OBJECTIVE Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population. RESEARCH DESIGN AND METHODS A total of 80 children aged 2.0–5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy. RESULTS There were no episodes of severe hypoglycemia or diabetic ketoacidosis. By study end, HbA1c decreased by 0.55% (6.0 mmol/mol) (P < 0.0001). Time with sensor glucose levels in target range 70–180 mg/dL increased by 10.9%, or 2.6 h/day (P < 0.0001), while time with levels <70 mg/dL declined by median 0.27% (P = 0.0204). CONCLUSIONS Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline.

中文翻译：

---

无管自动胰岛素输送系统对 1 型糖尿病幼儿的安全性和血糖结果：单臂多中心临床试验


目的 患有 1 型糖尿病的幼儿常常难以达到血糖目标，使他们面临长期并发症的风险，并给护理人员带来巨大的管理负担。我们对该人群进行了 Omnipod 5 自动胰岛素输送系统的首次评估。研究设计和方法 共有 80 名 2.0-5.9 岁的儿童在一项单臂研究中使用了该研究系统，为期 13 周，之后进行了 14 天的基线数据收集和常规治疗。结果 未发生严重低血糖或糖尿病酮症酸中毒。到研究结束时，HbA1c 降低了 0.55% (6.0 mmol/mol) (P < 0.0001)。传感器葡萄糖水平处于目标范围 70–180 mg/dL 的时间增加了 10.9%，即 2.6 小时/天 (P < 0.0001)，而水平处于 <70 mg/dL 的时间中位数下降了 0.27% (P = 0.0204) 。结论 使用自动胰岛素输送系统是安全的，与基线相比，参与者在研究阶段经历了血糖测量的改善和低血糖的减少。