Covid19, Diabetes Mellitus
Conditions
Brief 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.
Detailed description
Study participation involves placement of a continuous glucose monitor (CGM) on the abdomen of hospitalized patients who have a diagnosis of COVID19. The CGM will measure glucose levels every 5 minutes which will be accessible for viewing using a receiver phone placed outside the patient's room and/or an iPad located at the nursing station. Alarm limits for hypoglycemia and hyperglycemia will be set on the receiver phone for nursing staff to review. These alarms settings will vary depending on whether the patient is on IV insulin infusion vs. subcutaneous (SQ) insulin. The number of glucose checks required with these two types of insulin varies significantly and requires separate handling. Hospital glucometers will be used to confirm the accuracy of CGM readings during an initial Adjustment Phase of the study. If CGMs are found to be accurate, then finger-stick glucometer check frequency will be decreased, and some of the CGM values will be used to dose insulin therapy during the Utilization Phase of the study. The instructions for these phases will differ for patients on IV insulin infusion vs. SQ insulin infusion and are detailed in separate protocols. Nursing staff will choose the appropriate protocol at the time of CGM placement based on the type of insulin the patient is receiving. Different patient variables (demographics, comorbidities, labs and vitals, administered medications) will be collected from electronic health record and will be evaluated to determine if they interfere with CGM readings. At the time of discharge, patients will receive a survey regarding satisfaction with the use of CGM monitors to manage their diabetes during their inpatient stay.
Interventions
DEVICEContinuous Glucose Monitor (CGM)
A CGM will be placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose will be monitored continuously while the patients are in the hospital.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Relative Difference (MARD) | From date of enrollment and until discharge from the hospital up to 30 days. | Per patient, the absolute relative difference is calculated as the absolute difference between Point of Care (POC) glucose measurements and the nearest Continuous glucose monitor (CGM) measurement (within 5 minutes of POC), divided by the POC glucose value and expressed as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM Recorded Hyperglycemia Episodes | From date of enrollment and until discharge from the hospital up to 30 days. | The number of patients that experience GCM recorded hyperglycemia episodes (glucose level above 250 mg/dl). |
| Mean Arterial Pressure (MAP) | From date of enrollment and until discharge from the hospital up to 30 days. | MAP is a calculation that checks whether there's enough blood flow to supply blood to all the major organs. Too much resistance and pressure may impede that flow. MAP is the average pressure in the arteries throughout one cardiac cycle. Normal MAP is between 70 and 100 mm Hg |
| Blood Oxygen Level (SpO2) | From date of enrollment and until discharge from the hospital up to 30 days. | SpO2 is a measure of oxygen saturation levels in the blood. It is the percentage of oxygenated hemoglobin (the protein the carries oxygen) compared to the total amount of hemoglobin in the blood. A normal SpO2 level for healthy lungs is typically between 95 and 100 percent. |
| CGM Accuracy in Lactic Acidosis. | From date of enrollment and until discharge from the hospital up to 30 days. | CGM accuracy via MARD when patients have a lactic acid above 2.2 mmol/L |
| CGM Recorded Hypoglycemia Episodes | From date of enrollment and until discharge from the hospital up to 30 days. | The total number of hypoglycemia episodes (glucose level below 70 mg/dl). |
| Sensor Related Skin Reactions | From date of enrollment and until discharge from the hospital up to 30 days. | The number of subjects who experienced sensor related skin reactions |
| Patient Satisfaction Using the Patient Satisfaction Survey | From date of admission and until discharge from the hospital up to 30 days. | The number of patients who reported being satisfied and very satisfied. The Patient Satisfaction Survey measures the level of patient satisfaction with the question of How satisfied were you with the nursing staff using a CGM to measure your blood sugar? the score ranges from 0 (not at all) to 5 (very satisfied). |
| Continuous Glucose Monitor (CGM) Calibrations | From date of enrollment and until discharge from the hospital up to 30 days. | The number of calibrations that were performed on the CGM per patient. |
| Hospitalization Length of Stay | subject hospital discharge, up to approximately 3 months | Total number of days subjects were admitted to the hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Glucose Monitor (CGM) Use Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitor (CGM) Use |
|---|---|
| Age, Continuous | 59 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 20 |
| other Total, other adverse events | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Mean Absolute Relative Difference (MARD)
Per patient, the absolute relative difference is calculated as the absolute difference between Point of Care (POC) glucose measurements and the nearest Continuous glucose monitor (CGM) measurement (within 5 minutes of POC), divided by the POC glucose value and expressed as a percentage.
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitor (CGM) Use | Mean Absolute Relative Difference (MARD) | 10.1 percentage of MARD | Standard Deviation 2.3 |
Secondary
Blood Oxygen Level (SpO2)
SpO2 is a measure of oxygen saturation levels in the blood. It is the percentage of oxygenated hemoglobin (the protein the carries oxygen) compared to the total amount of hemoglobin in the blood. A normal SpO2 level for healthy lungs is typically between 95 and 100 percent.
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitor (CGM) Use | Blood Oxygen Level (SpO2) | 94.0 percentage of oxygenated hemoglobin | Standard Deviation 3.22 |
Secondary
CGM Accuracy in Lactic Acidosis.
CGM accuracy via MARD when patients have a lactic acid above 2.2 mmol/L
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Population: Data was not collected nor analyzed
Secondary
CGM Recorded Hyperglycemia Episodes
The number of patients that experience GCM recorded hyperglycemia episodes (glucose level above 250 mg/dl).
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitor (CGM) Use | CGM Recorded Hyperglycemia Episodes | 19 Participants |
Secondary
CGM Recorded Hypoglycemia Episodes
The total number of hypoglycemia episodes (glucose level below 70 mg/dl).
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Glucose Monitor (CGM) Use | CGM Recorded Hypoglycemia Episodes | 4 hypoglycemia episodes |
Secondary
Continuous Glucose Monitor (CGM) Calibrations
The number of calibrations that were performed on the CGM per patient.
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Glucose Monitor (CGM) Use | Continuous Glucose Monitor (CGM) Calibrations | 2.5 calibration per patient |
Secondary
Hospitalization Length of Stay
Total number of days subjects were admitted to the hospital
Time frame: subject hospital discharge, up to approximately 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuous Glucose Monitor (CGM) Use | Hospitalization Length of Stay | 11.0 days |
Secondary
Mean Arterial Pressure (MAP)
MAP is a calculation that checks whether there's enough blood flow to supply blood to all the major organs. Too much resistance and pressure may impede that flow. MAP is the average pressure in the arteries throughout one cardiac cycle. Normal MAP is between 70 and 100 mm Hg
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitor (CGM) Use | Mean Arterial Pressure (MAP) | 91.8 mm Hg | Standard Deviation 12.49 |
Secondary
Patient Satisfaction Using the Patient Satisfaction Survey
The number of patients who reported being satisfied and very satisfied. The Patient Satisfaction Survey measures the level of patient satisfaction with the question of How satisfied were you with the nursing staff using a CGM to measure your blood sugar? the score ranges from 0 (not at all) to 5 (very satisfied).
Time frame: From date of admission and until discharge from the hospital up to 30 days.
Population: 4 subjects did not complete the survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitor (CGM) Use | Patient Satisfaction Using the Patient Satisfaction Survey | 12 Participants |
Secondary
Sensor Related Skin Reactions
The number of subjects who experienced sensor related skin reactions
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitor (CGM) Use | Sensor Related Skin Reactions | 0 Participants |