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 shared positive results from its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) type 2 diabetes pivotal trial at the American Diabetes Association (ADA) 84th Scientific Sessions in Orlando, Florida.

马萨诸塞州阿克顿市（商业新闻短讯）--Insulet Corporation（纳斯达克：PODD）（Insulet或该公司）是无管胰岛素泵技术的全球领导者，拥有Omnipod®品牌的产品，今天在佛罗里达州奥兰多举行的美国糖尿病协会（ADA）第84届科学会议上，分享了其Omnipod 5自动胰岛素输送系统（Omnipod 5）2型糖尿病关键试验的积极成果。

This landmark study evaluated the impact of AID in a diverse group of people with type 2 diabetes who require insulin..

这项具有里程碑意义的研究评估了AID对需要胰岛素的多种2型糖尿病患者的影响。。

The SECURE-T2D pivotal trial results showed glycemic improvements with the use of Omnipod 5 compared with prior treatment of insulin injections or pump therapy in adults with type 2 diabetes. The study results showed significant reductions in HbA1c, time in hyperglycemia, and total daily insulin dose, and a large improvement in time in range (TIR), without increasing time in hypoglycemia.

SECURE-T2D关键试验结果显示，与先前对2型糖尿病成人进行胰岛素注射或泵治疗相比，使用Omnipod 5可改善血糖。研究结果显示，HbA1c，高血糖时间和每日总胰岛素剂量显着降低，时间范围（TIR）有很大改善，而低血糖时间没有增加。

The study also demonstrated a clinically meaningful improvement in diabetes distress..

该研究还证明了糖尿病困扰的临床意义改善。。

“These data demonstrate that simple, easy-to-use AID technology, such as Omnipod 5, can be adopted by a broad population of people with type 2 diabetes and improve their lives,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “A major strength of this study is the diversity of the enrolled population in terms of varying education level, income, ethnicity, and race.

“这些数据表明，简单易用的AID技术，如Omnipod 5，可以被广泛的2型糖尿病患者所采用，并改善他们的生活，”Trang Ly MBBS博士，FRACP博士，Insulet高级副总裁兼医学主任说。“这项研究的一个主要优势是入学人口在不同的教育水平、收入、种族和种族方面的多样性。

These results could have a particularly striking impact among Black and Hispanic people, who experience a higher prevalence of type 2 diabetes and increased mortality rates.”.

这些结果可能对黑人和西班牙裔人群产生特别显着的影响，他们的2型糖尿病患病率更高，死亡率更高。”。

Even though over 30 million people live with type 2 diabetes in the United States,1 there are no AID systems currently FDA-cleared for this population. Insulet recently submitted these study results to the FDA for an expansion of Omnipod 5’s indications for use for people with type 2 diabetes and, subject to FDA clearance, expects to commercially launch in the U.S.

尽管美国有3000多万人患有2型糖尿病，但目前还没有FDA批准的针对这一人群的援助系统。Isulet最近向FDA提交了这些研究结果，以扩大Omnipod 5用于2型糖尿病患者的适应症，并在获得FDA批准后，预计将在美国商业推出。

in early 2025. Omnipod 5 is currently FDA-cleared in the U.S. and C.E. marked for use in those with type 1 diabetes aged two years and older..

2025年初。Omnipod 5目前已在美国获得FDA批准，并被C.E.标记用于2岁及以上的1型糖尿病患者。。

“Our findings demonstrate substantial improvements in blood glucose outcomes and overall quality of life, highlighting the potential for this innovative technology to transform type 2 diabetes management with automated insulin delivery,” said Dr. Francisco Pasquel, MD, MPH of Emory University and chair of the study.

埃默里大学公共卫生硕士、医学博士兼研究主席Francisco Pasquel博士说：“我们的研究结果表明，血糖结果和总体生活质量有了实质性改善，突出了这项创新技术通过自动胰岛素输送改变2型糖尿病管理的潜力。”。

“As the largest study of AID therapy in people with type 2 diabetes, we look forward to these results supporting the FDA clearance of Omnipod 5 as a safe and effective therapy for this patient population.”.

“作为对2型糖尿病患者进行AID治疗的最大规模研究，我们期待这些结果支持FDA批准Omnipod 5作为该患者群体的安全有效疗法。”。

Study Overview

研究概述

The primary objective of the SECURE-T2D Pivotal Trial was to evaluate change in HbA1c with Omnipod 5 in adults aged 18-75 years, living with type 2 diabetes with a current insulin regimen for at least three months. Other criteria included a baseline HbA1c between 7% and 12% for those using basal insulin only, and 12% or less for those using basal and bolus or pre-mixed insulin.

SECURE-T2D Pivotal试验的主要目的是评估18-75岁成年人中使用Omnipod 5的HbA1c变化，目前使用胰岛素治疗至少三个月的2型糖尿病患者。其他标准包括仅使用基础胰岛素的患者的基线HbA1c在7%至12%之间，使用基础和推注或预混合胰岛素的患者的基线HbA1c在12%或更低。

Secondary objectives included demonstrating improvements in time in range, and time in hyperglycemia, as well as demonstrating non-inferiority for hypoglycemia. Additionally assessed as a secondary objective was diabetes distress, a patient-reported outcome..

。另外被评估为次要目标的是糖尿病困扰，这是患者报告的结果。。

As one of the most racially diverse studies in diabetes technology, the data represented 305 participants from 21 sites across the U.S., including 24% Black and 22% Hispanic participants. More than half (55%) were on a stable dose of GLP-1 receptor agonists, and 73% used multiple daily injections of insulin, while 21% used basal-only insulin at baseline, and only 5.6% used an insulin pump at baseline.

作为糖尿病技术中种族差异最大的研究之一，这些数据代表了来自美国21个地点的305名参与者，其中包括24%的黑人和22%的西班牙裔参与者。超过一半（55%）服用稳定剂量的GLP-1受体激动剂，73%每天多次注射胰岛素，21%在基线时仅使用基础胰岛素，只有5.6%在基线时使用胰岛素泵。

After an initial 14 days of standard therapy, the study participants used the Omnipod 5 AID system for 13 weeks. They could eat and exercise with no restrictions and were given the option to bolus for blood glucose corrections only, for actual carbohydrate intake, or for a set carbohydrate regimen..

经过最初14天的标准治疗后，研究参与者使用Omnipod 5 AID系统13周。他们可以不受限制地饮食和运动，并且可以选择仅用于血糖校正，实际碳水化合物摄入量或固定碳水化合物方案的推注。。

Key Data Highlights

关键数据亮点

Mean HbA1c (%) was significantly reduced with Omnipod 5, lowering from 8.2% to 7.4%, or a reduction of 0.8%.

Omnipod 5的平均HbA1c（%）显着降低，从8.2%降至7.4%，或降低0.8%。

Those with a higher baseline HbA1c had a greater decrease: reduction in HbA1c was 2.1% for those with a baseline HbA1c ≥9.0%.

基线HbA1c较高的患者下降幅度较大：基线HbA1c≥9.0%的患者HbA1c下降2.1%。

Significant improvements for HbA1c were observed regardless of prior therapy at the start of the trial, including:

无论在试验开始时是否进行过治疗，均观察到HbA1c的显着改善，包括：

Multiple daily injections and in those transitioning from basal-only insulin therapy

每日多次注射，以及从仅基础胰岛素治疗过渡的患者

GLP-1 users and non-GLP-1 users, suggesting that adults with type 2 diabetes who require insulin therapy can greatly benefit from AID regardless of whether they are already using other glucose-lowering medication

GLP-1使用者和非GLP-1使用者，这表明需要胰岛素治疗的2型糖尿病成年人可以从AID中受益匪浅，无论他们是否已经在使用其他降糖药物

Current users or non-users of continuous glucose monitoring (CGM), suggesting an added benefit of AID in type 2 diabetes beyond the glycemic benefit observed with CGM use

目前使用或不使用连续血糖监测（CGM），这表明AID对2型糖尿病的额外益处超出了使用CGM所观察到的血糖益处

Time in range significantly improved with Omnipod 5, increasing by 20%, or 4.8 hours/day, from 45% to 66%. This finding was driven by reductions in hyperglycemia levels including time above 180, 250 and 300 mg/dL.

Omnipod 5的射程时间显着改善，从45%增加到66%，增加了20%，即每天4.8小时。这一发现是由于高血糖水平的降低，包括时间超过180250和300 mg/dL。

Time below 54 mg/dL (%) and time below 70 mg/dL (%) were shown to be non-inferior (within a 0.5% and 2.0% margin, respectively), demonstrating that improving glycemic control with Omnipod 5 did not increase hypoglycemia risk.

低于54 mg/dL（%）和低于70 mg/dL（%）的时间被证明是非劣效的（分别在0.5%和2.0%的范围内），表明用Omnipod 5改善血糖控制不会增加低血糖风险。

Additional outcomes analysis showed that the amount of insulin used was reduced from an average of 0.80 U/kg/day during standard therapy to 0.57 U/kg/day during AID. This corresponds to an average decrease of 23 U/day.

。这相当于平均每天减少23 U。

As reported by patients through individual surveys (T2-DDAS), there was a significant and clinically meaningful improvement in diabetes distress: the percentage of participants with high diabetes distress (T2-DDAS total score ≥2.0) was significantly reduced.

正如患者通过个人调查（T2-DDAS）报告的那样，糖尿病困扰有了显着且具有临床意义的改善：糖尿病困扰程度高（T2-DDAS总分≥2.0）的参与者百分比显着降低。

There were no instances of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS). There was one occurrence of severe hypoglycemia during the treatment phase, deemed unrelated to trial device malfunction. There were 13 additional serious adverse events, but none were glycemia-related nor related to the trial device..

