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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Hyperglycemia, Vaccine Adverse Reaction

Intervention / Treatment
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* Other: None (not interventional)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetics who receive mRNA COVID-19 vaccine<br>Patients that have a history of Diabetes Mellitus Type I or Type II who received Pfizer-N-Biotech or Moderna mRNA COVID-19 vaccines | Other: None (not interventional)<br>* This is not an intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AUC glucose level above expected baseline | Change in area under the curve glucose level above expected baseline | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak glucose level above expected baseline | Change in peak glucose level above expected baseline | 7 days | 
| Change in fasting blood glucose levels above expected baseline | Change in fasting blood glucose levels above expected baseline | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mRNA Vaccine, Hyperglycemia, Hypoglycemia, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, COVID-19 Vaccine