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OpenTrials
Completed

NCT Number: NCT04923386

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Vaccine Adverse Reaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

East Coast Medical Associates

Boca Raton, Florida, 33433, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

None (not interventional)

Other

This is not an intervention

Primary outcomes

  1. Change in AUC glucose level above expected baseline

    Time frame: 7 days

    Change in area under the curve glucose level above expected baseline

Secondary outcomes

  1. Change in peak glucose level above expected baseline

    Time frame: 7 days

    Change in peak glucose level above expected baseline

  2. Change in fasting blood glucose levels above expected baseline

    Time frame: 7 days

    Change in fasting blood glucose levels above expected baseline

Sponsors and collaborators

Lead sponsor

Levenson, David I., M.D.

Indiv

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 11, 2021
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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