Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA1c: Extension phase results after a 12-week randomized controlled trial.

Abstract

Aim: To investigate extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with type 1 diabetes mellitus (T1DM) and elevated HbA_1c (7.5-12.2% [58-110 mmol/mol]).

Methods: One hundred children with T1DM aged 4-13 years were initially in a 12-week randomised controlled trial (RCT) comparing glycaemic outcomes with isCGM 2.0 (intervention group, n = 49) with self-monitored blood glucose (Control group, n = 51). After the 12-week RCT both groups were offered an extension phase with isCGM 2.0 for another 12 weeks. HbA_1c, CGM metrics, psychological outcomes and device utilization attitudes were measured.

Results: After the initial 12-week RCT, 66 participants completed this 12-week extension: 36/49 (73%) and 30/51 (58.8%) from the isCGM/isCGM and Control/isCGM groups, respectively. In the isCGM/isCGM group, time below range 70 mg/dL (3.9 mmol/L) (TBR70) reduced from 10.7 ± 11.3% at baseline to 2.8 ± 2.8% and 2.1 ± 2.4% at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). Glucose test frequency increased from 4.7 (2.7) at baseline to 10.7 (4.6) and 9.2 (4.7) at 12 and 24 weeks, respectively (p < 0.01 for both 12 and 24 weeks). The Control/isCGM group decreased TBR70 from 10.7 ± 7.4% at 12 weeks to 2.9 ± 2.8% at 24 weeks and increased daily glucose test frequency from 3.2 (1.6) to 10.7 (5.4) from 12 to 24 weeks (both p < 0.01). However, HbA_1c and time in range (TIR) were non-significant at 24 weeks in both groups.

Conclusions: Extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA_1c showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.