Effect of predicted low suspend pump treatment on improving glycaemic control and quality of sleep in children with type 1 diabetes and their caregivers: the QUEST randomized crossover study

Abstract

BackgroundIn attempting to achieve optimal metabolic control, the day-to-day management is challenging for a child with type 1 diabetes (T1D) and his family and can have a major negative impact on their quality of life. Augmenting an insulin pump with glucose sensor information leads to improved outcomes: decreased haemoglobin A1c levels, increased time in glucose target and less hypoglycaemia. Fear of nocturnal hypoglycaemia remains pervasive amongst parents, leading to chronic sleep interruption and lack of sleep for the parents and their children.The QUEST study, an open-label, single-centre randomized crossover study, aims to evaluate the impact on time in target, in hypoglycaemia and hyperglycaemia and the effect on sleep and quality of life in children with T1D, comparing a sensor-augmented pump (SAP) with predictive low glucose suspend and alerts to the use of the same insulin pump with a flash glucose measurement (FGM) device not interacting with the pump.Methods/designSubjects meeting the inclusion criteria are randomized to treatment with the SAP or treatment with an insulin pump and independent FGM for 5 weeks. Following a 3-week washout period, the subjects cross over to the other study arm for 5 weeks. During the week before and in the last week of treatment, the subjects and one of their caregivers wear a sleep monitor in order to obtain sleep data. The primary endpoint is the between-arm difference in percentage of time in glucose target during the final 6 days of each treatment arm, measured by a blinded continuous glucose measurement (CGM).Additional endpoints include comparison of quantity and quality of sleep as well as quality of life perception of the subjects and one of their caregivers in the two different treatment arms.Recruitment started in February 2017. A total of 36 patients are planned to be randomized. The study recruitment was completed in April 2018.DiscussionWith this study we will provide more information on whether insulin pump treatment combined with more technology (SmartGuard® feature and alerts) leads to better metabolic control. The inclusion of indicators on quality of sleep with less sleep interruption, less lack of sleep and perception of quality of life in both children and their primary caregivers is essential for this study and might help to guide us to further treatment improvement.Trial registrationClinicalTrials.gov, NCT03103867. Registered on 6 April 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3034-4) contains supplementary material, which is available to authorized users.

Facilitators and Barriers of Sleep in Young Adults With Type 1 Diabetes

“…Technologies such as linked CGMs and insulin pumps that can sense and stop insulin infusions when blood glucose is low have the potential to reduce the fear of hypoglycemia and actual hypoglycemia. Closed-loop systems that use computer-based algorithms for insulin therapy have been reported to demonstrate reductions in sleep disturbances for caregivers and adolescents with T1D 42 ; however, in a study of 16 middle-aged adults and 12 adolescents, no differences were noted in selfreported sleep quality for those with T1D using a closedloop system or insulin pump. 43 Although there is potential for better outcomes with these recent advancements, diabetes devices disrupt sleep with alarms, and there is a need to acclimate to this technology.…”

Evaluation of sleep characteristics of children and adolescents with type 1 diabetes mellitus

“…Thus, treatment with Basal-Bolus insulins requires frequent adherence and monitoring by parents and the children/adolescents themselves. [20][21][22] No difference was found in the prevalence of daytime sleepiness according to the type of insulin therapy (MDI or CSII). Both therapies are known to require strict glycemic controls and frequent self-care practices, which can impact patients' sleep.…”

Sleep characteristics in young adults with type 1 diabetes

“…Technologies such as continuous glucose monitors and insulin pumps that can sense and stop insulin infusions when blood glucose is low have the potential to reduce the fear of and actual hypoglycemia. In some studies closed-loop systems combining computer-based algorithms for insulin therapy are beginning to demonstrate reductions in sleep disturbances for caregivers and adolescents with T1D; 48,52 however in one study of 16 adults (mean age 42.1 years) and 12 adolescents (mean age 15.2 years), no differences were noted in selfreported sleep quality for those with T1D using a closed-loop system or insulin pump. 53 Further, only <7% of young adults use a CGM, 54 a finding that warrants the need for a better understanding in this age group about the barriers and facilitators of the use of such diabetes technology.…”