Abstract
BackgroundThe factory calibrated FreeStyle Libre (FSL) flash glucose monitoring system has been recently introduced for use in patients with diabetes mellitus. There are no reports available regarding its use in patients with congenital hyperinsulinism (CHI). We have assessed the accuracy of FSL compared to the finger prick capillary blood glucose (CBG) over 2 weeks period in patients with CHI and evaluated the parents’ experience of using FSL.MethodsFour hundred sixty-seven episodes of CBG along with corresponding swipe FSL readings were available from 11 children with CHI (0.5–5 years). A detailed questionnaire was completed by the parents.ResultsThe mean variation between the two methods was 0.29 mmol/l (SD ±1.07), higher readings by FSL compared to CBG. The FSL sensors stayed in-situ for an average period of 11.5 days. There was a positive correlation between the two methods (r = 0.7). The FSL tended to overestimate compared to CBG (bias = 0.29 mmol/l; 95% CI: 0.19 to 0.38). Only 70% of values were within the reference standard (±0.83 mmol/l) at glucose concentrations less than 5.6 mmol/l. The overall Mean Absolute Relative Difference (MARD) was 17.9%. Forty two episodes of hypoglycaemia (CBG < 3.5 mmol/l) were noted but FSL identified only 52% of these episodes. The Bland Altman analysis showed the 95% limits of agreement between the two methods ranging from − 1.8 (95% CI: -1.97 to − 1.64) to 2.37 (95% CI: 2.21 to 2.54). Majority of the parents found the glucose trend on FSL to be useful to detect and prevent hypoglycaemic episodes. All parents felt that FSL is a very easy and convenient method to measure the glucose especially during sleep. A significant proportion of parents felt that FSL readings were not accurate and 56% of parents expressed interest to continue using FSL after the trial period.ConclusionNoticeable variability between the two methods of measuring the glucose was noted. Despite the ease of using the FSL system, concerns related to accuracy, especially at low glucose values do remain although parents find the glucose trend to be very useful. Further larger trials are needed in CHI patients before FSL is recommended as a routine alternative method for measuring glucose levels.
Highlights
The factory calibrated FreeStyle Libre (FSL) flash glucose monitoring system has been recently introduced for use in patients with diabetes mellitus
Accuracy of flash glucose monitoring system (FGMS) in congenital hyperinsulinism (CHI) patients The mean variation between the two methods was 0.29 mmol/l (SD ±1.07), higher readings by FSL compared to capillary blood glucose (CBG)
The FSL tended to overestimate compared to CBG with a positive mean difference
Summary
The factory calibrated FreeStyle Libre (FSL) flash glucose monitoring system has been recently introduced for use in patients with diabetes mellitus. There are no reports available regarding its use in patients with congenital hyperinsulinism (CHI). Majority of the patients with CHI are either infants or preschool children and the blood glucose levels are monitored on a regular basis by the parents using the standard glucometers. Continuous glucose monitoring systems (CGMS) are mainly used for patients with diabetes mellitus. The use of CGMS is not widespread in the management of CHI patients for various reasons including the cost of the equipment, the lack of evidence, the need for regular calibration for accuracy [7] and the short lifespan of the sensors
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have