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Content ArticleDespite its prevalence, treatment of hypothyroidism has long divided opinion in the research and clinical fields. In a paper for Nature Reviews Endocrinology, I share my experience as a patient living with hypothyroidism for 16 years, as well as the difficulties I have faced in achieving consistent and effective treatment tailored to my individual needs. Hypothyroid patients will recognise many aspects of their own journey in this personal report. Achieving a prompt, accurate diagnosis and appropriate, effective treatment is difficult, sometimes impossible. NHS guidance is confusing and restrictive. There have been huge advances in the science of endocrinology in recent decades that has not filtered down to those at the coal face, dealing with patients.
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Content ArticleThyroid disease is a common endocrine disorder in women of childbearing age. There is variation in clinical practice and approach to thyroid diseases globally, in part influenced by differences in population iodine status. There remains controversy regarding testing for and management of thyroid disorders before conception, during pregnancy and postpartum. This guideline presents the available evidence for best practice and where evidence is lacking, consensus opinion by a multidisciplinary, cross-specialty team of authors is presented. Both inadequate and excessive treatment of thyroid disorders, the choice of treatment, as well as delayed commencement and adjustment of treatment, can result in detrimental effects on the pregnancy and fetus. Therefore, care should be optimised when planning pregnancy, during pregnancy and after birth, and where possible, provided by clinicians with appropriate obstetric and endocrine experience.
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Content ArticleHealthcare professionals are reminded to inform patients about the common and serious side effects associated with glucagon-like peptide-1 receptor agonists (GLP-1RAs). Advice for healthcare professionals: Inform patients upon initial prescription and when increasing the dose about the common risk of gastrointestinal side effects which may affect more than 1 in 10 patients. These are usually non-serious, however can sometimes lead to more serious complications such as severe dehydration, resulting in hospitalisation. Be aware that hypoglycaemia can occur in non-diabetic patients using some GLP-1RAs for weight management; ensure patients are aware of the symptoms and signs of hypoglycaemia and know to urgently seek medical advice should they occur. Patients should also be warned of the risk of falsified GLP-1RA medicines for weight loss if not prescribed by a registered healthcare professional, and be aware that some falsified medicines have been found to contain insulin. Be aware there have been reports of potential misuse of GLP-1RAs for unauthorised indications such as aesthetic weight loss report suspected adverse drug reactions to the Yellow Card scheme.
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Content Article
Partha Kar, National Specialty Advisor for NHS England, has led work that has had an enormous impact for patients and for patient safety. In this video podcast, Steph O'Donohue from Patient Safety Learning talks to Partha about his leadership style and how it has helped him drive forward significant change in an often challenging context. Partha talks about the power of the patient community, workforce morale, sharing failures and leading with honesty. -
Content ArticleGetting It Right First Time (GIRFT) is designed to improve the quality of care within the NHS by reducing unwarranted variations. By tackling variations in the way services are delivered across the NHS, and by sharing best practice between trusts, GIRFT identifies changes that will help improve care and patient outcomes, as well as delivering efficiencies such as the reduction of unnecessary procedures and cost savings. Poorly controlled diabetes can lead to complications including diabetic ketoacidosis (DKA), foot ulceration and amputation, sight loss, stroke and heart disease. Many of these outcomes are avoidable with better management of the condition and coordination of diabetes care services. Recommendations in this report, such as systems to support virtual clinics, can help the NHS as it faces the substantial challenge of recovering services following the COVID-19 pandemic, while remaining ready for any future surges, by operating more effectively and safely than ever before.
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Content ArticleGetting It Right First Time (GIRFT) is designed to improve the quality of care within the NHS by reducing unwarranted variations. By tackling variations in the way services are delivered across the NHS, and by sharing best practice between trusts, GIRFT identifies changes that will help improve care and patient outcomes, as well as delivering efficiencies such as the reduction of unnecessary procedures and cost savings. The endocrine system controls hormones in the body which regulate functions such as sexual development, metabolism and growth. There are over 600,000 endocrinology appointments in the NHS each year, and that number is steadily increasing. This GIRFT national report for endocrinology makes 17 recommendations to improve patient experience and outcomes in England. You will need a FutureNHS account to view this report, or you can view a short video summary which includes key recommendations.
