Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin
delivery and diabetes technology company, announced data presented
this week on real-world use of the t:slim X2™ insulin pump with
Control-IQ™ advanced hybrid closed-loop technology at the 14th
International Conference on Advanced Technologies and Treatments
for Diabetes (ATTD). Several presentations detailed positive
outcomes, including a plenary session today by Boris Kovatchev,
PhD, Director of the Center for Diabetes Technology at the
University of Virginia, which demonstrated immediate and sustained
improvements in time in range (TIR) in more than 9,000 people with
diabetes who wore the system for 12 months.
“Experience matters in automated insulin dosing systems, and
Control-IQ technology is performing as well in the real world as it
did in the pivotal studies,” said Dr. Jordan Pinsker, Medical
Director at Tandem Diabetes Care. "Additionally, patient-reported
outcomes, including reduced diabetes burden and improved sleep
quality, demonstrate that our Control-IQ technology can make a
positive and sustained impact on the lives of people with
diabetes.”
ATTD PRESENTATION
SUMMARIES
Glycemic trends in people with type 1 diabetes based on their
time of adoption of Control-IQ technology. Session: 270 - Oral
Presentation 08 Thursday, June 3, 2021 @ 20:30 - 21:40 CET
This presentation reported glycemic trends in people with type 1
diabetes based on their time of adoption of the t:slim X2 insulin
pump with Control-IQ technology. Study sample included 6,233 people
with type 1 diabetes who had initiated Control-IQ technology
between its launch (January 15, 2020) and July 15, 2020.
Participants were divided into three groups based on their time of
adoption: within four weeks of launch (Group A), between 3-4 months
(Group B) and 5-6 months (Group C). Irrespective of when Control-IQ
technology was adopted, significant improvements in sensor TIR were
experienced by all groups.
Quality of life outcomes and glycemic control from the t:slim
X2 pump with Control-IQ technology – real-world observations from
the CLIO study. Session: 360 - Oral Presentation 11 Friday,
June 4, 2021 @ 17:15 - 18:25 CET
This presentation reported outcomes from the ongoing Control-IQ
Observational (CLIO) Study evaluating real-world use of the t:slim
X2 insulin pump with Control-IQ technology in diverse groups of
people with type 1 diabetes. The study sample included 700
participants from diverse ethnic groups who had uploaded at least
21 days of pump data to the t:connect™ web application (Tandem
Diabetes Care, US only) and had at least 75 percent CGM use during
this time. Participants completed patient-reported outcome measures
at baseline and three months after study start. Continued use of
t:slim X2 pump with Control-IQ technology resulted in sensor time
in range of 72.5 percent (median, IQR=71-73 percent) and sensor
time <70 mg/dl of 1.1 percent (median, IQR=1.3-1.2 percent). In
conjunction with improved glycemic profiles, data from validated
quality of life survey measures completed by participants at
baseline and three months showed significant reductions in diabetes
impact and greater satisfaction with Control-IQ technology compared
to their prior insulin delivery devices.
Plenary Session: Advances in Closed-Loop Systems – Lessons
Learnt from Clinical Studies. Plenary Session 03 Friday, June
4, 2021 @ 18:30 - 20:05 CET
Boris Kovatchev, Ph.D. from the University of Virginia Centers
for Diabetes Technology presented outcomes from 12 consecutive
months of real-world Control-IQ technology use, representing more
than 1 billion data points analyzed. Results showed an overall
median Time in Range of 73.6% (increase of 10% from baseline,
63.6%), mirroring results from the pivotal trials. The median
percent time in automation or “closed-loop” was 94.2%. Median
percent time below 70 mg/dL remained constant at approximately
1%.
Corporate Symposium: Catching Some ZZZ’s. A symposium on user
experience and clinical outcomes with the t:slim X2 insulin pump
with Control-IQ technology. Friday, June 4, 2021 @ 17:15-18:15
CET
This symposium featured three short talks, providing insights
and information on the Control-IQ algorithm and system performance,
patient-reported outcomes on quality of life, and implications for
clinical practice. Real-world analysis of more than 72,000
individuals using Control-IQ technology showed significant
improvements in nighttime glycemic control. Validated
patient-reported outcomes measures were used to qualitatively
confirm a decrease in diabetes burden and increase in device
satisfaction. Specific case studies provided guidance for
practitioners on ways to optimize patient expectations and
experience.
