Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.
Diabetes, Endocrinology and Nutrition Unit, Hospital Universitari Dr. Josep Trueta, Institut d'Investigació Biomèdica de Girona, Girona, Spain.
Diabetes Technol Ther. 2021 Mar;23(3):175-186. doi: 10.1089/dia.2020.0301.
The Patient Empowerment through Predictive Personalized Decision Support (PEPPER) system provides personalized bolus advice for people with type 1 diabetes. The system incorporates an adaptive insulin recommender system (based on case-based reasoning, an artificial intelligence methodology), coupled with a safety system, which includes predictive glucose alerts and alarms, predictive low-glucose suspend, personalized carbohydrate recommendations, and dynamic bolus insulin constraint. We evaluated the safety and efficacy of the PEPPER system compared to a standard bolus calculator. This was an open-labeled multicenter randomized controlled crossover study. Following 4-week run-in, participants were randomized to PEPPER/Control or Control/PEPPER in a 1:1 ratio for 12 weeks. Participants then crossed over after a washout period. The primary end-point was percentage time in range (TIR, 3.9-10.0 mmol/L [70-180 mg/dL]). Secondary outcomes included glycemic variability, quality of life, and outcomes on the safety system and insulin recommender. Fifty-four participants on multiple daily injections (MDI) or insulin pump completed the run-in period, making up the intention-to-treat analysis. Median (interquartile range) age was 41.5 (32.3-49.8) years, diabetes duration 21.0 (11.5-26.0) years, and HbA1c 61.0 (58.0-66.1) mmol/mol. No significant difference was observed for percentage TIR between the PEPPER and Control groups (62.5 [52.1-67.8] % vs. 58.4 [49.6-64.3] %, respectively, = 0.27). For quality of life, participants reported higher perceived hypoglycemia with the PEPPER system despite no objective difference in time spent in hypoglycemia. The PEPPER system was safe, but did not change glycemic outcomes, compared to control. There is wide scope for integrating PEPPER into routine diabetes management for pump and MDI users. Further studies are required to confirm overall effectiveness. ClinicalTrials.gov NCT03849755.
PEPPER 系统通过预测个性化决策支持为 1 型糖尿病患者提供个性化的推注建议。该系统结合了自适应胰岛素推荐系统（基于案例推理，一种人工智能方法），以及一个安全系统，包括预测性血糖警报和报警、预测性低血糖暂停、个性化碳水化合物推荐和动态推注胰岛素限制。我们评估了 PEPPER 系统与标准推注计算器相比的安全性和疗效。这是一项开放标签、多中心、随机对照交叉研究。经过 4 周的预试验后，参与者按照 1:1 的比例随机分为 PEPPER/对照或对照/PEPPER 组，进行 12 周的试验。参与者在洗脱期后交叉。主要终点是血糖控制达标时间百分比（TIR，3.9-10.0mmol/L[70-180mg/dL]）。次要结局包括血糖变异性、生活质量以及安全系统和胰岛素推荐的结果。54 名接受多次皮下注射（MDI）或胰岛素泵治疗的患者完成了预试验期，纳入意向治疗分析。中位（四分位间距）年龄为 41.5（32.3-49.8）岁，糖尿病病程 21.0（11.5-26.0）年，HbA1c 61.0（58.0-66.1）mmol/mol。PEPPER 组和对照组 TIR 百分比无显著差异（分别为 62.5[52.1-67.8]%和 58.4[49.6-64.3]%， = 0.27）。对于生活质量，尽管在低血糖时间方面没有客观差异，但参与者报告使用 PEPPER 系统时感知到的低血糖发生率更高。与对照组相比，PEPPER 系统是安全的，但对血糖控制结果没有影响。对于使用胰岛素泵和 MDI 的患者，将 PEPPER 系统整合到常规糖尿病管理中具有广泛的应用前景。需要进一步的研究来证实其总体疗效。ClinicalTrials.gov NCT03849755。
