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临床试验/NCT04923386
NCT04923386已完成不适用

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.

Levenson, David I., M.D.1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年6月15日最近更新:
适应症

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

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

发起方
Levenson, David I., M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

David I. Levenson, MD

Principal Investigator

Levenson, David I., M.D.

研究点 (1)

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