20
KIT
Do the twiist
Sequel twist Automated Insulin Delivery (AID) system
receives FDA clearance. By Sue Marshall
Sequel Med Tech and its
partner, DEKA Research &
Development Corp., have
received 510(k) clearance
from the U.S. Food and Drug
Administration (FDA) for its 'twiist'
Automated Insulin Delivery (AID)
system, powered by Tidepool.
The twiist AID system is,
according to the company, the first
drug delivery system that directly
measures the volume and flow of
insulin delivered with every microdose. Cleared
for people ages 6 and
up with Type 1 diabetes, the twiist
AID system offers the capability and
flexibility to address each patient's
individual dosing needs.
AID systems integrate data from
a continuous glucose monitoring
(CGM) device, a control algorithm,
and an insulin pump to automate
insulin delivery, providing patients
with the ability to manage their
blood sugar levels more effectively.
The twiist AID system takes
advantage of the FDA's medical
device interoperability standards,
which are designed to help patients
better tailor their treatments to their
individual needs.
Sequel CEO and Co-Founder,
Alan Lotvin, MD comments, "The
clearance of the twiist AID system
is a pivotal first step in Sequel's
quest to make day-to-day life easier
for people with Type 1 diabetes.
The twiist system combines drug
delivery technology that directly
and precisely measures each dose
of insulin, providing the opportunity
for better control and flexibility.
Sequel is working to simplify living
with diabetes by introducing product
and process innovation while
expanding access for all. It's why we
expect to distribute twiist through
the pharmacy channel so more
people with Type 1 diabetes have a
convenient, affordable way to get
started on an AID system. As we get
closer to launch, we will share more
details about additional initiatives
designed to expand access and
simplify the patient experience."
Changing tides
The twiist system incorporates
FDA-cleared Tidepool Loop
technology, which enables the
system to automatically adjust insulin
delivery based on CGM readings
and predicted glucose levels. Sequel
chose to partner with Tidepool,
a diabetes-focused non-profit
organization, because the underlying
technology is community-driven,
designed for and by people living
with diabetes, providing individuals
with a high degree of customization
and delivers the clinical results
patients are looking for.
Howard Look, President and
Chief Executive Officer of Tidepool.
"There's been a real need for
continued innovation in insulin
delivery, and the twiist AID system
powered by Tidepool represents a
substantial leap forward. The twiist
AID system takes advantage of the
Tidepool Loop algorithm, the first
and only FDA-cleared glycaemic
controller that originated as a
patient-led initiative. We are thrilled
to see twiist come to market and
bring new advancements to people
living with Type 1 diabetes."
The underlying drug delivery
technology was developed by
DEKA Research & Development
Corp., which was founded by Dean
Kamen, an American inventor and
entrepreneur who commercialized
the first wearable insulin pump
for diabetes, which he developed
while still in high school. Kamen
is a co-founder of Sequel. He
adds, "The FDA's clearance marks
a transformative moment, and
we would like to thank the FDA
for their vision of interoperability
in insulin delivery that will help
improve diabetes therapies for
years to come. The twiist system
was designed from the start to
integrate with the latest available
innovation, and it represents the next
generation of insulin delivery. The
twiist AID system reimagines how
insulin is measured and delivered
for more personalization with a
simpler design. I believe the twiist
AID system will set a new standard
for precise, dependable insulin
delivery going
www.twiist.com