Summary
This is the fourth and final Health Services Safety Investigations Body (HSSIB) report in a series considering the self-administration of insulin by people with diabetes mellitus (diabetes) in community settings. This report focuses on the availability and design of diabetes technologies and insulin pen devices. It also shares findings from across the series of investigations and identifies learning to inform strategic plans for supporting patients in community settings.
Many people with diabetes administer their own insulin to manage their blood sugar levels, either by injection or using an insulin pump. However, a disability or impairment may affect someone’s ability to safely administer their own insulin if they are not supported. This can lead to short-term and long-term health problems, which can be life threatening.
Across this series of investigations, HSSIB identified patient safety incidents in which people with diabetes requiring insulin, who also had disabilities or impairments, were harmed when they were not supported to administer their insulin safely.
Content
Findings
Diabetes technologies, such as combined glucose monitoring and insulin pump systems – which can be combined in a hybrid closed loop system – can support patient safety and wellbeing, but access to these is variable and inequitable. Difficulties accessing technology faced by people with conditions such as a learning disability could be exacerbated by current implementation plans.
Workforce capability is not keeping pace with the adoption of diabetes technologies. Community and non-specialist staff are increasingly encountering patients using diabetes technologies, but report they have limited confidence, training and support to help them care for these patients.
Some patients described choosing to use do-it-yourself closed loop systems for their insulin management, in some cases due to difficulties accessing technology on the NHS. These systems are unregulated in England and no supporting guidance is available for the NHS.
The design of insulin pen devices does not always support safe use by people with disabilities or impairments. There are gaps between manufacturers’ assurance of user-centred design and the real-world experiences of patients and staff.
There is limited guidance to help staff match insulin pen devices to individual patient needs. Staff may not have enough accessible information about which devices are best suited to people with visual, dexterity, cognitive or memory-related needs.
People with diabetes, who self-administer insulin and have co-existing disabilities or impairments, are at risk of harm where they are not supported to safely manage their care in the community.
Specialist diabetes care provision, and collaboration with other services, varies across the country; there is limited clarity on future national plans to manage the risks this variation creates for patient safety.
Living with various disabilities – including a mental health problem or learning disability – affects access to diabetes care and diabetes technology, and the safe use of insulin pen devices. Evidence of potential discrimination was also found in relation to disability and age.
Fluctuating mental capacity to make decisions about insulin self-management was repeatedly seen to contribute to patient harm. Proactive safety planning for when a person may lose capacity was limited.
Recommendations
Safety recommendation R/2026/099:
HSSIB recommends that NHS England/Department of Health and Social Care develops guidance that supports the ongoing implementation, provision and management of diabetes technology, including hybrid closed loop (HCL) systems. This guidance should:
be informed by the evaluation of real-world data around uptake and impact of the roll-out of diabetes technology to date
consider both the benefits and risks associated with HCL systems for patients with different and multiple needs – including cognitive, sensory, physical and mental health needs – and disseminate learning on where HCL systems have been effectively implemented for these patient groups
seek to support collaboration across organisations to identify educational opportunities and resources to build the capability of the healthcare workforce in relation to diabetes technology.
This is to support long-term provision and wider implementation of diabetes technology in a safe, effective and equitable way.
Safety recommendation R/2026/100:
HSSIB recommends that the Medicines and Healthcare products Regulatory Agency – through their oversight of Approved Bodies – ensures conformity assessments promote comprehensive assessment of insulin-related medical devices that:
consider the needs, characteristics and capabilities of diverse user populations, including people with protected characteristics, and the potential impact of device design on equitable access, usability and safety for the intended user
identify, assess and mitigate risks associated with intentional and unintentional misuse, including situations where a person’s physical, cognitive or mental health needs may affect the safe use of a device.
This is to support the safety of the diverse range of people who administer insulin, and to promote the development of devices that better recognise and mitigate risks associated with insulin administration.
Safety recommendation R/2026/101:
HSSIB recommends that the Association of British HealthTech Industries and the Association of the British Pharmaceutical Industry facilitate the engagement of manufacturers with healthcare and people with lived experience to inform inclusive and user-centred design of insulin pen devices based on the findings of this investigation. This is to ensure that insulin pen devices meet the diverse needs of users and address risks associated with the task of insulin administration.
Safety recommendation R/2026/102:
HSSIB recommends that NHS England/Department of Health and Social Care, working with integrated care boards, develops specifications for community and home-based diabetes care to address gaps in collaboration between provider organisations that impact on the safety of patients. This should include consideration of the:
availability of, and access to, specialist diabetes services in community settings
shared care arrangements between specialist diabetes, mental health (including specialist eating disorder), learning disability, and general practice services
capability and capacity of services to care for the increasing number of people with diabetes and the use of diabetes technologies
identification of, and ways to address, disparities in access to care, and removal of disadvantages experienced by people with protected characteristics.
This is to support a co-ordinated approach to diabetes care, such as through Neighbourhood Health plans, to enable services to safely and effectively care for people with diverse cognitive, physical, sensory and mental health needs.
Local-level learning
HSSIB investigations include local-level learning where this may help providers/organisations respond to a patient safety issue at the local level. Informed by the findings in this report, the investigation shares the following local-level learning.
How does your organisation ensure staff who are likely to be caring for patients who use diabetes technology have the required knowledge and skills to support patients to manage their technology safely?
How does your organisation support staff to explore how a patient’s disability or impairment may influence their ability to use an insulin pen device or diabetes technologies?
Does your organisation have resources to support prescribers to know which insulin pen devices are suited to patients with different disabilities or impairments?
How does your organisation ensure staff are aware of their responsibilities to report incidents associated with diabetes medication, devices and technology, including to manufacturers and the Medicines and Healthcare products Regulatory Agency?
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