Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy.
Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy.
复制标题
Omnipod 5自动胰岛素输送系统在2型糖尿病的成年人中的安全性和功效：从注射到混合闭环治疗。
作者：
自动胰岛素输注（AID）很少在2型糖尿病成人中进行研究。我们在一项多中心门诊试验中测试了使用Omnipod 5系统治疗2型糖尿病的可行性。受试者既往仅使用基础胰岛素或基础-餐时胰岛素注射，使用或不使用动态血糖监测仪（CGM），基线HbA 1c ≥8%（≥64 mmol/mol）。受试者完成了2周的CGM传感器数据收集（对之前未使用CGM的受试者设盲），接受标准治疗（ST），然后过渡到8周的AID。之前仅使用基础注射的参与者在开始AID之前以手动模式使用AID系统2周。根据临床医生判断是否继续使用降糖药。主要安全性结局为AID期间探头葡萄糖≥250 mg/dL且<54 mg/dL的时间百分比。其他结局包括HbA 1c和目标范围内时间（TIR）（70-180 mg/dL）。参与者（N = 24）的平均（± SD）年龄为61 ± 8岁，基线HbA 1c为9.4% ± 0.9%（79 ± 10 mmol/mol），糖尿病病程为19 ± 9年。使用AID时，传感器葡萄糖≥250 mg/dL的时间百分比减少了16.9% ± 16.2%（P < 0.0001），而在ST和AID期间，传感器葡萄糖<54 mg/dL的时间百分比仍然较低（中位数[四分位数间距] 0.0% [0.00%，0.06%] vs. 0.00% [0.00%，0.03%]; P = 0.4543）。AID患者HbA 1c（± SD）降低1.3% ± 0.7%（14 ± 8 mmol/mol; P < 0.0001），TIR增加21.9% ± 15.2%（P < 0.0001），但每日胰岛素总量或BMI无显著变化。在血糖结果不理想的2型糖尿病成人患者中进行AID的可行性试验的结果证明了在该人群中进一步评估该技术的合理性。
Automated insulin delivery (AID) has rarely been studied in adults with type 2 diabetes. We tested the feasibility of using AID for type 2 diabetes with the Omnipod 5 System in a multicenter outpatient trial. Participants previously were using either basal-only or basal-bolus insulin injections, with or without the use of a continuous glucose monitor (CGM), and had a baseline HbA1c ≥8% (≥64 mmol/mol). Participants completed 2 weeks of CGM sensor data collection (blinded for those not previously using CGM) with their standard therapy (ST), then transitioned to 8 weeks of AID. Participants who previously used basal-only injections used the AID system in manual mode for 2 weeks before starting AID. Antihyperglycemic agents were continued at clinician discretion. Primary safety outcomes were percentage of time with sensor glucose ≥250 mg/dL and <54 mg/dL during AID. Additional outcomes included HbA1c and time in target range (TIR) (70–180 mg/dL). Participants (N = 24) had a mean (± SD) age of 61 ± 8 years, baseline HbA1c of 9.4% ± 0.9% (79 ± 10 mmol/mol), and diabetes duration of 19 ± 9 years. Percentage of time with sensor glucose ≥250 mg/dL decreased with AID by 16.9% ± 16.2% (P < 0.0001), whereas percentage of time at <54 mg/dL remained low during both ST and AID (median [interquartile range] 0.0% [0.00%, 0.06%] vs. 0.00% [0.00%, 0.03%]; P = 0.4543). HbA1c (± SD) decreased by 1.3% ± 0.7% (14 ± 8 mmol/mol; P < 0.0001) and TIR increased by 21.9% ± 15.2% (P < 0.0001) without a significant change in total daily insulin or BMI with AID. Findings from this feasibility trial of AID in adults with type 2 diabetes with suboptimal glycemic outcomes justify further evaluation of this technology in this population.