SAN DIEGO--(BUSINESS WIRE)--
Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and
manufacturer of the only touchscreen insulin pumps available in the
United States, today presented results from a feasibility study for its
predictive low glucose suspend (PLGS) algorithm, designed to suspend
insulin delivery when low blood sugar is predicted. The data was
presented by Dr. Gregory Forlenza of the Barbara Davis Center for
Diabetes during an oral abstract presentation at the 77th
Scientific Sessions of the American Diabetes Association (ADA) in San
Diego, CA.
The overnight, hospital-based study recruited 10 subjects with type 1
diabetes ages 18 to 30 years old at the Barbara Davis Center for
Diabetes and Stanford University. Participants started on the PLGS
system in the evening, and low glucose was induced via increased basal
insulin overnight. The system performed as expected during the study,
successfully suspending insulin delivery when continuous glucose
monitoring (CGM) values were predicted to be below 80 mg/dL in the next
30 minutes, and subsequently resuming insulin when CGM values began to
rise. No hypoglycemic events were observed during the study, defined as
reference glucose values < 60 mg/dL, and peak CGM values two hours after
suspension averaged 91 mg/dl, reflecting normal glycemic control without
rebound hyperglycemia.
"The Tandem predictive low glucose suspend algorithm was extremely
effective in anticipating low blood sugar and modulating insulin
delivery accordingly," said Gregory Forlenza, MD, Assistant Professor of
Pediatrics at the Barbara Davis Center for Diabetes. "The touchscreen on
the Tandem pump was simple to read and interpret, and this algorithm
requires minimal interaction to operate. Based on this study, we are
enthusiastic about the potential for this product, and we look forward
to seeing data from the upcoming pivotal trial."
"The results from this feasibility study are very encouraging. The IDE
for our pivotal trial, which will use the predictive low glucose suspend
algorithm on a t:slim X2™ Pump with Dexcom G5® Mobile CGM integration,
was approved by the FDA in May, and we look forward to starting
enrollment soon," said Kim Blickenstaff, president and CEO of Tandem
Diabetes Care. "Our goal remains to submit our t:slim X2 Pump with
predictive low glucose suspend to the FDA later this year, and we
continue to plan for launch of this product in early 2018, subject to
FDA approval."
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com)
is a medical device company with an innovative, user-centric and
integrated approach to the design, development and commercialization of
products for people with diabetes who use insulin. The Company
manufactures and sells the t:slim X2™ Insulin Pump, the slimmest and
smallest durable insulin pump currently on the market, the t:flex®
Insulin Pump, the first pump designed for people with greater insulin
requirements, and the t:slim G4™ Insulin Pump, the first continuous
glucose monitoring-enabled pump with touchscreen simplicity. Tandem is
based in San Diego, California.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2,
#tslimG4, #tflex, #tconnect, and $TNDM.
Follow Tandem Diabetes Care
on Facebook at www.facebook.com/TandemDiabetes.
Follow
Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.
Tandem Diabetes Care is a registered trademark, and t:slim X2 and t:slim
G4 are trademarks of Tandem Diabetes Care, Inc. Dexcom and Dexcom G5 are
registered trademarks of Dexcom, Inc. All other trademarks are the
property of their respective owners.
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
include statements regarding the Company's plans to commence enrollment
in the pivotal trial for the PLGS algorithm soon, submit the PLGS
algorithm to the FDA later this year and launch the product in early
2018. The Company's actual results may differ materially from those
indicated in these forward-looking statements due to numerous risks and
uncertainties, including the Company's ability to coordinate and
implement the appropriate training of personnel at each clinical trial
site for the performance of the study, the Company's reliance on third
parties to commence the enrollment for the clinical trial when
anticipated and to devote sufficient resources to the completion of the
study, the Company's ability to successfully complete clinical trials
for new products when anticipated (or at all), the potential that the
results of any such clinical trials may not be sufficient to support
regulatory approvals for new products as anticipated and the Company's
ability to obtain regulatory approvals for future products and product
features generally. Other risks and uncertainties are identified in the
Company's most recent Annual Report on Form 10-K and Quarterly Report on
Form 10-Q, and other documents that the Company files with the
Securities and Exchange Commission. Investors are cautioned not to place
undue reliance on these forward-looking statements, which speak only as
of the date of this release. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170612005291/en/
Tandem Diabetes Care, Inc.
Media Contact:
Steve
Sabicer, 714-907-6264
ssabicer@thesabicergroup.com
or
Investor
Contact:
Susan Morrison, 858-366-6900 x7005
smorrison@tandemdiabetes.com
Source: Tandem Diabetes Care, Inc.
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