Ignite Creation Date:
2024-05-06 @ 9:06 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02904512
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2016-08-30
Brief Title:
Inpatient Diabetes Mellitus DM Management With Continuous Glucose Monitoring Devices a Pilot Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2021-05
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:
Several observational studies have shown that uncontrolled hyperglycemia in hospitalized patients in the non-critical care non-Intensive Care Unit non-ICU setting is associated with prolonged length of stay increased mortality and an increased incidence of infections Randomized clinical trials in both the critical and the non-ICU settings have shown that by improving glucose control there is a decrease in the incidence of infections length of stay and inpatient health care costs
Continuous glucose monitoring CGM systems have evolved as useful devices providing excellent clinical care in patients with Diabetes Mellitus DM These systems detect glucose in subcutaneous interstitial fluid using a glucose sensor that transmits glucose measurements to a receiving device that reads out average glucose levels every couple of minutes
In this clinical trial the investigators propose to examine the clinical use of CGM in hospitalized patients with Diabetes Mellitus type 2 DM2 CGM use may improve glucometric values and clinical outcomes in hospitalized individuals with Diabetes Mellitus type 2 DM2
We use CGM devices to monitor but also to transmit glucose values wirelessly to monitoring devices that are in the nursing station Half of the participants are placed on Real Time CGM alarms turned on and half of them are placed on blinded CGM values alarms turned off Nursing staff will be notified when glucose is 85 mgdl in order to treat and potentially prevent a potential hypoglycemic episode
Continuous glucose monitoring CGM systems have evolved as useful devices providing excellent clinical care in patients with Diabetes Mellitus DM These systems detect glucose in subcutaneous interstitial fluid using a glucose sensor that transmits glucose measurements to a receiving device that reads out average glucose levels every couple of minutes
In this clinical trial the investigators propose to examine the clinical use of CGM in hospitalized patients with Diabetes Mellitus type 2 DM2 CGM use may improve glucometric values and clinical outcomes in hospitalized individuals with Diabetes Mellitus type 2 DM2
We use CGM devices to monitor but also to transmit glucose values wirelessly to monitoring devices that are in the nursing station Half of the participants are placed on Real Time CGM alarms turned on and half of them are placed on blinded CGM values alarms turned off Nursing staff will be notified when glucose is 85 mgdl in order to treat and potentially prevent a potential hypoglycemic episode
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None