– Additional data presented at the 18th
International Conference on Advanced Technologies & Treatments
for Diabetes –
Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a leading insulin
delivery and diabetes technology company, today announced
publication by The New England Journal of Medicine (NEJM) of
positive results from the company’s pivotal trial of Control-IQ+
automated insulin delivery (AID) technology in people with type 2
diabetes. The article is now available on the journal website,
www.NEJM.org. Additional study findings were presented today during
a symposium at the 18th International Conference on Advanced
Technologies & Treatments for Diabetes (ATTD) in Amsterdam, the
Netherlands.
Results published in NEJM demonstrate significant improvements
in time in range and hemoglobin A1c (A1C) in people with type 2
diabetes when using Control-IQ+ technology compared to a control
group (CGM group) who continued their pre-study insulin delivery
method in conjunction with a continuous glucose monitoring (CGM)
system. A reduction in A1C of 0.9% was observed in people using
Control-IQ+ technology (N=215) compared with 0.3% in the CGM group
(N=104). A1C reduction of 2.3% was observed with Control-IQ+ in
people entering the study with an A1C of 9% or higher. These
improvements were seen across a racially and socio-economically
diverse population spanning ages 19 to 87 years old. Both groups
used a Dexcom G6 CGM System for the duration of the study.
“This study represents the most rigorous evaluation of automated
insulin delivery technology for people with type 2 diabetes ever
conducted. The randomized controlled design and broad inclusion
goals that did not limit participation based on A1C levels allowed
us to truly determine the treatment effect of the algorithm,” said
Roy W. Beck, MD, PhD, medical director of the Jaeb Center for
Health Research, who coordinated the study. “These results
demonstrate the substantial value of Control-IQ+ technology for
people with type 2 diabetes who use insulin. It was encouraging
that even people using insulin plus a GLP-1 receptor agonist drug,
such as Ozempic, had substantial A1C improvement with the addition
of Control-IQ+ to their treatment regimen.”
“The benefits of Control-IQ+ technology were evident across an
incredibly diverse population, regardless of pre-study glycemic
control or experience with diabetes technology. In fact, those with
low and high numeracy scores at baseline did equally as well,
suggesting that the technology was simple to use regardless of
education level or their general understanding of diabetes,” said
Jordan Pinsker, MD, chief medical officer at Tandem Diabetes Care.
“These results underscore the potential of this technology to
improve outcomes for people living with type 2 diabetes who use
insulin, while helping alleviate daily therapy burden and improve
quality of life.”
Study Design
The primary outcome of the 13-week study was to evaluate change
in A1C with Control-IQ+ technology in adults ages 18 and older
living with type 2 diabetes compared to a control group who
continued their pre-study insulin regimen along with a real-time
CGM system. Additional outcomes included changes in CGM-measured
time in range, time in hyperglycemia, time in hypoglycemia, as well
as safety events including severe hypoglycemia, diabetic
ketoacidosis, and other serious adverse events.
The study included data from 319 participants across 21 clinical
centers in the United States and Canada, including one U.S.
Veterans Administration Hospital. The study population represents
one of the most diverse studies of AID technology in type 2
diabetes with 39% of participants identifying as minority race or
ethnicity, including 22% Black and 11% Hispanic. Nearly half (44%)
were on a stable dose of a GLP-1 receptor agonist and 37% were on a
stable dose of an SGLT-2 inhibitor, which they continued throughout
the study. 40% used more than 100 units of insulin per day, and
only 4% were using an insulin pump at baseline.
Importantly, participants came into the study with very varied
insulin regimens. 75% of participants were using a form of fixed
dosing to calculate meal boluses prior to joining the study. All
participants were given the option to use simplified boluses by
dosing with preset amounts of carbohydrate or units of insulin
during the study (for example, small, medium or large meals).
Key Data Highlights Published by NEJM
Glycemic Control
- Mean A1C decreased by 0.9% with Control-IQ+, from 8.2% to 7.3%,
and by 0.3% for the CGM group, from 8.1% to 7.7%.
- A1C decreased by 2.3% for those with the highest A1Cs in the
Control-IQ+ arm at the start of the study (≥9%).
- Time in range improved by 16% with Control-IQ+, resulting in
3.8 more hours/day in range (70-180 mg/dL) than baseline, and 3.4
more hours/day in range than the control group.
- Time in range increased from 48% to 64% with Control-IQ+, and
51% to 52% for the control group. The treatment effect with
Control-IQ+ was evident in the first week and sustained for the
duration of the study.
- Mean glucose, time >180 mg/dL, time >250 mg/dL, and the
frequency of prolonged hyperglycemic events were all lower with
Control-IQ+ compared to the CGM only group.
- Treatment effects of Control-IQ+ on time in range and mean
glucose were evident during both daytime and nighttime hours.
- Insulin use decreased by 8 units/day in the Control-IQ+ group,
compared to an increase of 2 units/day in the CGM group,
representing a difference of -10 units/day in favor of
Control-IQ+.
- Benefits of Control-IQ+ compared to the control group were
evident across a broad range of baseline characteristics including
sex, race/ethnicity, body mass index, income, education, and prior
experience with diabetes technology.
Safety
- Use of Control-IQ+ proved safe, raising no new safety signals
unique to type 2 diabetes users compared to previous type 1
diabetes studies.
