Insulet’s Randomized Controlled Trial (OP5-003) Demonstrates Omnipod® 5 Automated Insulin Delivery System is Superior to Pump Therapy

Rhea-AI Summary

Insulet Corporation (PODD) presents positive results from the OP5-003 Trial, showcasing improved glycemic outcomes with the Omnipod 5 Automated Insulin Delivery System. The trial demonstrated a 17.5% increase in time in range, reduced HbA1c levels, and improved patient-reported outcomes for individuals with type 1 diabetes.

Positive

• The OP5-003 Trial highlighted a 17.5% improvement in time in range (TIR) for participants using the Omnipod 5 system.
• Participants showed a decrease in HbA1c levels and mean glucose with Omnipod 5 compared to standard pump therapy with CGM.
• Omnipod 5 led to significant reductions in hypoglycemia and improvements in psychosocial measures for individuals with type 1 diabetes.
• The trial results suggest that Omnipod 5 should be considered as a first-line therapy for adults with type 1 diabetes.

Negative

• None.

Endocrinologist

The results of the OP5-003 trial indicate a significant advancement in the management of type 1 diabetes (T1D) through the use of the Omnipod 5 Automated Insulin Delivery (AID) System. The reported improvement in Time in Range (TIR) by 17.5% is a critical measure, as TIR is directly correlated with the long-term health outcomes of individuals with diabetes. A higher TIR indicates better controlled glucose levels, which can reduce the risk of diabetes-related complications. The reduction in HbA1c is also notable, as it suggests better overall glycemic control. Furthermore, the decrease in hypoglycemic events is a substantial benefit, as hypoglycemia can be dangerous and is a common concern among patients and clinicians. These clinical outcomes suggest that the Omnipod 5 AID System could become a preferred treatment option, potentially leading to broader adoption in clinical practice.

Healthcare Industry Analyst

The data presented from the OP5-003 trial could have a considerable impact on Insulet Corporation's market position. The improvements in glycemic control and patient-reported outcomes may drive increased demand for the Omnipod 5 system. This demand could be reflected in Insulet's revenue growth and market share expansion, especially if the system is adopted as a first-line therapy for T1D. The trial's international scope also hints at potential for global market penetration, which is a key factor for investors considering the scalability of Insulet's business model. However, it is important to monitor how the healthcare reimbursement landscape adapts to these new technologies, as this will influence the accessibility and affordability that are critical for widespread adoption.

Medical Device Regulatory Expert

The successful international trial of the Omnipod 5 AID System represents a significant step towards global regulatory approvals. Positive RCT results are often a prerequisite for regulatory bodies such as the FDA and the EMA when considering medical devices for approval. The fact that there were zero events of severe hypoglycemia or diabetic ketoacidosis (DKA) with the Omnipod 5 is a strong safety signal that regulatory agencies will consider. The trial's adherence to rigorous standards, including randomized control groups and the achievement of primary and secondary endpoints, will likely support Insulet's submissions for international regulatory clearance. This could lead to an expanded market presence and could be a catalyst for stock growth, depending on the company's ability to navigate the complex regulatory environment efficiently.

ACTON, Mass.--(BUSINESS WIRE)-- 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 17^th 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.

View source 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

Source: Insulet Corporation

FAQ

What were the key highlights of the OP5-003 Trial for Insulet Corporation (PODD)?

The trial showed a 17.5% increase in time in range, reduced HbA1c levels, and improved patient-reported outcomes.

How did Omnipod 5 perform compared to standard pump therapy with CGM in the trial?

Omnipod 5 demonstrated significant improvements in glycemic outcomes and psychosocial measures.

What were the main improvements seen in participants using Omnipod 5 in the trial?

Participants experienced increased time in range, reduced hypoglycemia, and improved quality of life measures.

What did the trial results suggest about Omnipod 5 as a therapy option for adults with type 1 diabetes?

The results indicate that Omnipod 5 should be considered as a first-line therapy for type 1 diabetes.

Where were the OP5-003 Trial results presented?

The results were presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes in Florence, Italy.

Who shared the evidence of the efficacy and safety of Omnipod 5 in the trial?

Professor Eric Renard, MD, PhD of Montpellier University Hospital shared the trial results.

What were the primary and secondary endpoints of the trial?

All primary and secondary endpoints of the study were met, indicating the success of the trial.

What improvements were reported in psychosocial measures for participants using Omnipod 5?

Participants showed improvements in diabetes distress, hypoglycemia confidence, and diabetes-related quality of life measures.

Were there any adverse events reported with the use of Omnipod 5 in the trial?

There were zero events of severe hypoglycemia or DKA reported with Omnipod 5 use.

What was the key objective of the OP5-003 Trial?

The trial aimed to evaluate Omnipod 5 in a real-world population with HbA1c levels above 8%.

How did the participants using Omnipod 5 fare in terms of HbA1c reduction compared to the control group?

Participants using Omnipod 5 showed a greater reduction in HbA1c levels compared to the control group.

What were the key data highlights of the trial in terms of glycemic control?

Participants using Omnipod 5 demonstrated improvements in time in range, mean glucose levels, and time spent in hypoglycemia.

Who is the Senior Vice President and Medical Director of Insulet Corporation?

Dr. Trang Ly MBBS, FRACP, PhD serves as the Senior Vice President and Medical Director of Insulet Corporation.