Clinical trial NCT05233592: Glycemic Effects of the COVID-19 Booster Vaccine in Type 1 Diabetes
Official title: Glycemic Effects of the COVID-19 Booster Vaccine in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Diabetes Mellitus, Type 1
Keywords: COVID-19
Vaccine
Hyperglycemia
Insulin Resistance
Continuous Glucose Monitor
CGM
Booster
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2022-02-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with Type 1 Diabetes who have received either 2 doses of Moderna/Pfizer COVID-19 vaccine or 1 dose of Johnson \& Johnson, but have not yet received their COVID-19 booster (first or second booster dose).

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 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).

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, particularly those with type 1 diabetes (T1D). Vaccines cause an inflammatory reaction, because the vaccines prime the body's immune system against a potential virus. Reports have described temporary hyperglycemia and/or insulin resistance after COVID vaccine administration. However, to date this has not been studied in a rigorous fashion. The objective of the study is to determine if the COVID-19 booster causes increased sugar levels and insulin dose adjustments in patients with T1D. This is a study in adult patients with Type 1 Diabetes who have not yet received the COVID-19 booster vaccine. The study consists of two short outpatient (clinic) visits. Visit 1 occurs 3-5 days before receiving the COVID-19 booster vaccine (pre-vaccine visit). During this visit, the participant will fill out a questionnaire and have a blinded Dexcom G6 Pro CGM applied to the participant. An optional second "backup" Dexcom G6 Pro CGM will be provided, in case the first continuous glucose monitor (CGM) falls off accidentally. Visit 2 occurs 10 days after Visit 1 (about 5 days after receiving the first or second booster vaccine shot), at which time the CGM would be removed. Participants will continue participants' usual routine diabetes care while participating in the study, including using the participants' own glucometer or CGM. Participants will also be asked to keep track of participants' insulin doses administered during the 10-day study.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Has already received a COVID-19 booster vaccine dose
2. 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.)
3. 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.)
4. 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)).
5. Pregnant or actively trying to get pregnant
6. Planned PET, CT, or MRI test in the next 10 days
7. Unwilling or unable to keep track of insulin usage during the study

Primary outcomes:
measure: Total Daily Insulin Resistance (TDIR)
timeFrame: Day 1 post-vaccine as compared to baseline
Secondary outcomes:
measure: Change in TDIR
timeFrame: Days 1 to 5 post-vaccine as compared to baseline
measure: Change in Time in Range
timeFrame: Day 1 post-vaccine as compared to baseline
measure: Change in Daily Insulin Requirement
timeFrame: Day 1 post-vaccine as compared to baseline
measure: Change in Time in Hyperglycemia
timeFrame: Day 1 post-vaccine as compared to baseline
Other outcomes:
measure: Post-hoc ANOVA
timeFrame: Days 1 to 5 post-vaccine as compared to baseline
measure: Post-hoc t-test
timeFrame: Days 1 to 5 post-vaccine as compared to baseline
Locations:
city: Columbia
country: United States
facility: Cardiovascular Specialists of Central Maryland
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Andrew P Demidowich, MD
role: PRINCIPAL_INVESTIGATOR
References: