Diabetes – new phase looking at standardising information from medical devices

Diabetes device data sharing

There has been a significant investment in technology to improve the lives of people with diabetes. Devices that help people to monitor and manage glucose levels lead to improved quality of life and fewer diabetes emergencies.
 
However, many of the potential benefits of this technology remain untapped. Health professionals cannot easily or quickly access patient-generated data between or during clinic sessions, whether for direct clinical care or, as a digital safety net, to support patient-initiated follow-up and ensure those who need support are prioritised for review.
 
Currently, data is often shown to the healthcare professional on a smartphone by the person with diabetes or accessed through proprietary systems. However, if integrated with electronic health records, this data could enable healthcare professionals to more easily provide better personalised treatment.
 
There is a rapidly a growing number of devices and proprietary platforms but there are currently no internationally agreed interoperability standards to enable consistent data sharing.

On this page

Background - The Diabetes Standard

Commissioned by NHS England and developed by PRSB with input from over 500 consultation participants, version 1.0 was published in 2023 with an Information Standards Notice (ISN) under section 250 of the Health and Social Care Act 2012.
 
The standard is endorsed by organisations and professional bodies including the Association of British Clinical Diabetologists, Diabetes UK, Royal Colleges of Emergency Medicine, General Practitioners, Nursing, Ophthalmologists, Psychiatrists, the Royal Pharmaceutical Society, the UK Kidney Association and the College of Podiatry.
 
The next release is planned for 2026 as part of this phase of work focused on patient-generated data from diabetes management devices.

 

 

the current diabetes standard

Aims of next phase

This next phase of work will build on the existing record standard, enabling the standardised, safe, interoperable, and scalable sharing of patient-generated data from diabetes management devices across health and care settings in England.
 
The main focus will be to support clinicians to integrate patient generated data from diabetes management devices into routine care safely and efficiently. We will also explore how this data can be used to identify people with a higher clinical risk, so that clinical resources are directed to those who need support most, particularly where capacity is limited, and services can be redesigned around a more proactive, risk based approach.
 
Throughout this work, we will collaborate with healthcare professionals, the Association of British HealthTech Industries, industry partners, Diabetes UK, and international standards initiatives to develop solutions that support the sharing of patient-generated data. This data may be captured from Continuous Glucose Monitors (CGM), insulin pumps and connected insulin pens and Hybrid Closed Loop/ Fully Closed Loop systems (which are automated insulin delivery systems: including sensor glucose readings, insulin delivery events and information about the algorithm used for calculation).

Areas of focus

1. Information models that align with the latest international clinically-validated consensus guidance for insulin and glucose metrics (e.g. time in range)
2. Scalable architectural options to support implementation of diabetes device data sharing across the NHS.
3. HL7 FHIR resources to support the sharing of data from diabetes devices based on international standards.
4. Information Governance and medico-legal guidance to provide clarity on lawful bases under UK GDPR and the common law duty of confidentiality for processing device data for direct care and population health management. Guidance will address medico-legal concerns, including clinician liability where device data is accessible outside routine appointments, clarification of expectations regarding active monitoring versus availability of data and risk management approaches and patient communications.
5. Consensus agreement for the consistent display of data supporting clinicians in safely and effectively using device data. 
6. Identification of pilot areas for testing and evaluating the outputs from this work.

Consultation

We will be seeking input as part of the consultation process and working with stakeholders to inform development of this next phase of the standard. Information and invitations to get involved will be shared as the work progresses.

Please follow our social media channels and visit this page for updates. If you are interested in contributing to this work, please complete the form below or contact us at info@theprsb.org.

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Better records for better care

CHAT theory also explicitly addresses five areas which if addressed systematically will help overcome stakeholder differences in pursuit of the common goal:

1. Understanding the artefacts that characterise the group and its activity.
• The artefacts might be clinical settings or the forms and templates used to capture and share information. During the pilot we heard about hard copy Dialog response forms; locally generated templates for collating information from different systems; letters and emails to GPs; images, poems or other non-text artefacts that service users might want to include in their ‘about me’ or care plan.

2. Understanding the multi-views of the group. Such groups are always a community of multiple points of view, traditions and interests. 
• Different participants in the group will have different roles and will bring to the group and their roles their own histories, language, and ‘rules’. During our Stocktake preparations and workshops we worked with psychiatrists, mental health nurses, occupational therapists, social workers, transformation leads and voluntary sector representatives, all professions and interests with their own language, approaches professional ‘rules’ but united in their interest in care plans, care planning.

3. Activity systems (like the ICSs) take shape and get transformed over periods of time. ‘Historicity’ is a term coined to express how the group’s problems and potentials can only be understood against their own history. 

 

• ‘We’ve always done it this way’, ‘that didn’t work before’, ‘it’s always like this’, ‘it wasn’t always like this’, ‘they are changing things again’, are all typical statements that often frustrate those charged with overseeing change initiatives. Without addressing the experiences that lie behind such comments you risk repeating mistakes of the past, alienating your stakeholders or just not understanding the real starting point for your transformation project. This is particularly the case for the implementation of the PCSP standard, the success of which will be largely reliant on point-of-care practices and information protocols as well as having systems which are user friendly and appropriately configured.

4. The central role of contradictions as sources of change and development. Contradictions are not the same as problems or conflicts. Contradictions are historically accumulating structural tensions within and between activity systems. Collectively addressing contradictions in how policy, practice, culture and technology interact will empower teams to find genuinely novel solutions for apparently intractable challenges, like interoperability and shared care plan/planning. 

This links to the fifth principle that:

5. the possibility of expansive transformations in activity systems. As the contradictions of an activity system are aggravated, some individual participants begin to question and deviate from its established norms. In some cases, this escalates into collaborative envisioning and a deliberate collective change effort. “An expansive transformation is accomplished when the object and motive of the activity are re-conceptualised to embrace a radically wider horizon of possibilities than in the previous mode of the activity.”

Successful teams have the functional skills to lead a task, benefit from diversity, and are led in a way that creates time and space for reflection; the ability to take stock periodically, of the task and of the way in which the team is engaged in delivering it. Your stakeholder analysis [HYPERLINK] should help you assemble the most appropriate team and identify how the team interacts and relates to other stakeholders like sponsors, services users, etc.

The variation in the size, both in terms of population served and numbers of constituent organisations, and of complexity, between Integrated Care Systems, precludes the possibility of any prescriptive guidance on the way in which this team is assembled.

Engeström’s expansive learning cycle of learning actions explains how there are 7 stages of learning actions;