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

NCT02904512 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-06-22

Study results available
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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

Interventions

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

OTHER

Point of Care (POC) blood glucose

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

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-12-22
Completion
2017-12-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02904512 on ClinicalTrials.gov