Insulet’s Omnipod® Horizon™ Hybrid Closed-Loop System Improves Glycemic Control in Patients as Young as Two Years Old with Type 1 Diabetes
June 10, 2019
Pediatric Scientific Data for the Omnipod Horizon System Presented at
the American Diabetes Association’s 79th
Scientific Sessions
ACTON, Mass.–(BUSINESS WIRE)–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 that positive
results from the most recent clinical trial of the Omnipod® Horizon™ Automated
Insulin Delivery System (Omnipod Horizon System) were presented during
the American
Diabetes Association (ADA) 79th Scientific Sessions in San
Francisco, California. The study demonstrated that the investigational
Omnipod Horizon System performed well and was safe for up to four days
of use in children as young as two years old with type 1 diabetes.1
The study was conducted in a supervised hotel setting under free-living
conditions with unrestricted meals and daily exercise and included
pediatric participants between two and six years old. The study was
preceded by seven days of their usual therapy at home with continuous
glucose monitoring. Study participants spent significantly less time in
hyperglycemia (≥250 mg/dL), spent significantly more time in the target
glucose range (70-180 mg/dL), and had better overnight glycemic control
compared to their usual therapy, which is in line with the positive
performance observed in earlier studies including older pediatric,
adolescent and adult study participants. During the study, glucose
control was maintained in the target range for 73% of the time overall
and 85% of the time during the overnight period. The percentage of time
spent in the hypoglycemic range (<70 mg/dL) was very low, at 2.9%
overall and 2.0% overnight. The investigational Omnipod Horizon System
includes unique features that allow diabetes management to be customized
by adjusting the target blood glucose levels and insulin delivery.
“Critical for the pediatric population is the ability for caregivers, or
kids, to customize insulin delivery to maintain optimal glycemic
control, especially during exercise and following high fat meals or
periods after increased activity,” said Jennifer L. Sherr, MD, PhD, of
Yale University School of Medicine. “These data show that Insulet’s
Omnipod Horizon System is able to meet that need in our youngest
patients. This is critical, as children aged two- to six-years face
unique diabetes management challenges and they are frequently under
studied.”
“We believe it’s critical to test innovations for patients of all ages.
The results for the Omnipod Horizon System in pediatric patients as
young as two years of age are promising,” said Dr. Trang Ly, Senior Vice
President and Medical Director at Insulet. “We strive to be a
game-changer for people with diabetes and bring them safe and effective
diabetes management therapies that fit into their day-to-day lives at
all stages, from baby’s first steps to running a 5K and beyond.”
The Omnipod Horizon System is anticipated for commercial release in the
second half of 2020 and will expand upon the current Omnipod DASH System
platform. Six additional abstracts with data on Insulet’s Omnipod
Insulin Management System were selected for presentation at the ADA
scientific sessions during June 7-11, 2019.
For more about Insulet’s future innovation pipeline, please visit myomnipod.com/innovation.
1Buckingham BA, Forlenza GP, Sherr JL, Galderisi A, Lee JB,
O’Connor JB, Dumais B, Huyett LM, Layne JE, Ly TT. Safety and
Performance of the Omnipod Hybrid Closed-Loop System in Young Children
Aged 2-6 Years with Type 1 Diabetes. Presented at the ADA 79th Scientific
Sessions, June 9, 2019.
About the Omnipod DASH System:
Insulet’s Omnipod DASH System was designed to serve as the foundation
for the Company’s future innovation. Designed with patient discretion
and convenience in mind, the Omnipod DASH is a continuous insulin
delivery system consisting of two simple components: a tubeless,
waterproof*, Bluetooth® wireless technology Pod (pump)
that holds up to 200 units of U-100 insulin and a modern, color
touch-screen Personal Diabetes Manager (PDM) that controls the Pod. The
Omnipod DASH System will have a suite of optional mobile apps for users,
caregivers and HCPs to help simplify diabetes management. The Omnipod
DASH System, which received FDA clearance in June 2018, is the only DTSec and ISO
27001 certified insulin pump for cyber and information security and
safety.
About Insulet Corporation:
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is
an innovative medical device company dedicated to making the lives of
people with diabetes and other conditions easier through the use of its
Omnipod product platform. The Omnipod Insulin Management System provides
a unique alternative to traditional insulin delivery methods. With its
simple, wearable design, the disposable Pod provides up to three days of
non-stop insulin delivery, without the need to see or handle a needle.
Insulet also leverages the unique design of its Pod, by tailoring its
Omnipod technology platform for the delivery of non-insulin subcutaneous
drugs across other therapeutic areas.
For more information, please visit: www.insulet.com and 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 in February 2019 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.
*The Pod has a waterproof IP28 rating for up to 25 feet for 60
minutes. The PDM is not waterproof.
© 2019 Insulet Corporation. Omnipod, DASH, and Horizon are trademarks or
registered trademarks of Insulet Corporation. All rights reserved.
Contacts
Investor and Corporate Communications Contact:
Deborah
R. Gordon, 978-600-7717
Vice President, Investor Relations and
Corporate Communications
[email protected]
Consumer
Contact:
Natalie Toomey, 978-600-7421
Marketing
Manager, Global Public Relations & Field Programs
[email protected]