Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin
delivery and diabetes technology company, announced positive data
presented today on its automated insulin delivery technologies,
including data from a study of the t:slim X2™ insulin pump with
Control-IQ™ advanced hybrid closed-loop technology demonstrating
increased time in range (70 mg/dL -180 mg/dL) 1 in children ages
six to thirteen. In a separate presentation, real-world data was
presented on the t:slim X2 insulin pump with Basal-IQ® predictive
low glucose technology, showing sustained reductions in sensor time
spent below 70 mg/dL and improvements in user satisfaction compared
to previous therapy. Data was presented during a corporate
symposium at the 13th International Conference on Advanced
Technologies and Treatments for Diabetes (ATTD) in Madrid,
Spain.
“These results align with our vision to establish Tandem as a
global company that provides easy-to-use insulin therapy management
solutions for improved clinical outcomes to children and adults
living with diabetes,” said John Sheridan, president and chief
executive officer. “In support of this goal, we plan to submit a
regulatory filing with the FDA next month to expand the age
indication for t:slim X2 with Control-IQ technology to include
patients 6 years of age and older.”
Control-IQ Advanced Hybrid Closed Loop Technology
Data
International Diabetes Closed Loop Protocol-5 (DCLP5) Study
Results
Details from the Protocol 5 (DCLP5) of the National Institutes
of Health (NIH)-funded International Diabetes Closed Loop (iDCL)
program, an international consortium of academic centers led by the
University of Virginia, were presented by Dr. R. Paul Wadwa,
Associate Professor of Pediatrics, at the Barbara Davis Center for
Diabetes, University of Colorado Anschutz Medical Campus, and the
protocol chair for this trial.
“This study demonstrated that in school-aged children with type
1 diabetes, who often struggle with diabetes management for a
variety of reasons, use of Control-IQ technology led to improved
glucose control during both the day and night,” said Dr. Wadwa. “We
are thrilled with these results and are hopeful that this system
will ultimately offer a valuable treatment option to benefit
children with type 1 diabetes.”
The DCLP5 study is a 16-week 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, 101 patients with type 1
diabetes ages 6 to 13 were randomized 3:1 to Control-IQ technology
(n=78) or sensor-augmented pump (SAP) therapy (n=23) and followed
for 16 weeks. The entry HbA1c for participants in the study ranged
from 5.7 to 10.1 with a mean of 7.9 in the SAP group and 7.6 in the
Control-IQ technology group. Approximately 20 percent of
participants were new to pump therapy and the large majority were
already using a CGM. All participants completed the study.
Time in range (70 mg/dL – 180 mg/dL)1 for children using
Control-IQ technology for 6 months increased from 53 percent to 67
percent, compared to those in the control group who increased from
51 percent to 55 percent using SAP alone (p<0.001). During the
overnight period, sensor time in range with Control-IQ technology
was 80 percent compared to 54 percent in the control group.
Time spent with sensor glucose values above 180 mg/dL was 31
percent in those using Control-IQ technology compared to 43 percent
in the control group (p<0.001). Sensor time spent below 70 mg/dL
was very low at baseline (<2 percent in both treatment groups)
and not different between groups at the 16-week follow up interval.
These results were demonstrated in people with and without prior
experience with insulin pump therapy. The treatment effect was
evident in the first month and appeared consistent over 4 months.
In addition to sensor time in range, those using Control-IQ
technology also saw statistically significant reductions in mean
sensor glucose.
No severe hypoglycemia or diabetic ketoacidosis (DKA) was
reported in the study. The system operated in active closed-loop 93
percent of the 4-month time period.
International Diabetes Closed Loop Protocol-3 (DCLP3) Study
Results
A review of the evolution of Control-IQ technology, and a
summary of available Control-IQ clinical data was presented by Dr.
Marc Breton, the Associate Director of Research for The Center for
Diabetes Technology at the University of Virginia, and the
Principal Investigator of the DCLP5 study. In addition, Dr. Breton
presented details from the National Institutes of Health
(NIH)-funded International Diabetes Closed Loop (iDCL) trial,
Protocol 3 (DCLP3) in adults and adolescents.
The NIH-funded DCLP3 study was the first large-scale, 6-month
closed-loop study that included a dedicated control group. There
were no exclusion criteria based on hemoglobin A1c (HbA1c), history
of acute complications, or previous experience using an insulin
pump or CGM. Time in range (70 mg/dL – 180 mg/dL)1 for participants
using Control-IQ technology for 6 months averaged 71 percent
compared to 59 percent for participants in the control group using
SAP alone (p<0.0001). During the overnight period, sensor time
in range with Control-IQ technology averaged 76 percent compared to
59 percent in the control group (p<0.0001). Time spent with
sensor 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). Sensor 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 sensor time spent below 54 mg/dL was 0.21 percent
compared to 0.24 percent in the control group (p=0.02). These
results were demonstrated in participants with and without prior
insulin pump therapy experience. In addition to sensor time in
range, those using Control-IQ technology also saw statistically
significant improvements in HbA1c and reductions in mean glucose.
One report of diabetic ketoacidosis (DKA) was reported in the
Control-IQ study arm due to an infusion set issue. No severe
hypoglycemia was reported in the study.
