Monitoring glucose levels in hospitalized veterans with diabetes
Continuous Glucose Monitoring in Insulin Treated Hospitalized Veterans With DM2 at Higher Risk for Hypoglycemia
This study is testing a new wireless system that continuously checks glucose levels in hospitalized veterans with Type 2 Diabetes to see if it can help prevent low blood sugar and improve their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03508934 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on developing a novel Glucose Telemetry System (GTS) to continuously monitor glucose levels in hospitalized veterans with Type 2 Diabetes Mellitus. The GTS allows for wireless transmission of glucose values from the patient's bedside to a monitor at the nursing station, aiming to reduce the incidence of hypoglycemia, which can lead to severe complications. The study addresses the limitations of traditional Point of Care (POC) testing by providing real-time glucose monitoring, potentially improving patient outcomes and reducing hospital costs associated with diabetes management.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans with a history of Type 2 Diabetes Mellitus managed with insulin who are admitted to the Baltimore VA Medical Center and have at least one risk factor for hypoglycemia.
Not a fit: Patients who may not benefit from this study include those with Type 1 Diabetes Mellitus, those managed with diet or oral medications only, and those hospitalized for significant hyperglycemia or diabetic ketoacidosis.
Why it matters
Potential benefit: If successful, this approach could significantly decrease hypoglycemic events in hospitalized veterans, leading to better clinical outcomes and reduced healthcare costs.
How similar studies have performed: Previous studies have shown that Continuous Glucose Monitoring devices are superior to Point of Care testing in detecting hypoglycemia, although this specific application in a non-ICU setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ilias Spanakis, MD — Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- Study coordinator: Ilias Spanakis, MD
- Email: Ilias.Spanakis@va.gov
- Phone: (410) 605-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.