Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Continuous glucose Monitoring and Point of Care blood glucose
Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose
  • 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
Placebo Comparator
Point of Care (POC) blood glucose
Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only
  • Other: Point of Care (POC) blood glucose
    Testing Blood Glucose levels with Point of Care (POC) blood glucose

Recruiting Locations

Baltimore VA Medical Center
Baltimore, Maryland 21201
Contact:
Ilias Spanakis, MD
410-605-7000
ispanakis@som.umaryland.edu

More Details

NCT ID
NCT02904512
Status
Recruiting
Sponsor
University of Maryland, College Park

Study Contact

Ilias Spanakis, MD
4106057000
ispanakis@medicine.umaryland.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.