没有糖尿病酮症酸中毒（DKA）或高渗性高血糖综合征（HHS）的病例。。另外还有13例严重不良事件，但与血糖无关，也与试验装置无关。。

The SECURE-T2D pivotal trial data will be discussed in several events at ADA this weekend, including:

SECURE-T2D关键试验数据将于本周末在ADA的多个活动中进行讨论，包括：

Saturday, June 22, 2024, 12:30 – 1:30 p.m. ET (Poster Hall)

2024年6月22日星期六，美国东部时间下午12:30–1:30（海报厅）

Poster Presentation: 1904-LB Glycemic Improvement with Use of the Omnipod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes — Results of the SECURE-T2D Pivotal Trial with Dr. Francisco Pasquel

海报展示：1904-LB在2型糖尿病成人中使用Omnipod 5自动胰岛素输送系统改善血糖-与Francisco Pasquel博士进行的SECURE-T2D关键试验的结果

Sunday, June 23, 2024, 10:15 – 11:00 a.m. ET (Product Theater #1)

2024年6月23日星期日，美国东部时间上午10:15–11:00（产品影院#1）

Insulet Product Theater: Omnipod 5: Advancing Automated Insulin Delivery for All with Francisco Pasquel, Dr. Gregory Forlenza, and Dr. Trang Ly

胰岛素产品剧院：Omnipod 5：与Francisco Pasquel，Gregory Forlenza博士和Trang Ly博士一起推进所有人的自动胰岛素输送

Sunday, June 23, 2024, 1:50 – 2:00 p.m. ET (ePoster Theater A)

2024年6月23日星期日，美国东部时间下午1:50–2:00（ePoster剧院A）

ePoster Theater: 1904-LB Glycemic Improvement with Use of the Omnipod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes — Results of the SECURE-T2D Pivotal Trial with Dr. Francisco Pasquel

Analysis of GLP-1 and Insulin Use in Type 2 Diabetes

2型糖尿病患者胰高血糖素样肽-1及胰岛素使用分析

Separately, Insulet also partnered with Optum® Health Economics and Outcomes Research to conduct a retrospective, real-world analysis of GLP-1 and non-GLP-1 patient cohorts. This analysis demonstrates that GLP-1s are additive to the treatment paradigm in type 2 diabetes. Patients who adopt GLP-1 therapy are twice as likely to initiate insulin therapy within 12 months.

另外，Isulet还与Optum®健康经济学和结果研究合作，对GLP-1和非GLP-1患者队列进行回顾性现实分析。该分析表明，GLP-1是2型糖尿病治疗范例的添加剂。采用GLP-1治疗的患者在12个月内开始胰岛素治疗的可能性是前者的两倍。

To learn more, read the Market Opportunity & Impact of GLP-1s..

要了解更多信息，请阅读GLP-1s的市场机会和影响。。

1National Diabetes Statistics Report: https://www.cdc.gov/diabetes/php/data-research/

1国家糖尿病统计报告：https://www.cdc.gov/diabetes/php/data-research/

About Insulet Corporation:

关于Islet 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.

总部位于马萨诸塞州的Insulet Corporation（NASDAQ:PODD）是一家创新型医疗器械公司，致力于通过其Omnipod产品平台简化糖尿病和其他疾病患者的生活。Omnipod胰岛素管理系统为传统的胰岛素输送方法提供了独特的替代方案。

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 in the U.S.

无管一次性Pod设计简单，可穿戴，无需查看或操作针头，可提供长达三天的不间断胰岛素输送。Insulat的旗舰创新产品Omnipod 5自动胰岛素输送系统与连续血糖监测仪集成，无需每天多次注射即可管理血糖，无需手指，并且可以通过美国兼容的个人智能手机进行控制。

or by 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..

或通过Omnipod 5控制器。Insulat还利用其Pod的独特设计，定制其Omnipod技术平台，用于在其他治疗领域输送非胰岛素皮下药物。有关更多信息，请访问insulet.com和omnipod.com。。

Forward-Looking Statement:

前瞻性声明：

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.

本新闻稿可能包含有关Islet对未来的期望、预期、意图、信念或策略的前瞻性声明。这些前瞻性声明基于其目前对未来发展及其对岛屿的潜在影响的期望和信念。

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.

无法保证影响岛屿的未来发展将是其预期的发展。这些前瞻性陈述涉及许多风险、不确定性（其中一些超出其控制范围）或其他假设，这些风险、不确定性或假设可能导致实际结果或表现与这些前瞻性陈述所明示或暗示的结果或表现有实质性差异，以及表10-K年度报告中描述的其他风险和不确定性，表10-K于2024年2月23日提交给证券交易委员会，标题为“风险因素”一节，以及不时提交给证券交易委员会的其他文件中描述的其他风险和不确定性。

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..

如果出现一个或多个此类风险或不确定性，或者如果其任何假设被证明不正确，实际结果可能与这些前瞻性声明中预测的结果有很大差异。岛屿不承担公开更新或修改任何前瞻性声明的义务。。

©2024 Insulet Corporation. Omnipod is a registered trademark of Insulet Corporation. All rights reserved. All other trademarks are the property of their respective owners.

©2024年岛屿公司。Omnipod是Islet Corporation的注册商标。保留所有权利。所有其他商标均为其各自所有者的财产。