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to work together to create an
interoperable automated insulin
pump system. Medtronic would
develop a future Bluetooth-enabled
MiniMed pump that would be
compatible with Tidepool Loop and
its app for iPhone and Apple Watch,
which was in development.
Both companies worked closely
with the FDA through the regulatory
process to garner approvals for
both the Tidepool Loop app and
the Bluetooth-enabled MiniMed
pump that works with Tidepool
Loop. This included pursuing iCGM
(Integrated Continuous Glucose
Monitoring) classification for the
Medtronic's Guardian sensor and
ACE (Alternate Controller Enabled)
pump classification for a future
Bluetooth-enabled MiniMed pump.
This is what lead the way to the
newly FDA-cleared interoperable
system. The ACE pump and iCGM
sensor components can be mixed
and matched with the Tidepool Loop
app as the user chooses.
Ali Dianaty, vice president of
research and development for the
Diabetes Group at Medtronic said
at the time, "We have been listening
and engaging with the diabetes
community to understand what is
important to them. We recognize
that collaboration with Tidepool
is a way to further drive industry
innovation. Working with Tidepool
and supporting interoperability, we
can increase the options available for
people with diabetes to manage their
condition as they seek out solutions
that help them achieve better health
and improve quality of life."
At that time, Tidepool also entered
into a partnership with Dexcom and
Medtronic to work to bring Loop
to market. The agreement meant
that Tidepool and Dexcom worked
to formally integrate the Dexcom
G6 CGM with Tidepool Loop, while
Tidepool and Medtronic worked
to integrate Tidepool Loop with a
Bluetooth-enabled MiniMed pump.
Tidepool also previously had
entered into an agreement with
Insulet to integrate an Omnipod
pump with Loop.
Device manufacturers and the
FDA have been working in recent
years to change regulations to allow
for the development of an automated
system that can be compatible with
more than one pump, CGM, or
controlling algorithm.
By January 2021, Tidepool
Loop was submitted to FDA. The
interoperable automated glycaemic
controller (iAGC), also known
as Tidepool Loop, was based on
experiences of people who make
their own artificial pump systems
(DIY APS). Tidepool Loop, an
automated insulin dosing app for
iPhone, was passed the American
Federal Drugs Administration (FDA)
for review for the management of
Type 1 diabetes. It was presented
as an interoperable automated
glycaemic controller (iAGC).
And so to January 2023.
Patient-led project
Now that it has been cleared,
Tidepool Loop is the first app for
iOS cleared for the automatic dosing
of insulin. It was a first-of-itskind project,
to take a patient-led
innovation and shepherd it through
US FDA's regulatory process with the
goal to make the app more broadly
accessible to people with diabetes
and their clinicians.
The app is designed to connect
with a variety of compatible insulin
pumps and continuous glucose
monitoring systems (CGM) to
automatically dose insulin for the
treatment of insulin-requiring
diabetes in an effort to keep a user's
glucose level within the desired
range. The goal of the interoperable
design is to provide flexibility for
users - and their healthcare teams -
so that they can choose compatible
components to which they either
The tide does turn.