CGM Use in Hospitalized Patients With Diabetes Mellitus
Phase: NA
Conditions: Diabetes Mellitus
Sponsor: Mayo Clinic

 
 
Continuous Glucose Monitoring in Hospitalized 
Patients With Diabetes Mellitus 
 
NCT#04653454 
 
12August2020 

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
Page 6 of 6 
 
Data Analysis Plan:  
 
Data will be described as percentages or means. Pearson χ2 and Kruskal Wallis tests will be used to compare 
categorical and continuous variables respectively. Odds ratios, 95% confidence intervals and p-values will be 
reported for each model. All tests of significance will be 2-sided and the level of statistical significance will be 
set at p-value < 0.05. 
 
Mean Absolute Relative Differences will be calculated between matched pairs of POC monitors and the closest 
CGM reading (within 5 minutes of POC). Additionally, level of agreement between the two devices will be 
examined with Bland-Altman plots, with particular attention focused on detection agreement in range (70-180 
g/dl). Poisson or negative binomial regression will be utilized to assess count variables such as number of 
alarms, nurse notification, and hypo or hyperglycemia events adjusting for patient characteristics. Finally, 
longitudinal analysis will be conducted to determine differences associated with medications, clinical 
parameters or diagnosis. Analysis will seek to define if there are any differences between CGM and POC 
measurement based on these changes. 
 
Endpoints 
Primary: CGM accuracy - mean absolute relative difference (MARD) 
 
Secondary:  
• CGM accuracy at detection of hypo or hyperglycemia episodes when compared with POC monitors. 
(MARD for readings <70g/dl, >180g/dl, >250g/dl) 
• CGM accuracy for detecting time in range (70-180 g/dl MARD).  
• Number of CGM alarms and the clinical result of these alarms: nurse notification, treatment of hypo or 
hyperglycemia episodes, treatment for rapid declining glucose alarms. 
• Time in therapeutic range for glucose as measured by CGM and POC glucose monitor.  
• Detection of medications, clinical parameters or diagnoses that would interfere with CGM reading.  
• Effect of CGM use on length of hospital stay, post-surgical duration of hospitalization 
 
Clinical safety measures: 
• Number of sensors with failure.  
• Number of sensors removed for procedure.  
• Number of sensor related skin reaction (contact dermatitis, infection)