Diabetes Care - Remote HbA1c Monitoring
Overcoming the logistical issues and developing innovative care pathways SBRI Diabetes Open Innovation Challenge
SBRI Diabetes Open Innovation Challenge
Public Contracts Scotland LINK
Launch Event
A briefing event will be held Tuesday 28 March 2023 10:00 am – 12:00 pm. To register please go to: Remote HbA1c Monitoring launch event
Objective
This open innovation challenge call provides an opportunity for companies, working in partnership with NHS Scotland Regional Innovation Test Beds, to develop disruptive innovative solutions that address person-centred care, improve care pathway and optimise service delivery in HbA1c testing. Challenge The aim of the competition is to develop disruptive innovative solutions that deliver sustainable, accessible and equitable remote HbA1c self-testing. This will include the development, distribution and return of self-collection blood sample kits with instructions on self-phlebotomy for patients and integration of the results within the current NHS infrastructure.
A) Data driven approach to risk stratification and prioritisation: Identification of a clinically meaningful patient population at risk of T2DM or with existing diabetes in whom at home HbA1c may help support a virtual/hybrid care model.
B) Demonstrate an effective user friendly self-collection blood test kit, validation of the sample volume, quality and analytical performance. This includes the ability to distribute to identified patients ensuring linkage within the request of sample to patient, return for analysis and instructions for use of test and return of samples by the patient.
C) Demonstrate viable service for distribution of self-collection kit to patients and return to a UKAS accredited laboratory or by a UKAS accredited point of care testing facility (POCT) (ISO15189) method for analysis. Either the sample or the result to return to NHSinfrastructure for integration within the patient record.
Once established this solution could be utilised for testing in primary prevention and other aspects of chronic disease.
Background
Challenges in Developing Virtual Diabetes Care Models & Type 2 Diabetes Prevention
COVID Related Issues: there has been significant disruption in the management of all healthcare needs. Many services including diabetes have moved to a virtual care model. This has been beneficial in the short term but has impacted on the ability to provide long term condition surveillance and in particular HbA1c monitoring. All boards face a challenge in addressing the backlog in care. Restructuring of services as part of COVID recovery plans affords the opportunity to revise care models to provide a person-centred approach that addresses many longstanding issues such as equity of access and deprivation. High Volume: The 2020 Scottish Diabetes Survey showed there were 16,430 new type 2 diabetes diagnoses and there are 317,128 people living with diabetes in Scotland (278,239 (87.7%) with T2 and 34,087 (10.7%) with T1). This represents 5.8% of the population. 10-15% of healthcare budgets are spent treating diabetes, 80% of costs being due to preventable complications. It is estimated that around 10% of cases of type 2 diabetes remain undiagnosed . Diabetes Scotland also estimates that over 500,000 people in Scotland are at high risk of developing type 2 diabetes (T2DM) . Detecting diabetes and optimising glycaemic control is therefore paramount in improving diabetes related healthcare, societal and personal costs.
Type 2 Diabetes Prevention: there is an ongoing focus in the ‘A Healthier Future: type 2 Diabetes prevention, early detection and intervention: framework ’ on identifying individuals ‘at risk’ or with previously undiagnosed T2DM. The proposed prevention pathway involves using a risk stratification online tool e.g. Diabetes UK – Know Your Risk of Type 2 diabetes and if at increased risk having a confirmatory test, such as an HbA1c, performed.
Developing ‘once for Scotland’ care models that facilitates ready access to both risk stratification tools and confirmatory testing that does not put undue pressure on primary care services will be key to implementing the T2DM prevention framework.
The Framework also focuses on embedding remission treatment programmes across Scotland for people newly diagnosed with type 2 diabetes (within 6 years). Monitoring HbA1c is necessary to determine remission and provides the necessary encouragement to patients to continue with their diet and lifestyle interventions.
Diabetes Improvement Plan : the development of remote HbA1c testing would directly support several priorities within the Diabetes Improvement Plan. These include:
• Priority 1 - Prevention and Early Detection of Diabetes and its Complications
• Priority 2 - Type 1 Diabetes: to improve the care and outcomes of all people living with type 1 diabetes
• Priority 4 - Equity of Access: to reduce the impact of deprivation, ethnicity and other factors which can disadvantage diabetes detection, care and outcomes for people
• Priority 8 – Innovation: to accelerate the development and roll-out of innovative solutions to improve treatment, care and quality of life of people living with diabetes
Long term vision
The goal of innovation and service redesign is to support person centred care models that allow individuals ‘at risk’ or with established diabetes to detect and/or monitor their condition remotely while still receiving support via a virtual/face-to-face care model. Enhanced ability to remotely self-monitor HbA1c would:
Person-Centred Care
• Support optimisation of glycaemic control.
• Support the recognition of those individuals with undiagnosed type 2 diabetes or high risk individuals with ‘pre-diabetes’.
• Improve Equity of Access particularly in areas of significant deprivation.
Optimise Service Delivery:
• Reduce the burden on existing services which currently provide HbA1c monitoring. This will include primary and secondary care and phlebotomy resources.
