Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes
More than 25% of the patients admitted in the general wards have a history of Diabetes Mellitus (DM). Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In Veterans, the prevalence is disproportionally higher. It is estimated that 40-50% of hospitalized Veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System (GTS), with which glucose values can be wirelessly transmitted from the patient's bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes.
Conditions:
🦠 Diabetes Mellitus, Type 2 🦠 Hypoglycemia
🗓️ Study Start (Actual) 1 July 2018
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 11 July 2025
👥 Enrollment (Estimated) 244
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Veterans with history of DM2 managed with insulin (either basal bolus, basal only or basal with per os DM medications), admitted to the Baltimore VA Medical Center, who have at
    • * least 1 risk factor of hypoglycemia

    Exclusion Criteria:

    • * Veterans with history of type 1 DM.
    • * Veterans with history of DM2 managed with diet or any combination of oral antidiabetic drugs only.
    • * Veterans hospitalized with significant hyperglycemia or diabetic ketoacidosis
    • * Pregnant Veterans
    • * Veterans receiving glucocorticosteroids in doses (equivalent) to 20 mg of hydrocortisone/day
    • * Veterans that are expected to require a hospital stay \<3 days will also be excluded
Ages Eligible for Study: 21 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 April 2018
  • First Submitted that Met QC Criteria 24 April 2018
  • First Posted 26 April 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 June 2024
  • Last Update Posted 6 June 2024
  • Last Verified June 2024