Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA.
Atlanta Diabetes Associates, Atlanta, Georgia, USA.
Diabetes Technol Ther. 2024 Jun;26(6):383-393. doi: 10.1089/dia.2023.0506. Epub 2024 Feb 21.
To evaluate the long-term safety and effectiveness of the Omnipod 5 Automated Insulin Delivery (AID) System in very young children with type 1 diabetes with up to 2 years of use. Following a 13-week single-arm, multicenter, pivotal trial that took place after 14 days of standard therapy data collection, participating children (2-5.9 years of age at study enrollment) were provided the option to continue use of the AID system in an extension phase. HbA1c was measured every 3 months, up to 15 months of total use, and continuous glucose monitor metrics were collected through the completion of the extension study (for up to 2 years). Participants ( = 80) completed 18.2 [17.4, 23.4] (median [interquartile range]) total months of AID, inclusive of the 3-month pivotal trial. During the pivotal trial, HbA1c decreased from 7.4% ± 1.0% (57 ± 10.9 mmol/mol) to 6.9% ± 0.7% (52 ± 7.7 mmol/mol, < 0.0001) and was maintained at 7.0% ± 0.7% (53 ± 7.7 mmol/mol) after 15 months total use ( < 0.0001 from baseline). Time in target range (70-180 mg/dL) increased from 57.2% ± 15.3% during standard therapy to 68.1% ± 9.0% during the pivotal trial ( < 0.0001) and was maintained at 67.2% ± 9.3% during the extension phase ( < 0.0001 from standard therapy). Participants spent a median 97.1% of time in Automated Mode during the extension phase, with one episode of severe hypoglycemia and one episode of diabetic ketoacidosis. This evaluation of the Omnipod 5 AID System indicates that long-term use can safely maintain improvements in glycemic outcomes with up to 2 years of use in very young children with type 1 diabetes. NCT04476472.
评估 Omnipod 5 自动化胰岛素输送 (AID) 系统在接受标准治疗 14 天后进行为期 13 周的单臂、多中心、关键试验后,患有 1 型糖尿病的 2 至 5.9 岁儿童长达 2 年的长期安全性和有效性。参加研究的儿童(在研究入组时年龄为 2-5.9 岁)可以选择在扩展阶段继续使用 AID 系统。糖化血红蛋白每 3 个月测量一次,最长可达 15 个月总使用时间,通过扩展研究完成收集连续血糖监测指标(最长可达 2 年)。80 名参与者完成了 18.2 [17.4, 23.4](中位数[四分位距])总 AID 月,包括 3 个月的关键试验。在关键试验中,糖化血红蛋白从 7.4%±1.0%(57±10.9mmol/mol)降至 6.9%±0.7%(52±7.7mmol/mol, <0.0001),并且在总使用 15 个月后维持在 7.0%±0.7%(53±7.7mmol/mol)(与基线相比, <0.0001)。目标范围内时间(70-180mg/dL)从标准治疗时的 57.2%±15.3%增加到关键试验时的 68.1%±9.0%( <0.0001),并且在扩展阶段维持在 67.2%±9.3%(与标准治疗相比, <0.0001)。参与者在扩展阶段有中位数 97.1%的时间处于自动化模式,发生 1 次严重低血糖事件和 1 次糖尿病酮症酸中毒事件。这项对 Omnipod 5 AID 系统的评估表明,在患有 1 型糖尿病的非常年幼的儿童中,长达 2 年的长期使用可以安全地维持血糖结果的改善。NCT04476472。