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

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose; Other: Point of Care (POC) blood glucose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02904512

HP-00070039

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups, including a placebo group

Continuous glucose Monitoring and Point of Care blood glucose

Active Comparator group

Description:

Hospitalized patients with Diabetes Mellitus type 2 (DM2) managed with Continuous glucose monitoring (CGM) and Point of Care (POC) Finger sticks blood glucose

Treatment:

Device: Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose

Point of Care (POC) blood glucose

Placebo Comparator group

Description:

Hospitalized Diabetes Mellitus type 2 (DM2) patients managed with Point of Care (POC) blood glucose only

Treatment:

Other: Point of Care (POC) blood glucose