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

NCT05233592 | Completed

• 1 other identifier: IRB00305567
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes; Diabetes Mellitus, Type 1

Keywords

COVID-19; Vaccine; Hyperglycemia; Insulin Resistance; Continuous Glucose Monitor; CGM; Booster

Outcome Measures

Primary Outcomes (1)

• Total Daily Insulin Resistance (TDIR)

  Mean glucose multiplied by total daily insulin dose.

  Day 1 post-vaccine as compared to baseline

Secondary Outcomes (4)

• Change in TDIR

  Days 1 to 5 post-vaccine as compared to baseline

• Change in Time in Range

  Day 1 post-vaccine as compared to baseline

• Change in Daily Insulin Requirement

  Day 1 post-vaccine as compared to baseline

• Change in Time in Hyperglycemia

  Day 1 post-vaccine as compared to baseline

Other Outcomes (2)

• Post-hoc ANOVA

  Days 1 to 5 post-vaccine as compared to baseline

• Post-hoc t-test

  Days 1 to 5 post-vaccine as compared to baseline

Study Arms (1)

T1D Patients Using CGM

Type 1 Diabetes patients using CGM who have received COVID-19 vaccine booster shot (first or second)

Device: CGM

Interventions

CGM DEVICE

Patients wear a CGM to measure the effects of the COVID-19 booster vaccine on blood sugar levels.

T1D Patients Using CGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Cardiovascular Specialists of Central Maryland

Columbia, Maryland, 21044, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; COVID-19; Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hyperinsulinism

Study Officials

• Andrew P Demidowich, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 10, 2022
• Study Start: March 8, 2022
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

US (1)