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有葡萄糖感應器的胰島素幫浦比多次的每日注射更能有效降低HbA1c
作者：Becky McCall  
出處：WebMD醫學新聞

　　October 5, 2009 (奧地利維也納) — 研究者在歐洲糖尿病協會(EASD)第45屆年會報告指出，一種增強感應的幫浦(SAP)，同時有胰島素幫浦與連續性葡萄糖感應器，可以比多次的每日注射更能降低糖化血色素(HbA1c)值，且不會增加低血糖。這可以讓幫浦注射器更接近封閉型系統的目標，對於第1型糖尿病患來說，使用更方便且控制更佳。
　　
　　標準幫浦可讓病患連續輸注短效型胰島素，取代使用長效型胰島素、較無彈性的多次每天注射療程。SAP則同時包括了連續性的葡萄糖感應器與胰島素幫浦。
　　
　　荷蘭阿姆斯特丹大學醫學院附設醫學中心的Jeroen Hermanides醫師在發表時表示，藉由每5分鐘測量皮下組織的葡萄糖濃度，病患可以有穩定的資訊，而沒有使用感應器的病患，必須每天多次在手指扎針來測量血糖。以前，病患每天只有5或6次的測量時間點，現在可以整天都有相關數據。
　　
　　共同作者、阿姆斯特丹大學醫學院附設醫學中心的J. Hans DeVries醫師向Medscape Diabetes Endocrinology指出，我們特別希望有糖尿病控制問題的病患瞭解，這些感應器不是玩具，許多人為了方便性而使用感應器，而不是有需要才使用。
　　
　　這個跨國的多中心隨機控制試驗，包括了83名第1型糖尿病患。全部病患的HbA1c值大於等於8.2%。全部都接受26週的SAP治療或者標準照護、多次的每日注射。全部病患的HbA1c都控制不佳。在第13和26週測量HbA1c值，也紀錄低血糖和高血糖的發生率。也測量發生高血糖事件的期間。
　　
　　26週的SAP治療之後， HBA1c從8.46± 0.95%降低到7.23± 0.65%。多次的每日注射組中，平均HbA1c值在治療前為8.59± 0.82%，治療後為8.46 ± 1.04%。Hermanides醫師指出，當我們把開始時的HbA1c納入考量，且和多次的每日注射組比較，這是多達1.21%的改變。另外，我們也發現，高血糖事件的期間縮短；因此有較少的高血糖事件，而且期間縮短。相較於必須等待再度扎手指檢測血糖的病患，可以更迅速矯正低血糖。
　　
　　除了連續監測之外，SAP有一個稱為Bolus Wizard的程式，可提供病患需要多少胰島素來應付餐點的建議，且不需要扎手指檢測。DeVries醫師解釋，我們發現SAP控制葡萄糖值並不會增加發生低血糖事件。如果你從注射方式改用胰島素幫浦，可以有適當的胰島素給藥，而且可以藉由Bolus Wizard而有連續的葡萄糖資料和訊息，獲得的HbA1c值結果自然大不相同。
　　
　　法國Sainte Marguerite大學醫院的糖尿病專家Denis Raccah醫師對於使用胰島素幫浦提出建議時表示，SAP是邁向封閉迴路型系統重要一步，對病患也有重要幫助。目前還不是封閉型迴路，因為我們缺乏血糖值和胰島素劑量之間的演算方式；它依舊是一個開放型迴路系統。病患可以即時評估他們的血糖，因而避免在夜間發生低血糖事件。有時候病患在晚上不感覺發生低血糖，所以此裝置可以設定警報。它在體能活動方面也很有用。
　　
　　他繼續解釋，在Raccah醫師領導的REAL Trend研究中顯示，當多次的每日注射仍控制不佳的病患轉用有胰島素幫浦和感應器的整合型系統，而非需用傳統方法測量葡萄糖的幫浦時，在6個月後可以發現HbA1c有明顯改善，低血糖事件也沒有比單用幫浦者增加。
　　
　　DeVries醫師指出有接受Medtronic的資助。Raccah醫師的REAL Trend研究也接受Medtronic的資助。
　　
　　歐洲糖尿病協會(EASD)第45屆年會：摘要90。發表於2009年10月1日。

Insulin Pump With Glucose Sensor More Effective at Lowering HbA1c Than Multiple Daily Injections

By Becky McCall
Medscape Medical News

October 5, 2009 (Vienna, Austria) — A sensor-augmented pump (SAP), which combines an insulin pump with a continuous glucose sensor, delivers lower hemoglobin?(Hb)A1c levels than multiple daily injections, without an increase in hypoglycemia. This finding potentially moves pumps a step nearer to the ultimate aim of a closed system and greater control and convenience for patients with type?1 diabetes, researchers reported here at the European Association for the Study of Diabetes 45th Annual Meeting.

