UNLIMITED, real-time readings of blood glucose without the need for a finger prick – a few years ago that seemed little more than a dream for UK diabetic patients and the NHS.
Today flash glucose monitoring devices are in routine use. In November 2020 the second generation of the FreeStyle Libre (FSL) system was approved and added to the NHS Drug Tariff for England, Wales, Scotland and Northern Ireland.
The system involves a sensor which is fixed to the skin by adhesive – usually on the back of the arm. It uses a tiny subcutaneous filament allowing glucose readings from the interstitial fluid (ISF) rather than blood. ISF readings have been proven to reliably reflect blood glucose level although there is a five to 10-minute delay in response to changes.
The latest version of FSL allows for readings taken from the sensor to be displayed on either a small meter or a smartphone app. One advantage of flash glucose monitoring devices is they allow diabetics to view continuous sensor readings plotted against desired ranges showing management over time – not just a snapshot but a view of peaks and troughs in response to variables, such as insulin dosage, meals and exercise.
A recent study* based on data from 9,159 type 1 diabetic patients found that use of the system led to better blood glucose control and a reduction in diabetes-related distress from 50 to 26 per cent.
Smartphone diagnosis
Use of devices such as FSL reflects a continuing aspiration of the NHS to employ digital technology to improve health outcomes – an aspiration that led former Health and Social Care secretary Matt Hancock to launch the digital transformation unit NHSX in 2019.
NHSX recently announced support for another smartphone-based technology to detect early stage chronic kidney disease (CKD) in patients with diabetes and high blood pressure. Developed by Israeli start-up Healthy.io, the Minuteful Kidney service transforms a smartphone camera into a clinical grade diagnostic device.
Patients receive a test kit by mail, which includes a standard urine dipstick, a urine collection pot and a colour board. An app guides the user through the test, which includes scanning the dipstick on the colour board using a standard smartphone camera. The app is able to read the dipstick results using AI and colourmetric analysis and results can then be shared remotely with a clinician for follow up.
The technology is one of 42 innovations that are being supported by the first round of the AI in Health and Care Award programme, managed by the Accelerated Access Collaborative in partnership with NHSX and the National Institute for Health Research.
A pilot project of the technology at Sussex Community NHS Foundation Trust among people with type 1 diabetes reported that the testing rate rose from zero to 79 per cent, and almost one in five were found to have abnormal or highly abnormal results.
Dr David Lipscomb, diabetes clinical lead at the Trust, said: “The service has enabled us to identify and prioritise follow-up care for people who may have early-stage chronic kidney disease that could have otherwise gone undetected. It allows us to offer our patients a new way of engaging with their care that is more convenient for both patients and staff.”
The technology is being tested and evaluated over a three-year period to explore its benefits at scale before a potential roll-out across the NHS. An independent evaluation by the York Health Economics Consortium estimates that the technology has the potential to save more than 11,000 lives and reduce NHS expenditure by £660 million over five years.
Regulation
NHSX recently launched a new assessment process to ensure that promising digital health tools, such as the Healthy.io system, meet NHS standards. The new Digital Technology Assessment Criteria (DTAC) is intended to be a rapid process that can be completed in days and designed to equip local and national NHS and social care teams with the guidance to decide which health technologies they should be buying or recommending to patients.
Rhod Joyce, deputy director of innovation development at NHSX, said: “We want to support the adoption and scale of good, safe health technologies for those buying health tech within the system, which will ultimately help NHS patients across the country.
“Through DTAC we are clearly setting out from the very start the criteria innovators need to meet for their products to be used by the NHS.”
Some medical apps are regulated as medical devices by The Medicines and Healthcare product Regulatory Agency (MHRA). It has overall responsibility for ensuring that standards are met, and developers must ensure that products considered medical devices have the necessary CE marking. This is to certify they are safe, perform as intended and that benefits outweigh risks. Brexit has led to the development of a new UK certification process (UKCA, UK Conformity Assessed), which is due to be fully enacted by 1 January 2023.
Linked devices
Another promising smartphone app has been helping patients with chronic obstructive pulmonary disease (COPD) to monitor and manage their condition at home. A trial involving 50 recovering Covid-19 patients in Bradford District and Carven CCG utilised an app developed by the Dutch firm Luscii.
In optimised form, the Luscii systems utilise a smartphone app connected wirelessly with home-based measuring devices such as BP monitors and pulse oximeters. An in-app feature called ‘Know your normal’ features simple charts and information to help patients self-manage their condition and identify when additional support may be needed, including instant alerts sent directly to a clinic. There is even a messaging service providing early warnings of changes in weather that can affect people with COPD.
Use of the Luscii systems is now set to be expanded across Bradford and Craven with over £400,000 being invested by NHS England over the next two years, allowing 6,000 COPD patients access as part of the district’s Act as One Respiratory Programme.
Dr Katherine Hickman, GP and Respiratory Lead for NHS Bradford District and Craven CCG, said: “This funding announcement is fantastic news as it gives us the opportunity to scale up the use of remote monitoring and supported self-management for people with COPD. For patients not using the Luscii App, the information pack will be provided in paper format at the point of referral that will include educational content and signposting to services and helplines.”
Digital divide
The reference here to paper highlights one serious challenge to the NHS in this brave new world of AI and smartphone healthcare apps – the digital divide that can exclude segments of society without access to internet or mobile technology, such as the elderly, homeless and deprived communities.
In a recent edition of Digital Health Unplugged, deputy director of mHabitat Pete Nuckley said: “NHS.uk is about as free as it is free to walk on the moon. So I can walk on the moon for free but I need to buy a rocket and learn how to drive a rocket, and that’s the same if you’re digitally excluded.”
How that divide is to be closed in the coming years may not be quite so neatly addressed by a technological solution.
*Deshmukh H et al. Predictors of diabetes-related distress before and after FreeStyle Libre-1 use: Lessons from the Association of British Clinical Diabetologists nationwide study. Diabetes, Obesity and Metabolism. 17 June 2021
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