Insulet presented results from its first randomized controlled trial of the Omnipod 5 automated insulin delivery (AID) system. It’s also the first time Omnipod 5 has been evaluated by international participants.

Insulet介绍了其Omnipod 5自动胰岛素输送（AID）系统的首次随机对照试验的结果。这也是Omnipod 5首次由国际参与者进行评估。

The trial results from 194 patients were shared at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). Omnipod 5 was compared to insulin pump therapy with continuous glucose monitoring (CGM) in adults with Type 1 diabetes in the U.S. and France.

第17届糖尿病先进技术与治疗国际会议（ATTD）分享了194名患者的试验结果。在美国和法国，将Omnipod 5与具有连续血糖监测（CGM）的胰岛素泵治疗进行了比较。

The control group used their usual insulin pump with a Dexcom G6 CGM, and the intervention group used Omnipod 5 with Dexcom G6. Data showed that using Omnipod 5 led to 17.5% improvement in time in range (TIR), lowered HbA1c, decreased percentage of time in hypoglycemia, and lessened mean glucose in those with elevated HbA1c levels. .

对照组使用常规胰岛素泵和Dexcom G6 CGM，干预组使用Omnipod 5和Dexcom G6。数据显示，使用Omnipod 5可使HbA1c水平升高的患者的时间范围（TIR）改善17.5%，降低HbA1c，降低低血糖时间百分比，并降低平均血糖。。。

All primary and secondary trial endpoints were met, and there were no events of severe hypoglycemia or DKA with Omnipod 5.

所有主要和次要试验终点均得到满足，Omnipod 5无严重低血糖或DKA事件。

Insulet also presented patient-reported results for psychosocial measures: diabetes distress, hypoglycemia confidence, and diabetes-related quality of life. Using Omnipod 5, according to the company, showed meaningful improvements in these three measures.

Islet还介绍了患者报告的心理社会测量结果：糖尿病困扰，低血糖信心和糖尿病相关的生活质量。据该公司称，使用Omnipod 5在这三项措施中显示出有意义的改进。

The company said this trial data shows superiority of Omnipod 5 compared to standard pump therapy with CGM and indicates it should be offered as first-line therapy for adults with type 1 diabetes.

该公司表示，该试验数据显示Omnipod 5与CGM标准泵疗法相比具有优越性，并表明它应作为1型糖尿病成人的一线疗法。

“Since Omnipod 5’s first commercial launch in the United States, we have been working diligently to expand into new markets and improve access to this life-changing technology,” said Dr. Trang Ly MBBS, FRACP, Ph.D., Insulet’s senior VP and medical director. “By gathering evidence from international participants through a randomized controlled trial, we have demonstrated the true benefit of using our tubeless, disposable automated insulin delivery (AID) system to manage type 1 diabetes over alternative forms of therapy and illustrated the superiority of Omnipod 5 compared to standard pump therapy with CGM for people with type 1 diabetes.” .

“自从Omnipod 5在美国首次商业推出以来，我们一直在努力开拓新市场，改善这种改变生命的技术的使用，”Trang Ly MBBS博士，FRACP博士，Insulet的高级副总裁兼医疗总监说。“通过一项随机对照试验从国际参与者那里收集证据，我们证明了使用我们的无管一次性自动胰岛素输送（AID）系统管理1型糖尿病的真正益处，而不是替代治疗形式，并说明了Omnipod 5与标准的CGM泵治疗1型糖尿病患者相比的优越性。”。。

Last month, the Omnipod 5 AID gained CE mark clearance to add compatibility of Abbott’s FreeStyle Libre 2 Plus CGM sensor for type 1 diabetes patients aged two years and older.

上个月，Omnipod 5 AID获得CE标志许可，为两岁及以上的1型糖尿病患者增加了雅培FreeStyle Libre 2 Plus CGM传感器的兼容性。