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Stelo by Dexcom, the First Over-the-Counter Glucose Biosensor in the U.S., Is Now Available

Stelo by Dexcom, the First Over-the-Counter Glucose Biosensor in the U.S., Is Now Available

德康医疗的Stelo是美国首款非处方葡萄糖生物传感器,现已上市
德康医疗 ·  08/26 00:00
  • Available for purchase today at Stelo.com for people in the U.S. 18 and older not using insulin

  • Provides 24/7 powerful and personalized glucose insights directly to a smartphone, *                                                 revealing how food, exercise and sleep can affect glucose                                            

  • Tracking glucose just got easier, with no prescription and no fingersticks, ever

  • Specifically designed to help people with Type 2 diabetes not using insulin and those with prediabetes reach their A1c goals and potentially slow the progression of diabetes.†,1-3

  • 美国18岁及以上未使用胰岛素的人士可于今天在Stelo.com上购买

  • 直接向智能手机提供全天候强大的个性化血糖见解,*揭示食物、运动和睡眠如何影响血糖

  • 追踪血糖变得更容易了,从来没有处方也没有指尖

  • 专为帮助不使用胰岛素的 2 型糖尿病患者和糖尿病前期患者实现 A1c 目标并可能减缓糖尿病的进展†,1-3

SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that Stelo, the first over-the-counter glucose biosensor in the U.S., is now available for purchase without a prescription 4 at Stelo.com.                                    

圣地亚哥--(美国商业资讯)--糖尿病患者实时持续血糖监测领域的全球领导者DexCom, Inc.(纳斯达克股票代码:DXCM)今天宣布,Stelo是美国首款非处方葡萄糖生物传感器,现在无需处方即可在Stelo.com上购买。

Stelo is designed to help people with Type 2 diabetes not using insulin and those with prediabetes. (Photo: Dexcom)

Stelo 旨在帮助不使用胰岛素的 2 型糖尿病患者和糖尿病前期患者。(照片:Dexcom)

Stelo is a small biosensor worn on the back of the upper arm that leverages Dexcom's most accurate glucose sensing technology.                                        5                                         It is specifically designed to provide the 125 million Americans                                        6                                         with Type 2 diabetes not using insulin and those with                                                                                prediabetes with powerful, personalized glucose insights sent directly to a smartphone,* revealing how food, exercise and sleep can affect glucose – all without painful fingersticks.                                    

Stelo 是一款佩戴在上臂背部的小型生物传感器,利用了 Dexcom 最精确的血糖传感技术。5 它专为不使用胰岛素的 12500万 6 名 2 型糖尿病患者和糖尿病前期患者提供直接发送到智能手机的强大个性化血糖见解,* 揭示食物、运动和睡眠如何影响葡萄糖——所有这些都不会造成手指疼痛。

"Dexcom has been at the forefront of glucose biosensing for 25 years. With the launch of Stelo, we're defining a brand-new category and once again setting the gold standard for people to easily take control of their health," said Jake Leach, executive vice president and chief operating officer at Dexcom. "Now, millions more have access to 24/7, easy-to-understand glucose insights that can inform their daily lifestyle choices and support behavior modification."

“25年,Dexcom一直处于葡萄糖生物传感的最前沿。随着Stelo的推出,我们正在定义一个全新的类别,并再次为人们轻松控制自己的健康设定了黄金标准。” Dexcom执行副总裁兼首席运营官杰克·利奇说。“现在有更多的人可以全天候获得易于理解的葡萄糖见解,这些见解可以为他们的日常生活方式选择提供信息,并支持行为改变。”

The benefits of glucose biosensing have been shown when used alone, or alongside other diabetes and weight management medications.                                        7                                         Studies show the use of Dexcom glucose biosensing by people with Type 2 diabetes is associated with clinically meaningful improvement in time in range, A1c and quality of life.                                        8-11

单独使用或与其他糖尿病和体重管理药物一起使用时,葡萄糖生物传感的益处已得到证实。7项研究表明,2型糖尿病患者使用Dexcom葡萄糖生物传感与治疗时间、A1c和生活质量的临床上有意义的改善有关。8-11

