胰岛素泵自动阀门可提高安全性

根据1型糖尿病的ASPIRE试验结果，一种胰岛素泵当循环后休息，持续性检测血糖水平，降低夜间低血糖和防止严重的情况发生。

明尼苏达周圣路易斯公园的国际糖尿病中心的Richard Bergenstal博士表示，测曲线下区域，与同样的设备但没有软件的相比，此类设备有软件的患者平均严重程度和夜间低血糖时间降低了38% (P<0.001)。

整体血糖控制也不错，他们将结果汇报在美国糖尿病协会会议上同时也在线刊登在新英格兰杂志上。

设备设定为当血糖到达70 mg/dL的阈值时停止胰岛素给药2个小时，无严重低血糖发生。但是在泵没有此类额外程序的患者中有4个发生了低血糖。

Bergenstal在新闻发布会时告诉记者，这也许是从过去以来第一个研究表明了无严重的低血糖。

"他补充道，这个胰岛素自动化的想法，将'大脑'放到泵中，是真正值得去继续探索的事情，现在还只是个开始。

会议主持人洛杉矶南加州大学的Anne Peters博士建议，这些新的发现是MiniMed 530 G系统的一部分，目前正在接受FDA的审查，也许能使患者更加愿意去尝试积极的治疗。

她在接受MedPage Today采访时评论道：低血糖是人们不愿看到的结果，低血糖让人们害怕严格控制血糖。降低这个事件，甚至让人们能感到这个事件在降低，这样能使人们会潜在地感到自信，并且我真的认为这个很重要。

该设备离真正模仿胰腺还有很多步要走。但是预测并不是应对已经出现的低血糖水平，使泵根据一整天趋势改变胰岛素剂量，并将胰高血糖素加入泵中去预防低血糖都已经实现了。

Bergenstal说道，在我30年的生命中，第一个我真正感觉到人工胰腺是可行的，在这之前是一个梦想，现在我们已经都有它的第一部分并且我认为我们可以看到它的发展。

他的在家庭中自动化模拟胰岛素反应（ASPIRE）试验招募了247名具有夜间低血糖记录的1型糖尿病患者，将这些患者随机分到具有阈值暂停和没有阈值暂停的持续监测血糖水平的胰岛素泵组中。

暂停胰岛素的阈值可以设定为60-90 mg/dL，但通常设置在70 mg/dL。

超过2/3的低血糖发生在晚上，阈值暂停组的患者发生夜间低血糖的次数降低到一星期1.5次，而对照组是一星期2.2次，32%的相对差异。

有了阈值暂停功能后，白天和晚上总体低血糖事件较正常的水平降低了30%。

这功能降低了更多的更严重的事件，60 to 70 mg/dL的轻度低血糖相对减少40%，但50 mg/dL.的低血糖降低了57%。

胰岛素暂停2小时候的低血糖发生风险较低。

Bergenstal说道：令人担心的是血糖会升的太快，但是令我们高兴的是看到经过2小时暂停后血糖最终在92 or 93 mg/dL，这个恰恰是回到正常水准。

对于最初的安全性检测设定截点，糖化血红蛋白水平在阈值暂停组与对照组间是相似的（7.24% 和7.14%,符合非劣效性标准）。

无论在总的胰岛素剂量，丸剂，传感器磨损和校准，和体重变化上，组间治疗特征相似。因此Bergenstal认为软件是导致不同结果的主要因素。

他在新闻发布会上告诉MedPage Today，尽管该研究只招录了记录有夜间低血糖的患者，但是结果是普遍性的（意思是结论是可靠的，可以推广的）。

Peters表示大多数1型糖尿病患者至少一个月都会经历几次夜间低血糖情况。

Bergenstal补充道，整个年龄段和整个糖化血红蛋白范围内的患者都可以从降低低血糖中受益，对于16-70岁的患者有相当类似的影响。

（丁香园：dellysu）

ADA: Auto Off for Insulin Pump Boosts Safety

An insulin pump that takes a break when the looped-in, continuous glucose monitor detects low glucose levels reduced nighttime hypoglycemia and prevented serious events, according to results of the ASPIRE trial in type 1 diabetes.