A recording of the corporate symposium is available at
https://www.tandemdiabetes.com/providers/connect-with-us/events.
About Control-IQ Advanced Hybrid Closed-Loop
Technology
The t:slim X2 insulin pump with Control-IQ technology uses
Dexcom G6 CGM values, in conjunction with other variables such as
insulin on board, to predict sensor glucose levels 30 minutes ahead
and adjust insulin delivery accordingly.1,2,3 Control-IQ technology
is designed to increase sensor time in range by automatically
increasing, decreasing, or stopping insulin delivery, or giving an
automatic correction bolus based on predicted glucose levels.
Control-IQ technology also offers optional settings for sleep and
exercise that will change treatment values to better match the
different physiologic needs during these activities.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical
device company dedicated to improving the lives of people with
diabetes through relentless innovation and revolutionary customer
experience. The Company takes an innovative, user-centric approach
to the design, development, and commercialization of products for
people with diabetes who use insulin. Tandem manufactures and sells
the t:slim X2 insulin pump with Control-IQ technology. The t:slim
X2 pump is capable of remote feature updates using a personal
computer and is the only automated insulin dosing device approved
for children as young as six years old. Tandem is based in San
Diego, California.
Important Safety Information:
The t:slim X2 insulin pump with Control-IQ technology (the
System) consists of the t:slim X2 insulin pump, which contains
Control-IQ technology, and a compatible continuous glucose monitor
(CGM, sold separately). The t:slim X2 insulin pump is intended for
the subcutaneous delivery of insulin, at set and variable rates,
for the management of diabetes mellitus in people requiring
insulin. The t:slim X2 insulin pump can be used solely for
continuous insulin delivery and as part of the System. When used
with a compatible CGM, the System can be used to automatically
increase, decrease, and suspend delivery of basal insulin based on
CGM sensor readings and predicted glucose values. The System can
also deliver correction boluses when the glucose value is predicted
to exceed a predefined threshold. The pump and the System are
indicated for use in individuals six years of age and greater. The
pump and the System are intended for single user use. The pump and
the System are indicated for use with NovoRapid or Humalog U-100
insulin. The System is intended for the management of Type 1
diabetes.
WARNING: Control-IQ technology should not
be used by anyone under the age of six years old. It should also
not be used in patients who require less than 10 units of insulin
per day or who weigh less than 25 kilograms.
The System is not indicated for use in pregnant women, people on
dialysis, or critically ill users. Do not use the System if using
hydroxyurea.
Users of the pump and the System must: be willing and able to
use the insulin pump, CGM, and all other system components in
accordance with their respective instructions for use; test blood
glucose levels as recommended by their healthcare provider;
demonstrate adequate carb-counting skills; maintain sufficient
diabetes self-care skills; see healthcare provider(s) regularly;
and have adequate vision and/or hearing to recognize all functions
of the pump, including alerts, alarms, and reminders. The t:slim X2
pump and the CGM transmitter and sensor must be removed before MRI,
CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for
additional important safety information.
© 2021 Tandem Diabetes Care, Inc. All rights reserved. Tandem
Diabetes Care, t:slim X2, Control-IQ, and t:connect 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 third-party marks are
the property of their respective owners.
___________________________ 1 If glucose alerts and CGM readings
do not match symptoms or expectations or if taking over the
recommended maximum dosage amount of 1000mg of acetaminophen every
6 hours, use a blood glucose meter to make diabetes treatment
decisions. 2 Dexcom G6 CGM sold separately. 3 The Dexcom G6 CGM
transmitter can only be paired with one medical device (either a
Dexcom receiver or t:slim X2 pump) and one consumer device (phone
or tablet) at the same time.
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version on businesswire.com: https://www.businesswire.com/news/home/20210604005557/en/
Media: Steve Sabicer, 714-907-6264, ssabicer@thesabicergroup.com
Investors: Susan Morrison, 858-366-6900 x7005,
IR@tandemdiabetes.com
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