Effect of mRNA Based-Covid-19 Vaccine on Blood Glucose Levels Recorded by Continuous Glucose Monitoring in Patients With a History of Diabetes Mellitus Type I and Type II.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in AUC glucose level above expected baseline
研究概览
简要总结
To determine if patients with a history of Diabetes Mellitus Type I or II developed a change in blood glucose levels as reported on Continuous glucose monitoring devices (CGMS) within the first week following administration of each dose of the COVID-19 vaccine.
详细描述
A retrospective review of all patient data from the Dexcom and Libre CGMS devices available at a single site, solo endocrinology practice will be obtained. This data will include fasting morning glucose, postprandial glucose, and daily glucose area under the curve for seven days following vaccination administration, as well as daily glucose area under the curve seven days prior to vaccine administration that will be used as a control. Patients >=18 y/o with a history of Diabetes Mellitus Type I or Type II will be selected. Brand of vaccine administered (Moderna or Pfizer-BioNTech) and the change in average blood glucose, peak blood glucose, and percentage of time spent in normal range as well as above average range of blood glucose level following vaccine administration will be assessed. Patients will fill out a visual analog symptom scale based on how symptomatic and uncomfortable they were following each dose of the COVID-19 vaccine. Patients will describe side effects that they experienced following each dose of the COVID-19 vaccine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Diabetes Mellitus Type I or Type II
- •Received the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine
排除标准
- •Patients <18y/o.
- •Patients that did not receive a COVID-19 vaccine.
- •Patients who did not have a CGMS downloaded for a week prior and a week after vaccination.
结局指标
主要结局
Change in AUC glucose level above expected baseline
时间窗: 7 days
Change in area under the curve glucose level above expected baseline
次要结局
- Change in fasting blood glucose levels above expected baseline(7 days)
- Change in peak glucose level above expected baseline(7 days)
研究者
David I. Levenson, MD
Principal Investigator
Levenson, David I., M.D.
