Skip to main content
OpenTrials
Completed

NCT Number: NCT02904512

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Device

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

Point of Care (POC) blood glucose

Other

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

Primary outcomes

  1. Percentage of Time Spent in Hyperglycemia > 180 mg/dL

    Time frame: Through study completion, during hospital stay, an average of 1 week

  2. Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL)

    Time frame: Through study completion, during hospital stay, an average of 1 week

  3. Number of Participants With Hypoglycemic Events (< 70mg/dL)

    Time frame: Through study completion, during hospital stay, an average of 1 week

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • DexCom, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2016
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.