Inpatient Diabetes Mellitus (DM) Management With Continuous Glucose Monitoring Devices, a Pilot Study.

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904512
• Other study ID #: HP-00070039
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 22, 2017

Study information

• Verified date: May 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 mg/dl , in order to treat and potentially prevent a potential hypoglycemic episode.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of Diabetes Mellitus type 2 (DM2) on insulin

Exclusion Criteria

• Patients that are expected to require a hospital stay =3 days

• Pregnant patients

• Subjects that have significant hyperglycemia or Diabetic Ketoacidosis (DKA) that requires treatment with intravenous insulin infusion

• Patients receiving glucocorticosteroids in doses (equivalent) to = 20 mg of hydrocortisone/day

• Any mental condition rendering the subject incapable of understanding the objectives and potential consequences of the study

• Patients that need hospitalization in the critical care (ICU) setting.

• History of Diabetes Mellitus type 1 (DM1)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose

Other:
• Point of Care (POC) blood glucose
Testing Blood Glucose levels with Point of Care (POC) blood glucose

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Time Spent in Hyperglycemia > 180 mg/dL		Through study completion, during hospital stay, an average of 1 week
Primary	Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL)		Through study completion, during hospital stay, an average of 1 week
Primary	Number of Participants With Hypoglycemic Events (< 70mg/dL)		Through study completion, during hospital stay, an average of 1 week