Diabetes Mellitus, Type 2NCT04923386
mRNA Based-Covid-19 Vaccine Effects on Blood Glucose Levels
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Levenson, David I., M.D. at 1 site in United States.
Trial summary
To determine if patients with a history of Diabetes Mellitus Type I or II developed a change in blood glucose levels as reported on Continuous glucose monitoring devices (CGMS) within the first week following administration of each dose of the COVID-19 vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Hyperglycemia
- What is being tested?
- None (not interventional)
- Type of treatment
- Vaccines
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2021to 1 Feb 2022
- 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: All eligible patients in the PI's database.
Who may be able to join
- Clinical diagnosis of Diabetes Mellitus Type I or Type II
- Received the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine
Who cannot join
- Patients <18y/o.
- Patients that did not receive a COVID-19 vaccine.
- Patients who did not have a CGMS downloaded for a week prior and a week after vaccination.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Coast Medical Associates
Boca Raton, Florida, 33433
About this study
Official title: Effect of mRNA Based-Covid-19 Vaccine on Blood Glucose Levels Recorded by Continuous Glucose Monitoring in Patients With a History of Diabetes Mellitus Type I and Type II.
To determine if patients with a history of Diabetes Mellitus Type I or II developed a change in blood glucose levels as reported on Continuous glucose monitoring devices (CGMS) within the first week following administration of each dose of the COVID-19 vaccine.
Read the detailed description
A retrospective review of all patient data from the Dexcom and Libre CGMS devices available at a single site, solo endocrinology practice will be obtained. This data will include fasting morning glucose, postprandial glucose, and daily glucose area under the curve for seven days following vaccination administration, as well as daily glucose area under the curve seven days prior to vaccine administration that will be used as a control. Patients >=18 y/o with a history of Diabetes Mellitus Type I or Type II will be selected. Brand of vaccine administered (Moderna or Pfizer-BioNTech) and the change in average blood glucose, peak blood glucose, and percentage of time spent in normal range as well as above average range of blood glucose level following vaccine administration will be assessed. Patients will fill out a visual analog symptom scale based on how symptomatic and uncomfortable they were following each dose of the COVID-19 vaccine. Patients will describe side effects that they experienced following each dose of the COVID-19 vaccine.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Hyperglycemia, Vaccine Adverse Reaction
- Being tested
- None (not interventional)
- Keywords
- mRNA Vaccine, Hyperglycemia, Hypoglycemia, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, COVID-19 Vaccine
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (not interventional)Other
This is not an intervention
| Study group | Role | What they receive |
|---|---|---|
| Diabetics who receive mRNA COVID-19 vaccine | Patients that have a history of Diabetes Mellitus Type I or Type II who received Pfizer-N-Biotech or Moderna mRNA COVID-19 vaccines Receives: Other: None (not interventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AUC glucose level above expected baseline
Change in area under the curve glucose level above expected baseline
Measured: 7 days
Secondary outcomes (2)
Change in peak glucose level above expected baseline
Change in peak glucose level above expected baseline
Measured: 7 days
Change in fasting blood glucose levels above expected baseline
Change in fasting blood glucose levels above expected baseline
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start15 Jun 2021
- Primary completion15 Dec 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levenson, David I., M.D.
- Responsible party
- Principal investigator, David I. Levenson, MD, Levenson, David I., M.D.
- Investigators
- David I Levenson, M.D., Principal investigator, East Coast Medical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923386
- Sponsor's protocol ID
- Macknofsky 1
- Status last verified
- Aug 2022
- First submitted
- 6 Jun 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of mRNA Based-Covid-19 Vaccine on Blood Glucose Levels Recorded by Continuous Glucose Monitoring in Patients With a History of Diabetes Mellitus Type I and Type II.
- ClinicalTrials.gov ID
- NCT04923386
- Acronym / sponsor ID
- Macknofsky 1
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Hyperglycemia, Vaccine Adverse Reaction
- Keywords
- mRNA Vaccine, Hyperglycemia, Hypoglycemia, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, COVID-19 Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Levenson, David I., M.D.
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 11 Jun 2021 (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.
To determine if patients with a history of Diabetes Mellitus Type I or II developed a change in blood glucose levels as reported on Continuous glucose monitoring devices (CGMS) within the first week following administration of each dose of the COVID-19 vaccine.
Detailed description
A retrospective review of all patient data from the Dexcom and Libre CGMS devices available at a single site, solo endocrinology practice will be obtained. This data will include fasting morning glucose, postprandial glucose, and daily glucose area under the curve for seven days following vaccination administration, as well as daily glucose area under the curve seven days prior to vaccine administration that will be used as a control. Patients >=18 y/o with a history of Diabetes Mellitus Type I or Type II will be selected. Brand of vaccine administered (Moderna or Pfizer-BioNTech) and the change in average blood glucose, peak blood glucose, and percentage of time spent in normal range as well as above average range of blood glucose level following vaccine administration will be assessed. Patients will fill out a visual analog symptom scale based on how symptomatic and uncomfortable they were following each dose of the COVID-19 vaccine. Patients will describe side effects that they experienced following each dose of the COVID-19 vaccine.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetics who receive mRNA COVID-19 vaccine | – | Other: None (not interventional)Patients that have a history of Diabetes Mellitus Type I or Type II who received Pfizer-N-Biotech or Moderna mRNA COVID-19 vaccines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients in the PI's database.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Diabetes Mellitus Type I or Type II
- Received the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine
Key exclusion criteria (3 listed)
- Patients <18y/o.
- Patients that did not receive a COVID-19 vaccine.
- Patients who did not have a CGMS downloaded for a week prior and a week after vaccination.
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 |
|---|---|---|
| None (not interventional)This is not an intervention | Other | Diabetics who receive mRNA COVID-19 vaccine |
Primary outcome
Change in AUC glucose level above expected baseline
Time frame: 7 days
Change in area under the curve glucose level above expected baseline
2 secondary outcomes
Change in peak glucose level above expected baseline
Time frame: 7 days
Change in fasting blood glucose levels above expected baseline
Time frame: 7 days
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 Aug 2022.
- Individual participant dataSharing planned: No. No IPD will be shared.
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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.
David I Levenson, M.D. principal investigator
East Coast Medical Associates
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 Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Levenson, David I., M.D. 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 2 inclusion and 3 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 Aug 2022. 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?
Change in AUC glucose level above expected baseline (time frame: 7 days). 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 Aug 2022.