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

NCT02904512 | Completed Results FDA Device

• 1 other identifier: HP-00070039
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Continuous glucose Monitoring and Point of Care blood glucose

ACTIVE COMPARATOR

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

Point of Care (POC) blood glucose

PLACEBO COMPARATOR

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

Other: Point of Care (POC) blood glucose

Interventions

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

Continuous glucose Monitoring and Point of Care blood glucose

Point of Care (POC) blood glucose OTHER

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

Point of Care (POC) blood glucose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of Diabetes Mellitus type 2 (DM2) on insulin

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring; Surgical Instruments; Point-of-Care Systems; Blood Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Surgical Equipment; Equipment and Supplies; Hospital Information Systems; Hospital Administration; Health Facility Administration; Organization and Administration; Health Services Administration; Management Information Systems; Patient Care Management; Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Dr. Ilias (Elias) Spanakis
• Organization: Veterans Affairs Medical Center

ispanakis@som.umaryland.edu

(617) 319-9731

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 19, 2016
• Study Start: October 1, 2016
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: June 22, 2021
• Results First Posted: June 22, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)