Reliability of real‐time continuous glucose monitoring in infants

Abstract

Background: Neonatal hypoglycemia is a common and treatable risk factor for neurological impairment. Real-time continuous glucose monitoring (RT-CGM) can show glucose concentration in real time. Using an RT-CGM alarm, physicians can be alerted and intervene in hypoglycemia. No reports, however, have evaluated the reliability of RT-CGM at low glucose levels in infants. This study therefore investigated the difference between blood glucose (BG) and RT-CGM sensor data at low glucose levels and assessed the optimum method of using a hypoglycemic alarm in infants. Methods: We enrolled infants whose glycemic management was difficult. We calculated the mean absolute difference (MAD) and mean absolute relative difference (MARD) between BG and RT-CGM sensor data. We compared the MAD and MARD between the low BG fluctuation and high BG fluctuation groups. Results: We used RT-CGM for 12 patients (29 times) and investigated 448 pairs of BG and RT-CGM sensor data. The MAD between these pairs was 9.3 AE 8.9 mg/dL, and the MARD was 11.5%. The MAD at low glucose was 7.7 AE 6.0 mg/dL, and the MARD was 16.2%. The MAD and MARD were 6.8 AE 5.4 mg/dL and 7.8% in the low fluctuation group and 10.1 AE 9.5 mg/dL and 12.7% in the high fluctuation group, respectively. Conclusions: The difference between BG and RT-CGM sensor data changes with the degree of fluctuation in BG. When physicians set the hypoglycemic alarm, consideration of this difference and a change in the alarm setting according to the degree of fluctuation in BG may be useful.

Continuous glucose monitoring for hypoglycaemia in children: Perspectives in 2020

“…MARD is the average of the absolute error between all CGM values and is routinely calculated and reported as a key metric by manufacturers. Despite significant improvements in CGM since first-generation devices 15 , accuracy is still not clinically acceptable at hypoglycaemia values 16,17 and more so in non-diabetic patients: The best published MARD value in neonates at hypoglycaemia is 16% 18 with only 86% of values in Zone A (allowing clinically correct decisions) on a Modified Clarke Error Grid (MCEG) 19 (Figure 2). In the clinical setting these values are suboptimal when compared to manufacturers figures for patients with diabetes 20,21 .…”

Complexities in the medical management of hypoglycaemia due to congenital hyperinsulinism

“…In contrast, continuous glucose monitoring (CGM) is an attractive alternative and is widely used by people with type 1 diabetes. The accuracy of CGM in babies with hypoglycaemia remains contentious with unacceptable levels of correlation with standard methods of glucose testing . However, CGM is increasingly improving with evolution of sensor quality and ability to correlate with plasma glucose at the lower end of the glucose range.…”

Accuracy of continuous glucose monitoring in preterm infants: a systematic review and meta-analysis

“…Twenty-five of these studies were excluded because they did not meet the eligibility criteria (online supplemental eTable 2). Open access Fifteen articles were included [24][25][26][27][28][29][30][31][32][33][34][35][36][37][38] as 14 studies (two records reported on the same population. 34 36 Two of these studies 37 38 had a mixed population consisting of both term and preterm infants.…”

“…One looked at patients with a mean age of 65 days 29 and one at patients between 5 and 140 days of age. 33 Thresholds most commonly used in included studies were <2.5 and <2.6 mmol/L (range 2.2-2.8 mmol/L) for hypoglycaemia, >10 mmol/L for hyperglycaemia (range 6.7-10 mmol/L). All studies used CGM devices as their index test but calibrated with different frequencies.…”