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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1D Patients Using CGM | Type 1 Diabetes patients using CGM who have received COVID-19 vaccine booster shot (first or second) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM | Device | Patients wear a CGM to measure the effects of the COVID-19 booster vaccine on blood sugar levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Daily Insulin Resistance (TDIR) | Mean glucose multiplied by total daily insulin dose. | Day 1 post-vaccine as compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TDIR | Mean glucose multiplied by total daily insulin dose. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Post-hoc t-test | Assess whether secondary variables from individual days are significantly different from baseline. |
Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Andrew P Demidowich, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Specialists of Central Maryland | Columbia | Maryland | 21044 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D000086382 | COVID-19 |
| D006943 | Hyperglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Day 1 post-vaccine as compared to baseline |
| Change in Daily Insulin Requirement | Total Daily insulin dose. | Day 1 post-vaccine as compared to baseline |
| Change in Time in Hyperglycemia | Percentage of time that participants' sugar level is above 180mg/dL. | Day 1 post-vaccine as compared to baseline |
| Days 1 to 5 post-vaccine as compared to baseline |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006946 | Hyperinsulinism |