Detecting Unusual Continuous Glucose Monitor Measurements: A Stochastic Model Approach Matthew Signal, Deborah L. Harris, Philip J. Weston, Aaron Le Compte, J. Geoffrey Chase, Jane E. Harding, on behalf of the CHYLD Study Group 8 Background: Continuous glucose monitors (CGMs) have recently been used to monitor blood glucose (BG) levels in critically ill adults and infants, where hyperglycaemia and hypoglycaemia have been associated with negative outcomes. However, there have been concerns regarding the accuracy and reliability of these devices in critically ill patients. Objective: Use CGM data from neonatal infants to develop a tool that will aid clinicians in identifying unusual CGM behavior, retrospectively or in real-time. BG (mmol/L) INTRODUCTION CGM Ref BG 6 4 2 0 500 1000 1500 2000 2500 time (mins) (www.medtronic.com) RESULTS Example Patient 1 Stable, flat CGM trace with little variability over the METHODS ~3.5 days of monitoring No measurements classified as being very unusual 1. CREATE STOCHASTIC MODEL 14 3. CLASSIFY UNUSUAL CGM MEASUREMENTS 12 Consider: CGMn-1 = 5.0 mmol/L and CGMn = 5.5 mmol/L. This would be classified as follows: 8 1. Using the model distribution at 5.0 mmol/L, locate 5.5 mmol/L and determine the percentile: n CGM (mmol/L) 10 6 4 2 0 0 2 4 6 CGM n-1 8 (mmol/L) 10 12 14 Example Patient 2 Figure 1: Poincare plot of empirical CGM data (~67,000 measurements) A slightly more variable CGM trace with several sections of aqua and yellow Stochastic model equations Of particular interest is the hypoglycaemic event at ~1 day, which is classified as very unusual and consequently coloured red interpret with care 80th percentile 4 5 6 2. Use the percentile to colour that section of CGM trace using the following classifications: Example Patient 3 10 - 90th Percentiles 5 - 95th Percentiles 0.5 - 99.5th Percentiles Figure 4: CGM colour classification Figure 2: Stochastic model surface. Note the variations in model surface with increasing CGMn-1, reinforcing that a single distribution is not applicable to the entire range of CGMn-1 This CGM trace appears to be fairly good until ~day 3, after which there are a lot of very unusual measurements (potentially sensor degradation) 3. Repeat classification steps 1 and 2 until all paired CGM measurements (CGMn-1, CGMn) have been classified 2. CHECK MODEL FIT CONCLUSIONS Figure 3: PDF’s from the model at different values of CGMn-1 compared to PDF’s created using empirical data Table 1: Results from a 5 fold validation, Monte Carlo simulated 25 times. Percent of measurements in each confidence interval presented as Median [IQR] 80% CI 90% CI 99% CI Variation 0.83 [0.79 - 0.86] 0.91 [0.89 - 0.93] 0.99 [0.98 - 0.99] While BG measurements are required to make definitive conclusions about glycaemic abnormalities, the stochastic classification provides another level of information to aid users in interpretation and decision making. Furthermore, in the real-time application, clinical protocols might use stochastic information to justify an added BG measurement to clarify a potentially significant event.