Blood Glucose Training for Women with Type 1 Diabetes Contemplating Pregnancy

描述(由申请人提供)：在怀孕前和怀孕期间对血糖(BG)水平的管理不力，一直与严重的母婴并发症有关。除了这些并发症给患者带来的身体和心理负担外，与处理这些问题相关的医疗成本也很高。孕前护理强调在孕前阶段和怀孕早期严格控制血糖，可以极大地降低这些风险。然而，由于各种组织、提供者和以患者为中心的因素，美国预产期护理的使用率低得令人失望。此外，努力实现严格的血糖控制可能会增加T1 DM妇女患严重低血糖(SH)的风险，可能导致严重的健康后果(如交通事故、产妇死亡)。这也可能会阻碍患者实现其 怀孕时的血糖升高目标。与其他糖尿病患者相比，上述原因共同使BG管理对这一患者群体更具挑战性。迫切需要让这一关键的TIDM孕妇群体具备实用的自我管理技能，她们可以积极利用这些技能来更好地了解和管理自己的血糖水平，实现目标血糖控制，而不会有不必要的低血糖风险。BGATHome是一个自动化的、量身定做的互联网版本的血糖意识训练(BGAT)，是我们的研究团队为T1 DM患者开发的面对面的心理教育干预。该计划在改善血糖控制、降低极端血糖水平、SH、糖尿病酮症酸中毒和改善患者心理功能方面证明是有效的。从历史上看，在我们的BGAT相关研究中，我们排除了正在考虑怀孕或在研究过程中怀孕的T1 DM妇女，因为她们有独特的糖尿病相关临床需求。在这个项目中，我们将开发和测试BGATHome的专门版本，供正在考虑怀孕的T1 DM妇女使用，以检验其作为干预措施的有效性，以更好地调节她们的血糖水平，并满足她们与糖尿病相关的受孕临床目标。利用对目标患者、他们的重要其他人和提供者的形成性研究，我们将确定和 创建为该人群量身定做的BGATHome的新版本。这项名为“BGAT-妊娠”的新干预措施随后将在一项针对考虑怀孕的T1 DM妇女的随机对照试验中进行测试，以检查可行性和初步疗效。对试验参与者的采访，他们的重要意义 将对其他项目和潜在的提供者进行评估，以进一步优化干预措施，为后续的R01提交做准备。这将是第一项调查使用互联网来改善对打算怀孕的T1 DM妇女极端血糖水平的检测和管理的研究。如果被证明有效，BGAT怀孕之家将为美国T1 DM妇女的孕前护理提供重要的补充，大大减少危险的并发症，并改善心理结果。

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.