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

对患有糖尿病的学龄前儿童使用闭环系统和行为支持

基本信息

批准号：
8810602
负责人：
BRUCE A BUCKINGHAM
金额：
$ 213.16万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-25 至 2019-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8810602
关键词：
Address Adherence Adult Affect Algorithms American Anxiety Behavior Therapy Behavioral Blood Glucose Bolus Infusion Brain Caring Child Childhood Clinic Clinical Trials Clinical Trials Design Cognitive Colorado Complex Data Development Devices Diabetes Mellitus Diagnosis Distress Eating Enrollment Ensure Event Exposure to Family Family Study Fright Funding Glucose Goals Grant Guidelines Health Health Professional Hyperglycemia Hypoglycemia Impaired cognition Indiana Infusion Pumps Insulin Insulin Infusion Systems Insulin-Dependent Diabetes Mellitus Intervention Intervention Studies Magnetic Resonance Imaging Measures Nursery Schools Parents Patients Pattern Phase Physical activity Pilot Projects Population Preschool Child Problem Solving Pump Quality of life Randomized Randomized Clinical Trials Reading Regimen Registries Research Research Design Risk Seizures Structure Study Subject Symptoms System Techniques Technology Test Result Testing Time Toddler Universities Voice advanced system age group base blood glucose regulation clinical practice clinical research site cognitive function design diabetes control diabetes management executive function experience glucose monitor glucose sensor glycemic control improved innovation meetings neurocognitive test neuropsychological prevent processing speed psychologic public health relevance sensor success

项目摘要

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.

描述（由申请人提供）：1型糖尿病幼儿的护理极具挑战性。越来越多的证据表明，高血糖和低血糖都可能损害这个年龄组的大脑发育。胰岛素泵和动态血糖传感器等技术的可用性有可能改善正常血糖范围内的时间，并降低长期严重低血糖的风险。这些技术的实施在早期的研究中产生了令人失望的结果。该技术需要在适当的支持下引入，以确保这些设备的长期成功。在本研究中，我们将使用更先进的系统（该系统利用胰岛素泵和葡萄糖传感器在低血糖发生前暂停胰岛素输注过夜，以尽量减少低血糖事件。在这个项目中，我们将首先测试4种干预措施，以帮助hlp家庭更好地使用技术并改善他们的血糖控制：1）一种干预措施旨在通过讨论遇到的困难和使用解决问题的方法来克服技术障碍，帮助家庭对技术感到更舒适; 2）第二种干预措施侧重于减少痛苦。这种干预包括识别父母的恐惧，并通过认知行为技术减少这些恐惧：3）第三种干预利用餐时双餐时胰岛素输注，旨在减少餐后高血糖; 4）第四种干预旨在减少对低血糖的恐惧。在这里，我们将使用传感器信息，讨论恐惧和焦虑，并利用技术来帮助增加父母对糖尿病护理的信心。我们将在一组18个家庭中测试这4种干预措施，这些家庭已经使用传感器增强泵治疗，但使用不一致，未达到血糖目标。这在临床实践中并不罕见，这些家庭将最有可能从干预措施中受益。最初的工作将使我们能够改进和包装干预措施，以便在更大的患者群体中进行测试。在初步试点研究之后，我们将测试这些干预措施，因为我们实施了一个系统，预测孩子的血糖何时会在夜间降低，然后暂停胰岛素输注以防止低血糖发生。当探头葡萄糖水平开始升高时，系统恢复胰岛素输注。这项技术有可能减少父母对夜间低血糖的恐惧，并允许夜间改善血糖水平。在这项研究中，我们将招募90个家庭，并研究该系统的使用超过6个月。当患者在依从性或实现血糖目标方面遇到挑战时，我们将随机将他们分配到初始试点中开发的干预措施中，以查看他们是否对改善血糖控制有影响。该项目将提供有关成功实施糖尿病技术所需的行为支持的重要信息，并将确定预测性低血糖暂停系统是否可以改善幼儿的整体血糖控制。