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

Study Overview
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Brief Summary
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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.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
* Other: Point of Care (POC) blood glucose


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous glucose Monitoring and Point of Care blood glucose<br>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<br>* Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose<br>|
| Placebo Comparator: Point of Care (POC) blood glucose<br>Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only | Other: Point of Care (POC) blood glucose<br>* Testing Blood Glucose levels with Point of Care (POC) blood glucose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time Spent in Hyperglycemia > 180 mg/dL |  | Through study completion, during hospital stay, an average of 1 week | 
| Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL) |  | Through study completion, during hospital stay, an average of 1 week | 
| Number of Participants With Hypoglycemic Events (< 70mg/dL) |  | Through study completion, during hospital stay, an average of 1 week |