Home » Tandem Diabetes Care Reports Positive Results From Two Studies of the t:slim X2 Insulin Pump With Control-IQ Technology

Tandem Diabetes Care Reports Positive Results From Two Studies of the t:slim X2 Insulin Pump With Control-IQ Technology

by 100IQ Win The Knowledge



Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery
and diabetes technology company, today announced positive results from
two studies of the t:slim X2™ insulin pump with Control-IQ™ advanced
hybrid closed-loop technology. Data from both studies demonstrated that
the system achieved the primary outcome of increasing time in range
(70-180 mg/dL) without any severe hypoglycemic events. The t:slim X2
insulin pump with Control-IQ technology utilizes Dexcom G6 continuous
glucose monitoring (CGM) sensor values to predict glucose levels and
adjust insulin delivery to prevent highs and lows, while still allowing
the user to manually bolus for meals. The system also automates
correction boluses, which is a feature not commercially available today
on automated insulin delivery devices.


Details from the two studies, which included Protocol 3 (DCLP3) of the
National Institutes of Health (NIH)-funded International Diabetes Closed
Loop (iDCL) trial and interim data from the Freelife Kid AP study, were
presented today at the 79th Scientific Sessions of the
American Diabetes Association (ADA) in a session moderated by Dr. Boris
Kovatchev, Director of the Center for Diabetes Technology at the
University of Virginia and principal investigator of the iDCL Trials.
Presenters included Dr. Sue Brown, Associate Professor at the Center for
Diabetes Technology at the University of Virginia and the
endocrinologist who served as the protocol chair for this trial, and Dr.
Eric Renard, Division Chief of Diabetic Medicine at University Hospital
Center of Montpellier and the principal investigator for the Freelife
Kid AP study.


International Diabetes Closed Loop Protocol-3 (DCLP3) Study Results


The NIH-funded DCLP3 study is the first large-scale, 6-month closed-loop
study that included a dedicated control group, increasing the clinical
significance of the study results. There were no exclusion criteria
based on hemoglobin A1c (HbA1c), history of acute complications, or
previous experience using an insulin pump or CGM. Following a two to
eight-week run-in period, the length of which was determined based on
previous pump and CGM experience, 168 patients with type 1 diabetes ages
14 and up were randomized 2:1 to Control-IQ technology (n=112) or
sensor-augmented pump (SAP) therapy (n=56) and followed for 26 weeks.
The entry HbA1c for participants in the study ranged from 5.4 to 10.6
with a mean of 7.4 percent. Approximately 20 percent of participants
were new to pump therapy and the large majority were already using a
CGM. All participants completed the study.


Glycemic Control – Time in range (70 mg/dL – 180 mg/dL) for
participants using Control-IQ technology for 6 months was 71 percent per
day compared to 59 percent per day for participants in the control group
using SAP alone (p<0.0001). During the overnight period, time in range
with Control-IQ technology was 76 percent compared to 59 percent in the
control group (p<0.0001). Time spent with glucose values above 180 mg/dL
was 27 percent in those using Control-IQ technology compared to 39
percent in the control group (p<0.001). Time spent below 70 mg/dL was
1.4 percent with Control-IQ technology compared to 1.9 percent in the
control group (p<0.001), and time spent below 54 mg/dL was 0.32 percent
compared to 0.21 percent in the control group (p=0.02). These results
were demonstrated in people with and without prior experience with
insulin pump therapy. In addition to time in range, those using
Control-IQ technology also saw statistically significant improvements in
HbA1cand reductions in mean glucose. One report of diabetic
ketoacidosis (DKA) was reported in the Control-IQ study arm due to an
infusion set failure. No severe hypoglycemia was reported in the study.


System Performance and Usability – The system operated in active
closed-loop mode an average of 92 percent of the time. Those using
Control-IQ technology also participated in a technology acceptance
survey to assess the impact the system had in their lives, and their
general feelings about how simple or burdensome they found the
technology. On a five-point scale, with 1 representing “not at all” and
5 representing “extremely”, participants rated the Control-IQ system a
4.8 for desire to continue use of the system, 4.7 for ease of use, 4.6
for usefulness and, 4.5 for trust.


“The contributions of the iDCL Trial to the body of automated insulin
delivery research and its implications for the future of closed-loop
technology is invaluable to the diabetes community,” said Dr. Kovatchev.
“The NIH have provided an incredible service with their forward-thinking
approach and support for this enormous undertaking.”


The iDCL trial was funded by the NIH’s National Institute of Diabetes
and Digestive and Kidney Diseases under grant DK108483.


Freelife Kid AP Study Results


The Freelife Kid AP study is a multi-center, randomized assessment of
the efficacy of closed-loop insulin therapy in prepubertal children,
comparing nocturnal and 24-hour use of Control-IQ technology over 18
weeks, followed by an 18-week extension. The completed study, taking
place in France, is expected to include 120 participants with type 1
diabetes ages 6 to 12 years old. An interim analysis was planned after
12 weeks from the first 30 included subjects to assess percent of time
in closed-loop mode, incidence of any severe adverse events and efficacy
measures based on CGM data.


