Strong results show potential for Horizon to
improve clinical outcomes in pediatric and adolescent age groups
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 additional promising data from the first feasibility
study of the Omnipod® Horizon™ Automated Glucose Control System
(Omnipod Horizon) hybrid closed-loop system. Initial results
presented earlier this year demonstrated Insulet’s personalized
model predictive control (MPC) 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.1 New data revealed today at the American Diabetes
Association (ADA) 77th Scientific Sessions in San Diego
demonstrated pediatric and adolescent populations experienced
positive results consistent with the performance in the adult
population, reinforcing Insulet’s expectation of the many future
benefits of the Omnipod Horizon.
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The 36-hour study included a modified version of Insulet's
Omnipod System, a Dexcom® continuous glucose sensor, and Insulet's
personalized MPC algorithm with announced meals ranging from 30-90
grams of carbohydrates and limited physical activity. Overall, the
study included 34 adults, 12 adolescents and 12 pediatric patients
with type 1 diabetes.1-3 Key findings in the pediatric and
adolescent patients included greater than 70% of time spent in the
target blood glucose range overall and approximately 85% or greater
time in the target range overnight. These initial results indicate
that the algorithm performance can address the unique challenges
faced by pediatric populations with high insulin sensitivity and
adolescents who tend to be insulin resistant.
"We are thrilled to see positive results that show the potential
of the Omnipod Horizon to improve clinical outcomes among pediatric
and adolescent age groups in addition to the adult population,
especially because of the unique challenges children with type 1
diabetes face,” said Dr. Trang Ly, Vice President and Medical
Director. "The early findings indicate this hybrid closed-loop
algorithm has demonstrated good improvements in glycemic control
during the day and night and we are looking forward to further
advances with this extremely promising system.”
"This new data for our Omnipod Horizon Automated Glucose Control
System illustrates that the technology is a potentially exciting
solution for providing exceptional glucose control for people of
all ages who are living with type 1," said Shacey Petrovic,
President and Chief Operating Officer. "Insulet is committed to
improving the lives of people with diabetes, and we’re delighted to
see the tremendous potential impact Horizon could have on improving
the quality of life and clinical outcomes for Podders.”
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.
2 Buckingham BA, Forlenza GP, Schneider J, Peyser TA, Dassau E,
Bok Lee J, O’Connor J, Layne JE, Ly TT. Safety and Feasibility of
Omnipod Hybrid Closed-Loop in Children Aged 6-12 Years with Type 1
Diabetes Using an Enhanced Personalized Model Predictive Control
Algorithm. Presented at the American Diabetes Association® (ADA)
77th Scientific Sessions, June 12, 2017.
3 Buckingham BA, Forlenza GP, Schneider J, Peyser TA, Dassau E,
Bok Lee J, O’Connor J, Layne JE, Ly TT. Safety and Feasibility of
Omnipod Hybrid Closed-Loop in Adolescents with Type 1 Diabetes
Using an Enhanced Personalized Model Predictive Control Algorithm.
Presented at the American Diabetes Association® (ADA) 77th
Scientific Sessions, June 12, 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 provides
up to three days of non-stop insulin delivery, without the need to
see or handle a needle. Insulet's Delivery Systems business also
partners with global pharmaceutical and biotechnology companies to
adapt 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
28, 2017 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, Horizon, Omnipod and Podder are
trademarks or registered trademarks of Insulet Corporation. All
rights reserved. All other trademarks are the property of their
respective owners. The use of third party trademarks does not
constitute an endorsement or imply a relationship or other
affiliation.
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Insulet CorporationDeborah R. Gordon, 978-600-7717Vice
President, Investor Relations and Corporate
Communicationsdgordon@insulet.com
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