Trials / Completed
CompletedNCT04923386
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- Levenson, David I., M.D. · Individual
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | None (not interventional) | This is not an intervention |
Timeline
- Start date
- 2021-06-15
- Primary completion
- 2021-12-15
- Completion
- 2022-02-01
- First posted
- 2021-06-11
- Last updated
- 2022-08-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04923386. Inclusion in this directory is not an endorsement.