The mean severity and duration of nocturnal hypoglycemia fell by 38% as measured by area-under-the-curve compared with the same device without the software (P<0.001), Richard Bergenstal, MD, of the International Diabetes Center at Park Nicollet in St. Louis Park, Minn., and colleagues found.

Overall glucose control didn't suffer, they reported here at the American Diabetes Association meeting and simultaneously online in the New England Journal of Medicine.

No severe hypoglycemia occurred with devices set to suspend insulin dosing for 2 hours after hitting the 70 mg/dL glucose threshold compared with four events among patients whose pumps did not have the extra programming.

"That's probably one of the first studies ever to show no severe hypoglycemia," Bergenstal told reporters at a press conference.

"This idea of automating insulin, putting some 'brains' in the pump, is really something worth continuing to explore," he added. "This is the beginning."

These findings with the new feature, part of the MiniMed 530 G system now under FDA review, might actually make patients more willing to try more aggressive therapy, suggested press conference moderator Anne Peters, MD, of the University of Southern California in Los Angeles.

"Hypoglycemia is their limiting step, it's what makes them afraid of tight glycemic control," she commented in an interview with MedPage Today. "Reducing it, and even the perception that you have less, will make people potentially feel more confident, and I really think that matters."

Devices are still a few major steps away from truly mimicking the pancreas. But predicting rather than reacting to already low glucose levels, having the pump alter dose based on trends throughout the day, and adding glucagon to the pump to manage hypoglycemia are in the works.

"For the first time in my 30 years, I'm really feeling this artificial pancreas is feasible," Bergenstal said. "Before it was a dream, now we have the first part of it and I think we will see this develop."

His Automation to Simulate Pancreatic Insulin Response (ASPIRE) In-Home Study included 247 type 1 diabetes patients with documented nocturnal hypoglycemia randomized to receive the continuous glucose monitor-linked insulin pump with or without the threshold-suspend feature for 3 months.

The threshold can be programmed to suspend insulin at 60 to 90 mg/dL but usually is set at 70 mg/dL.

The number of nocturnal hypoglycemia events dropped to an average of 1.5 per week in patients with the threshold-suspend device versus 2.2 per week in the control group, a 32% relative difference (P<0.001). More than two-thirds of hypoglycemia happened at night.

Overall day and night events were likewise 30% less common with the threshold-suspend feature (3.3 versus 4.7 per week, P<0.001).

The feature cut down more on the more severe events, with a relative 40% reduction in mild hypoglycemia of 60 to 70 mg/dL but a 57% reduction in events reaching under 50 mg/dL.

Risk of rebound hyperglycemia after 2-hour insulin suspension was low.

The concern was that glucose might shoot too high, "but we were pleased to see that at the end of that 2-hour suspension blood sugar was 92 or 93 mg/dL," Bergenstal noted. "It had just drifted back up to the normal range."

For the primary safety endpoint, hemoglobin A1c levels were similar between the threshold-suspend pump therapy and the control group (7.24% and 7.14%, which met non-inferiority criteria).

Treatment characteristics were similar between groups in terms of total insulin dosage, boluses, sensor wear and calibration, and body weight change, which Bergenstal said supported the software as the main factor in the results.

Although the study included only patients with documented nocturnal hypoglycemic episodes, that shouldn't limit generalizability, he told MedPage Today at the briefing.

Most patients with type 1 diabetes do experience nighttime hypoglycemia at least a couple of times a month, Peters noted.

The benefits of reducing hypoglycemia were seen across the whole age and A1c spectrum, with fairly similar impact for patients ages 16 to 70, Bergenstal added.

原文链接：http://www.medpagetoday.com/MeetingCoverage/ADA/40027

编辑： belinda_1231    来源：丁香园