Insulet’s Randomized Controlled Trial (OP5-003) Demonstrates Omnipod® 5 Automated Insulin Delivery System is Superior to Pump Therapy
2024年3月8日 - 8:00PM
ビジネスワイヤ(英語)
Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the
global leader in tubeless insulin pump technology with its Omnipod®
brand of products, today presented positive results from its first
randomized controlled trial (RCT) showing improved glycemic and
patient-reported outcomes in type 1 diabetes with the Omnipod 5
Automated Insulin Delivery System (Omnipod 5). The OP5-003 Trial
results were presented at the 17th International Conference on
Advanced Technologies & Treatments for Diabetes (ATTD) in
Florence, Italy.
Professor Eric Renard, MD, PhD of Montpellier University
Hospital, shared evidence of the efficacy and safety of the
automated Omnipod 5 System compared to insulin pump therapy with
continuous glucose monitoring (CGM) in adults with type 1 diabetes
(T1D) in the United States and France. Omnipod 5 use led to a 17.5%
improvement in time in range (TIR), decreased HbA1c, decreased
percentage of time in hypoglycemia, and decreased mean glucose in
individuals with baseline HbA1c levels above the recommended
target.
"Omnipod 5 continues to demonstrate impressive clinical outcomes
for people with type 1 diabetes,” said Professor Renard. “We expect
this latest set of compelling evidence to have a profound impact on
international accessibility and affordability, allowing more people
with diabetes to experience the benefits provided by this
innovative technology.”
It is the first Omnipod 5 randomized controlled trial to date,
and the first time the system has been evaluated by international
participants.
“Since Omnipod 5’s first commercial launch in the United States,
we have been working diligently to expand into new markets and
improve access to this life-changing technology,” said Dr. Trang Ly
MBBS, FRACP, PhD, Insulet Senior Vice President and Medical
Director. “By gathering evidence from international participants
through a randomized controlled trial, we have demonstrated the
true benefit of using our tubeless, disposable automated insulin
delivery (AID) system to manage type 1 diabetes over alternative
forms of therapy and illustrated the superiority of Omnipod 5
compared to standard pump therapy with CGM for people with type 1
diabetes.”
Study Overview
A key objective of the OP5-003 trial was to evaluate Omnipod 5
in a population that was representative of the real world,
primarily participants with an HbA1c above 8% at baseline. Insulet
presented data for 194 adults who had used traditional (non-AID)
insulin pump therapy (including 87% using the Omnipod or Omnipod
DASH® Insulin Management System) for three months or longer and had
a HbA1c between 7 and 11% (mean 8.5%). The participants had type 1
diabetes for at least one year and were enrolled at 14 institutions
across the United States (61%) and France (39%).
The participants were randomized into two groups and studied
over the course of 13 weeks. The control group (n=62) continued to
use their usual insulin pump with a Dexcom G6 CGM, while the
intervention group (n=132) used Omnipod 5 with Dexcom G6.
Key Data Highlights
- The participants using Omnipod 5 showed a significantly greater
TIR (70-180 mg/dL) by 17.5% (43.8% in Control group versus 61.2% in
Intervention group), or an additional 4.2 hours per day, and a
greater reduction in HbA1c by 0.58% (1.24% with Omnipod 5 vs. 0.68%
in the Control group). The final HbA1c was 7.25% in the Omnipod 5
group versus 7.84% in the Control group.
- Significantly lower mean glucose and time above 180 mg/dL (%)
were also observed in the Omnipod 5 group versus the Control
group.
- Time spent below 70 mg/dL (%) was significantly lower with
Omnipod 5 by 0.36%, with mean time below 70 mg/dL (%) decreasing
from 1.66% to 1.18% with Omnipod 5, while it increased from 1.66%
to 1.75% in the Control group.
- Time below 54 mg/dL (%) was shown to be non-inferior (within a
1% margin) between the two groups. This mean value decreased from
0.32% to 0.23% with Omnipod 5 and decreased from 0.42% to 0.37% in
the Control group.
- There were zero events of severe hypoglycemia or DKA with
Omnipod 5, and one event of severe hypoglycemia and zero events of
DKA in the Control group.
- All of the primary and secondary endpoints of the study were
met. Exploratory endpoints showed no significant difference in
change in total daily dose from baseline or change in body mass
index from baseline between the Omnipod 5 and Control groups.
Insulet also presented positive patient-reported results related
to three key psychosocial measures that were included as secondary
endpoints: diabetes distress, hypoglycemia confidence, and
diabetes-related quality of life. As reported by study participants
through individual surveys, Omnipod 5 use resulted in both
statistically significant and clinically meaningful improvements in
each of these three measures compared to the Control group. These
results demonstrate that Omnipod 5 provides clinically meaningful
improvements in key psychosocial aspects of living with type 1
diabetes.
In conclusion, this multi-national, RCT data demonstrates the
superiority of the Omnipod 5 AID System compared to standard pump
therapy with CGM and indicates that it should be offered as a
first-line therapy for adults with type 1 diabetes. These results
will be submitted for publication later this year.
About Insulet Corporation:
Insulet Corporation (NASDAQ: PODD), headquartered in
Massachusetts, is an innovative medical device company dedicated to
simplifying life for people with diabetes and other conditions
through its Omnipod product platform. The Omnipod Insulin
Management System provides a unique alternative to traditional
insulin delivery methods. With its simple, wearable design, the
tubeless disposable Pod provides up to three days of non-stop
insulin delivery, without the need to see or handle a needle.
Insulet’s flagship innovation, the Omnipod 5 Automated Insulin
Delivery System, integrates with a continuous glucose monitor to
manage blood sugar with no multiple daily injections, zero
fingersticks, and can be controlled by a compatible personal
smartphone or the Omnipod 5 Controller. 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:
insulet.com and omnipod.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 23, 2024 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 materially
from those projected in these forward-looking statements. Insulet
undertakes no obligation to publicly update or revise any
forward-looking statements.
©2024 Insulet Corporation. Omnipod and Omnipod DASH are
registered trademarks of Insulet Corporation in the United States
of America and other various jurisdictions. All rights reserved.
Dexcom is a registered trademark of Dexcom, Inc. and used with
permission.
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version on businesswire.com: https://www.businesswire.com/news/home/20240308063720/en/
Investor Relations: Deborah R. Gordon Vice President,
Investor Relations (978) 600-7717 dgordon@insulet.com
Media: Angela Geryak Wiczek Senior Director, Corporate
Communications (978) 932-0611 awiczek@insulet.com
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