Blood Glucose Training for Women with Type 1 Diabetes Contemplating Pregnancy

描述（由申请人提供）：孕前和妊娠期间血糖（BG）水平的无效管理与严重的母体和胎儿并发症相关。除了这些并发症对患者造成的身体和心理负担外，与管理这些问题相关的医疗保健成本也很高。孕前保健强调在孕前期间严格控制血糖，并持续到怀孕早期，可以大大降低这些风险。然而，由于各种组织，提供者和以患者为中心的因素，在美国使用孕前保健的比例一直很低。此外，努力实现严格的血糖控制可增加T1 DM女性中严重低血糖（SH）的风险，可能导致严重的健康后果（例如，交通事故、产妇死亡）。这也可能阻碍患者实现其 怀孕的血糖目标。与其他糖尿病患者相比，上述原因使该患者人群的血糖管理更具挑战性。迫切需要为考虑怀孕的TIDM女性这一关键人群提供实用的自我管理技能，使其能够积极使用这些技能来更好地了解和管理其BG水平，并在没有过度低血糖风险的情况下实现其目标血糖控制。BGATHome是一个自动化的，量身定制的，血糖意识培训（BGAT）的互联网版本，一个面对面的，由我们的研究团队开发的T1 DM患者的心理教育干预。该计划已证明在改善血糖控制、降低极端BG水平、SH、糖尿病酮症酸中毒和改善患者心理功能方面有效。从历史上看，在我们的BGAT相关研究中，我们排除了考虑怀孕或在我们的研究过程中怀孕的T1 DM女性，因为她们具有独特的糖尿病相关临床需求。在本项目中，我们将开发和测试一种专门版本的BGATHome，用于考虑怀孕的T1 DM女性，以检查其作为这些女性干预措施的有效性，以更好地调节其BG水平，并满足其糖尿病相关的临床受孕目标。通过对目标患者、他们的重要他人和提供者进行形成性研究，我们将确定并 创建一个新版本的BGATHome为这一人群量身定制。这种新的干预措施，“BGAT-妊娠”，然后将在一项涉及打算怀孕的T1 DM女性的RCT中进行测试，以检查可行性和初步疗效。与试验参与者的访谈，他们的重要 其他人和潜在提供商将进行评估，以进一步优化干预措施，为后续的R 01提交做准备。这将是第一项研究，调查使用互联网，以改善检测和管理极端血糖水平的T1 DM妇女考虑怀孕。如果证明有效，BGATHome for Pregnancy将为美国T1 DM女性提供孕前护理的重要补充，大大减少危险的并发症，并改善心理结局。

DESCRIPTION (provided by applicant): Ineffective management of blood glucose (BG) levels during preconception and pregnancy has been associated with severe maternal and fetal complications. Apart from the physical and psychological burden of these complications on patients, healthcare costs related to managing these issues are substantial. Preconception care emphasizing stringent glycemic control in the preconception period and continued through early pregnancy can dramatically reduce these risks. However, the use of preconception care in the US has been disappointingly low due to a variety of organizational, provider, and patient centered factors. Furthermore, efforts to achieve tight glycemic control can increase the risk of severe hypoglycemia (SH) in T1DM women, potentially leading to serious health consequences (e.g., traffic accidents, maternal death). This may also impede patients' progress to achieve their glycemic targets for pregnancy. Aforementioned reasons together make BG management even more challenging for this patient population compared to others with diabetes. There is a vital need to equip this critical population of TIDM women contemplating pregnancy with practical self-management skills that they can actively use to better understand and manage their BG levels, and achieve their target glycemic control without undue risk of hypoglycemia. BGATHome is an automated, tailored, Internet version of Blood Glucose Awareness Training (BGAT), a face- to-face, psycho-educational intervention for T1DM patients developed by our research team. The program has demonstrated effectiveness in terms of improving glycemic control, reducing extreme BG levels, SH, diabetic ketoacidosis, and improving patients' psychological functioning. Historically, in our BGAT-related studies, we have excluded T1DM women who were either contemplating pregnancy or were pregnant during the course of our studies given their unique diabetes-related clinical needs. In this project, we will develop and test a specialized version of BGATHome for use with T1DM women who are contemplating pregnancy to examine its efficacy as an intervention for these women to better regulate their BG levels and to meet their diabetes-related clinical targets for conception. Using formative research with the targeted patients, their significant others, and providers, we will determine and create a new version of BGATHome tailored for this population. This new intervention, "BGAT-Pregnancy," will then be tested in a RCT involving T1DM women contemplating pregnancy to examine feasibility and preliminary efficacy. Interviews with trial participants, their significant others, and potential providers will be conducted to enable further optimization of the intervention in preparation for a subsequent R01 submission. This will be the first study investigating the use of the Internet to improve detection and management of extreme BG levels in T1DM women contemplating pregnancy. If proven efficacious, BGATHome for Pregnancy would provide a crucial supplement to preconception care for the US T1DM women, substantially reducing dangerous complications, and improving psychological outcomes.