Reducing inpatient hypoglycemia in the general wards using real-time CGM- the Glucose Telemetry system: A randomized clinical trial

OBJECTIVE: Use of real-time continuous glucose monitoring (RT-CGM) systems in the inpatient setting is considered investigational. The objective of this study was to evaluate whether RT-CGM, using the glucose telemetry system (GTS), can prevent hypoglycemia in the general wards. <p>RESEARCH DESIGN AND METHODS: In a randomized clinical trial, insulin-treated patients at high risk for hypoglycemia with type 2 diabetes were recruited. Participants were randomized to RT-CGM/GTS or point of care (POC) blood glucose testing. The primary outcome was difference in inpatient hypoglycemia.</p> <p>RESULTS: Seventy-two participants were included in this interim analysis, 36 in the RT-CGM/GTS group and 36 in the POC group. RT-CGM/GTS group experienced fewer hypoglycemic events (<70 mg/dL) per patient (0.67 events per patient, 95% CI 0.34-1.30 versus 1.69 events per patient, 95% CI 1.11-2.58, <i>p</i>=0.024) and fewer clinically significant hypoglycemic events (<54 mg/dL) per patient (0.08 events per patient, 95% CI 0.03-0.26 versus 0.75, 95% CI 0.51-1.09, <i>p</i>=0.003). RT-CGM/GTS had lower percentage of time spent below range <70 mg/dl (0.40%, 95% CI 0.18%-0.92% versus 1.88%, 95% CI 1.26%-2.81%, <i>p</i>=0.002) and <54 mg/dL (0.05%, 95% CI 0.01%-0.43% versus 0.82%, 95% CI 0.47%-1.43%, <i>p</i>=0.017) compared to POC group. No differences in nocturnal hypoglycemia, time in range 70-180 mg/dL, time above range >180-250 mg/dL and >250 mg/dL were found between the groups. RT-CGM/GTS group had no prolonged hypoglycemia compared to 0.20 episodes <54mg/dL and 0.40 episodes <70mg/dL per patient in the POC group. </p> <p>CONCLUSIONS: RT-CGM/GTS can decrease hypoglycemia among hospitalized high risk insulin treated patients with type 2 diabetes.</p>