Forlenza Gregory P, DeSalvo Daniel J, Aleppo Grazia, Wilmot Emma G, Berget Cari, Huyett Lauren M, Hadjiyianni Irene, Méndez José J, Conroy Lindsey R, Ly Trang T, Sherr Jennifer L
Department of Pediatrics, Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA.
Diabetes Technol Ther. 2024 Aug;26(8):514-525. doi: 10.1089/dia.2023.0578. Epub 2024 Feb 16.
The Omnipod 5 Automated Insulin Delivery System was associated with favorable glycemic outcomes for people with type 1 diabetes (T1D) in two pivotal clinical trials. Real-world evidence is needed to explore effectiveness in nonstudy conditions. A retrospective analysis of the United States Omnipod 5 System users (aged ≥2 years) with T1D and sufficient data (≥90 days of data; ≥75% of days with ≥220 continuous glucose monitor readings/day) available in Insulet Corporation's device and person-reported datasets as of July 2023 was performed. Target glucose setting usage (i.e., 110-150 mg/dL in 10 mg/dL increments) was summarized and glycemic outcomes were examined. Subgroup analyses of those using the lowest average glucose target (110 mg/dL) and stratification by baseline characteristics (e.g., age, prior therapy, health insurance coverage) were conducted. In total, 69,902 users were included. Multiple and higher glucose targets were more commonly used in younger age groups. Median percentage of time in range (TIR; 70-180 mg/dL) was 68.8%, 61.3%, and 53.6% for users with average glucose targets of 110, 120, and 130-150 mg/dL, respectively, with minimal time <70 mg/dL (all median <1.13%). Among those with an average glucose target of 110 mg/dL ( = 37,640), median TIR was 65.0% in children and adolescents (2-17 years) and 69.9% in adults (≥18 years). Subgroup analyses of users transitioning from Omnipod DASH or multiple daily injections and of Medicaid/Medicare users demonstrated favorable glycemic outcomes among these groups. These glycemic outcomes from a large and diverse sample of nearly 70,000 children and adults demonstrate effective use of the Omnipod 5 System under real-world conditions.
在两项关键临床试验中，Omnipod 5自动胰岛素输送系统与1型糖尿病（T1D）患者良好的血糖控制结果相关。需要真实世界证据来探索该系统在非研究条件下的有效性。对截至2023年7月Insulet公司设备和个人报告数据集中有足够数据（≥90天数据；≥75%的天数每日连续血糖监测读数≥220次）的美国T1D Omnipod 5系统用户（年龄≥2岁）进行了回顾性分析。总结了目标血糖设定的使用情况（即110 - 150mg/dL，以10mg/dL为增量）并检查了血糖控制结果。对使用最低平均血糖目标（110mg/dL）的用户进行亚组分析，并按基线特征（如年龄、既往治疗、医疗保险覆盖范围）进行分层。总共纳入了69,902名用户。多个更高的血糖目标在较年轻年龄组中更常用。平均血糖目标为110、120和130 - 150mg/dL的用户，血糖达标时间（TIR；70 - 180mg/dL）的中位数分别为68.8%、61.3%和53.6%，血糖<70mg/dL的时间极少（所有中位数<1.13%）。在平均血糖目标为110mg/dL的用户中（n = 37,640），儿童和青少年（2 - 17岁）的TIR中位数为65.0%，成年人（≥18岁）为69.9%。对从Omnipod DASH或多次每日注射转换而来的用户以及医疗补助/医疗保险用户的亚组分析显示，这些组的血糖控制结果良好。近70,000名儿童和成年人的大量多样样本的这些血糖控制结果表明，Omnipod 5系统在真实世界条件下得到了有效使用。
