Randomized controlled trial of continuous glucose monitoring compared to point of care glucose testing following hospital discharge on 12-week diabetic foot ulcer healing rates

糖尿病足溃疡(DFU)是糖尿病的一种破坏性并发症，对 服务不足的人群。DFU是住院的常见原因，也是#年肢体丧失的主要原因 美国。DFU和由此导致的截肢是与高度抑郁相关的改变生活的事件 利率、丧失独立性和死亡。虽然改善血糖控制的好处是好的 对于其他糖尿病并发症，它对DFU愈合的影响还不够充分 调查过了。连续血糖监测仪(CGM)已被证明可以改善血糖指标(包括 HbA1c和时间范围内)以及患者报告的1型和2型糖尿病患者的结果。 然而，据我们所知，还没有关于CGM对糖尿病并发症的影响的研究报道。实时 CGM(RT-CGM)允许患者密切监测血糖模式，而不需要频繁使用手指 并提供有助于自我管理和临床医生指导治疗的详细措施 干预措施。对于R03的应用，我们提出了一项比较RT-CGM和标准的随机对照试验 DFU患者的护理点指棒测试。我们将招募96名住院治疗的患者 DFU从出院后开始随机分配到每个干预组，并持续12周的随访 句号。我们将遵循务实的真实世界研究设计，其中患者自我管理和药物治疗 调整将由临床糖尿病专家指导，而不是由研究团队指导。我们的整体 假设RT-CGM将通过改善以下方面来增加12周的DFU愈合率(目标1主要结果) 血糖控制(目标2)。护理点小组的参与者将获得盲目CGM，允许我们积累 血糖控制指标(范围内的时间、上下范围的时间以及血糖控制指标)的强大数据集 可变性)，以调查血糖控制和DFU愈合之间的关系。最后，我们将测试RT- CGM可改善患者报告的结果，如糖尿病痛苦和自我效能(目标3)。我们将进行 这项试验在格雷迪纪念医院进行，这是一家亚特兰大的安全网医院，那里有250人(80%是黑人) 每年与DFU一起住院。我们的发现将解决文献中的两个重要差距：(1)是否 血糖控制促进DFU愈合？(2)RT-CGM是否影响糖尿病并发症？重要的是，我们会 在服务不足的人群中研究这些差距，这些人群通常较少获得卫生技术，如 CGM。这个方案是我的K23的自然延伸，它实现了对医院的务实设计 糖尿病的管理。在我的K培训期间，我共同创建了一个由临床医生和研究人员组成的多学科团队 总部设在格雷迪纪念医院，其使命是改善糖尿病足的护理，以减少截肢。使用 来自这个团队的支持和我导师的持续支持，这项研究将为成为 独立调查员。来自R03的发现将为我们未来的R01提供支持，我将领导设计和 实施最先进的技术，找到降低糖尿病相关截肢率的创新解决方案。

Diabetic foot ulcers (DFUs) are a devastating complication of diabetes that disproportionally impact underserved populations. DFUs are a frequent cause of hospitalization and the leading cause of limb loss in the United States. DFUs and resultant amputations are life-altering events associated with high depression rates, loss of independence, and death. While the benefits of improved glycemic control have been well demonstrated for other diabetes complications, it’s impact on DFU healing has not been adequately investigated. Continuous glucose monitors (CGMs) have been shown to improve glycemic metrics (including HbA1c and time in range) along with patient-reported outcomes for patients with type 1 and type 2 diabetes. However, no studies to our knowledge have reported on CGM’s impact on diabetes complications. Real-time CGM (rt-CGM) allows patients to closely monitor glycemic patterns without the burden of frequent finger sticks and provide detailed measures that assist in both self-management and clinician guided therapeutic interventions. For this R03 application, we propose a randomized controlled trial comparing rt-CGM to standard of care point of care finger stick testing in patients with DFUs. We will enroll 96 subjects hospitalized with a DFU randomized to each intervention arm starting post-discharge and continued for a 12 week follow up period. We will follow a pragmatic real-world study design where patient self-management and medication adjustments will be guided by a clinical diabetes specialist rather than by the research team. Our overall hypothesis is that rt-CGM will increase 12-week DFU healing rates (Aim 1 primary outcome) by improving glycemic control (Aim 2). Participants in the point of care group will have a blinded CGM allowing us to accrue a robust dataset of glycemic controls metrics (time in range, time above and below range, and glycemic variability) to investigate the associations between glycemic control and DFU healing. Lastly, we will test if rt- CGM improves patient reported outcomes such as diabetes distress and self-efficacy (Aim 3). We will conduct this trial at Grady Memorial Hospital, an Atlanta safety-net hospital where >250 people (80% Black) are hospitalized with DFU annually. Our findings will address two important gaps in the literature: (1) Does glycemic control improve DFU healing? (2) Does rt- CGM impact a diabetes complication? Importantly, we will study these gaps in an underserved population that generally has lower access to health technologies such as CGM. This proposal is a natural extension of my K23 which implement a pragmatic design to hospital management of diabetes. During my K training, I co-founded a multidisciplinary team of clinician-researchers based at Grady Memorial Hospital, whose mission is to improve diabetic foot care to reduce amputations. With support from this team and ongoing support from my mentor, this study will pave the way to becoming an independent investigator. The findings from this R03 will feed our future R01 which I will lead to design and implement state of the art technology to find innovative solutions to lower rates of diabetes-related ampuations.