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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose; Other: Point of Care (POC) blood glucose

• Registration Number: NCT02904512
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Study Start: 2016-10
• Primary Completion: 2017-12-22
• Study Completion: 2017-12-22
• Results First Submitted: 2021-04-25
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-29
• Last Update Submitted: 2021-05-29
• Results First Posted: 2021-06-22
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Hypoglycemic Events (< 70mg/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
Percentage of Time Spent in Hyperglycemia > 180 mg/dL	Through study completion, during hospital stay, an average of 1 week

Trial Locations

Locations (1)

Baltimore VA Medical Center; 🇺🇸 Baltimore, Maryland, United States