"Dexcom glucose biosensors are an essential and proven tool for diabetes management – driving strong clinical outcomes regardless of medication use                                        9                                         and even potentially slowing the progression of diabetes,                                        †,1-3                                        " said Thomas Grace, MD, head of clinical advocacy and outcomes at Dexcom. "In a world where GLP-1 use is becoming increasingly more common, glucose biosensors like Stelo can help make those medications more effective.                                        12                                        "                                    

Dexcom临床宣传和结果主管托马斯·格雷斯医学博士说:“Dexcom葡萄糖生物传感器是糖尿病管理的重要且经过验证的工具——无论使用何种药物都会带来良好的临床疗效 9,甚至有可能减缓糖尿病的进展,†,1-3”“在使用 GLP-1 变得越来越普遍的世界中,像 Stelo 这样的葡萄糖生物传感器可以帮助提高这些药物的有效性。12”

Key features of Stelo

Stelo 的主要功能

  • No fingersticks, ever                                            : The only over-the-counter glucose biosensor designed for people with diabetes that doesn't require any fingersticks.                                        

  • Up to 15-day wear time and waterproof§                                            : The longest biosensor wear time on the market                                            ‡                                            with the highest waterproof rating.                                        

  • A personalized, easy-to-use app 4                                            : Provides daily, weekly and session summary insights that can help form healthier habits.                                        

  • Spike and pattern detection 4                                            : The only over-the-counter glucose biosensor for people with diabetes featuring spike detection, designed to identify meaningful glucose variability as it happens so users can make informed changes.                                        

  • Proven results with Dexcom glucose sensors†                                            : Using Dexcom glucose sensors like Stelo helps lower A1c                                            †,1,10, 13-19                                            for people with Type 2 diabetes and may help slow the progression of diabetes.                                            †,1-3                                             Only Dexcom glucose sensors have been associated with significant improvements in glucose and cardiovascular risk reduction measures as early as three months.                                            ||,13

  • 永远不用手指:唯一一款专为糖尿病患者设计且不需要任何指尖的非处方葡萄糖生物传感器。

  • 长达 15 天的佩戴时间‡ 且防水§:市场上最长的生物传感器磨损时间‡ 具有最高的防水等级。

  • 个性化、易于使用的应用程序 4:提供每日、每周和会话摘要见解,有助于养成更健康的习惯。

  • 峰值和模式检测 4:唯一一款针对糖尿病患者的非处方葡萄糖生物传感器,具有峰值检测功能,旨在识别发生的有意义的葡萄糖变异性,以便用户做出明智的改变。

  • Dexcom 葡萄糖传感器已证实效果†:使用像 Stelo 这样的 Dexcom 葡萄糖传感器有助于降低 2 型糖尿病患者的 A1c †,1,10、13-19,并可能有助于减缓糖尿病的进展。†,1-3 早在三个月内,只有 Dexcom 葡萄糖传感器就能显著改善血糖和心血管风险降低措施。||,13

Effortless ordering, delivered directly to your door

轻松订购,直接送货上门

Stelo improves access to critical health technology for people with Type 2 diabetes not using insulin and those with                                                                                prediabetes who might not have insurance coverage for prescription glucose biosensors. Stelo is currently available for purchase in the U.S. at                                         Stelo.com                                         and is FSA and HSA eligible.                                    

