Do-It-Yourself Artificial Pancreas System (DIY APS) Audit

This audit is due for launch in Q1 2020. Although primarily aimed at a UK audience we will happily accept data from verified overseas centres providing they register with our audit team. This audit will include paediatric as well as adult DIY APS users. This audit is ABCDs second device related audit following the success of the nationwide FreeStyle Libre audit which launched in 2017.

What is DIY APS?
DIY APS systems first came to attention in 2015-2016, spearheaded by the #WeAreNotWaiting movement led by Dana Lewis. Since the development of OpenAPS, the first system, two more systems have become widely used (Loop and AndroidAPS).

These systems use glucose data from a sensor (such as FreeStyle Libre or DexCom) which is communicated via bluetooth to an intermediary device, usually a smartphone. This glucose data is then entered into an algorithm which subsequently communicates with an insulin pump device to either sustain, increase, decrease or suspend insulin delivery in order to maintain glucose levels between pre-specificed target levels.  

What issues surround DIY APS?
There are an increasing number of compatible devices and pumps which mean the availability and thus utilisation of these systems is increasing all of the time. It is likely most diabetes clinics will find themselves having a handful of people with diabetes opting to use these systems.

Although users report high levels of safety and efficacy, and the constituent parts are broadly being used within remit, the combination of devices and algorithms necessary are not licensed and approved and therefore have not been subjected to robust assessment in clinical trials. Most of the data currently available to healthcare professionals, being user reported, may contain a degree of bias. There is no healthcare professional recorded safety or efficacy data published to provide objective evidence.

Whilst commercially available closed-loop systems are increasing in availability users of DIY APS argue their systems have different functionalities and in addition, most of the components utilised (certainly the sensors and pumps) are available free of the charge to the user via NHS funding in the UK.

The lack of evidence and regulation leaves healthcare professionals in a difficult ethical and medicolegal situation: should they be supporting the use of the systems or warning against? Are there potential issues even providing ongoing funding for devices which they know may be used in these systems? If a person with diabetes using these systems comes to harm, given that any robust evidence of potential risks are limited, is the healthcare professional responsible?

In response to this, Diabetes UK has produced guidance on how to approach people with diabetes who opt to use these systems and urges healthcare professionals to ensure the potential risks are emphasised at each clinical encounter. Diabetes UK also endorsed this audit programme as a means of assessing DIY APS use and ensuring outcomes are recorded.

About the ABCD nationwide DIY APS audit
Our aim is to collect routine anonymised clinical data from users of DIY APS in order to provide efficacy and safety information which may help inform future practice. In contrast to previous audits, as no clinical trial data exists for DIY systems, this will be the first healthcare professional collected dataset on these systems. We have moved away from the N3 system which means logins can be away from NHS systems but all users will be verified by the team before being allowed to input or view data. Additionally, this means we can open the audit up to a potential global audience. The on-line tool became available for general use on XXXXX. Paper forms are also available from the links below to assist with data collection prior to entry into the on-line tool. As this audit is anticipated to be retrospective i.e. a person with diabetes will arrive using DIY APS, the first “baseline form” will be needed to register the DIY APS and collect retrospective data. The “follow-up form” should then also be completed in the same visit to record data since commencement of DIY APS.

Web-based audit tool
The audit tool for the DIY APS audit is similar to that being used for the other ABCD audits. The tool is easy to use. Although no longer on N3, all data is encrypted and secured to a high level and is fully GDPR compliant meaning it has optimum security for patient identifiable data with regard to your own patients,but anonymises the data when it is utilised in the national audit. There are some special features with regard to the data export both for your own local analysis and for the nationwide analysis. The export now allows you to choose which data to download for analysis as well as providing all data. It also allows you to choose to download the data aggregated to different time points.  The tool has the facility to detect data from the same patient entered in two sites (eg hospital and primary care) and to merge the data when exported - see centres and sites below.  

Structure of the audit – centres and sites
For this audit the concept of centres and sites is utilised in the same way as in the other ABCD audits. Typically, a centre might be an NHS Trust. Sites might be hospitals associated with that Trust, and/or health centres or GP surgeries in the local vicinity. If set up in this structure, designated leaders of the local audit would be given access to download the anonymised data of all the patients associated with the centre for more powerful local analysis of data involving higher numbers. Findings so made through such local analysis could be put forward for further testing on the full national dataset.

Collect data on-line or via paper forms
The on-line audit tool will be so easy to use that live data entry in clinic is a real option to be considered. Otherwise to facilitate data collection during clinics there are two paper forms which exactly match the data that can be entered into the audit tool. The baseline registration form should be completed alongside a follow-up form at the first visit. You can download and print these forms locally via the link.