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



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 2016
Contact:Ilias Spanakis, MD
Email:ispanakis@medicine.umaryland.edu
Phone:4106057000

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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.


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)
We found this trial at
1
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Baltimore, Maryland 21201
Phone: 410-605-7000
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