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预测第一代混合闭环人工胰腺系统在儿童、青少年和青年 1 型糖尿病患者中的治疗效果:一项模型开发和验证研究。

Predicting Success with a First-Generation Hybrid Closed-Loop Artificial Pancreas System Among Children, Adolescents, and Young Adults with Type 1 Diabetes: A Model Development and Validation Study.

机构信息

Barbara Davis Center for Childhood Diabetes, School of Medicine, University of Colorado Anschutz Campus, Aurora, Colorado, USA.

Department of Biostatistics and Informatics, University of Colorado Anschutz Campus, Aurora, Colorado, USA.

出版信息

Diabetes Technol Ther. 2022 Mar;24(3):157-166. doi: 10.1089/dia.2021.0326. Epub 2021 Dec 1.

Abstract

Hybrid Closed-Loop (HCL) systems aid individuals with type 1 diabetes in improving glycemic control; however, sustained use over time has not been consistent for all users. This study developed and validated prognostic models for successful 12-month use of the first commercial HCL system based on baseline and 1- or 3-month data. Data from participants at the Barbara Davis Center ( = 85) who began use of the MiniMed 670G HCL were used to develop prognostic models using logistic regression and Lasso model selection. Candidate factors included sex, age, duration of diabetes, baseline hemoglobin A1c (HbA1c), race, ethnicity, insurance status, history of insulin pump and continuous glucose monitor use, 1- or 3-month Auto Mode use, boluses per day, and time in range (TIR; 70-180 mg/dL), and scores on behavioral questionnaires. Successful use of HCL was predefined as Auto Mode use ≥60%. The 3-month model was then externally validated against a sample from Stanford University ( = 55). Factors in the final model included baseline HbA1c, sex, ethnicity, 1- or 3-month Auto Mode use, Boluses per Day, and TIR. The 1- and 3-month prognostic models had very good predictive ability with area under the curve values of 0.894 and 0.900, respectively. External validity was acceptable with an area under the curve of 0.717. Our prognostic models use clinically accessible baseline and early device-use factors to identify risk for failure to succeed with 670G HCL technology. These models may be useful to develop targeted interventions to promote success with new technologies.

摘要

混合闭环 (HCL) 系统有助于 1 型糖尿病患者改善血糖控制;然而,并非所有用户都能持续长时间使用。本研究基于基线和 1 个月或 3 个月的数据,开发并验证了首个商业 HCL 系统成功使用 12 个月的预测模型。使用 Barbara Davis 中心 ( = 85) 参与者的数据,他们开始使用 MiniMed 670G HCL,使用逻辑回归和 Lasso 模型选择来开发预测模型。候选因素包括性别、年龄、糖尿病病程、基线糖化血红蛋白 (HbA1c)、种族、民族、保险状况、胰岛素泵和连续血糖监测器使用史、1 个月或 3 个月自动模式使用情况、每日胰岛素剂量和目标范围内时间 (TIR;70-180mg/dL),以及行为问卷得分。HCL 的成功使用被预定义为自动模式使用量≥60%。然后,使用来自斯坦福大学的样本 ( = 55) 对 3 个月模型进行外部验证。最终模型中的因素包括基线 HbA1c、性别、民族、1 个月或 3 个月自动模式使用情况、每日胰岛素剂量和 TIR。1 个月和 3 个月的预测模型具有很好的预测能力,曲线下面积值分别为 0.894 和 0.900。外部有效性可接受,曲线下面积为 0.717。我们的预测模型使用临床可及的基线和早期设备使用因素来识别未能成功使用 670G HCL 技术的风险。这些模型可能有助于制定有针对性的干预措施,以促进新技术的成功。

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1
Candidate Selection for Hybrid Closed Loop Systems.混合闭环系统的候选者选择
Diabetes Technol Ther. 2021 Nov;23(11):760-762. doi: 10.1089/dia.2021.0217. Epub 2021 Oct 13.

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