Outpatient Randomized Crossover Automated Insulin Delivery Versus Conventional Therapy with Induced Stress Challenges.
Outpatient Randomized Crossover Automated Insulin Delivery Versus Conventional Therapy with Induced Stress Challenges.
复制标题
门诊随机交叉自动胰岛素输送与诱导应激挑战的传统疗法。
DOI：
10.1089/dia.2021.0436
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发表时间：
2022
影响因子：
5.4
通讯作者：
Kudva,YogishC
中科院分区：
文献类型：
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作者：
Kaur,RavinderJeet;Deshpande,Sunil;Pinsker,JordanE;Gilliam,WesleyP;McCrady-Spitzer,Shelly;Zaniletti,Isabella;Desjardins,Donna;Church,MeiMei;DoyleIii,FrancisJ;Kremers,WalterK;Dassau,Eyal;Kudva,YogishC
背景：尚未在1型糖尿病的心理和药理应激背景下评价自动胰岛素输送（AID）系统。我们的目的是确定血糖控制和胰岛素的使用与区域模型预测控制（区MPC）AID系统增强持续高血糖状态与传感器增强泵（SAP）在门诊use.Materials和方法：随机，交叉，2周的试验区MPC AID与SAP在14名成人1型糖尿病。在每组中，每名参与者在临床上进行了心理应激诱导研究（特里尔社会应激测试[TSST]和社会评估冷加压素测试[SECPT]），然后通过口服氢化可的松进行药理应激诱导（每位参与者共四次）。主要结果是2周的连续血糖监测百分比时间范围（TIR）70-180 mg/dL，和葡萄糖和胰岛素的结果期间和过夜后stressinduction.Results：在心理应激，AID降低血糖变异性百分比为13.4%（P= 0.009）。在药物应激期间，包括随后的过夜，AID和医生辅助的SAP之间的血糖结果和总胰岛素没有差异。然而，对于药物应激，AID的总用户要求的胰岛素降低了6.9 U（P= 0.01）。通过心率和唾液皮质醇水平的变化来验证应激诱导。在使用AID的2周内，TIR为74.4%（vs. SAP 63.1%，P = 0.001），夜间TIR为78.3%（vs. SAP 63.1%，P = 0.004）。没有不良事件。结论：区域MPC AID可以降低血糖变异性和需要用户要求的胰岛素在药理学应激，可以改善整体血糖结果。临床试验标识符NCT 04142229。
Background:Automated insulin delivery (AID) systems have not been evaluated in the context of psychological and pharmacological stress in type 1 diabetes. Our objective was to determine glycemic control and insulin use with Zone Model Predictive Control (zone-MPC) AID system enhanced for states of persistent hyperglycemia versus sensor-augmented pump (SAP) during outpatient use, including in-clinic induced stress.Materials and Methods:Randomized, crossover, 2-week trial of zone-MPC AID versus SAP in 14 adults with type 1 diabetes. In each arm, each participant was studied in-clinic with psychological stress induction (Trier Social Stress Test [TSST] and Socially Evaluated Cold Pressor Test [SECPT]), followed by pharmacological stress induction with oral hydrocortisone (total four sessions per participant). The main outcomes were 2-week continuous glucose monitor percent time in range (TIR) 70–180 mg/dL, and glucose and insulin outcomes during and overnight following stress induction.Results:During psychological stress, AID decreased glycemic variability percentage by 13.4% (P= 0.009). During pharmacological stress, including the following overnight, there were no differences in glucose outcomes and total insulin between AID and physician-assisted SAP. However, with AID total user-requested insulin was lower by 6.9 U (P= 0.01) for pharmacological stress. Stress induction was validated by changes in heart rate and salivary cortisol levels. During the 2-week AID use, TIR was 74.4% (vs. SAP 63.1%,P= 0.001) and overnight TIR was 78.3% (vs. SAP 63.1%,P= 0.004). There were no adverse events.Conclusions:Zone-MPC AID can reduce glycemic variability and the need for user-requested insulin during pharmacological stress and can improve overall glycemic outcomes. Clinical Trial Identifier NCT04142229.