Glycemic Effects of the COVID-19 Booster Vaccine in Type 1 Diabetes

Completed

Conditions studied: Type 1 Diabetes, Diabetes Mellitus, Type 1

In brief

Vaccines for COVID-19 are an essential part of combating the coronavirus pandemic. Vaccines "prime" the immune system against an invader (in this case the SARS-CoV-2 virus) by causing a temporary increased immune or inflammatory response. Inflammation can temporarily increase sugar levels and/or insulin requirements among patients with diabetes. The purpose of this study is to investigate whether the "booster" COVID-19 vaccine dose causes temporarily increased sugar levels and/or insulin dose requirements among patients with Type 1 Diabetes (T1D).

Key facts

Study ID

NCT05233592

Run by

Johns Hopkins University

People needed

21

Starts

2022-03-08

Expected to finish

2023-04-04

Last updated by the study team

2023-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (age ≥18yo)
• Type 1 Diabetes
• Is already fully vaccinated against COVID-19 (e.g. received 2 doses of Pfizer or Moderna or one dose of Johnson \& Johnson)
• Available to receive a COVID-19 booster vaccine (first or second booster dose)

You may not qualify if…

• Has already received a COVID-19 booster vaccine dose
• Known physical or psychological disorder which would prohibit the patient from complying with the study procedures (e.g. allergy to adhesive, profound skin disorder, known to have severe adverse reactions previously to CGMs, poorly controlled schizophrenia, etc.)
• Recent, acute, or chronic medical condition which may significantly affect insulin resistance or measurements of glucose (e.g. severe cirrhosis, acute infection, cancer on chemotherapy, etc.)
• On a medication known to cause significant hyperglycemia (e.g. supraphysiologic dose of steroids) or negatively affect readings of CGM (e.g. supraphysiologic doses of acetaminophen (e.g. >4g/d)).
• Pregnant or actively trying to get pregnant
• Planned PET, CT, or MRI test in the next 10 days
• Unwilling or unable to keep track of insulin usage during the study

Where it is running

• Cardiovascular Specialists of Central Maryland — Columbia, Maryland, United States

Full record on ClinicalTrials.gov

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