16
NEWS
T1 and T2 in Tandem
Tandem Diabetes Care has
announced that its nextgeneration
automated insulin
delivery (AID) algorithm,
Control-IQ+ technology (ControlIQ+),
has been cleared by the United
States Food and Drug Administration
(FDA) for use by people with Type 2
diabetes ages 18 and older. ControlIQ+,
already cleared for use by people
with Type 1 diabetes, builds on the
company's Control-IQ algorithm
and includes enhancements to
accommodate input of expanded
weight and total daily insulin
ranges. Control-IQ+ is expected to
be available for new and existing
customers in the United States in
March 2025.
John Sheridan, president and
chief executive officer at Tandem,
says, "We have seen firsthand,
through numerous clinical and
real-world studies, how ControlIQ
has improved health outcomes
and quality of life for our users
with Type 1 diabetes," said. "It is a
natural evolution of our mission
to bring the same AID technology
that helped to make Tandem the #1
recommended insulin pump brand by
both healthcare providers and people
living with Type 1 diabetes to adults
with Type 2."
Major studies of Tandem's
technology in Type 1 diabetes show
immediate and sustained glycaemic
improvements, including more time
in range and improved sleep.
This expanded label indication for
tTpe 2 diabetes is based on results
from a recently completed pivotal
trial, representing the first largescale,
randomized, controlled study
of an automated insulin delivery
system, completed in more than 300
people with Type 2 diabetes. The trial
compared use of a t:slim X2 pump
with Control-IQ+ technology to a
control group who continued their
existing multiple daily injections
regimens. Both groups used a
Dexcom G6 Continuous Glucose
Monitoring (CGM) system for the
duration of the study. Full study
results will be presented at the
18th International Conference on
Advanced Technologies & Treatments
for Diabetes (ATTD) taking place
in Amsterdam, the Netherlands in
March 2025.
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