Status:
COMPLETED
Glycemic Effects of the COVID-19 Booster Vaccine in Type 1 Diabetes
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
DexCom, Inc.
Conditions:
Type 1 Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Brief Summary
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 incr...
Detailed Description
Over 30 million people in the US have diabetes. It's well known that acute inflammation can temporarily increase blood sugar levels (hyperglycemia) and insulin resistance among patients with diabetes,...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
March 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 4 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05233592
Start Date
March 8 2022
End Date
April 4 2023
Last Update
May 17 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiovascular Specialists of Central Maryland
Columbia, Maryland, United States, 21044