Glycemic Control –Time in range (70 mg/dL – 180 mg/dL) at 12
weeks for participants using the Control-IQ feature full time increased
from 60 percent to 72 percent per day overall (p<0.001) and 83 percent
during the overnight period. Time spent with glucose values above 180
mg/dL was reduced from 36 percent to 25 percent (p<0.001), and time
spent below 70 mg/dL was reduced from 4 percent to 3 percent (p=0.006).
In addition to time in range, study participants using Control-IQ
technology full time also saw a reduction in mean glucose. No severe
hypoglycemia was reported.


System Performance – The system operated in active closed-loop
mode an average of 97 percent of the time in the group using the
Control-IQ feature 24 hours per day.


“Waking up with glucose levels in control decreases the risk of both
high and low blood glucose throughout the entire day, so the
improvements in time in range seen in these studies using Control-IQ
technology, particularly in the overnight period, are extremely
compelling,” said Dr. Renard. “But not only do new hybrid closed-loop
systems need to be effective at improving glycemic control, they must
also be easy to understand and use so patients can experience the full
benefits of the technology. The t:slim X2 insulin pump with Control-IQ
technology easily achieved both of these objectives.”


About the t:slim X2 Insulin Pump with Control-IQ Technology


The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6
CGM sensor values to predict glucose levels 30 minutes ahead and adjust
insulin delivery to help prevent highs and lows, while still allowing
the user to manually bolus for meals. The system also automates
correction boluses, which is a feature not commercially available today
on automated insulin delivery devices. Control-IQ technology was created
from a series of algorithms developed by TypeZero Technologies, now a
wholly owned subsidiary of Dexcom, from initial research conducted at
the University of Virginia. Tandem entered in to a worldwide,
non-exclusive license for use of TypeZero’s technology in July 2016.
Prior to this, a phone-based system running the TypeZero algorithms had
been used in over 30 clinical studies that included more than 450
participants.


“The Control-IQ technology data presented today are a testament to our
commitment to offer customers simple-to-use products that deliver
superior performance,” said John Sheridan, president and CEO of Tandem
Diabetes Care. “We plan to submit data from the DCLP3 study in a
regulatory filing to the FDA in the coming weeks and continue to prepare
for commercial launch of the t:slim X2 with Control-IQ technology in the
second half of 2019, subject to FDA approval.”


“Combining Tandem’s t:slim X2 pump with Control-IQ technology and the
exceptional accuracy of our Dexcom G6 CGM which requires zero
fingersticks for operation has delivered what promises to be the most
advanced, simple-to-use hybrid closed-loop system to date,” said Kevin
Sayer, president and CEO of Dexcom. “The impressive data released today,
combined with our iCGM classification, will help to accelerate
innovation and bring powerful insulin delivery tools to people with
diabetes more quickly.”


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’s flagship product, the t:slim X2
insulin pump, is capable of remote software updates using a personal
computer and features integrated continuous glucose monitoring. Tandem
is based in San Diego, California.


Tandem Diabetes Care is a registered trademark, and t:slim X2 and
Control-IQ are trademarks of Tandem Diabetes Care, Inc. Dexcom and
Dexcom G6 are registered trademarks of Dexcom, Inc. All other trademarks
are the property of their respective owners.


The content in this release is the sole responsibility of the authors
and does not necessarily represent the official views or imply
endorsement of the National Institutes of Health.


Forward Looking Statement


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, that
concern matters that involve risks and uncertainties that could cause
actual results to differ materially from those anticipated or projected
in the forward-looking statements. These forward-looking statements
relate to, among other things, the implications of the iDCL Trial and
Freelife Kid AP study on the future of closed-loop insulin delivery
technology, the expected number of participants in the remainder of the
Freelife Kid AP study and the outcomes of this study, the planned
submission of data from the DCLP3 study in a regulatory filing with the
FDA, the anticipated commercial launch of the t:slim X2 insulin pump
with Control-IQ technology, and our ability to accelerate innovation
and bring insulin delivery tools to people with diabetes within
particular timeframes or at all. These statements are subject to
numerous risks and uncertainties and our actual results may differ
significantly from those expressed or implied by these statements. For
instance, we may encounter challenges that could delay or prevent the
commercial launch of the t:slim X2 insulin pump with Control-IQ
technology; the t:slim X2 pump with Control-IQ technology may not
provide the expected benefits to people with diabetes or may
have unforeseen negative effects; there may be challenges in
successfully completing ongoing clinical studies on the timeline we
expect or at all; and competitive products or other technological
developments and breakthroughs for the monitoring, treatment or
prevention of diabetes may render our products obsolete or less
desirable. Other significant risks and uncertainties include market
acceptance of our existing products and products under development by
physicians and people with diabetes; and possible future actions of the
FDA or other regulatory body with respect to the Company’s products; as
well as other risks identified in our most recent Annual Report on Form
10-K and Quarterly Reports on Form 10-Q, respectively, 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. We undertake no obligation to update or review any
forward-looking statement in this press release because of new
information, future events or other factors.



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