KITLIVING
"The fact that it is referred
to as DIY tells of its grass
roots growth. However,
the fact that these
specific set-ups are not
found via the usual routes means that
there are potential concerns about the
ethical and medico-legal implications
of their use. To be clear, DIY APS and
closed-loop systems are incredibly
similar, in some cases the same, but the
latter is commercial, right out of the box.
Whatever you call it, these systems
usually involve a pump (to put the insulin
in), a sensor (to check blood glucose) and
an algorithm (that decides less, more,
stop or same in terms of insulin delivery).
There may be an additional device, such
as a smartphone / other reader, or PDM
(personal diabetes manager). The fact
that there are so many interconnected
components is why it's called a system.
The NHS does support closed-loop
systems if they are available on the NHS.
Increasingly, however, we are finding that
HCP's in the diabetes sector are realising
that patients coming who have rigged up
their own DIY APS still need support. Data
from clinical trials is usually how systems
can be 'rubber-stamped', but these take
time. Subsequent steps are needed for
regulatory approval, a process we are all
likely more aware of in the era of Covid
vaccines. Once this has been achieved,
guidelines on the use of new devices are
issued to HCPs and eventually, once any continued over
funding issues are resolved, it will make
it into the hands of users. Further data
on safety continues to be collected and
any incidents are reported widely to raise
awareness and improve safety.
Taking control
We estimate potentially around 3000-5000
DIY APS users globally, so why would
they be doing this this if these systems are
becoming available commercially? This
routes back an online campaign that went
under the hashtag '#wearenotwaiting'.
Big companies can take a long time to get
devices and software platforms through
trials and to get passed by the FDA and
gain CE accreditation in Europe - with
just a few of the many steps highlighted
above. People who were really concerned
about either their own diabetes or - in
many instances - those who had children
with diabetes, and who also had software
and coding experience who realized that
they shouldn't/didn't have to wait to get
better control and peace of mind. The
idea that it was 'unsafe' was countered by
the fact that having diabetes and injecting
a potentially lethal drug was inherently
unsafe in some situations. There is always
some risk.
What we have been seeing is people
with diabetes directing their own care,
which is what we've been asking them
to do for decades: check your blood
glucose, count carbs, decide a dose
based on these factors plus anticipated
activity.
DIY APS users tend to have moderately
improved glycaemic outcomes, but more
than that, what they report is a significant
and, in some cases, drastically improved
quality of life. They were using algorithms
as a support for decision-making, not
spending all their time calculating carbs,
insulin ratios and so on - like any closedloop system, it automated some of
the endless calculations and decisionmaking.
What is involved with building a DIY
APS system? There are three commonly
encountered systems: Loop, Android
APS and OpenAPS. Which one is used
is often dictated by the availability of the
constituent parts. Put simply, you have to
'cherry-pick' parts of the system based
on what bits of the system you already
have. For an Android APS: a FreeStyle
Libre can be turned into a CGM to collect
data using a MiaoMiao attachment which
then feeds data into Nightscout. This
data can be entered into the algorithm,
held within the Android APS app (which
has to be built, but with readily available
codes). This algorithm will then bear the
brunt of decision making so long as it
knows your settings - you basal rates,
sensitivity factors and carbohydrate
ratios. Changes in insulin delivery rates will
be communicated to the pump - pump
availability also dictating which of the three
systems can be created. It can even deal