N/A
N=20
CGM Use in COVID19 Patients (Infection With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2))
Diabetes Mellitus · Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04756141 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Mean Absolute Relative Difference (MARD) — 10.1 percentage of MARD
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Glucose Monitor (CGM) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Absolute Relative Difference (MARD) |
10.1 | — |
| SECONDARY CGM Recorded Hypoglycemia Episodes |
4 | — |
| SECONDARY CGM Recorded Hyperglycemia Episodes |
19 | — |
| SECONDARY Mean Arterial Pressure (MAP) |
91.8 | — |
| SECONDARY Blood Oxygen Level (SpO2) |
94.0 | — |
| SECONDARY CGM Accuracy in Lactic Acidosis. |
— | — |
| SECONDARY Hospitalization Length of Stay |
11.0 | — |
| SECONDARY Sensor Related Skin Reactions |
— | — |
| SECONDARY Patient Satisfaction Using the Patient Satisfaction Survey |
12 | — |
| SECONDARY Continuous Glucose Monitor (CGM) Calibrations |
2.5 | — |
Summary
The purpose of this research is to determine if CGM (continuous glucose monitors) used in the hospital in patients with COVID-19 and diabetes treated with insulin will be as accurate as point of care (POC) glucose monitors. Also if found to be accurate, CGM reading data will be used together with POC glucometers to dose insulin therapy.
Eligibility Criteria
Inclusion Criteria
- Patients 18 years or older.
- Patients with diagnosis of COVID-19 respiratory infection.
- Patient with recent positive SARS-COV2 infection and still positive polymerase chain reaction (PCR) admitted of non-respiratory diagnoses.
- Diagnosis of diabetes mellitus type 1 or type 2.
- Diagnosis of medication (steroid) induced hyperglycemia (persistent glucose more than 180 mg/dl).
- Taking insulin either SQ or IV.
Exclusion Criteria
- Patient in shock.
- Patient intubated on mechanical ventilation.
- Patient placed on Extracorporeal membrane oxygenation (ECMO).
- Patient taking hydroxyurea.
- Patient taking more than 4g of acetaminophen in 24 hours or more than 1g acetaminophen in 6 hours.
- Pregnant or nursing female patients.
- Patients with skin lesions at the application site that may interfere with placement of the sensor.
- Patients with known allergy to medical grade adhesive.
Data sourced from ClinicalTrials.gov (NCT04756141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.