獲准Medtronic 世界第一人工智慧胰島素自動注射 (Minimed 640G insulin pump)

「人造胰臟」測試結果出爐了！ 健康醫療網／記者蘇湘雲報導2016-12-30糖尿病可不只一種，糖尿病主要分為第一型糖尿病、第二型糖尿病、其他型糖尿病與妊娠糖尿病等。第一型糖尿病又稱為「胰島素依賴型糖尿病」或「幼年型糖尿病」，屬於自體免疫疾病，由於身體淋巴細胞中的T細胞攻擊胰臟內的「貝他細胞」，導致胰島素分泌大量減少、血糖上升，患者必須終生接受胰島素治療。在台灣，每年每10萬人口就有1.5人罹患第一型糖尿病。

第一型糖尿病　患者多為兒童、青少年 第一型糖尿病患者必須長時間注射胰島素，胰島素用量也必須精準，胰島素劑量太低，血糖控制效果就不好，長時間下來，心血管疾病、腎臟疾病等各式糖尿病併發症就會提早報到。若胰島素劑量過高，則會引發低血糖，患者嚴重時可能昏厥、休克，加上第一型糖尿病患者多為兒童、青少年，血糖控制更需謹慎。美國醫師協會期刊（JAMA）刊出一篇研究報告顯示，專為第一型糖尿病病患量身打造的「人造胰臟」通過安全性測驗。這種人造胰臟可幫助血糖維持穩定，降低血糖過高或過低的風險 。

人造胰臟　有助降低糖化血色素值 另有研究發現，人造胰臟也可降低糖化血色素值，研究顯示，一群糖化血色素平均為7.4%的受試者，在使用期間平均降至6.9%。然而，這些受試者至少年滿14歲，第一型糖尿病病史也多在2年以上，且原已使用胰島素幫浦。對於未滿14歲的兒童、未有使用胰島素幫浦經驗的患者來說，安全性仍有待檢驗。 這類「混合性封閉式人造胰臟」（Hybrid Closed-loop artificial pancreases）使用皮下血糖感應器針測量血糖，並傳送訊號至胰島素施打系統，經由演算法精算出所需劑量。該系統納入患者進食需求考量，所以餐前還是必須計算胰島素劑量，手動調整幫浦參數，以調整藥物劑量。

台灣多數患者　以注射胰島素為主 成大兒童遺傳代謝暨內分泌科主治醫師蔡孟哲指出，因醫療技術、衛教、照護制度的進步，第一型糖尿病患者的疾病控制獲得很大改善，在現行健保制度中，第一型糖尿病患可以無後顧之憂地使用胰島素、血糖試紙，台灣醫藥界對第一型糖尿病患者的照護程度，可能不輸其他先進國家。 而針對人工胰臟在台灣推行的可能性，蔡孟哲醫師表示，現在絕大部份的病人還是以自行注射胰島素為主，礙於自費價格的緣故，只有一小部份的人使用胰島素幫浦，而使用幫浦的病人需要搭配使用即時血糖監測機，這部分也仍未普及。人工胰臟雖然通過美國食藥署核可，目前還無法在台灣使用，未來能否在台灣上市、普遍使用還是未知數。

參考資料、文獻來源：

1.翻譯作者：國立成功大學醫學院公共衛生研究所兼任助理吳懷玨2. Bergenstal, R. M., Garg, S., Weinzimer, S. A., Buckingham, B. A., Bode, B. W., Tamborlane, W. V., & Kaufman, F. R. (2016). Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. Jama, 316(13), 1407-1408. http://jamanetwork.com/journals/jama/article-abstract/2552454  3. Voelker R. "Artificial Pancreas" Is Approved. JAMA. 2016;316(19):1957. doi:10.1001/jama.2016.16344/ http://jamanetwork.com/journals/jama/article-abstract/2584035  4. The Journal Of The American Medical Association Publishes Medtronic's Hybrid Closed Loop System Pivotal Trial Results（September 15, 2016）http://www.meddeviceonline.com/doc/the-journal-of-the-american-hybrid-closed-loop-system-pivotal-trial-results-0001  5. Diabetes Patients Design Their Own 'Artificial Pancreas'（April 21, 2016） http://www.medscape.com/viewarticle/862064 6.資料出處：科技部補助｢新媒體科普傳播實作計畫｣執行團隊、科技大觀園

 

Medtronic PLC (MDT) Soars With The Approval Of CoreValve Evolut R System

Published on December 27, 2016 at 11:08 am by MARKET EXCLUSIVE in News Medtronic PLC (NYSE:MDT) is expanding, thanks to the reimbursement approval and launch of its CoreValve Evolut R System. The system, which has been implanted in more than 120,000 patients around the world, gained its approval in Japan in March 2015. It is the first self-expanding TAVI (transcatheter aortic valve implantation) in the country to get such an endorsement and it is used to treat patients who are at intermediate risk for open-heart surgery. Given the patient population in Europe, director of the Structural Heart Program at University Hospital in Bonn, Germany, Prof. Eberhard Grube says, "The highly-anticipated intermediate risk indication marks an important milestone for the industry as we look to safely expand TAVI access to younger and less sick patient populations." Today's world is all about growth, innovation, and expansion. Grube says that the Evolut R System's ability to recapture and reposition the heart valve that improves positioning accuracy and control is one of the many advances in the industry. It will play a vital role in the growth of the transcatheter space. According to the general manager and vice president of the heart valve therapies business, Rhonda Robb, the system is the first of its kind, which demonstrates competency of benefits that new patient populations will get. Robb also outlines their commitment to supporting global heart teams through advanced training and education facilities.

Addition Of Key Products By Medtronic For Potential Growth Being one of the major industry players, Medtronic PLC (NYSE:MDT) has also been focusing on its diabetes portfolio in recent years. Its aim is to accelerate the growth of its market share. For this purpose, the company has not only added key products to its portfolio through acquisitions but it has also set the pace of various launches. One of the additions is that of the Minimed 640G insulin pump to its diabetes range. It has also received an approval of the Minimed 670G, which is the world's first approved hybrid closed-loop (or HCL) insulin delivery system. Medtronic's diabetes segment is the company's fastest-growing segment and continues to gain several approvals. This may have occasioned its current partnership with Fitbit Inc (NYSE:FIT), which will necessitate the creation and integration of diabetes care platforms for type 2 diabetes patients. The company, which employs more than 85,000 people worldwide, is now striving to continue offering the broadest range of innovative medical technology to healthcare consumers and providers around the world. Meanwhile, Medtronic PLC (NYSE:MDT)'s stock closed at $71.95 witnessing an increase of $0.21 or 0.29%.