Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756141
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2021-02-12
Brief Title:
CGM Use in COVID19 Patients Infection With Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV-2
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Continuous Glucose Monitor CGM Use in COVID-19 Patients
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients room andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None