PDF(Pubmed)
Abstract：
BACKGROUND: This exploratory study compares self-reported COVID-19 vaccine side effects and breakthrough infections in people who described themselves as having diabetes with those who did not identify as having diabetes.
OBJECTIVE: The study uses person-reported data to evaluate differences in the perception of COVID-19 vaccine side effects between adults with diabetes and those who did not report having diabetes.
METHODS: This is a retrospective cohort study conducted using data provided online by adults aged 18 years and older residing in the United States. The participants who voluntarily self-enrolled between March 19, 2021, and July 16, 2022, in the IQVIA COVID-19 Active Research Experience project reported clinical and demographic information, COVID-19 vaccination, whether they had experienced any side effects, test-confirmed infections, and consented to linkage with prescription claims. No distinction was made for this study to differentiate prediabetes or type 1 and type 2 diabetes nor to verify reports of positive COVID-19 tests. Person-reported medication use was validated using pharmacy claims and a subset of the linked data was used for a sensitivity analysis of medication effects. Multivariate logistic regression was used to estimate the adjusted odds ratios of vaccine side effects or breakthrough infections by diabetic status, adjusting for age, gender, education, race, ethnicity (Hispanic or Latino), BMI, smoker, receipt of an influenza vaccine, vaccine manufacturer, and all medical conditions. Evaluations of diabetes medication-specific vaccine side effects are illustrated graphically to support the examination of the magnitude of side effect differences for various medications and combinations of medications used to manage diabetes.
RESULTS: People with diabetes (n=724) reported experiencing fewer side effects within 2 weeks of vaccination for COVID-19 than those without diabetes (n=6417; mean 2.7, SD 2.0 vs mean 3.1, SD 2.0). The adjusted risk of having a specific side effect or any side effect was lower among those with diabetes, with significant reductions in fatigue and headache but no differences in breakthrough infections over participants\' maximum follow-up time. Diabetes medication use did not consistently affect the risk of specific side effects, either using self-reported medication use or using only diabetes medications that were confirmed by pharmacy health insurance claims for people who also reported having diabetes.
CONCLUSIONS: People with diabetes reported fewer vaccine side effects than participants not reporting having diabetes, with a similar risk of breakthrough infection.
BACKGROUND: ClinicalTrials.gov NCT04368065; https://clinicaltrials.gov/study/NCT04368065.
OBJECTIVE: The study uses person-reported data to evaluate differences in the perception of COVID-19 vaccine side effects between adults with diabetes and those who did not report having diabetes.
METHODS: This is a retrospective cohort study conducted using data provided online by adults aged 18 years and older residing in the United States. The participants who voluntarily self-enrolled between March 19, 2021, and July 16, 2022, in the IQVIA COVID-19 Active Research Experience project reported clinical and demographic information, COVID-19 vaccination, whether they had experienced any side effects, test-confirmed infections, and consented to linkage with prescription claims. No distinction was made for this study to differentiate prediabetes or type 1 and type 2 diabetes nor to verify reports of positive COVID-19 tests. Person-reported medication use was validated using pharmacy claims and a subset of the linked data was used for a sensitivity analysis of medication effects. Multivariate logistic regression was used to estimate the adjusted odds ratios of vaccine side effects or breakthrough infections by diabetic status, adjusting for age, gender, education, race, ethnicity (Hispanic or Latino), BMI, smoker, receipt of an influenza vaccine, vaccine manufacturer, and all medical conditions. Evaluations of diabetes medication-specific vaccine side effects are illustrated graphically to support the examination of the magnitude of side effect differences for various medications and combinations of medications used to manage diabetes.
RESULTS: People with diabetes (n=724) reported experiencing fewer side effects within 2 weeks of vaccination for COVID-19 than those without diabetes (n=6417; mean 2.7, SD 2.0 vs mean 3.1, SD 2.0). The adjusted risk of having a specific side effect or any side effect was lower among those with diabetes, with significant reductions in fatigue and headache but no differences in breakthrough infections over participants\' maximum follow-up time. Diabetes medication use did not consistently affect the risk of specific side effects, either using self-reported medication use or using only diabetes medications that were confirmed by pharmacy health insurance claims for people who also reported having diabetes.
CONCLUSIONS: People with diabetes reported fewer vaccine side effects than participants not reporting having diabetes, with a similar risk of breakthrough infection.