• Support sustainability & positive environmental impact by reducing the need to travel to appointments for testing.
• Establish a test case to assess the feasibility of remote diagnostic testing for the diagnosis/surveillance of other medical conditions.
• Support the proposed development of mobile diabetes outreach services: on board HbA1c testing would allow opportunistic testing in ‘at risk’ individuals as well as monitoring of those with established diabetes.
Improved Care Pathways / Optimisation of Diabetes Management
• Simplify referral pathways: this may include direct self-assessment, remote testing and self-referral into T2DM prevention programmes.
• Streamline access to digital care models for those identified by remote HbA1c testing to have undiagnosed T2DM or pre-diabetes.
• Optimise Virtual Care Models – remote HbA1c testing would allow further development of virtual/hybrid care models for T1DM and T2DM, including possible integration with the T2DM Remission ConnectMe remote health pathway currently in development
Identification/Management of High Risk Cohorts
• Support timely diagnosis of ‘pre-diabetes’ and T2DM: remote testing would facilitate earlier detection and intervention for this high risk cohort.
• Provide an option for post-partum follow-up blood testing after gestational diabetes; this cohort are often lost to follow up at present.
Integrated:
• Data integration with existing infrastructure within NHS Scotland such as SCI-store/SCI-diabetes.
• Positive impact on optimising glycaemic control within virtual care models which have been developed as a response to COVID or currently being developed e.g. Remission ConnectMe pathway.
This vision aligns to several commitments within the 2021 Diabetes Improvement Plan and the implementation milestones for the Diabetes Prevention Framework. This would also support asynchronous care models in line with the Modernising Outpatient Programme. Such initiatives will work with local, regional and national NHS Boards, Regional Test beds, ConnectMe/TEC Scotland, Scottish Diabetes, National Diabetes MCN, Primary Care and Diagnostic groups to provide solutions which are readily tested, evaluated and reported in 12-18 month timescales to affect wider national strategies and NHS adoption.
Project details
Funded by the Scottish Health Industry Partnership (SHIP), organisations can apply for a share of £250,000, inclusive of VAT, split across two potential phases.
The challenge ambition is to support pre-commercial experimental development, feasibility testing and evidence gathering to enable future commercial procurement across NHS Scotland.
The programme will be delivered in up to 2 phases. This is phase 1. A decision to proceed with phase 2 will depend on the outcomes from phase 1. Only successful applicants from phase 1 will be able to apply to take part in phase 2.
It is expected that organisations can apply for a share of £250,000, inclusive of VAT over a 2 phase competition. A total of £80,000 is assigned to phase 1. Phase 1 projects can range in size up to total costs of £20,000 inclusive of VAT, for a period of 3 months. Phase 2 is expected to award 2 contracts to develop a prototype and undertake field testing for up to 12 months. Phase 2 projects can range in size up to total costs of £55,000 each inclusive of VAT.
There is a preference for projects at an advanced stage of development, near ready to be deployed in a real world situation. Projects will be expected to undertake the necessary evaluations demonstrating the prototypes in real world situations. For projects already at an advanced prototype stage, evidence of certification of the appropriate EN or ISO standard, or plans to achieve this must be provided.
Projects showing high potential but at an earlier stage of development may also be considered.
Your project’s total eligible costs must include all costs associated with any subcontractors and VAT. Successful applicants receive 100% funding and access to advice from the NHS Scotland innovation hubs.
Eligibility
To lead a project, you can: · be any type of organisation of any size, registered in the UK, European Union (EU) or the European Economic Area (EEA) that can demonstrate a credible and practical route to market.
· work alone or with others from business, research organisations, research and technology organisations or the third sector as subcontractors.
You must:
· work in conjunction with one of the NHS Scotland Innovation test beds to deliver R&D services
· provide details of certification and compliance with relevant standards, accreditation and regulatory approval for well-developed prototypes.
Contracts will be awarded to a single legal entity only.
NHS Scotland Innovation Test Beds
How to contact the NHS Scotland Innovation Test Beds:
North of Scotland Test Bed Contact: gram.nosinnovationtestbed@nhs.scot
West of Scotland Website: West of Scotland Innovation Hub
Contact: innovation@ggc.scot.nhs.uk
Health Innovation South East Scotland Website: NHS Health Innovation South East Scotland
Contact: innovations@nhslothian.scot.nhs.uk
Applicants should complete the Initial Contact Form and email it to the Test Bed they wish to partner with
Further Information
For further information on the scope of the challenge please contact innovation@ggc.scot.nhs.uk or SHIP@gov.scot
A briefing event will be held Tuesday 28 March 2023 10:00 am – 12:00 pm. To register please go to: Remote HbA1c Monitoring launch event
The Digital Health & Care Innovation Centre has produced a briefing document to support this SBRI call which provides information on the current and future state context for the introduction of remote HbA1c to enhance the route to impact at scale within NHS Scotland.
SHIP Remote HbA1c Monitoring Open Innovation Challenge - Briefing Document