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

 描述(申请人提供)：1型糖尿病儿童的护理具有极大的挑战性。越来越多的证据表明，在这个年龄段，高血糖和低血糖都可能对大脑发育造成损害。胰岛素泵和连续血糖传感器等技术的出现有可能改善在正常血糖范围内花费的时间，并降低长期严重低血糖的风险。在早期的研究中，这些技术的实施产生了令人失望的结果。这项技术需要在适当的支持下推出，以确保这些设备的长期成功。在这项研究中，我们将使用一种更先进的系统(它同时使用胰岛素泵和葡萄糖传感器来在低血糖之前暂停胰岛素的连夜输送，以将低血糖事件降至最低。在这个项目中，我们将首先测试4种干预措施，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服；2)第二种坚持干预措施侧重于减少痛苦。这一干预措施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)第三种干预措施利用两剂胰岛素在用餐时给药，旨在减少餐后高血糖；4)第四种干预措施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，并利用技术来帮助父母增加对糖尿病护理的信心。我们将在18个家庭中测试这4种干预措施，这些家庭已经在使用传感器增强泵疗法，但使用不一致，没有达到血糖目标。这在临床实践中并不少见，这些家庭将最有可能从干预中受益。最初的工作将允许我们改进和打包干预措施，以便在更大的患者群体中进行测试。在最初的试点研究之后，我们将在实施系统时测试这些干预措施，该系统将 预测儿童夜间低血糖的时间，然后暂停胰岛素的供应，以防止低血糖的发生。当传感器血糖水平开始上升时，该系统恢复胰岛素输送。这项技术有可能减少父母对夜间低血糖的担忧，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，并在6个月内研究该系统的使用情况。当患者在坚持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最初试点中制定的干预措施中，看看他们是否对改善血糖控制有效果。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，并将确定预测性低糖悬浮系统是否可以改善幼儿的整体血糖控制。

 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.