Insulet Presents Strong Omnipod® Horizon™ Hybrid Closed-Loop Study Results at ATTD in Paris
February 17 2017 - 6:00AM
Business Wire
First Feasibility Study on the Automated
Glucose Control Algorithm Demonstrates Beneficial Results in Adults
with Type 1 Diabetes
Insulet Corporation (NASDAQ: PODD) (Insulet or the
Company), the leader in tubeless insulin pump technology with its
Omnipod® Insulin Management System (Omnipod System), today
announced positive results from the first feasibility study of the
Omnipod Horizon™ hybrid closed-loop system. The study demonstrated
that the Omnipod automated glucose control algorithm performed
well, was safe during the day and night for adults with type 1
diabetes, and was very effective at night with minimal hypoglycemia
and excellent fasting glucose. These data were presented today at
the 10th International Conference on Advanced Technologies &
Treatments for Diabetes (ATTD) in Paris, France. Additional studies
are underway to further validate the performance in adult and
pediatric populations.
Study participants included 24 adults with type 1 diabetes. The
36-hour study1 included a modified version of Insulet’s Omnipod, a
Dexcom® continuous glucose sensor, and Insulet’s personalized model
predictive control algorithm. Results showed use of the Company’s
hybrid closed-loop system was associated with significantly less
time spent in hypoglycemic blood glucose range compared to ranges
prior to the study. Key findings included patients achieving and
remaining in the target blood glucose control range 69% of the time
over the course of the study and maintaining target blood glucose
control 90% of the time during the overnight period.
“These very positive results, particularly in the overnight
period, demonstrate the potential for the Omnipod Horizon System to
improve clinical outcomes in patients with type 1 diabetes,” said
Dr. Bruce Buckingham, Professor of Pediatric Endocrinology at the
Lucille Salter Packard Children’s Hospital, Stanford University,
and Principal Investigator of the study. “This is a safe system
providing significant reductions in hypoglycemia both during the
day and night, and the system made significant improvements in
overnight glucose control, decreasing glucose variability and
bringing fasting glucose values into range. These are very positive
early findings and I think I speak for the entire team when I say I
am excited to see how the Horizon system continues to perform in
future clinical studies.”
“We are incredibly excited by the early results of this trial,
which demonstrated excellent glucose control and tremendous promise
to make a significant impact for patients,” said Shacey Petrovic,
President and Chief Operating Officer. “Omnipod allows our users to
feel more confident, and to experience improved quality of life and
outcomes, and we are thrilled our Omnipod Horizon System is already
demonstrating the ability to continue to make a significant impact
on improving the lives of people with diabetes.”
1 Buckingham BA, Pinsker JE, Christiansen, MP, Schneider J,
Peyser TA, Dassau E, Bok Lee J, O’Connor J, Layne JE, Ly TT.
Feasibility of Omnipod Hybrid Closed-loop Control in Adults with
Type 1 Diabetes Using an Enhanced Personalized Model Predictive
Control Algorithm. Presented at the 10th International Conference
on Advanced Technologies & Treatments for Diabetes, February
17, 2017.
About the Omnipod Insulin Management System:
The Omnipod® Insulin Management System is an innovative
continuous insulin delivery system that provides all the proven
benefits of continuous subcutaneous insulin infusion (CSII) therapy
in a way no conventional insulin pump can. The Omnipod System's
innovative design and features allows people living with diabetes
to live their life—and manage their diabetes—with unprecedented
freedom, comfort, convenience, and ease. The Omnipod System
consists of two components: (i) a Pod that stores and delivers
insulin; and (ii) a Personal Diabetes Manager (PDM) that wirelessly
programs the user's personalized insulin delivery, calculates
suggested doses and insulin on board, and has a convenient,
built-in blood glucose meter. The small, light-weight Pod can be
worn in multiple locations, including the abdomen, hip, back of
upper arm, upper thigh or lower back and, because it is waterproof
(IPX8), there is no need to remove when showering, swimming or
performing other activities. This means that Omnipod can provide up
to three days of non-stop insulin delivery, without the need to
disconnect a tube set or manually inject insulin. The Pod and
PDM communicate wirelessly to offer precise, personalized and
continuous insulin delivery with customizable basal and bolus
delivery options, as well as important safety checks. The Pod's
auto-cannula insertion is quick, simple, and virtually pain-free.
Users never have to handle a needle. The user simply pushes a
button on the PDM and the Pod's automated insertion system inserts
the cannula beneath the skin and begins delivering insulin
according to the user's programmed basal rate.
The Omnipod System is the world's first commercially available
tubeless insulin delivery system that allows users to live
untethered by tubing and without the stress and anxiety of multiple
daily injections. By breaking down the barriers to insulin pump
therapy, the Omnipod System offers freedom for users to live life
on their own terms and with the ease of use they deserve.
About Insulet Corporation:
Insulet Corporation (NASDAQ: PODD) is an innovative medical
device company dedicated to making the lives of people with
diabetes easier. Through its Omnipod Insulin Management
System, Insulet seeks to expand the use of insulin pump
therapy among people with insulin-dependent diabetes. The Omnipod
is a revolutionary and easy-to-use tubeless insulin pump that
features just two parts and a fully-automated cannula
insertion. Insulet's Delivery Systems business also
partners with global pharmaceutical and biotechnology companies to
tailor the Omnipod technology platform for the delivery of
subcutaneous drugs across multiple therapeutic areas. Founded in
2000, Insulet Corporation is based in Billerica,
Massachusetts. For more information, please
visit: http://www.myomnipod.com.
Forward-Looking Statement:
This press release may contain forward-looking statements
concerning Insulet's expectations, anticipations,
intentions, beliefs or strategies regarding the future. These
forward-looking statements are based on its current expectations
and beliefs concerning future developments and their potential
effects on Insulet. There can be no assurance that future
developments affecting Insulet will be those that it has
anticipated. These forward-looking statements involve a number of
risks, uncertainties (some of which are beyond its control) or
other assumptions that may cause actual results or performance to
be materially different from those expressed or implied by these
forward-looking statements, and other risks and uncertainties
described in its Annual Report on Form 10-K, which was filed with
the Securities and Exchange Commission on February
29, 2016 in the section entitled "Risk Factors," and in its
other filings from time to time with the Securities and
Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should any of its assumptions prove
incorrect, actual results may vary in material respects from those
projected in these forward-looking
statements. Insulet undertakes no obligation to publicly
update or revise any forward-looking statements.
© 2017 Insulet Corporation. Omnipod, the Omnipod logo, Horizon,
and the Horizon logo are trademarks or registered trademarks of
Insulet Corporation. Dexcom and Dexcom G4 are registered trademarks
of Dexcom, Inc. and used with permission. All rights reserved.
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version on businesswire.com: http://www.businesswire.com/news/home/20170217005019/en/
Investor Relations and Media Contact:Insulet
CorporationDeborah R. Gordon, 978-600-7717Vice President, Investor
Relations and Corporate Communicationsdgordon@insulet.com
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