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Content ArticleRobbie Powell, 10, from Ystradgynlais, Powys, died at Swansea's Morriston Hospital, of Addison's disease in 1990. Four months earlier Addison's disease had been suspected by paediatricians at this hospital, when an ACTH test was ordered but was not carried out. Although Robbie's GPs were informed of the suspicion of Addison's disease, the need for the ACTH test and that Robbie should be immediately admitted back to hospital, if he became unwell, this crucial and lifesaving information was not communicated to Robbie's parents. At the time of Robbie's death, the Swansea Coroner refused the Powells' request for an inquest claiming that the child had died of natural causes. However, the Powells secured a 'Fiat' [Court Order] from the Attorney General in 2000 and an inquest took place in 2004, fourteen years after Robbie died. The verdict was 'natural causes contributed by neglect' confirming that an inquest should have taken place in 1990. Since Robbie's death, his father Will Powell, has mounted a long campaign to get a public inquiry into Robbie's case. In the two weeks before his death Robbie was seen seven times by five different GPs. The child was seen by three different GPs four times in the last three days when he was so weak and dehydrated he was bedbound and unable to stand unassisted. Only one GP read the medical records, six days before death, and was aware of the suspicion of Addison's disease, the need for the ACTH test and the instruction to immediately admit the child back to hospital if he became unwell. The GP informed the Powells that he would refer Robbie back to hospital immediately that day but did not inform them that Addison's disease had been suspected. The referral letter was not typed until after Robbie had already died and was backdated to the day following the consultation. In a statement after Robbie's death this GP stated: "An Addisonian crisis is precipitated by an intercurrent illness and the stress it induces." Dyfed-Powys Police investigated Robbie's death between 1994 and 1996 but asserted, supported by the Crown prosecution Service in Wales, that there was no evidence of crimes committed by the GPs who, incidentally, were retained by this police force as police surgeons. Following a complaint by Will Powell (Robbie's father) in 1998 against the Deputy Chief Constable of Dyfed-Powys Police, regarding the inadequacies of the criminal investigation, a second criminal investigation was agreed, which commenced in January 1999. As with the first criminal investigation, there was a gross failure to adequately investigate the criminality of the doctors. This resulted in Will Powell making a formal complaint against the Chief Constable of Dyfed-Powys Police in late 1999. This complaint against the Chief Constable resulted in Dyfed-Powys Police appointing an outside police force to review Robbie's case in 2000. Detective Chief Inspector Robert Poole [DCI Poole] from West Midlands Police was appointed. DCI Poole’s investigation report, entitled 'Operation Radiance', which was based on the documents provided to Dyfed Powys Police in March 1994, by Will Powell and his solicitor, was submitted to CPS York in March 2002. This report put forward 35 suggested criminal charges against five GPs and their medical secretary. The listed charges were: gross negligence manslaughter forgery attempting to pervert the course of justice conspiracy to pervert the course of justice. DCI Poole's investigation also resulted in a disciplinary inquiry by Avon & Somerset Constabulary into Will Powell's allegations of misconduct against Dyfed-Powys Police officers with regards to their two inept criminal investigations between 1994 and 2000. Dyfed-Powys Police was found to have been 'institutionally incompetent' but no police officer was made accountable. In April 2003, Will Powell met representatives from the CPS in London, who accepted there was sufficient evidence to prosecute two GPs and their secretary for forgery and perverting the course of justice. However, they would not prosecuted because of (1) the passage of time, which was caused by a decade of cover ups between 1990 and the appointment of DCI Poole in 2000, (2) Dyfed Powys Police had provided the GPs with a letter of immunity, and (3) the available evidence had been initially overlooked by the police and the CPS, between 1994 and 2000, for a variety of reasons. Following a 2013 adjournment debate, in the House of Commons, the Director of Public Prosecutions subsequently agreed, in October 2014, that there would be an independent review of the decisions made by Crown Prosecution Service, in 2003, not to prosecute, when there was sufficient evidence to do so. The reviewing Queen's Counsels have been provided with a report, written by myself ( a healthcare IT professional, former head of IT in an NHS trust and clinician) on major anomalies in Robbie's Morriston Hospital computerised records, which were erased during the first criminal investigation between 1994 and 1996. The review has not been concluded six years on. The letter below (and also attached) from the English and Welsh Ombudsman was sent on 10 November 2020 sets out the case for a Public Inquiry.
