Mode
Text Size
Log in / Sign up
N/A N=16 Randomized Treatment

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

Diabetes Mellitus

Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Percentage of Time Spent in Hyperglycemia > 180 mg/dL — 35.47; 35.25 percentage of time spent > 180mg/dL

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose (Device); Point of Care (POC) blood glucose (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Maryland, Baltimore
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Time Spent in Hyperglycemia > 180 mg/dL
35.47; 35.25
PRIMARY
Percentage of Time Spent in Significant Hyperglycemia (>300 mg/dL)
3.28; 5.52
PRIMARY
Number of Participants With Hypoglycemic Events (< 70mg/dL)
2; 6

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.

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02904512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search