BACKGROUND: ClinicalTrials.gov NCT04368065; https://clinicaltrials.gov/study/NCT04368065.
摘要：
背景：这项探索性研究比较了自我报告的COVID-19疫苗副作用和突破性感染，这些人自称患有糖尿病，而那些没有确定患有糖尿病的人。
目的：该研究使用个人报告的数据来评估患有糖尿病的成年人和未报告患有糖尿病的成年人对COVID-19疫苗副作用的感知差异。
方法：这是一项回顾性队列研究，使用居住在美国的18岁及以上的成年人在线提供的数据进行。在2021年3月19日至2022年7月16日期间自愿参加IQVIACOVID-19主动研究体验项目的参与者报告了临床和人口统计信息，COVID-19疫苗接种，他们是否有任何副作用，测试确认的感染，并同意与处方索赔挂钩。这项研究没有区分糖尿病前期或1型和2型糖尿病，也没有验证COVID-19检测阳性的报告。使用药房声明验证了个人报告的药物使用情况，并将相关数据的子集用于药物效果的敏感性分析。使用多变量逻辑回归来估计糖尿病状态下疫苗副作用或突破性感染的调整比值比。调整年龄，性别,教育,种族,种族（西班牙裔或拉丁裔），BMI,吸烟者,接种流感疫苗,疫苗制造商，和所有的医疗条件。以图形方式说明了糖尿病药物特异性疫苗副作用的评估，以支持检查用于管理糖尿病的各种药物和药物组合的副作用差异的幅度。
结果：报告患有糖尿病的人（n=724）在接种COVID-19疫苗2周内出现的副作用少于没有糖尿病的人（n=6417；平均2.7，SD2.0与平均3.1，SD2.0）。在糖尿病患者中，具有特定副作用或任何副作用的调整风险较低，疲劳和头痛显著减少，但与参与者的最长随访时间相比，突破性感染没有差异。糖尿病药物的使用并没有持续影响特定副作用的风险，使用自我报告的药物使用或仅使用通过药房健康保险索赔确认的糖尿病药物，这些药物也报告患有糖尿病。
结论：糖尿病患者报告的疫苗副作用少于未报告患有糖尿病的参与者，具有类似的突破性感染风险。
背景：ClinicalTrials.govNCT04368065;https://clinicaltrials.gov/study/NCT04368065。
目的：该研究使用个人报告的数据来评估患有糖尿病的成年人和未报告患有糖尿病的成年人对COVID-19疫苗副作用的感知差异。
方法：这是一项回顾性队列研究，使用居住在美国的18岁及以上的成年人在线提供的数据进行。在2021年3月19日至2022年7月16日期间自愿参加IQVIACOVID-19主动研究体验项目的参与者报告了临床和人口统计信息，COVID-19疫苗接种，他们是否有任何副作用，测试确认的感染，并同意与处方索赔挂钩。这项研究没有区分糖尿病前期或1型和2型糖尿病，也没有验证COVID-19检测阳性的报告。使用药房声明验证了个人报告的药物使用情况，并将相关数据的子集用于药物效果的敏感性分析。使用多变量逻辑回归来估计糖尿病状态下疫苗副作用或突破性感染的调整比值比。调整年龄，性别,教育,种族,种族（西班牙裔或拉丁裔），BMI,吸烟者,接种流感疫苗,疫苗制造商，和所有的医疗条件。以图形方式说明了糖尿病药物特异性疫苗副作用的评估，以支持检查用于管理糖尿病的各种药物和药物组合的副作用差异的幅度。
结果：报告患有糖尿病的人（n=724）在接种COVID-19疫苗2周内出现的副作用少于没有糖尿病的人（n=6417；平均2.7，SD2.0与平均3.1，SD2.0）。在糖尿病患者中，具有特定副作用或任何副作用的调整风险较低，疲劳和头痛显著减少，但与参与者的最长随访时间相比，突破性感染没有差异。糖尿病药物的使用并没有持续影响特定副作用的风险，使用自我报告的药物使用或仅使用通过药房健康保险索赔确认的糖尿病药物，这些药物也报告患有糖尿病。
结论：糖尿病患者报告的疫苗副作用少于未报告患有糖尿病的参与者，具有类似的突破性感染风险。
背景：ClinicalTrials.govNCT04368065;https://clinicaltrials.gov/study/NCT04368065。