Stelo改善了不使用胰岛素的2型糖尿病患者和可能没有处方葡萄糖生物传感器保险的糖尿病前期患者获得关键健康技术的机会。Stelo目前可以在美国的Stelo.com上购买,并且符合金融服务管理局和HSA的资格。

  • Pay-as-you-go:                                             Pay $99 for a single pack of two sensors (total wear time up to 30 days                                            ‡                                            ).                                        

  • Monthly subscription:                                             Subscribe and save 10%. Pay $89 per month for an ongoing subscription, with two sensors (total wear time up to 30 days                                            ‡                                            ) delivered every 30 days.                                        

  • 即用即付:支付 99 美元购买一包两个传感器(总磨损时间长达 30 天 ‡)。

  • 每月订阅:订阅并节省 10%。每月支付 89 美元即可持续订阅,每 30 天交付两台传感器(总磨损时间长达 30 天 ‡)。

Stelo is now part of Dexcom's overall portfolio of glucose biosensors, with a user base of more than 2.5 million people globally. The Dexcom portfolio in the U.S. consists of the Dexcom G6 and Dexcom G7 Continuous Glucose Monitoring Systems, and now Stelo, collectively designed to address the needs of people with all types of diabetes and prediabetes.

Stelo现在是Dexcom葡萄糖生物传感器整体产品组合的一部分,全球用户群超过250万。美国的Dexcom产品组合包括Dexcom G6和Dexcom G7连续血糖监测系统(现为Stelo),共同设计用于满足所有类型糖尿病和糖尿病前期患者的需求。

Each product in the portfolio is built for the people who use them, making it easier than ever for healthcare providers to get patients started with the glucose biosensor best for them. Dexcom G6 and Dexcom G7 are designed for people with diabetes using insulin or who are at risk of hypoglycemia and who have insurance coverage for glucose biosensors. Both systems require a prescription and are reimbursed by 97% of commercial insurers in the U.S., Medicare nationally and Medicaid in most states.                                        5                                         Stelo is designed for adults with Type 2 diabetes not using insulin or prediabetes who seek behavior change and optimized health and who do not have insurance coverage for glucose biosensors.                                    

产品组合中的每种产品都是为使用者设计的,这使得医疗保健提供者比以往任何时候都更容易让患者开始使用最适合他们的葡萄糖生物传感器。Dexcom G6 和 Dexcom G7 专为使用胰岛素的糖尿病患者或有低血糖风险且有葡萄糖生物传感器保险的糖尿病患者而设计。这两个系统都需要处方,由美国97%的商业保险公司、全国的医疗保险公司以及大多数州的医疗补助计划进行报销。5 Stelo专为未使用胰岛素或糖尿病前期、寻求行为改变和优化健康状况且没有葡萄糖生物传感器保险的2型糖尿病成年人而设计。

Visit Stelo.com today to get started with Stelo, or do a benefits check to see if you are eligible for Dexcom G7 at Dexcom.com/Start.

立即访问Stelo.com开始使用Stelo,或者在dexcom.com/Start上查看福利以查看您是否有资格获得Dexcom G7。

About DexCom, Inc.

关于 DexCom, Inc.

DexCom, Inc. empowers people to take control of health through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, Calif., and with operations across Europe and select parts of Asia/Oceania, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers and providers, Dexcom works to simplify and improve diabetes management around the world. For more information on Dexcom, visit                                                                                 .                                    

DexCom, Inc. 通过创新的持续血糖监测(CGM)系统使人们能够控制健康。Dexcom总部位于加利福尼亚州圣地亚哥,业务遍及欧洲和亚洲/大洋洲的部分地区,现已成为糖尿病护理技术的领导者。通过倾听用户、护理人员和提供者的需求,Dexcom 致力于简化和改善全球糖尿病管理。有关 Dexcom 的更多信息,请访问。

*Smart device sold separately. For Stelo app compatibility information, visit stelo.com/compatibility. †Results obtained from previous Dexcom device(s) in people with diabetes who may be on insulin. ‡A study was conducted to assess the sensor life where 77.9% of sensors lasted the full 15 days. In other words, when using the product per the package labeling, approximately 20% of sensors may not last for the full 15 days, 10% of these sensors may last less than 12 days. §The Stelo biosensor is waterproof and may be submerged under eight feet of water for up to 24 hours without failure when properly installed. If you are in or near water, your smartphone may need to be closer than 20 feet to get readings. If you are in water, you may not get readings until you get out.                                         ||                                        Cardiovascular risk refers to 10-year ASCVD risk. Visit                                         !/calculate/estimate/                                         to access the American College of Cardiology ASCVD Risk Estimator Plus.                                    

