closed-loop systems even more effective in managing blood glucose changes. Currently, most systems still require a level of input when it comes to taking insulin for meals, but ultra-rapid acting insulins may make closed-loop systems more effective in dealing with mealtime insulin delivery,[16] further relieving the burden of decisions for people with diabetes. The DIY APS is an inspiring example of how patients can lead progress in managing their condition. As Partha Kar highlights, “The DIY movement has fast-tracked diabetes care by 5-10 years and forced industry to change their way of working - and that’s no mean feat. This group is highly motivated and has shaken the industry up - now every diabetes tech company is thinking about looping. Those companies that are working with DIY developers will benefit from their experience and knowledge as they develop their technology.” The #WeAreNotWaiting movement has generated huge progress in diabetes treatment, but further research and guidance for clinicians is needed to ensure more people with diabetes can benefit. As a 2020 comprehensive review of the DIY APS states, “the lack of systematic practice-oriented studies is considered to be the stumbling block to the wider acknowledgement of DIYAP systems.”[17] But DIY loopers, researchers, clinicians and regulators are increasingly collaborating to see this issue overcome. Do you use a closed-loop artificial pancreas system? Have you made your own DIY APS? Share your experiences in the comments below. Further reading History and Perspective on DIY Closed Looping (Dana Lewis, OpenAPS) NHS Pilot: Patients with type 1 diabetes to get artificial pancreas on the NHS (NHS England) DIYAPS.org References 1 Fuchs J, Hovorka R, Smith L et al. Benefits and Challenges of Current Closed-Loop Technologies in Children and Young People With Type 1 Diabetes. Front Pediatr. 2021:9 2 Gawrecki A, Zozulinska-Ziolkiewicz D, Michalak M et al. Safety and glycemic outcomes of do-it-yourself AndroidAPS hybrid closed-loop system in adults with type 1 diabetes. PLOS ONE. 2021:16(4) 3 NHS type 1 diabetes - avoiding complications, accessed 8 November 2021 4 Rustad J, Musselman D, Skyler J et al. Decision-Making in diabetes mellitus type 1. J Neuropsychiatry Clin Neurosci. 2013:25:40-50 5 Marshall D, Holloway M, Korer M et al. Do-It-Yourself Artificial Pancreas Systems in type 1 diabetes: Perspectives of two adult users, a caregiver and three physicians. Diabetes Therapy. 2019:10:1553–1564 6 Leelarathna L, Choudhary P, Wilmot E et al. Hybrid Closed-loop therapy: Where are we in 2021? Diabetes Obes Metab. 2020 7 Forthcoming consensus statement offers guidance on DIY closed-looping. Medicine Matters. 5 June 2021 8 #WeAreNotWaiting - Using innovative, do-it-yourself hacks, healthcare consumers are creating solutions to help manage their diabetes. Genome Magazine 3 April 2018 9 Jeyaventhan R, Gallen G, Choudhary P et al. A real-world study of user characteristics, safety and efficacy of open-source closed-loop systems and Medtronic 670G. Diabetes Obes Metab. 2021:23(8):1989-1994 10 NICE guidance: insulin pump therapy for diabetes accessed 8 November 2021 11 Roberts J, Moore V, Quigley M. Prescribing unapproved medical devices? The case of DIY artificial pancreas systems. Medical Law International. 2021:21(1):42-68 12 The DIY artificial pancreas: Who is liable if something goes wrong? University of Birmingham website. 28 May 2020 13 Toffanin C, Kozak M, Sumnik Z et al. In Silico Trials of an Open-Source Android-Based Artificial Pancreas: A New Paradigm to Test Safety and Efficacy of Do-It-Yourself Systems. Diabetes technology & therapeutics. 2020:22(2):112-120 14 Melmer A, Züger T, Lewis D et al. Glycaemic control in individuals with type 1 diabetes using an open source artificial pancreas system. Diabetes Obes Metab. 2019:21(10):2333-2337 15 Lewis D. Errors of Commission or Omission: The Net Risk Safety Analysis Conversation We Should Be Having Around Automated Insulin Delivery Systems. Diabetic Medicine. 2021:9 16 Lal R, Ekhlaspour L, Hood K et al. Realizing a Closed-Loop (Artificial Pancreas) System for the Treatment of Type 1 Diabetes. Endocrine Reviews. 2019:40(6):1521–1546 17 Kesavadev J, Srinivasan S, Saboo B et al. The Do-It-Yourself Artificial Pancreas: A Comprehensive Review. Diabetes Ther. 2020:11(6):1217-1235