BACKGROUND AND AIMS: To evaluate the clinical accuracy of a flash glucose monitoring device FreeStyle Libre (FSL) among children with type 1 diabetes in real-world settings during a summer camp. MATERIALS AND METHODS: During a summer camp, children with type 1 diabetes (n = 79, aged 8-18 years) were provided with FSLs for 12 days. On days 3, 7, and 11 of the study, they underwent supervised glucose testing at 8 timepoints. Glycemia was estimated by using FSL and measured with a personal glucometer within a period of 2 min. The glucose trend arrows were recorded. RESULTS: The study was completed by 78 children (median: age 12.8 years, diabetes duration 5.8 years, HbA1c 58.5 mmol/mol). Mean absolute relative difference (MARD) between the FSL and the glucometer was 13.5% ± 12.9%. FSL was the most accurate in stable glycemic conditions: MARD 11.4% ± 10.4%, less accurate when glycemia was falling >2 mg/(dL·min) [0.111 mmol/(L·min)-MARD 22.6% ± 18.6%; P < 0.001 vs. stable conditions] and when the device could not determine the glucose trends (16.5% ± 16.3%, P = 0.01 vs. stable conditions). The FSL demonstrated lower accuracy during the day than the night [MARD 14.9% ± 14% vs. 11.2% ± 10.6%, P < 0.0001]. Out of 1655 data pairs of glucometer and FSL, using the Surveillance Error Grid methodology we determined that 80.36% of FSL readings were associated with no clinical risk, 18.73% with slight risk and only one high-risk measurement was detected. CONCLUSION: FSL is accurate in children, but its accuracy depends on the glucose trend. Results flagged by the rapid fall flag and "trend undetermined" should be verified by blood glucose measurements.
BACKGROUND AND AIMS: To evaluate the clinical accuracy of a flash glucose monitoring device FreeStyle Libre (FSL) among children with type 1 diabetes in real-world settings during a summer camp. MATERIALS AND METHODS: During a summer camp, children with type 1 diabetes (n = 79, aged 8-18 years) were provided with FSLs for 12 days. On days 3, 7, and 11 of the study, they underwent supervised glucose testing at 8 timepoints. Glycemia was estimated by using FSL and measured with a personal glucometer within a period of 2 min. The glucose trend arrows were recorded. RESULTS: The study was completed by 78 children (median: age 12.8 years, diabetes duration 5.8 years, HbA1c 58.5 mmol/mol). Mean absolute relative difference (MARD) between the FSL and the glucometer was 13.5% ± 12.9%. FSL was the most accurate in stable glycemic conditions: MARD 11.4% ± 10.4%, less accurate when glycemia was falling >2 mg/(dL·min) [0.111 mmol/(L·min)-MARD 22.6% ± 18.6%; P < 0.001 vs. stable conditions] and when the device could not determine the glucose trends (16.5% ± 16.3%, P = 0.01 vs. stable conditions). The FSL demonstrated lower accuracy during the day than the night [MARD 14.9% ± 14% vs. 11.2% ± 10.6%, P < 0.0001]. Out of 1655 data pairs of glucometer and FSL, using the Surveillance Error Grid methodology we determined that 80.36% of FSL readings were associated with no clinical risk, 18.73% with slight risk and only one high-risk measurement was detected. CONCLUSION: FSL is accurate in children, but its accuracy depends on the glucose trend. Results flagged by the rapid fall flag and "trend undetermined" should be verified by blood glucose measurements.
Authors: Nejla Ghane; Miranda M Broadney; Elisabeth K Davis; Robert W Trenschel; Shavonne M Collins; Sheila M Brady; Jack A Yanovski Journal: Pediatr Diabetes Date: 2019-08-29 Impact factor: 4.866