Abstract

INTRODUCTION: Hybrid closed-loop systems increase time-in-range and reduce glycemic variability. Person-reported outcomes (PROs) are essential to assess the utility of new devices and their impact on quality of life. This manuscript focuses on the PROs for pediatric participants (ages 6-13 yrs) with type 1 diabetes (T1D) and their parents during a trial using the Tandem Control-IQ system, which was shown to increase time-in-range and improve other glycemic metrics.METHODS: One-hundred-one children 6 to 13 years old with T1D were randomly assigned to closed-loop control (CLC) or sensor augmented pump (SAP) in a 16-week randomized clinical trial with extension to 28 weeks during which the SAP group crossed over to CLC. Health-related quality of life and treatment satisfaction measures were obtained from children and their parents at baseline, 16 weeks, and 28 weeks.RESULTS: Neither the children in the CLC group nor their parents had statistically significant changes in PRO outcomes compared with the SAP group at the end of the 16-week RCT and the 28-week extension. Parents in the CLC group reported non-significant improvements in some PRO scores when compared with the SAP group at 16 weeks, which were sustained at 28 weeks. Sleep scores for parents improved from "poor sleep quality" to "adequate sleep quality" between baseline and 16 weeks, however, the change in scores was not statistically different between groups.CONCLUSIONS: Children with T1D who used the Control-IQ system did not experience increased burden compared with those using SAP based on person-reported outcomes from the children and their parents.

View details for DOI 10.1089/dia.2020.0532

View details for PubMedID 33404325