1 Division of Pediatric Endocrinology, Department of Pediatrics, Stanford University , Stanford, California.
2 Diablo Clinical Research , Walnut Creek, California.
Diabetes Technol Ther. 2018 Sep;20(9):585-595. doi: 10.1089/dia.2018.0138. Epub 2018 Aug 2.
This study assessed the safety and performance of the Omnipod personalized model predictive control (MPC) algorithm using an investigational device in adults with type 1 diabetes in response to overestimated and missed meal boluses and extended boluses for high-fat meals.
A supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient open-loop run-in phase. Adults aged 18-65 years with type 1 diabetes and HbA1c 6.0%-10.0% were eligible. Primary endpoints were percentage time in hypoglycemia <70 mg/dL and hyperglycemia ≥250 mg/dL. Glycemic responses for 4 h to a 130% overestimated bolus and a missed meal bolus were compared with a 100% bolus for identical meals, respectively. The 12-h postprandial responses to a high-fat meal were compared using either a standard or extended bolus.
Twelve subjects participated in the study, with (mean ± standard deviation): age 35.4 ± 14.1 years, diabetes duration 16.5 ± 9.3 years, HbA1c 7.7 ± 0.9%, and total daily dose 0.58 ± 0.19 U/kg. Outcomes for the 54-h HCL period were mean glucose 153 ± 15 mg/dL, percentage time <70 mg/dL [median (interquartile range)]: 0.0% (0.0-1.2%), 70-180 mg/dL: 76.1% ± 8.0%, and ≥250 mg/dL: 4.5% ± 3.6%. After both the 100% and 130% boluses, postprandial percentage time <70 mg/dL was 0.0% (0.0-0.0%) (P = 0.50). After the 100% and missed boluses, postprandial percentage time ≥250 mg/dL was 0.2% ± 0.6% and 10.3% ± 16.5%, respectively (P = 0.06). Postprandial percentages time ≥250 mg/dL and <70 mg/dL were similar with standard or extended boluses for a high-fat meal.
The Omnipod personalized MPC algorithm performed well and was safe during day and night use in response to overestimated, missed, and extended meal boluses in adults with type 1 diabetes.
本研究旨在评估 Omnipod 个体化模型预测控制（MPC）算法在接受过估算和错过餐时推注以及高脂肪餐时延长推注的 1 型糖尿病成人中的安全性和性能。
在门诊开环运行 7 天后，在酒店环境中进行了一项为期 54 小时的有监督混合闭环（HCL）研究。年龄在 18-65 岁之间、1 型糖尿病且糖化血红蛋白（HbA1c）为 6.0%-10.0%的成人符合条件。主要终点是血糖<70mg/dL 的时间百分比和血糖≥250mg/dL 的时间百分比。分别比较了 130%估算过量的推注和错过的餐时推注与相同餐食的 100%推注的 4 小时血糖反应。使用标准或延长推注比较高脂肪餐后 12 小时的餐后反应。
12 名受试者参加了这项研究，（平均值±标准差）：年龄 35.4±14.1 岁，糖尿病病程 16.5±9.3 年，HbA1c 7.7±0.9%，总日剂量 0.58±0.19U/kg。54 小时 HCL 期间的结果为平均血糖 153±15mg/dL，血糖<70mg/dL 的时间百分比[中位数（四分位距）]：0.0%（0.0-1.2%），70-180mg/dL：76.1%±8.0%，血糖≥250mg/dL：4.5%±3.6%。在 100%和 130%推注后，餐后血糖<70mg/dL 的时间百分比均为 0.0%（0.0-0.0%）（P=0.50）。在 100%和错过的推注后，餐后血糖≥250mg/dL 的时间百分比分别为 0.2%±0.6%和 10.3%±16.5%（P=0.06）。使用标准或延长推注时，高脂肪餐后血糖≥250mg/dL 和<70mg/dL 的百分比相似。
在 1 型糖尿病成人中，Omnipod 个体化 MPC 算法在白天和夜间使用时表现良好且安全，可响应高估、错过和延长的餐时推注。