- The frequency of hypoglycemia was low in both groups. One
severe hypoglycemic event occurred in the Control-IQ+ group, which
was successfully treated with oral carbohydrates.
- There were no DKA or hyperosmolar hyperglycemic syndrome events
in the study.
Additional Data Highlights Presented at ATTD
Additional data related to bolus behavior and system
usability/satisfaction were presented today during a symposium at
the 18th International Conference on Advanced Technologies &
Treatments for Diabetes (ATTD).
Meal Bolusing Methods
Different bolusing strategies were permitted throughout the
study, including use of a carbohydrate calculator or entering a set
amount of carbohydrate or units of insulin for small, medium, and
large meals. 75% of participants were not performing carbohydrate
counting at enrollment.
- All bolus strategies were very effective with Control-IQ+,
resulting in similar, significant reductions in A1C across
groups
- Those who used fewer user-initiated boluses, receiving a high
percent of their insulin through Control-IQ+ moderated insulin
delivery, also did well.
- No increase in hypoglycemia was observed between bolusing
methods
Usability and Satisfaction
- Patient reported outcomes related to device satisfaction and
sleep quality improved significantly with Control-IQ+ compared to
the CGM group at the end of the study.
- Control-IQ+ received high usability scores regardless of
bolusing strategy
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, a global insulin delivery and diabetes
technology company, manufactures and sells advanced automated
insulin delivery systems that reduce the burden of diabetes
management, while creating new possibilities for patients, their
loved ones, and healthcare providers. The Company’s pump portfolio
features the Tandem Mobi system and the t:slim X2 insulin pump,
both of which feature Control-IQ+ advanced hybrid closed-loop
technology. Tandem Diabetes Care is based in San Diego, California.
For more information, visit tandemdiabetes.com.
Follow @TandemDiabetes on Facebook, Instagram, LinkedIn, TikTok,
and X.
©2025 Tandem Diabetes Care, Inc. All rights reserved. Tandem
Diabetes Care, the Tandem logo, Control-IQ+, t:slim X2, and Tandem
Mobi are either registered trademarks or trademarks of Tandem
Diabetes Care, Inc. in the United States and/or other countries.
Dexcom and Dexcom G6 are either registered trademarks or trademarks
of Dexcom, Inc. in the United States and/or other countries. All
other third-party marks are the property of their respective
owners.
Forward-looking Statements
This press release contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements relate to, among other
things, the potential of Control-IQ+ to improve outcomes for people
living with type 2 diabetes who use insulin, while helping
alleviate daily therapy burden and improve quality of life. These
forward-looking statements are subject to numerous risks and
uncertainties, including risks, for example, that the real-world
clinical benefits from use of Control-IQ+ technology may not match
the results reported in the study and the level of customer
satisfaction from the use of our products, as well as other risks
identified in our most recent Annual Report on Form 10-K, Quarterly
Reports on Form 10-Q, and other documents that we file with the
Securities and Exchange Commission. Readers are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date of this release. Actual results could
differ materially from those anticipated or projected in the
forward-looking statements. Tandem undertakes no obligation to
update or review any forward-looking statement in this press
release because of new information, future events or other
factors.
Important Safety Information
RX ONLY. The t:slim X2 pump with interoperable technology (the
pump) and Control-IQ+ technology (Control-IQ+) are intended for
single patient use. The pump and Control-IQ+ are indicated for use
with NovoLog or Humalog U-100 insulin. t:slim
X2 insulin pump: The pump is intended for the subcutaneous
delivery of insulin, at set and variable rates, for the management
of diabetes mellitus in persons requiring insulin. The pump is able
to reliably and securely communicate with compatible, digitally
connected devices, including automated insulin dosing software, to
receive, execute, and confirm commands from these devices. The pump
is indicated for use in persons 2 years of age and greater.
Control-IQ+ technology: Control-IQ+
technology is intended for use with compatible integrated
continuous glucose monitors (iCGM, sold separately) and alternate
controller enabled (ACE) pumps to automatically increase, decrease,
and suspend delivery of basal insulin based on iCGM readings and
predicted glucose values. It can also deliver correction boluses
when the glucose value is predicted to exceed a predefined
threshold. Control-IQ+ technology is intended for the management of
Type 1 diabetes mellitus in persons 2 years of age and greater and
of Type 2 diabetes mellitus in persons 18 years of age and
greater.
WARNING: Control-IQ+ should not be used in anyone under
the age of 2 years old with Type 1 diabetes or under the age of 18
years old with Type 2 diabetes. It should also not be used in
patients who require less than a total daily insulin dose of 5
units of insulin per day or who weigh less than 20 pounds (9
kilograms), as those are the required minimum values needed in
order for Control-IQ+ to operate safely.
Users of the pump and Control-IQ+ must: use the insulin pump,
iCGM, and all other system components in accordance with their
respective instructions for use. Failure to follow these
instructions for use could result in an over delivery or under
delivery of insulin. This can cause hypoglycemia (low BG) or
hyperglycemia (high BG) events. Visit tandemdiabetes.com/safetyinfo
for additional important safety information.
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version on businesswire.com: https://www.businesswire.com/news/home/20250318304173/en/
Media Contact: 858-366-6900 Media@tandemdiabetes.com
Investor Contact: 858-366-6900 IR@tandemdiabetes.com
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