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News Article
Covid lockdown blamed for deaths of more than 3,000 people with diabetes
Patient Safety Learning posted a news article in News
A lack of diabetes checks following the first Covid lockdown may have killed more than 3,000 people, a major NHS study suggests. Those with the condition are supposed to undergo regular checks to detect cardiac problems, infections and other changes that could prove deadly. But researchers said a move to remote forms of healthcare delivery and a reduction in routine care meant some of the most crucial physical examinations did not take place during the 12 months following the first lockdown. Experts said the findings showed patients had suffered “absolutely devastating” consequences and were being “pushed to the back of the queue”. The study, led by Prof Jonathan Valabhji, the national clinical director for diabetes and obesity, links the rise in deaths to a fall in care the previous year. It showed that, during 2020/21, just 26.5% of diabetes patients received their full set of checks, compared with 48.1% the year before. Those who got all their checks in 2019-20 but did not receive them the following year had mortality rates 66% higher than those who did not miss out, the study, published in Lancet Diabetes and Endocrinology, found. The study shows that foot checks, which rely on physical appointments, saw the sharpest drop, falling by more than 37%. “The care process with the greatest reduction was the one that requires the most in-person contact – foot surveillance – possibly reflecting issues around social distancing, lockdown measures, and the move to remote forms of healthcare delivery,” the study found. Those in the poorest areas were most likely to miss out. Read full story (paywalled) Source: The Telegraph, 30 May 2022 -
Content Article
Diabetes Update: Improving Insulin Safety in Hospital (2017)
Claire Cox posted an article in Diabetes
Medication errors are not uncommon among people with diabetes admitted to hospital and the consequences for their health can be very serious. Rowan Hillson Award winners from Derby, Sheffield and London talk to Diabetes Update about the work they are doing on insulin safety. Through its new Improving Inpatient Care programme, Diabetes UK will translate lessons learned from these examples of good practice to ensure hospital teams have the support they need to improve care for people with diabetes -
Content ArticleThe Joint British Diabetes Societies (JBDS) for Inpatient Care group was created in 2008. It aims to improve inpatient diabetes care by developing and promoting high quality evidence-based guidelines and creating better inpatient care pathways. The JBDS–IP group was created and supported by Diabetes UK, ABCD and the Diabetes Inpatient Specialist Nurse (DISN) UK group, and works with NHS England, TREND-UK and with other professional organisations. This webpage contains guidance on a wide range of subjects relating to inpatient care for people with diabetes, including: The hospital management of hypoglycaemia in adults with diabetes mellitus The management of diabetic ketoacidosis in adults Management of adults with diabetes undergoing surgery and elective procedures: improving standards Self-Management of diabetes in hospital Glycaemic management during enteral feeding for people with diabetes in hospital The management of the hyperosmolar hyperglycaemic state (HHS) in adults with diabetes Admissions avoidance and diabetes: guidance for clinical commissioning groups and clinical teams Management of hyperglycaemia and steroid (glucocorticoid) therapy The use of variable rate intravenous insulin infusion (VRIII) in medical inpatients Discharge planning for adult inpatients with diabetes Management of adults with diabetes on dialysis Managing diabetes and hyperglycaemia during labour and birth with diabetes The management of diabetes in adults and children with psychiatric disorders in inpatient settings A good inpatient diabetes service Inpatient care of the frail older adult with diabetes Diabetes at the front door The management of glycaemic control in people with cancer COncise adVice on Inpatient Diabetes (COVID:Diabetes) - hyperglycaemia Optimal staffing for a good inpatient diabetes service Using technology to support diabetes care in hospital
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Content Article
Diabetes - What the tech? poster (June 2024)
Patient-Safety-Learning posted an article in Diabetes