Standard pumps provide the patient with a continuous infusion of short-acting insulins instead of multiple daily injection therapy, which provides a one-time, less flexible hit with long-acting insulin. The SAP combines a continuous glucose sensor with the insulin pump.

"By measuring glucose concentration in the subcutaneous tissue every 5 minutes, the patient has a constant stream of information, compared with patients without a sensor who have to measure glucose levels with a finger stick test at mealtimes and a few extra times during the day. Previously, patients only had 5 or 6 measurement time points, but now they know this level throughout the day," said Jeroen Hermanides, MD, from the Academic Medical Centre in Amsterdam, the Netherlands, who presented the study.

Coauthor J. Hans DeVries, MD, also from the Academic Medical Centre in Amsterdam, added: "We particularly wanted patients who had a problem with diabetes control to counteract the common belief that sensors are toys for boys, that many people use sensors for convenience but don't necessarily need them," he told Medscape Diabetes Endocrinology.

The multinational, multicenter, randomized controlled trial involved 83 patients with type?1 diabetes. All patients had an HbA1c level above or equal to 8.2%. All received 26 weeks of therapy either with a SAP or with the standard of care, multiple daily injections. All patients had suboptimal control of HbA1c. Levels of HbA1c were measured at 13 and 26 weeks and the occurrence of hypoglycemic and hyperglycemic events was recorded. The duration of hyperglycemic events was also measured.

After 26 weeks of SAP therapy, the HBA1c decreased from 8.46?± 0.95% to 7.23?± 0.65%. In the multiple daily injection group, mean HbA1c was 8.59?± 0.82% before therapy and 8.46 ± 1.04% after. "When we account for baseline HbA1c, there is a 1.21% magnitude of change compared with [multiple daily injection] therapy. But we also saw the duration of hyperglycemic events decrease. So there weren't fewer hyperglycemic events but they were of shorter duration. Hyperglycemia is corrected earlier than if the patient has to wait for the next finger prick," added Dr. Hermanides.

In addition to continuous monitoring, the SAP has a program called a Bolus Wizard, which provides the patient with advice on the required amount of insulin to cover a meal without the need for a finger prick test. Dr. DeVries explained: "We found SAP-controlled glucose levels were not accompanied by a significant increase in hypoglycemia. If you optimize insulin delivery by moving from injections to an insulin pump, and in addition optimize glucose levels with a continuous stream of glucose data and information from the Bolus Wizard, then this will make a difference to HbA1c levels."

Commenting on the use of insulin pumps, Dr. Denis Raccah, MD, diabetologist from the University Hospital Sainte Marguerite in Marseille, France, said the SAP was an important step toward developing a closed loop system and a significant advance for patients. "It is not a closed loop system yet because we do not have the algorithm between glycemia and insulin dose; it is still an open loop system. Patients have real-time access to their glycemia, thus avoiding hypoglycemic events during the night. Sometimes patients don't feel hypoglycemic during the night so this device could be used with an alarm. It would also prove useful in physical activity."

He continued to explain that in the REAL Trend study, which Dr. Raccah led, it was shown that when a poorly controlled patient on multiple daily injections is transferred to an integrated system with an insulin pump and sensor, rather than a pump with glucose measured conventionally, then a significant improvement in HbA1c is seen after 6 months, and there is no increase in hypoglycemic events compared with using a pump alone."

Dr. DeVries reports receiving funding from Medtronic. Dr. Raccah's REAL Trend study was also funded by Medtronic.

European Association for the Study of Diabetes (EASD) 45th Annual Meeting: Abstract 90. Presented October 1, 2009.