mRNA Based-Covid-19 Vaccine Effects on Blood Glucose Levels

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04923386
• Other study ID #: Macknofsky 1
• Status: Completed
• Start date: June 15, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: August 2022
• Source: Levenson, David I., M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 1, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Diabetes Mellitus Type I or Type II
• Received the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Vaccine Adverse Reaction

Intervention

Other:
• None (not interventional)
This is not an intervention

Locations

Country	Name	City	State
United States	East Coast Medical Associates	Boca Raton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Levenson, David I., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AUC glucose level above expected baseline	Change in area under the curve glucose level above expected baseline	7 days
Secondary	Change in peak glucose level above expected baseline	Change in peak glucose level above expected baseline	7 days
Secondary	Change in fasting blood glucose levels above expected baseline	Change in fasting blood glucose levels above expected baseline	7 days