There has been an big increase in the use of diabetes technology in the NHS recently, especially in type 1 diabetes. Continuous glucose monitors (CGMs) are now standard care for people with type 1 diabetes, and work has begun to increase access to hybrid closed loop (HCL) systems, which are sometimes referred to as an 'artificial pancreas'. Along with this expansion, it is important to raise awareness of these devices when people with diabetes are admitted to hospital, whether this is directly for their diabetes or not. This information poster, developed by Mayank Patel and the diabetes team at University Hospital Southampton, aims to raise awareness of diabetes tech devices. It also addresses the issue of safe insulin delivery, especially related to pumps. -
Content ArticleMore than four million people have type 2 diabetes in the UK and the use of new technologies is becoming essential for effective diabetes care and patient empowerment. This report by Public Policy Projects (PPP) highlights the benefits of continuous glucose monitoring (CGM) for people with type 2 diabetes who use insulin, but finds that access remains limited due to stigma and financial barriers. The report contains findings that emerged during the second roundtable of PPP’s System-wide Strategies for Better Diabetes Care programme, which is designed to identify opportunities for improvements and transformation in diabetes care. The roundtable was attended by more than 30 sector leaders from primary and secondary care, pharmacy and integrated care system (ICS) and key industry representatives. The overarching theme was the opportunities and challenges brought by CGM technology to type 2 insulin users and other patient groups. The report finds that primary care staff are under-resourced to deal with the number of new guidelines published, and this is influencing willingness to adopt and push this technology. Also, financial constraints and stigma around the visibility of the sensor are slowing down the effective rollout of the technology across the UK.
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Content ArticleThis report from Public Policy Projects (PPP) calls for changes in the use of approved medicines to improve diabetes care in the UK. It is the first in a series looking at specific areas of diabetes care in the UK. Key findings Clinical inertia is slowing the use of medicines proven to improve outcomes for people with diabetes. Policy makers must use every available lever to encourage the use of medication that prevents complications such as heart failure and chronic kidney disease. Clinicians suggest a ‘Cardio-renal-metabolic’ outcomes bundle could be added to GP incentives to help increase uptake. Healthcare systems must employ population health management tools and technology to identify people at risk of diabetes, as well as those with unmanaged diabetes, to intervene early with lifestyle plans and using preventative medicines. There are vast inequalities in diabetes outcomes and this is compounded by stigma which impacts self-management of diabetes. There is a need to reconsider traditional healthcare models to reach underserved communities. Within diabetes using those embedded in communities such as community pharmacists and ‘Experts by Experience’ could break through some socio-economic barriers’ that prevent access to healthcare.
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Content ArticleThe adrenal glands are found in the fatty tissue at the back of the abdomen above each kidney, and produce steroid and adrenaline hormones. Surgery on tumours of the adrenal gland is uncommon compared with surgery for other tumours such as those of the breast, bowel, kidney and lung. Research has shown that the more adrenal operations a surgeon undertakes per year, the better the overall outcomes for patients undergoing that type of surgery. In this study, the outcomes from adrenal operations recorded over 18 years in the national adrenal surgical registry were analysed. The results confirmed previous findings showing that postoperative complications and length of hospital stay were reduced for patients operated by surgeons who did more adrenal operations per year. Operations done by keyhole surgery had better outcomes. Operations done either in older patients, or for the rare adrenal cancer tumours had worse outcomes, as did operations in which both adrenal glands were removed. The authors recommended that all surgeons performing adrenal surgery should monitor the outcomes of their operations, ideally in a national registry, and discuss these with patients before surgery; and undertake a minimum of six adrenal operations per year, but a minimum of 12 per year if doing surgery for adrenal cancer or surgery to remove both adrenal glands.
