Continuous Glucose Monitoring in Insulin Treated Hospitalized Veterans with DM2 at Higher Risk for Hypoglycemia

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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 award application, we describe the development of an innovative system that allows CGM glucose values to be transmitted from the patients' bedside to a monitoring device that is located at a central nursing station- a system that we call “Glucose Telemetry System” (GTS). We propose the conduction of a prospective randomized clinical trial that will examine whether GTS combined with a hypoglycemia prevention protocol, can decrease hypoglycemia in the medical wards without resulting in hyperglycemia- resulting to better clinical outcomes. Specifically we hypothesize that: (1) Veterans who will be randomized to GTS will have less hypoglycemia than Veterans randomized to control group (standard of care); (2) Veterans who will be randomized to GTS will not experience more frequent hyperglycemia, as a result of the frequent application of the hypoglycemia prevention protocol, compared to Veterans randomized to the control group; and (3) GTS use will reduce the frequency of hypoglycemia induced seizures during their hospitalization – decreasing length of stay and inpatient mortality. We will study 244 Veterans with DM2 who are at a higher risk for hypoglycemia. Consenting Veterans will be stratified in two groups based on the number of risk factors of hypoglycemia (≤2 risk factors, ≥3 risk factors); and then further randomized in a 1:1 randomization scheme (122 Veterans randomized to GTS and 122 randomized Veterans to standard of care- POC blood glucose monitoring). For the participants of the control group, retrospective CGM devices will be used in order to compare glycemic outcomes between the two groups. Our primary outcome is difference in hypoglycemic event rate between the two groups. Other outcomes of interest are times spent in hypoglycemia, normoglycemia, hyperglycemia and severe hyperglycemia, length of stay, seizure activity related to hypoglycemia and inpatient mortality. 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. We believe that our 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 we use cardiac telemetry for patients who are at an increased risk for developing arrhythmias.