share_log

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

德康醫療的Stelo是美國首款非處方葡萄糖生物傳感器,現已上市
德康醫療 ·  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

  • 美國18歲及以上未使用胰島素的人士可於今天在Stelo.com上購買

  • 直接向智能手機提供全天候強大的個性化血糖見解,*揭示食物、運動和睡眠如何影響血糖

  • 追蹤血糖變得更容易了,從來沒有處方也沒有指尖

  • 專爲幫助不使用胰島素的 2 型糖尿病患者和糖尿病前期患者實現 A1c 目標並可能減緩糖尿病的進展†,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.                                    

聖地亞哥--(美國商業資訊)--糖尿病患者實時持續血糖監測領域的全球領導者DexCom, Inc.(納斯達克股票代碼:DXCM)今天宣佈,Stelo是美國首款非處方葡萄糖生物傳感器,現在無需處方即可在Stelo.com上購買。

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

Stelo 旨在幫助不使用胰島素的 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傳感器,利用了 Dexcom 最精確的血糖傳感技術。5 它專爲不使用胰島素的 12500萬 6 名 2 型糖尿病患者和糖尿病前期患者提供直接發送到智能手機的強大個性化血糖見解,* 揭示食物、運動和睡眠如何影響葡萄糖——所有這些都不會造成手指疼痛。

"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一直處於葡萄糖生物傳感的最前沿。隨着Stelo的推出,我們正在定義一個全新的類別,並再次爲人們輕鬆控制自己的健康設定了黃金標準。」 Dexcom執行副總裁兼首席運營官傑克·利奇說。「現在有更多的人可以全天候獲得易於理解的葡萄糖見解,這些見解可以爲他們的日常生活方式選擇提供信息,並支持行爲改變。」

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

單獨使用或與其他糖尿病和體重管理藥物一起使用時,葡萄糖生物傳感的益處已得到證實。7項研究表明,2型糖尿病患者使用Dexcom葡萄糖生物傳感與治療時間、A1c和生活質量的臨床上有意義的改善有關。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臨床宣傳和結果主管托馬斯·格雷斯醫學博士說:「Dexcom葡萄糖生物傳感器是糖尿病管理的重要且經過驗證的工具——無論使用何種藥物都會帶來良好的臨床療效 9,甚至有可能減緩糖尿病的進展,†,1-3」「在使用 GLP-1 變得越來越普遍的世界中,像 Stelo 這樣的葡萄糖生物傳感器可以幫助提高這些藥物的有效性。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

  • 永遠不用手指:唯一一款專爲糖尿病患者設計且不需要任何指尖的非處方葡萄糖生物傳感器。

  • 長達 15 天的佩戴時間‡ 且防水§:市場上最長的生物傳感器磨損時間‡ 具有最高的防水等級。

  • 個性化、易於使用的應用程序 4:提供每日、每週和會話摘要見解,有助於養成更健康的習慣。

  • 峯值和模式檢測 4:唯一一款針對糖尿病患者的非處方葡萄糖生物傳感器,具有峯值檢測功能,旨在識別發生的有意義的葡萄糖變異性,以便用戶做出明智的改變。

  • Dexcom 葡萄糖傳感器已證實效果†:使用像 Stelo 這樣的 Dexcom 葡萄糖傳感器有助於降低 2 型糖尿病患者的 A1c †,1,10、13-19,並可能有助於減緩糖尿病的進展。†,1-3 早在三個月內,只有 Dexcom 葡萄糖傳感器就能顯著改善血糖和心血管風險降低措施。||,13

Effortless ordering, delivered directly to your door

輕鬆訂購,直接送貨上門

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改善了不使用胰島素的2型糖尿病患者和可能沒有處方葡萄糖生物傳感器保險的糖尿病前期患者獲得關鍵健康技術的機會。Stelo目前可以在美國的Stelo.com上購買,並且符合金融服務管理局和HSA的資格。

  • 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 美元購買一包兩個傳感器(總磨損時間長達 30 天 ‡)。

  • 每月訂閱:訂閱並節省 10%。每月支付 89 美元即可持續訂閱,每 30 天交付兩臺傳感器(總磨損時間長達 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現在是Dexcom葡萄糖生物傳感器整體產品組合的一部分,全球用戶群超過250萬。美國的Dexcom產品組合包括Dexcom G6和Dexcom G7連續血糖監測系統(現爲Stelo),共同設計用於滿足所有類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.                                    

產品組合中的每種產品都是爲使用者設計的,這使得醫療保健提供者比以往任何時候都更容易讓患者開始使用最適合他們的葡萄糖生物傳感器。Dexcom G6 和 Dexcom G7 專爲使用胰島素的糖尿病患者或有低血糖風險且有葡萄糖生物傳感器保險的糖尿病患者而設計。這兩個系統都需要處方,由美國97%的商業保險公司、全國的醫療保險公司以及大多數州的醫療補助計劃進行報銷。5 Stelo專爲未使用胰島素或糖尿病前期、尋求行爲改變和優化健康狀況且沒有葡萄糖生物傳感器保險的2型糖尿病成年人而設計。

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.

