mRNA Based-Covid-19 Vaccine Effects on Blood Glucose Levels
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.
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2021
CompletedFirst Posted
Study publicly available on registry
June 11, 2021
CompletedStudy Start
First participant enrolled
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedAugust 17, 2022
August 1, 2022
6 months
June 6, 2021
August 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in AUC glucose level above expected baseline
Change in area under the curve glucose level above expected baseline
7 days
Secondary Outcomes (2)
Change in peak glucose level above expected baseline
7 days
Change in fasting blood glucose levels above expected baseline
7 days
Study Arms (1)
Diabetics who receive mRNA COVID-19 vaccine
Patients that have a history of Diabetes Mellitus Type I or Type II who received Pfizer-N-Biotech or Moderna mRNA COVID-19 vaccines
Interventions
This is not an intervention
Eligibility Criteria
All eligible patients in the PI's database.
You may qualify if:
- Clinical diagnosis of Diabetes Mellitus Type I or Type II
- Received the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
East Coast Medical Associates
Boca Raton, Florida, 33433, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David I Levenson, M.D.
East Coast Medical Associates
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 6, 2021
First Posted
June 11, 2021
Study Start
June 15, 2021
Primary Completion
December 15, 2021
Study Completion
February 1, 2022
Last Updated
August 17, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
No IPD will be shared.