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Content ArticleThis leaflet aims to help people with type 1 diabetes decide between the different technologies available to manage diabetes. It contains summaries of devices available and infographics outlining eligibility criteria for continuous glucose monitors (CGM), insulin pumps and hybrid-closed loop systems. Diabetes care is one of the five clinical areas of focus for integrated care boards and partnerships to achieve system change and improve care as part of Core20Plus5 for children and young people with the aim to increase access to real-time continuous glucose monitors and insulin pumps across the most deprived quintiles and from ethnic minority backgrounds.
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Content ArticleThis report by the National Paediatric Diabetes Audit (NPDA) looks at diabetes care for children in England and Wales in 2021-22. The effectiveness of diabetes care is measured against NICE guidelines and includes treatment targets, health checks, patient education, psychological wellbeing, and assessment of diabetes-related complications including acute hospital admissions, all of which are vital for monitoring and improving the long-term health and wellbeing of children and young people with diabetes. In 2021/22, 100% of paediatric diabetes teams participated in the NPDA. Key findings The increase in incidence of Type 1 diabetes observed in the first year of the Covid-19 pandemic was followed by a continuing increase in the numbers newly diagnosed with the condition in 2021/22. Almost all of those with Type 2 diabetes were overweight or obese, and almost half had a diastolic or systolic blood pressure in the hypertensive range Despite reductions in the percentages recorded as requiring additional support between 2020/21 and 2021/22, over a third of children and young people were assessed as requiring additional psychological support outside of multidisciplinary meetings Inequalities persist in terms of the use of diabetes related technologies in relation to ethnicity and deprivation. Recommendations Commissioners should ensure adequate staffing of full multidisciplinary diabetes teams to manage the increasing numbers of cases of Type 1 and Type 2 diabetes observed since 2020, who are trained to facilitate the optimal use of new diabetes-related technologies. Children and young people with Type 1 diabetes should have equitable access to diabetes care, irrespective of social deprivation, ethnicity or geography. They should be offered a choice of diabetes technology that is appropriate for their individual needs with families being made aware of the potential differences in outcome with different modalities of insulin delivery and blood glucose monitoring. Health checks for children and young people with diabetes are essential for early recognition of complications. The need for tests and the results should be clearly communicated to families as part of their individual care package, and completion rates of checks should be monitored through the year. Awareness of diabetes symptomatology amongst the public should be enhanced to avoid newly diagnosed children and young people presenting with Diabetic ketoacidosis (DKA). Studies should be funded to derive evidence for interventions supporting pre-diabetic children young people to avoid progression to Type 2 diabetes.
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Content ArticleThis multinational research study in the journal Diabetes Research and Clinical Practice aimed to investigate perceived to people with diabetes adopting and maintaining open-source automated insulin delivery (AID) systems. 129 participants with type 1 diabetes from 31 countries were recruited online to elicit their perceived barriers towards the building and maintaining of an open-source AID system. The study identified a range of structural and individual-level barriers to the uptake of open-source AID, including: sourcing the necessary components lack of confidence in one's own technology knowledge and skills perceived time and energy required to build a system fear of losing healthcare provider support Some of these individual-level barriers may be overcome over time through the peer-support of the DIY online community as well as greater acceptance of open-source innovation among healthcare professionals. The findings have important implications for understanding the possible wider use of open-source diabetes technology solutions in the future. Further reading How safe are closed loop artificial pancreas systems?
