Tandem Diabetes Care Presents Findings from Predictive Low Glucose Suspend (PLGS) Feasibility Study & Announces Approval of I...
June 12 2017 - 12:00PM
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170612005291/en/
Tandem Diabetes Care, Inc.Media Contact:Steve
Sabicer, 714-907-6264ssabicer@thesabicergroup.comorInvestor
Contact:Susan Morrison, 858-366-6900
x7005smorrison@tandemdiabetes.com
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