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

TITLE=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

JOURNAL=Frontiers in Endocrinology

VOLUME=13

YEAR=2022

URL=https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2022.870916

DOI=10.3389/fendo.2022.870916

ISSN=1664-2392

ABSTRACT=<sec><title>Objective</title><p>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<sup>®</sup>) or pump with independent intermittent scanning continuous glucose monitoring (iscCGM, Freestyle libre <sup>®</sup>).</p></sec><sec><title>Methods</title><p>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 (<bold>A</bold>) or SAP with SmartGuard<sup>®</sup> (<bold>B</bold>) for 5 weeks followed by 5 additional weeks. The difference in percentages of time in glucose target (TIT), (3.9 – 8.0 mmol/l), &lt;3 mmol/l, &gt; 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<sup>®</sup>).</p></sec><sec><title>Results</title><p>31 children (15 girls) finished the study. With sensor compliance &gt; 60%, no difference in TIT was found, TIT: <bold>A</bold> 37.86%; 95% CI [33.21; 42.51]; <bold>B</bold> 37.20%; 95% CI [32.59; 41.82]; &lt; 3 mmol/l <bold>A</bold> 2.27% 95% CI [0.71; 3.84] <bold>B</bold> 1.42% 95% CI [-0.13; 2.97]; &gt; 8 mmol/l <bold>A</bold> 0.60% 95% CI [0.56, 0.67]; <bold>B</bold> 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.</p></sec><sec><title>Conclusions</title><p>In this study, no significant difference in glycemic control was found whether treated with SAP (SmartGuard<sup>®</sup>) or pump with iscCGM. The decision of all families to continue with CGM after the study suggests a positive impact, with preference for SmartGuard<sup>®</sup>.</p></sec><sec><title>Clinical Trial Registration</title><p>[<uri xlink:href="https://clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">clinicaltrials.gov</uri>], identifier NCT03103867.</p></sec>