Relaxed Glycemic Control and the Risk of Infections in Older Adults with Type 2 Diabetes

2 型糖尿病老年人放松血糖控制与感染风险

基本信息

批准号：
10686497
负责人：
Andrew John Karter
金额：
$ 40万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-15 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10686497
关键词：
Adult Age-Years American Amputation Anemia Bacteremia Blindness Blood Glucose Body mass index Bone Tissue California Cardiovascular Diseases Cardiovascular system Categories Cellulitis Clinical Clinical Trials Complex Complications of Diabetes Mellitus Cox Proportional Hazards Models Cystitis Data Diabetes Mellitus Elderly Ethnic Origin Event Geriatrics Glycosylated hemoglobin A Goals Graph Guidelines Health Health Status Hospitalization Hyperglycemia Hypoglycemia Immune response Impairment Infection Infection Control Influenza Kidney Kidney Failure Life Expectancy Longitudinal cohort Minority Non-Insulin-Dependent Diabetes Mellitus Observational Study Osteomyelitis Outcome Participant Patients Peripheral Nervous System Diseases Pharmaceutical Preparations Pneumonia Professional Organizations Pyelonephritis Race Recommendation Registries Research Respiratory Tract Infections Risk Risk Estimate Risk Factors Secondary to Sepsis Skin Tissue Societies Time Urinary tract Weight Work base comorbidity cost demographics ethnic diversity follow-up foot future implementation glycemic control hazard health plan hospitalization rates human old age (65+)immunosenescence infection risk older patient personalized management racial diversity social health determinants soft tissue treatment guidelines

项目摘要

Abstract Professional society guidelines for treatment of type 2 diabetes (T2D) endorse a glycemic goal of hemoglobin A1c (HbA1c) <7% for most nonpregnant adults to reduce the long-term risk of complications. However, for the ~12 million Americans ≥65 years of age who have T2D, current guidelines recommend individualized management and relaxed glycemic control (i.e., HbA1c 7% to <9%) for patients with multiple comorbidities, poor health or limited life expectancy. Recommendations for relaxed glycemic control are based on evidence that intensive therapy has significant risks (e.g., hypoglycemia), treatment burden and cost, and that time to benefit may exceed life expectancy in older patients. However, current guidelines fail to recognize the potential for relaxed glycemic control to increase the risk of infection in older adults. Because a clinical trial of the effect of relaxed vs. intensive glycemic control on infection is not feasible, we propose an observational study to estimate the short-term risk of hospitalization for infection associated with relaxed glycemic control (HbA1c 7% to <9%) compared with intensive glycemic control (HbA1c 6% to <7%). The proposed observational study will use longitudinal data from 116,484 racially and ethnically diverse (62% minority) adults ≥65 years of age with T2D who have HbA1c within the guideline-recommended range of 6% to <9%. The project will identify factors associated with 12-month risk of hospitalization for infection among older adults with T2D (Aim 1); determine rates and hazard ratios of hospitalizations for infection by levels of baseline HbA1c (Aim 2); and estimate the independent (unconfounded) effect of relaxed versus intensive glycemic control on risk of hospitalization for infection using propensity score-based overlap weighting and directed acyclic graph-informed multivariate adjustment to mitigate potential confounding (Aim 3). Throughout the project period, we will work closely with a Stakeholder Advisory Council of key operational and clinical health plan leaders to conduct ongoing review of our research strategy, disseminate our findings and plan future implementation. The proposed research will provide evidence needed to inform recommendations for safe glycemic goals in older patients with T2D and, in particular, to understand the association of relaxed glycemic control and short-term risk of hospitalization for infection.

抽象的 2 型糖尿病 (T2D) 治疗专业协会指南认可血红蛋白的血糖目标对于大多数非妊娠成年人来说，糖化血红蛋白 (HbA1c) <7% 可降低并发症的长期风险。约 1200 万年龄≥65 岁的美国人患有 T2D，当前指南建议个体化治疗对患有多种合并症的患者进行管理和放松血糖控制（即 HbA1c 7% 至 <9%），健康状况不佳或预期寿命有限的建议是基于证据。强化治疗具有重大风险（例如低血糖）、治疗负担和费用，以及治疗的时间获益可能超过老年患者的预期寿命然而，目前的指南未能认识到其潜力。放松血糖控制会增加老年人感染的风险，因为其效果的临床试验。放松与强化血糖控制对感染的影响是不可行的，我们提出一项观察性研究估计与放松血糖控制相关的感染短期住院风险（HbA1c 7% 与强化血糖控制（HbA1c 6% 至 <7%）相比，拟议的观察性研究将。使用来自 116,484 名年龄≥65 岁的不同种族和族裔（62% 少数族裔）成年人的纵向数据 HbA1c 处于指南建议的 6% 至 <9% 范围内的 T2D 该项目将确定因素。与患有 T2D 的老年人 12 个月感染住院风险相关（目标 1）；按基线 HbA1c 水平划分的感染住院率和风险比（目标 2）；放松与强化血糖控制对住院风险的独立（无混杂）影响使用基于倾向评分的重叠加权和有向非循环图告知的多变量进行感染调整以减轻潜在的混淆（目标 3）。由主要运营和临床健康计划领导者组成的利益相关者咨询委员会将持续审查我们的研究策略，传播我们的研究结果并计划未来的实施。提供所需的证据，为老年 T2D 患者的安全血糖目标提供建议，并且特别是，了解放松血糖控制与短期住院风险之间的关系感染。