ABCD nationwide Do-It-Yourself
Artificial Pancreas
(DIY-APS) audit
This
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 24/07/2020. 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.
Caldicott Guardian
approval
The ABCD nationwide audit programme has Caldicott Guardian approval. The
programme is audit not research. The NHS encourages audit of clinical
practice and there are strict guidelines which we follow, in particular
that we only to collect data from routine clinical practice, and
analysis is of data which is anonymised.
Further information
Further enquiries may be made to the ABCD nationwide audits database
administrator of the project,
Melissa Cull.
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