*智能设备单独出售。有关 Stelo 应用程序兼容性信息,请访问 stelo.com/compatibility。†从以前的 Dexcom 设备中获得的针对可能正在服用胰岛素的糖尿病患者的结果。‡ 进行了一项研究以评估传感器寿命,其中 77.9% 的传感器持续了整整 15 天。换句话说,当按照包装标签使用产品时,大约 20% 的传感器可能无法使用整整 15 天,其中 10% 的传感器可能持续不到 12 天。§Stelo 生物传感器具有防水功能,如果安装得当,可以在八英尺深的水下浸泡长达 24 小时而不会出现故障。如果你在水中或水附近,你的智能手机可能需要距离大于 20 英尺才能获得读数。如果你在水中,你可能要等到出来才能得到读数。|| 心血管风险是指 10 年的 ASCVD 风险。访问!/计算/估算/ 访问美国心脏病学会 ASCVD 风险估算器 Plus。

1 UKPDS Group. Lancet.1998;352(9131):837-53. 2 Battelino T, et al.                                         Diabetes Care                                        . 2019;42(8):1593-603. 3 Vigersky RA, et al.                                         Diabetes Technol Ther.                                         2019;21(2):81-85. 4 Stelo User Guide. 5 Dexcom, data on file, 2024. 6 Centers for Disease Control and Prevention. National Diabetes Statistics Report.                                                                                 . Accessed on August 12, 2024. 7 Grace T, Salyer J.                                         Diabetes Technol Ther                                        . 2022 Jan;24(1):26-31. 8 Cox DJ, Banton T, Moncrief M, et al.                                         J Endocr Soc                                         2020;4(11):bvaa118. 9 Hannah K, Nemlekar P, Norman G. Improved glycemic control after real-time continuous glucose monitor (rtCGM) initiation in patients with type 2 diabetes (PWT2D) stratified by insulin therapy and race/ethnicity. Presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2024), March 6-9, 2024, Florence, Italy and online. 10 Jepson LH, Welsh J, Green CR, et al.                                         Diabetes 2023                                        ;72(Supplement_1):941-P. 11 Layne J, Jepson, Thomas R, et al. Non-insulin treated adults with type 2 diabetes benefit from CGM use: real-world data. Presented at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2024), March 6-9, 2024, Florence, Italy and online. 12 Nemlekar et al.                                         Diabetes. 2024                                        ; 73 (Supplement_1): 1914–LB. 13 Reed J, et al.                                         Diabetes Obes Metab                                        . 2024;26(7):2881-9. 14 Polonsky W, et al.                                         ATTD                                        . 2024;O013(535). 15 Beck RW, et al.                                         JAMA                                        . 2017;317(4):371-378. 16 Beck RW, et al.                                         Ann Intern Med                                        . 2017;167(6):365-374. 17 Martens T, et al.                                         JAMA                                        . 2021;325(22):2262-2272. 18 Laffel LM, et al.                                         JAMA                                        . 2020;323(23):2388-2396. 19 Welsh JB, et al.                                         J Diabetes Sci Technol                                        . 2024;18(1):143-7.                                    

