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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05233592
• Other study ID #: IRB00305567
• Status: Completed
• Start date: March 8, 2022
• Est. completion date: April 4, 2023

Study information

• Verified date: May 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Cardiovascular Specialists of Central Maryland	Columbia	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-hoc ANOVA	One-way Repeated Measures ANOVA will be used to assess changes in secondary outcome variables over time.	Days 1 to 5 post-vaccine as compared to baseline
Other	Post-hoc t-test	Assess whether secondary variables from individual days are significantly different from baseline.	Days 1 to 5 post-vaccine as compared to baseline
Primary	Total Daily Insulin Resistance (TDIR)	Mean glucose multiplied by total daily insulin dose.	Day 1 post-vaccine as compared to baseline
Secondary	Change in TDIR	Mean glucose multiplied by total daily insulin dose.	Days 1 to 5 post-vaccine as compared to baseline
Secondary	Change in Time in Range	Percentage of time that the participant's blood sugar is between 70-180mg/dL.	Day 1 post-vaccine as compared to baseline
Secondary	Change in Daily Insulin Requirement	Total Daily insulin dose.	Day 1 post-vaccine as compared to baseline
Secondary	Change in Time in Hyperglycemia	Percentage of time that participants' sugar level is above 180mg/dL.	Day 1 post-vaccine as compared to baseline