Type 1 DiabetesNCT05233592
Glycemic Effects of the COVID-19 Booster Vaccine in Type 1 Diabetes
An observational study of Type 1 Diabetes and Diabetes Mellitus, Type 1, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- CGM
- Type of treatment
- Vaccines, Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2022to 4 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Specialists of Central Maryland
Columbia, Maryland, 21044
About this study
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).
Read the 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.
- Conditions
- Type 1 Diabetes, Diabetes Mellitus, Type 1
- Being tested
- CGM
- Keywords
- COVID-19, Vaccine, Hyperglycemia, Insulin Resistance, Continuous Glucose Monitor, CGM, Booster
- Medical subject headings
- Diabetes Mellitus, Type 1, COVID-19, Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
Patients wear a CGM to measure the effects of the COVID-19 booster vaccine on blood sugar levels.
| Study group | Role | What they receive |
|---|---|---|
| T1D Patients Using CGM | Type 1 Diabetes patients using CGM who have received COVID-19 vaccine booster shot (first or second) Receives: Device: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Daily Insulin Resistance (TDIR)
Mean glucose multiplied by total daily insulin dose.
Measured: Day 1 post-vaccine as compared to baseline
Secondary outcomes (4)
Change in TDIR
Mean glucose multiplied by total daily insulin dose.
Measured: Days 1 to 5 post-vaccine as compared to baseline
Change in Time in Range
Percentage of time that the participant's blood sugar is between 70-180mg/dL.
Measured: Day 1 post-vaccine as compared to baseline
Change in Daily Insulin Requirement
Total Daily insulin dose.
Measured: Day 1 post-vaccine as compared to baseline
Change in Time in Hyperglycemia
Percentage of time that participants' sugar level is above 180mg/dL.
Measured: Day 1 post-vaccine as compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start8 Mar 2022
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Andrew P Demidowich, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233592
- Sponsor's protocol ID
- IRB00305567
- Status last verified
- May 2023
- First submitted
- 9 Feb 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Effects of the COVID-19 Booster Vaccine in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05233592
- Acronym / sponsor ID
- IRB00305567
- Conditions
- Type 1 Diabetes, Diabetes Mellitus, Type 1
- Keywords
- COVID-19, Vaccine, Hyperglycemia, Insulin Resistance, Continuous Glucose Monitor, CGM, Booster
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T1D Patients Using CGM | – | Device: CGMType 1 Diabetes patients using CGM who have received COVID-19 vaccine booster shot (first or second) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGMPatients wear a CGM to measure the effects of the COVID-19 booster vaccine on blood sugar levels. | Device | T1D Patients Using CGM |
Primary outcome
Total Daily Insulin Resistance (TDIR)
Time frame: Day 1 post-vaccine as compared to baseline
Mean glucose multiplied by total daily insulin dose.
4 secondary outcomes
Change in TDIR
Time frame: Days 1 to 5 post-vaccine as compared to baseline
Change in Time in Range
Time frame: Day 1 post-vaccine as compared to baseline
Change in Daily Insulin Requirement
Time frame: Day 1 post-vaccine as compared to baseline
Change in Time in Hyperglycemia
Time frame: Day 1 post-vaccine as compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew P Demidowich, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Diabetes Mellitus, Type 1, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Daily Insulin Resistance (TDIR) (time frame: Day 1 post-vaccine as compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.