Technologies to support the management of type 1 diabetes have seen tremendous advances over the past few decades. Starting with the development of early insulin pumps and blood glucose meters, progress has accelerated in recent years with the development of new devices and integration with consumer electronics and cloud-based data systems. The past few weeks alone have seen news reports that Apple stores are to start selling Bluetooth-enabled glucose metres that link to the iPhone and Apple Watch, while Dexcom's G6 continuous glucose monitoring (CGM) system's software is being upgraded to work directly with Apple's smartwatch. Meanwhile, Abbott has announced a substantial ramping up of production of its flash glucose monitoring system—a variety of CGM in which glucose data are accessed retrospectively when the user flashes or scans the sensor with a receiver or smartphone—to meet increasing demand.
Other major recent developments include the approval of insulin smart pens (injector pens that record amount and timing of insulin doses, with data shared with mobile apps to track trends and make dosing recommendations), advances in CGM and insulin pump technologies, and the integration of CGM and insulin pumps into hybrid closed-loop systems that can adjust insulin delivery on the basis of live glucose measurements.
These developments make this a time of unique promise for people with type 1 diabetes, as well as parents of paediatric patients, with novel technologies offering the potential opportunity to ease the burden of self-management and to improve glycaemic control, reduce hypoglycaemia, and improve quality of life. However, important challenges remain.
On June 27, the US Food and Drug Administration (FDA) issued a warning that some Medtronic MiniMed insulin pumps were being recalled because of cybersecurity vulnerabilities, which could allow someone other than the user to connect wirelessly to a nearby pump and change the settings, with potentially dangerous consequences. Although such risks are largely theoretical (the FDA notes that it is “not aware of any reports of patient harm” related to these vulnerabilities), cybersecurity concerns are being taken seriously by the diabetes technology community. In 2016, the Diabetes Technology Society produced a voluntary Standard for Wireless Diabetes Device Security (known DTSec, updated in 2017), and in October, 2018, the Insulet Omnipod DASH insulin pump system became the first device to be certified under DTSec. Last year also saw the FDA and Health Canada release draft premarket guidance for the management of cybersecurity in medical devices generally, which should lead to improved standards for future device approvals.
Beyond technical and regulatory questions around cybersecurity, another major issue is cost and accessibility of novel diabetes technologies, with expensive devices and supplies limiting accessibility, whether based on private health insurance coverage or provision in publicly funded health systems. Even within the UK National Health Service (NHS), there is substantial geographical variation in access to diabetes technologies. In response, earlier this year the charity Diabetes UK, working with NHS England, produced a consensus guideline intended to rationalise and improve access to available technologies. The guideline—endorsed by several diabetes organisations—provides a unified pathway based on incremental use of technology monotherapies (insulin pumps, CGM, or flash glucose monitoring) or dual therapies, similar to pathways used for drug combinations during treatment intensification in patients with type 2 diabetes. The inclusion of flash glucose monitoring—which is generally cheaper and simpler to use than real-time CGM—in the guideline follows a campaign by Diabetes UK and others to end the so-called postcode lottery in availability of these devices, which led to a new NHS policy to harmonise access that came into effect in April this year.
The UK has generally lagged behind other high-income countries such as Germany and the USA in terms of patients accessing diabetes technologies. Hopefully the recommendations in the new consensus guidelines will help to ensure that more people who stand to benefit will have access to these devices. The guideline is intended both for local policy makers to ensure an integrated approach to availability and for clinicians to use as a guide for joint decision making with patients. Both functions will be important, in view of the crucial role that clinician attitudes to technology can have both in terms of access to and successful use of diabetes technologies.
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