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

Ulrike Schierloh, Gloria A Aguayo, Anna Schritz, Muriel Fichelle, Cindy De Melo Dias, Michel T Vaillant, Ohad Cohen, Inge Gies, Carine de Beaufort, Ulrike Schierloh, Gloria A Aguayo, Anna Schritz, Muriel Fichelle, Cindy De Melo Dias, Michel T Vaillant, Ohad Cohen, Inge Gies, Carine de Beaufort

Abstract

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 (A) or SAP with SmartGuard® (B) 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: A 37.86%; 95% CI [33.21; 42.51]; B 37.20%; 95% CI [32.59; 41.82]; < 3 mmol/l A 2.27% 95% CI [0.71; 3.84] B 1.42% 95% CI [-0.13; 2.97]; > 8 mmol/l A 0.60% 95% CI [0.56, 0.67]; B 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.

Keywords: children; insulin pump; iscCGM; predicted low suspend function; type 1 diabetes.

Conflict of interest statement

The sponsor of this project had the right of commenting but the authors retained the right to accept or reject comments or suggestions. OC is an employee of Medtronic. CB has received a honorary for giving talks on devices, developed by Medtronic, and has been member of Medtronic EU Psychology Advisory board (the development of an e learning tool on diabetes and adolescence). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Schierloh, Aguayo, Schritz, Fichelle, De Melo Dias, Vaillant, Cohen, Gies and de Beaufort.

Figures

Figure 1
Figure 1
Subject disposition.
Figure 2
Figure 2
Boxplot of percentage in glucose target, sensor compliance > 60%.

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