Diabetes MellitusNCT04756141
CGM Use in COVID19 Patients (Infection With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2))
A study testing Continuous Glucose Monitor (CGM) in people with Diabetes Mellitus and Covid19, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Covid19
- What is being tested?
- Continuous Glucose Monitor (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to 24 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Glucose Monitor (CGM) Use in COVID-19 Patients
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Covid19
- Being tested
- Continuous Glucose Monitor (CGM)
- Medical subject headings
- Diabetes Mellitus, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitor (CGM)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| CGM Use | Experimental | Determine CGM accuracy when compared with POC (point of care) glucometers. Receives: Device: Continuous Glucose Monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
Secondary outcomes (9)
CGM Recorded Hypoglycemia Episodes
The total number of hypoglycemia episodes (glucose level below 70 mg/dl).
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Hyperglycemia Episodes
The number of patients that experience GCM recorded hyperglycemia episodes (glucose level above 250 mg/dl).
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
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
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
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.
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
CGM Accuracy in Lactic Acidosis.
CGM accuracy via MARD when patients have a lactic acid above 2.2 mmol/L
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
Hospitalization Length of Stay
Total number of days subjects were admitted to the hospital
Measured: subject hospital discharge, up to approximately 3 months
Sensor Related Skin Reactions
The number of subjects who experienced sensor related skin reactions
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
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).
Measured: From date of admission and until discharge from the hospital up to 30 days.
Continuous Glucose Monitor (CGM) Calibrations
The number of calibrations that were performed on the CGM per patient.
Measured: From date of enrollment and until discharge from the hospital up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start3 Mar 2021
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian G. Dumitrascu, Mayo Clinic
- Investigators
- Adrian Dumitrascu, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756141
- Sponsor's protocol ID
- 20-010816
- Status last verified
- Aug 2023
- First submitted
- 12 Feb 2021
- Last updated
- 4 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitor (CGM) Use in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04756141
- Acronym / sponsor ID
- 20-010816
- Conditions
- Diabetes Mellitus, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Posted 4 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM Use | Experimental | Device: Continuous Glucose Monitor (CGM)Determine CGM accuracy when compared with POC (point of care) glucometers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Continuous 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. | Device | CGM Use |
Primary outcome
Mean Absolute Relative Difference (MARD)
Time frame: 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.
9 secondary outcomes
CGM Recorded Hypoglycemia Episodes
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Hyperglycemia Episodes
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Mean Arterial Pressure (MAP)
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Blood Oxygen Level (SpO2)
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
CGM Accuracy in Lactic Acidosis.
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Hospitalization Length of Stay
Time frame: subject hospital discharge, up to approximately 3 months
Sensor Related Skin Reactions
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Patient Satisfaction Using the Patient Satisfaction Survey
Time frame: From date of admission and until discharge from the hospital up to 30 days.
Continuous Glucose Monitor (CGM) Calibrations
Time frame: From date of enrollment and until discharge from the hospital up to 30 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Adrian Dumitrascu, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor (CGM) in people with Diabetes Mellitus and Covid19, run by Mayo Clinic 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 6 inclusion and 8 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 4 Aug 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?
Yes. Results are posted in the registry (first posted 4 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Absolute Relative Difference (MARD) (time frame: From date of enrollment and until discharge from the hospital up to 30 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 4 Aug 2023.