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 HbA1c (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. HbA1c, 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, HbA1c 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 HbA1c showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.
This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 19 February 2020 (ACTRN12620000190909p) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).