Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment: Does It Impact Time in Glucose Target and Treatment Preference? The QUEST Randomized Crossover Study.

Objective: To compare glycemic control and treatment preference in children with type 1 diabetes (T1D) using sensor augmented pump (SAP) with predictive low glucose suspend (SmartGuard) or pump with independent intermittent scanning continuous glucose monitoring (iscCGM, Freestyle libre ).

Methods: In this open label, cross-over study, children 6 to 14 years of age, treated with insulin pump for at least 6 months, were randomized to insulin pump and iscCGM () or SAP with SmartGuard () for 5 weeks followed by 5 additional weeks. The difference in percentages of time in glucose target (TIT), (3.9 - 8.0 mmol/l), <3 mmol/l, > 8 and 10 mmol/l, were analyzed using linear mixed models during the final week of each arm and were measured by blinded CGM (IPro2).

Results: 31 children (15 girls) finished the study. With sensor compliance > 60%, no difference in TIT was found, TIT: 37.86%; 95% CI [33.21; 42.51]; 37.20%; 95% CI [32.59; 41.82]; < 3 mmol/l 2.27% 95% CI [0.71; 3.84] 1.42% 95% CI [-0.13; 2.97]; > 8 mmol/l 0.60% 95% CI [0.56, 0.67]; 0.63% [0.56; 0.70]. One year after the study all participants were on CGM compared to 80.7% prior to the study, with a shift of 13/25 participants from iscCGM to SAP.

Conclusions: In this study, no significant difference in glycemic control was found whether treated with SAP (SmartGuard) or pump with iscCGM. The decision of all families to continue with CGM after the study suggests a positive impact, with preference for SmartGuard.

Clinical Trial Registration: [clinicaltrials.gov], identifier NCT03103867.