Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923386
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2021-06-06
Brief Title:
mRNA Based-Covid-19 Vaccine Effects on Blood Glucose Levels
Sponsor:
Levenson David I MD
Organization:
Levenson David I MD
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 yo 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None