LIVINGLIVING
KIT
REPORT
Say hello to the interoperable automated glycaemic controller
(iAGC), also known as Tidepool Loop, based on experiences of
people who make their own artificial pump systems (DIY APS).
TIDEPOOL LOOP GOES TO FDA
Tidepool, an open-source diabetes
non-profit company has submitted its
automated insulin dosing app - called
Tidepool Loop -- for iPhone to the
American Federal Drugs Administration
(FDA) for review for the management of
Type 1 diabetes. This is being presented
as an interoperable automated glycaemic
controller (iAGC). If cleared, Tidepool Loop
could become the first app for iOS cleared
for the automatic dosing of insulin.
Built on the do-it-yourself diabetes
community's original Loop app, Tidepool
Loop is a first-of-its-kind 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 within
a desired correction 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 have
the best access (e.g. is approved by their
healthcare provider) or with which they
are most familiar or comfortable using in
order to manage their diabetes self-care.
Basically, it's about choice and making
things easier for those living with T1D.
Howard Look, CEO and co-founder
of Tidepool says of the submission, "We
are standing on the shoulders of giants
- people in the open-source diabetes
community who believe
management tools should
work better together
and created software
for themselves and their
community, Just two
years from kicking off the
project, we've taken that
foundation and built a
system we're proud to put
in front of the FDA. We're
committed to working
alongside the agency and
our device partners to
drive progress in the areas
of device interoperability
and access. We look
forward to FDA's review."
Tidepool Loop was
initially supported by
grants from JDRF and The
Leona M. and Harry B.
Helmsley Charitable Trust,
and further supported
by partnerships with
device makers Dexcom,
Insulet (Omnipod) and
Medtronic as well as
donations from a diverse
community of individual
funders impacted by their
experience with diabetes.
Founded in 2013, Tidepool hosts
a suite of free software tools for people
with diabetes and the clinics that serve
them, including Tidepool Web, Tidepool
Uploader, Tidepool Mobile, and - pending
FDA submission, review, and clearance -
Tidepool Loop app itself.
tidepool.org
TOP: The partners involved
in Tidepool Loop.
ABOVE: It requires a CGM,
an insulin pump and an
iPhone-based app.