仿生胰腺对 6-17 岁 1 型糖尿病青少年血糖控制的积极影响：一项多中心随机试验。
Positive Impact of the Bionic Pancreas on Diabetes Control in Youth 6-17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial.
机构信息
Barbara Davis Center for Diabetes, University of Colorado, Aurora, Colorado, USA.
Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, California, USA.
出版信息
Diabetes Technol Ther. 2022 Oct;24(10):712-725. doi: 10.1089/dia.2022.0201.pub.
To evaluate the insulin-only configuration of the iLet bionic pancreas (BP) in youth 6-17 years old with type 1 diabetes (T1D). In this multicenter, randomized, controlled trial, 165 youth with T1D (6-17 years old; baseline HbA1c 5.8%-12.2%; 35% using multiple daily injections, 36% using an insulin pump without automation, 4% using an insulin pump with low glucose suspend, and 25% using a hybrid closed-loop system before the study) were randomly assigned 2:1 to use BP ( = 112) with insulin aspart or insulin lispro (BP group) or to a control group ( = 53) using their personal standard care insulin delivery (SC group) plus real-time continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. Mean HbA1c decreased from 8.1% ± 1.2% at baseline to 7.5% ± 0.7% at 13 weeks with BP versus 7.8% ± 1.1% at both baseline and 13 weeks with SC (adjusted difference = -0.5%, 95% CI -0.7% to -0.2%, < 0.001). Participants with baseline HbA1c ≥9.0% ( = 34) decreased mean HbA1c from 9.7% ± 0.8% to 7.9% ± 0.6% after 13 weeks with BP compared with 9.7% ± 0.5% to 9.8% ± 0.8% with SC. Over 13 weeks, mean time in range (TIR) 70-180 mg/dL increased by 10% (2.4 h per day) and mean CGM glucose was reduced by 15 mg/dL with BP compared with SC ( < 0.001). Analyses of time >180 mg/dL, time >250 mg/dL, and standard deviation of CGM glucose favored BP ( < 0.001). Time <54 mg/dL was low at baseline (median 0.2%) and not significantly different between groups over 13 weeks ( = 0.24). A severe hypoglycemia event occurred in 3 (2.7%) participants in the BP group and in 1 (1.9%) in the SC group. In youth 6-17 years old with T1D, use of insulin-only configuration of BP improved HbA1c, TIR, and hyperglycemic metrics without increasing CGM-measured hypoglycemia compared with standard of care. Improvement in glycemic metrics was most pronounced in participants with high baseline HbA1c levels. clinicaltrials.gov; NCT04200313.
评估 iLet 仿生胰腺（BP）在 6-17 岁 1 型糖尿病（T1D）青少年中的仅胰岛素配置。 在这项多中心、随机、对照试验中，165 名 T1D 青少年（6-17 岁；基线糖化血红蛋白 5.8%-12.2%；35%使用多次每日注射，36%使用无自动化胰岛素泵，4%使用低血糖暂停胰岛素泵，25%在研究前使用混合闭环系统）被随机分为 2:1 组，使用 BP（ = 112）给予门冬胰岛素或赖脯胰岛素或对照组（ = 53）给予个人标准护理胰岛素输送（SC 组）加实时连续血糖监测（CGM）。主要结局是 13 周时的糖化血红蛋白（HbA1c）。 与基线相比，BP 组的 HbA1c 从 8.1% ± 1.2%下降至 7.5% ± 0.7%，而 SC 组的 HbA1c 从 7.8% ± 1.1%下降至 7.8% ± 1.1%（调整差异 = -0.5%，95%CI-0.7%至-0.2%， < 0.001）。基线 HbA1c≥9.0%（ = 34）的参与者，与 SC 相比，BP 组在 13 周时的平均 HbA1c 从 9.7% ± 0.8%降至 7.9% ± 0.6%。 在 13 周内，BP 组 70-180mg/dL 的时间在目标范围内（TIR）增加了 10%（每天 2.4 小时），CGM 葡萄糖降低了 15mg/dL，而 SC 组为 15mg/dL（ < 0.001）。BP 组的时间>180mg/dL、时间>250mg/dL 和 CGM 葡萄糖标准差分析结果优于 SC 组（ < 0.001）。CGM 葡萄糖的时间<54mg/dL 在基线时较低（中位数 0.2%），13 周内两组之间无显著差异（ = 0.24）。BP 组有 3 名（2.7%）参与者发生严重低血糖事件，SC 组有 1 名（1.9%）参与者发生严重低血糖事件。 在 6-17 岁的 T1D 青少年中，与标准护理相比，仅使用 BP 的胰岛素配置可改善 HbA1c、TIR 和高血糖指标，而不会增加 CGM 测量的低血糖。在基线 HbA1c 水平较高的参与者中，血糖指标的改善最为明显。 临床试验.gov；NCT04200313。
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