1 UKPDS 小组。Lancet.1998;352 (9131): 837-53。2 Battelino t,等人糖尿病护理。2019;42 (8): 1593-603。3 Vigersky RA 等人Diabetes Technol Ther. 2019;21 (2): 81-85。4 Stelo 用户指南。5 Dexcom,存档数据,2024。6 美国疾病控制与预防中心。全国糖尿病统计报告。2024 年 8 月 12 日访问。7 Grace t、Salyer J. Diabetes Technol Ther. 2022 年 1 月;24 (1): 26-31。8 Cox DJ、Banton t、Moncrief m 等。J Endocr Soc 2020;4 (11): bvaa118。9 Hannah k、Nemlekar P、Norman G. 对按胰岛素疗法和种族/民族分层的 2 型糖尿病 (PWT2D) 患者启动实时连续血糖监测 (rtcGM) 后改善了血糖控制。于 2024 年 3 月 6 日至 9 日在意大利佛罗伦萨举行的第 17 届糖尿病先进技术与治疗国际会议(ATTD 2024)上发表,并在线发表。10 Jepson LH、Welsh J、Green CR 等2023 年糖尿病;72(Supplement_1): 941-P. 11 Layne J、Jepson、Thomas R 等。未接受胰岛素治疗的2型糖尿病成人受益于cGM的使用:真实世界的数据。2024年3月6日至9日在意大利佛罗伦萨举行的第17届糖尿病先进技术与治疗国际会议(ATTD 2024)上发表,并在线发表。12 Nemlekar等人。糖尿病。2024;73(Supplement_1):1914—Lb. 13 Reed J,等人。糖尿病肥胖症 Metab. 2024;26 (7): 2881-9。14 Polonsky W,等人。ATTD. 2024;O013 (535)。15 Beck RW,等人。JAMA。2017;317 (4): 371-378。16 Beck RW,等人Ann Interner Med. 2017;167 (6): 365-374。17 Martens t,等人JAMA. 2021;325 (22): 2262-2272. 18 Laffel Lm 等人JAMA. 2020;323 (23): 2388-2396. 19 Welsh Jb 等人糖尿病科学技术杂志 2024; 18 (1): 143-7。

STELO IMPORTANT INFORMATION: Consult your healthcare provider before making any medication adjustments based on your sensor readings and do not take any other medical action based on your sensor readings without consulting your healthcare provider. Do not use if you have problematic hypoglycemia. Failure to use Stelo and its components according to the instructions for use provided and to properly consider all indications, contraindications, warnings, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence. If your sensor readings are not consistent with your symptoms, a blood glucose meter may be an option as needed and consult your healthcare provider. Seek medical advice and attention when appropriate, including before making any medication adjustments and/or for any medical emergency.

STELO 重要信息:在根据您的传感器读数进行任何药物调整之前,请咨询您的医疗保健提供者,未经咨询您的医疗保健提供者,请勿根据您的传感器读数采取任何其他医疗措施。如果您有低血糖问题,请勿使用。未能按照所提供的使用说明使用Stelo及其成分,也未正确考虑这些使用说明中的所有适应症、禁忌症、警告和注意事项,可能会导致您错过严重的低血糖(低血糖)或高血糖(高血糖)事件。如果您的传感器读数与症状不一致,则可以根据需要选择血糖计,并咨询您的医疗保健提供者。在适当时寻求医疗建议和治疗,包括在进行任何药物调整和/或任何医疗紧急情况之前。

INDICATIONS FOR USE: The Stelo Glucose Biosensor System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.

使用说明:Stelo 葡萄糖生物传感器系统是一款非处方 (OTC) 集成式连续血糖监测仪 (iCGM),旨在持续测量、记录、分析和显示未服用胰岛素的 18 岁及以上人群的葡萄糖值。Stelo 葡萄糖生物传感器系统有助于检测正常(血糖)和低或高(血糖失调)的血糖水平。Stelo 葡萄糖生物传感器系统还可以帮助用户更好地了解生活方式和行为的改变,包括饮食和运动,如何影响血糖偏移。未经咨询合格的医疗保健专业人员,用户不得根据设备输出采取医疗措施。

Dexcom, Dexcom Clarity, Dexcom Follow, Dexcom One, Dexcom Share, Stelo, and any related logos and design marks are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. 2024 Dexcom, Inc. All rights reserved.

Dexcom、Dexcom Clarity、Dexcom Follow、Dexcom One、Dexcom Share、Stelo 以及任何相关徽标和设计标志均为 Dexcom, Inc. 在美国和/或其他国家的注册商标或商标。2024 Dexcom, Inc. 版权所有。

Category: IR

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Source: DexCom, Inc.

资料来源:DexCom, Inc.

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