Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Continuous Glucose Monitoring in Insulin Treated Hospitalized Veterans With DM2 at Higher Risk for Hypoglycemia

Conditions
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Diabetes Mellitus, Type 2, Hypoglycemia

Intervention / Treatment
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* Device: GTS (Continuous Glucose Monitoring)
* Other: POC (Point of Care)


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Glucose Telemetry System (Continuous Glucose Monitoring Devices) Active Comparator: Intervention group (Continuous Glucose Monitroring and POC) Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS) and Point of Care (POC) finger-stick blood glucose levels with application of hypoglycemia prevention protocol (activated based the GTS lower glucose alarms) Placebo Comparator: Control group (Point of Care-POC) Hospitalized patients with DM2 will be monitored with POC blood glucose levels and application of hypoglycemia prevention protocol (activated based the POC values)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group (Continuous Glucose Monitroring and POC)<br>Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS) and Point of Care (POC) finger-stick blood glucose levels with application of hypoglycemia prevention protocol (activated based the GTS lower glucose alarms) | Device: GTS (Continuous Glucose Monitoring)<br>* Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS)<br>Other: POC (Point of Care)<br>* Hospitalized patients with DM2 will be monitored with POC (Point of Care) blood glucose levels.<br>|
| Placebo Comparator: Control group (Point of Care-POC)<br>Hospitalized patients with DM2 will be monitored with POC blood glucose levels and application of hypoglycemia prevention protocol (activated based the POC values) | Other: POC (Point of Care)<br>* Hospitalized patients with DM2 will be monitored with POC (Point of Care) blood glucose levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in hypoglycemia during the hospitalization | GTS and the application of the hypoglycemia prevention protocol will lead to a decrease in hypoglycemia in the hospital | Through study completion-hospitalization (average length of stay at the hospital of 4-6 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, hypoglycemia, Continuous Glucose Monitoring, hospital, inpatient