Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Canada.
Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Canada.
Diabetes Obes Metab. 2023 Oct;25(10):2910-2927. doi: 10.1111/dom.15186. Epub 2023 Jul 6.
We aimed to develop and internally validate a real-world prognostic model for Level 3 hypoglycaemia risk compatible with outpatient care in the United States.
iNPHORM is a 12-month, US-based panel survey. Adults (18-90 years old) with type 1 diabetes mellitus or insulin- and/or secretagogue-treated type 2 diabetes mellitus were recruited from a nationwide, probability-based internet panel. Among participants completing 1 follow-up questionnaire(s), we modelled 1-year Level 3 hypoglycaemia risk using Andersen and Gill's Cox survival and penalized regression with multiple imputation. Candidate variables were selected for their clinical relevance and ease of capture at point-of-care.
In total, 986 participants [type 1 diabetes mellitus: 17%; men: 49.6%; mean age: 51 (SD: 14.3) years] were analysed. Across follow-up, 035.1 (95% CI: 32.2-38.1)% reported ≥1 Level 3 event(s), and the rate was 5.0 (95% CI: 4.1-6.0) events per person-year. Our final model showed strong discriminative validity and parsimony (optimism corrected c-statistic: 0.77). Numerous variables were selected: age; sex; body mass index; marital status; level of education; insurance coverage; race; ethnicity; food insecurity; diabetes type; glycated haemoglobin value; glycated haemoglobin variability; number, type and dose of various medications; number of SH events requiring hospital care (past year and over follow-up); type and number of comorbidities and complications; number of diabetes-related health care visits (past year); use of continuous/flash glucose monitoring; and general health status.
iNPHORM is the first US-based primary prognostic study on Level 3 hypoglycaemia. Future model implementation could potentiate risk-tailored strategies that reduce real-world event occurrence and overall diabetes burden.
我们旨在开发并内部验证一个与美国门诊护理兼容的 3 级低血糖风险的真实世界预后模型。
iNPHORM 是一项为期 12 个月的美国基于面板的调查。从全国性的、基于概率的互联网面板中招募了 18-90 岁的 1 型糖尿病或胰岛素和/或促分泌素治疗的 2 型糖尿病成人。在完成 1 次随访问卷的参与者中，我们使用 Andersen 和 Gill 的 Cox 生存和惩罚回归以及多重插补来对 1 年 3 级低血糖风险进行建模。候选变量是根据其临床相关性和在护理点易于捕获来选择的。
共有 986 名参与者[1 型糖尿病：17%；男性：49.6%；平均年龄：51（SD：14.3）岁]进行了分析。在随访期间，035.1%（95%CI：32.2-38.1）报告了≥1 次 3 级事件，发生率为 5.0（95%CI：4.1-6.0）事件/人年。我们的最终模型显示出较强的判别有效性和简约性（矫正后的 optimism c 统计量：0.77）。选择了许多变量：年龄；性别；体重指数；婚姻状况；受教育程度；保险覆盖范围；种族；民族；粮食不安全；糖尿病类型；糖化血红蛋白值；糖化血红蛋白变异性；各种药物的数量、类型和剂量；过去一年和随访期间需要住院治疗的 SH 事件的数量；合并症和并发症的类型和数量；与糖尿病相关的医疗保健就诊次数（过去一年）；连续/闪测血糖监测的使用情况；以及总体健康状况。
iNPHORM 是首个美国基于人群的 3 级低血糖预后研究。未来模型的实施可以增强风险定制策略，减少真实世界事件的发生和整体糖尿病负担。
