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

NCT ID: NCT02904512

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-12-22

Brief 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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Point of Care (POC) blood glucose

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

Group Type: PLACEBO_COMPARATOR

Point of Care (POC) blood glucose

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DEVICE

Point of Care (POC) blood glucose

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

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Ilias Spanakis

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baltimore VA Medical Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00070039

Identifier Type: -

Identifier Source: org_study_id