立即訪問Stelo.com開始使用Stelo,或者在dexcom.com/Start上查看福利以查看您是否有資格獲得Dexcom G7。

About DexCom, Inc.

關於 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. 通過創新的持續血糖監測(CGM)系統使人們能夠控制健康。Dexcom總部位於加利福尼亞州聖地亞哥,業務遍及歐洲和亞洲/大洋洲的部分地區,現已成爲糖尿病護理技術的領導者。通過傾聽用戶、護理人員和提供者的需求,Dexcom 致力於簡化和改善全球糖尿病管理。有關 Dexcom 的更多信息,請訪問。

*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.                                    

*智能設備單獨出售。有關 Stelo 應用程序兼容性信息,請訪問 stelo.com/compatibility。†從以前的 Dexcom 設備中獲得的針對可能正在服用胰島素的糖尿病患者的結果。‡ 進行了一項研究以評估傳感器壽命,其中 77.9% 的傳感器持續了整整 15 天。換句話說,當按照包裝標籤使用產品時,大約 20% 的傳感器可能無法使用整整 15 天,其中 10% 的傳感器可能持續不到 12 天。§Stelo 生物傳感器具有防水功能,如果安裝得當,可以在八英尺深的水下浸泡長達 24 小時而不會出現故障。如果你在水中或水附近,你的智能手機可能需要距離大於 20 英尺才能獲得讀數。如果你在水中,你可能要等到出來才能得到讀數。|| 心血管風險是指 10 年的 ASCVD 風險。訪問!/計算/估算/ 訪問美國心臟病學會 ASCVD 風險估算器 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 小組。Lancet.1998;352 (9131): 837-53。2 Battelino t,等人糖尿病護理。2019;42 (8): 1593-603。3 Vigersky RA 等人Diabetes Technol Ther. 2019;21 (2): 81-85。4 Stelo 用戶指南。5 Dexcom,存檔數據,2024。6 美國疾病控制與預防中心。全國糖尿病統計報告。2024 年 8 月 12 日訪問。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. 對按胰島素療法和種族/民族分層的 2 型糖尿病 (PWT2D) 患者啓動實時連續血糖監測 (rtcGM) 後改善了血糖控制。於 2024 年 3 月 6 日至 9 日在意大利佛羅倫薩舉行的第 17 屆糖尿病先進技術與治療國際會議(ATTD 2024)上發表,並在線發表。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。未接受胰島素治療的2型糖尿病成人受益於cGM的使用:真實世界的數據。2024年3月6日至9日在意大利佛羅倫薩舉行的第17屆糖尿病先進技術與治療國際會議(ATTD 2024)上發表,並在線發表。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 等人糖尿病科學技術雜誌 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:在根據您的傳感器讀數進行任何藥物調整之前,請諮詢您的醫療保健提供者,未經諮詢您的醫療保健提供者,請勿根據您的傳感器讀數採取任何其他醫療措施。如果您有低血糖問題,請勿使用。未能按照所提供的使用說明使用Stelo及其成分,也未正確考慮這些使用說明中的所有適應症、禁忌症、警告和注意事項,可能會導致您錯過嚴重的低血糖(低血糖)或高血糖(高血糖)事件。如果您的傳感器讀數與症狀不一致,則可以根據需要選擇血糖計,並諮詢您的醫療保健提供者。在適當時尋求醫療建議和治療,包括在進行任何藥物調整和/或任何醫療緊急情況之前。

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.

使用說明:Stelo 葡萄糖生物傳感器系統是一款非處方 (OTC) 集成式連續血糖監測儀 (iCGM),旨在持續測量、記錄、分析和顯示未服用胰島素的 18 歲及以上人群的葡萄糖值。Stelo 葡萄糖生物傳感器系統有助於檢測正常(血糖)和低或高(血糖失調)的血糖水平。Stelo 葡萄糖生物傳感器系統還可以幫助用戶更好地了解生活方式和行爲的改變,包括飲食和運動,如何影響血糖偏移。未經諮詢合格的醫療保健專業人員,用戶不得根據設備輸出採取醫療措施。

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 以及任何相關徽標和設計標誌均爲 Dexcom, Inc. 在美國和/或其他國家的註冊商標或商標。2024 Dexcom, Inc. 版權所有。

Category: IR

類別:投資者關係

Media Contact
James McIntosh                                        
619-884-2118                                        
james.mcintosh@dexcom.com

媒體聯繫人
詹姆斯麥金託什
619-884-2118
james.mcintosh@dexcom.com

Investor Contact
Sean Christensen                                        
858-203-6657                                        
sean.christensen@dexcom.com

投資者聯繫人
肖恩·克里斯滕森
858-203-6657
sean.christensen@dexcom.com

Source: DexCom, Inc.

資料來源:DexCom, Inc.

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
    搶先評論