Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/30/2018 |
| Start Date: | July 1, 2018 |
| End Date: | June 30, 2023 |
| Contact: | Ilias Spanakis, MD |
| Email: | Ilias.Spanakis@va.gov |
| Phone: | (410) 605-7000 |
Continuous Glucose Monitoring in Insulin Treated Hospitalized Veterans With DM2 at Higher Risk for Hypoglycemia
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.
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.
More than 25% of patients admitted to general wards/non Intensive Care Unit (non-ICU) setting
have a history of Diabetes Mellitus (DM); and as for 2012, $125 billion dollars were costs
associated with hospitalization of diabetics in the United States (US). Up to 30% of the
hospitalized diabetics develop hypoglycemia, a condition that is associated with higher
hospital charges, prolonged length of stay, and increased morbidity and mortality.
Reducing hypoglycemic events in the inpatient setting has led hospitals to develop
hypoglycemia prevention policies; policies which are however limited by the infrequent Point
of Care (POC) capillary blood glucose testing in the general wards. Continuous Glucose
Monitoring (CGM) devices represent additional ways to monitor blood glucose levels. Only a
limited number of studies have examined the use of CGM devices in the non-ICU setting. In all
these studies, CGM use was found to be superior compared to POC in hypoglycemia detection.
However, as the results of CGM were blinded (alarms were turned off) for both the
investigators and the participants, interventions to prevent hypoglycemia were not performed.
Additionally, one major limitation of CGM technology is that CGM receiver/monitor needs to be
located in the patient's room, due to Bluetooth Technology signal-strength restrictions,
necessitating nurses to enter frequently the patient's room in order to check CGM glucose
values. In the current application, the investigators are going to evaluate whether an
innovative system that the investigators call "Glucose Telemetry System" (GTS) can decrease
hypoglycemia and improve clinical outcomes in hospitalized Veterans with DM2.
Discovering novel ways to monitor glucose values in the hospital setting could have a
significant impact in preventing hypoglycemia in the inpatient setting- a condition that is
associated with adverse clinical outcomes. The investigators believe that this proposal is
highly innovative. The trial may lead to future wider use of CGM in hospitalized patients
with DM who are at a higher risk for hypoglycemia, similar to the way that the investigators
use cardiac telemetry for patients who are at an increased risk for developing arrhythmias.
have a history of Diabetes Mellitus (DM); and as for 2012, $125 billion dollars were costs
associated with hospitalization of diabetics in the United States (US). Up to 30% of the
hospitalized diabetics develop hypoglycemia, a condition that is associated with higher
hospital charges, prolonged length of stay, and increased morbidity and mortality.
Reducing hypoglycemic events in the inpatient setting has led hospitals to develop
hypoglycemia prevention policies; policies which are however limited by the infrequent Point
of Care (POC) capillary blood glucose testing in the general wards. Continuous Glucose
Monitoring (CGM) devices represent additional ways to monitor blood glucose levels. Only a
limited number of studies have examined the use of CGM devices in the non-ICU setting. In all
these studies, CGM use was found to be superior compared to POC in hypoglycemia detection.
However, as the results of CGM were blinded (alarms were turned off) for both the
investigators and the participants, interventions to prevent hypoglycemia were not performed.
Additionally, one major limitation of CGM technology is that CGM receiver/monitor needs to be
located in the patient's room, due to Bluetooth Technology signal-strength restrictions,
necessitating nurses to enter frequently the patient's room in order to check CGM glucose
values. In the current application, the investigators are going to evaluate whether an
innovative system that the investigators call "Glucose Telemetry System" (GTS) can decrease
hypoglycemia and improve clinical outcomes in hospitalized Veterans with DM2.
Discovering novel ways to monitor glucose values in the hospital setting could have a
significant impact in preventing hypoglycemia in the inpatient setting- a condition that is
associated with adverse clinical outcomes. The investigators believe that this proposal is
highly innovative. The trial may lead to future wider use of CGM in hospitalized patients
with DM who are at a higher risk for hypoglycemia, similar to the way that the investigators
use cardiac telemetry for patients who are at an increased risk for developing arrhythmias.
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
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Ilias Spanakis, MD
Phone: 410-605-7000
Click here to add this to my saved trials
