Using a Closed-Loop System Plus Behavioral Supports in Preschoolers with Diabetes

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 DESCRIPTION (provided by applicant): The care of young children with type 1 diabetes is extremely challenging. There is increasing evidence that both hyperglycemia and hypoglycemia may be damaging to brain development in this age group. The availability of technology such as insulin pumps and continuous glucose sensors has the potential to improve the time spent in the normal glucose range as well as reduce the risk of prolonged, severe hypoglycemia. The implementation of these technologies has yielded disappointing results in earlier studies. The technology needs to be introduced with appropriate supports to ensure long term success with these devices. In this study we will utilize a more advanced system (which utilizes both an insulin pump and glucose sensor to suspend insulin delivery overnight prior to hypoglycemia in order to minimize hypoglycemic events. In this project, we will initially test 4 interventions to hlp families better use the technology as well as improve their glucose control: 1) One intervention is designed to help families feel more comfortable with technology by discussing the difficulties encountered and by using a problem-solving approach to overcome barriers to technology; 2) A second adherence intervention focuses on distress reduction. This intervention involves identifying parental fear and reducing these through cognitive behavioral techniques: 3) a third intervention utilizes dual bolus insulin delivery at meals and is aimed at reducing postprandial hyperglycemia; 4) the fourth intervention is aimed at reducing fear of hypoglycemia. Here, we will use sensor information and discuss the fears and anxiety and utilize techniques to help increase parental confidence with diabetes care. We will test these 4 interventions in a group of 18 families who are already using sensor-augmented pump therapy but with inconsistent use and not reaching glucose targets. This is not an uncommon scenario in clinical practice and these families will be the ones who will most likely benefit from the interventions. The initial wok will allow us to refine and package the interventions to allow testing in a larger group of patient. After the initial pilot study, we will test these interventions as we implement a system which will predict when a child's glucose will be low overnight and then suspend insulin delivery to prevent the low glucose from occurring. The system resumes insulin delivery when sensor glucose levels begin to rise. This technology has the potential to decrease parental fears about nocturnal hypoglycemia and allow improved glucose levels overnight. For this study, we will enroll 90 families and study the use of the system over 6 months. As patients encounter challenges to adherence or with achieving glycemic targets, we will randomly assign them to interventions developed in the initial pilot to see if they there is an effect on improving glycemic control. Thi project will provide important information about the behavioral supports that are required in successful implementation of diabetes technologies and it will determine if a predictive low glucose suspend system can improve overall glycemic control in young children.