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Content ArticleThe Office for Health Improvement and Disparities, part of the UK Government Department of Health and Social Care, highlighted an emerging signal of increased non-COVID-19-related deaths in England between July and October, 2021, with a potentially disproportionate higher increase in people with diabetes. Valabhji et al. aimed to substantiate and quantify this apparent excess mortality, and to investigate the association between diabetes routine care delivery and non-COVID-19-related-mortality in people with diabetes before and after the onset of the pandemic. They examined whether completion of eight diabetes care processes in each of the two years before the index mortality year was associated with non-COVID-19-related death. Results of the study show an increased risk of mortality in those who did not receive all eight care processes in one or both of the previous two years. These results provide evidence that the increased rate of non-COVID-19-related mortality in people with diabetes in England observed between 3 July and 15 October 2021 is associated with a reduction in completion of routine diabetes care processes following the pandemic onset in 2020.
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Content ArticleIn this article for The BMJ, Partha Kar, consultant in diabetes and endocrinology, looks at the importance of education and peer support in self-management for people with long-term conditions. He looks at how diabetes peer support and education programmes have adapted to the need for remote access during the pandemic, and suggests that increased access to these elements of diabetes care may have helped reduce diabetic ketoacidosis hospital admissions during the first wave of Covid-19.
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Content ArticleThe National Paediatric Diabetes Audit (NPDA) is performed annually in England and Wales and aims to provide information that leads to improved quality care for children and young people affected by diabetes. The audit is funded by the Department of Health through the Healthcare Quality Improvement Partnership (HQIP). Key messages in this 2020-21 annual report on care processes and outcomes include: There was an increase of an increase of 20.7% in the number of children aged 0-15 diagnosed with type 1 diabetes compared with 2019-20. Completion rates on recommended health checks were lower than in previous years due to the impact of the Covid-19 pandemic. There was wide variation between paediatric diabetes units in the completion rates of all key annual health checks. A smaller percentage of newly-diagnosed children and young people started insulin pump therapy compared to previous years. The national median HbA1c (a measure of blood glucose control) reduced from 61.5 mmol/mol to 61.0mmol/mol between 2019/20 and 2020/21, following several years of year on year decreases (improvement) in the national median. Children from ethnic minorities were less likely to be using insulin pumps and continuous glucose monitors (CGMs) than white children. However, the highest percentage increase between audit years in the use of CGMs was seen in black children and young people with type 1 diabetes.
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Content ArticleStaying in hospital can be a frightening experience for people with diabetes. In 2017, an estimated 9,600 people required rescue treatment after falling into a coma following a severe hypoglycaemic attack in hospital and 2,200 people suffered from Diabetic Ketoacidosis (DKA) due to under treatment with insulin. This report by Diabetes UK outlines the patient safety issues and suggests the following measures are needed to make hospitals safer for people with diabetes: multidisciplinary diabetes inpatient teams in all hospitals better support in hospitals for people to take ownership of their diabetes better access to systems and technology more support to help hospitals learn from mistakes strong clinical leadership from diabetes inpatient teams knowledgeable healthcare professionals who understand diabetes.
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Content ArticleThis best practice guideline for healthcare professionals covers optimum injection technique for people with diabetes taking injectable medications. It is an update to the original Injection Technique Matters guideline published in 2009. This injection technique guideline provides information on: injection depth, sites and rotation psychological and educational issues lipohypertrophy bleeding and bruising pregnancy insulin pumps safety.
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Content ArticleThis guide for people who inject insulin or GLP-1 to treat diabetes includes information on: how to correctly inject insulin where to inject to ensure insulin and GLP-1 medication enter the body correctly how to avoid ‘Lipos’ how to store medication correctly how to dispose of needles safely.
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Content ArticleThis checklist is for people who inject insulin or GLP-1 medication to treat their diabetes. It details the steps patients should take to ensure they inject their medication correctly and explains the impact of failing to take certain steps - such as moving injection sites and changing needles - on blood glucose control.
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Content Article
For World Diabetes Day, Lotty Tizzard, Patient Safety Learning's Content and Engagement Manager, takes a look at the benefits of closed-loop insulin delivery, how patients have literally led on its development, and patient safety issues associated with artificial pancreas systems. 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