“We are excited to see the outcome of 15 years of research, and
have a lot of people to thank for it, including Benton Mize,
Antoine Robert, Patrick Keith-Hines, Stephen Patek, Colin Steele,
and Chad Rogers at Type Zero Technologies, who were instrumental in
transitioning the system from academia to the commercial
application,” said Dr. Breton. “After the resounding success of the
system in adolescents and adults last year in the DCLP3, it is very
rewarding to see our younger participants in the DCLP5 benefit as
well, and to the same extent.”
The iDCL program is funded by the NIH’s National Institute of
Diabetes and Digestive and Kidney Diseases under grant DK108483;
Tandem Diabetes Care partially funded the DCLP5 study.
Basal-IQ Predictive Low Glucose Suspend Technology
Data
Real World Satisfaction with Basal-IQ Technology
Details from a longitudinal satisfaction study of commercial
users of Basal-IQ technology were presented by Laurel Messer, RN,
PhD, CDE, Assistant Professor of Pediatrics at the Barbara Davis
Center for Diabetes at the University of Colorado Anschutz Medical
Campus. This study included 541 commercial users with
T1D/caregivers of T1D minors who completed the Diabetes Impact and
Device Satisfaction (DIDS) questionnaire (11 items scored on
10-point Likert scales) prior to Basal-IQ start, and 2, 4, and
6-months post-initiation. The study included people switching from
Multiple Daily Injections (MDI), non-Tandem insulin pumps, and
current Tandem pump users. Study aims were to measure device
satisfaction (e.g. ease of use, trust, perception of glucose
control) and diabetes impact (e.g. perception of sleep quality,
fear of lows, interference with daily activities). Basal-IQ
technology increased device satisfaction in former MDI and
non-Tandem pump users, and sustained satisfaction across all user
groups. Additionally, a reduction in diabetes impact was observed
by the midpoint of the study and sustained over 6 months for all
user groups.
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 accordingly2,3,4. If glucose values are
predicted to drop below 112.5 mg/dL, basal insulin delivery is
reduced, and when predicted to be below 70 mg/dL, basal insulin
delivery is stopped. If glucose values are predicted to be above
160 mg/dL in the next 30 minutes, basal insulin will be increased.
If glucose values are predicted to be above 180 mg/dL, Control-IQ
technology calculates and delivers a correction bolus with a target
of 110 mg/dL once an hour as needed. 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 Basal-IQ Predictive Low Glucose Suspend
Technology
The simple-to-use t:slim X2 insulin pump with Basal-IQ
predictive low glucose suspend technology uses glucose values from
an integrated Dexcom G6 continuous glucose monitor to predict and
help prevent lows with zero fingersticks2,3,4. Basal-IQ technology
uses CGM values to help reduce the frequency and duration of
low-glucose events by predicting glucose levels 30 minutes ahead
and suspending insulin if they are expected to drop below 80 mg/dL
or if a CGM reading falls below 70 mg/dL. Insulin delivery resumes
as soon as sensor glucose values begin to rise.
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. Tandem is based in San Diego, California.
Important Safety Information:
Caution: Federal (USA) law restricts the t:slim X2 insulin pump,
the t:slim X2 pump with Basal-IQ technology, and Control-IQ
technology to sale by or on the order of a physician. The t:slim X2
pump, the t:slim X2 pump with Basal-IQ technology, and Control-IQ
technology are intended for single patient use. The t:slim X2 pump,
the t:slim X2 pump with Basal-IQ technology, and Control-IQ
technology are indicated for use with NovoLog or Humalog U-100
insulin.
t:slim X2 insulin pump: The t:slim
X2 insulin pump with interoperable technology is an alternate
controller enabled (ACE) pump that is intended for the subcutaneous
delivery of insulin, at set and variable rates, for the management
of diabetes mellitus in people 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 individuals 6 years of age and greater.
t:slim X2 insulin pump with Basal-IQ technology: When used with a
compatible integrated continuous glucose monitor (iCGM), the t:slim
X2 insulin pump with Basal-IQ technology can be used to suspend
insulin delivery based on CGM sensor readings. The t:slim X2 pump
with Basal-IQ technology is indicated for use in individuals 6
years of age and greater. Control-IQ technology: Control-IQ
technology is intended for use with a compatible integrated
continuous glucose monitor (iCGM, sold separately) and ACE pump 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
14 years of age and greater.
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 55 pounds.
Control-IQ technology and the t:slim X2 pump with Basal-IQ
technology are not indicated for use in pregnant women, people on
dialysis, or critically ill patients. Users of the t:slim X2 pump,
the t:slim X2 pump with Basal-IQ technology, and Control-IQ
technology must: be able and willing 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, transmitter, and sensor
must be removed before MRI, CT, or diathermy treatment. For
additional important safety information, visit
tandemdiabetes.com/safetyinfo.
Tandem Diabetes Care and Basal-IQ are registered trademarks, and
t:slim X2, Control-IQ and t:simulator are trademarks of Tandem
Diabetes Care, Inc. Dexcom and Dexcom G6 are registered trademarks
of Dexcom, Inc. All other third-party marks 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 on the future of closed-loop insulin
delivery technology, the planned submission of data from the DCLP5
study in a regulatory filing with the FDA, and our ability to
accelerate innovation and bring insulin delivery solutions that
provide improved clinical outcomes 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, 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; 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.
__________ 1 As measured by CGM 2 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. 3 Dexcom G6 CGM sold separately 4 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/20200220005622/en/
Media: Steve Sabicer, 714-907-6264, ssabicer@thesabicergroup.com
Investors: Susan Morrison, 858-366-6900 x7005,
IR@tandemdiabetes.com
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