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）是糖尿病的一种毁灭性并发症， 服务不足的人群。DFU是住院的常见原因，也是肢体丧失的主要原因， 美国的DFU和由此导致的截肢是与高度抑郁症相关的改变生活的事件 率，失去独立性，死亡。虽然改善血糖控制的好处已经很好 对于其他糖尿病并发症，它对DFU愈合的影响还不充分。 研究了动态血糖监测仪（CGM）已被证明可以改善血糖指标（包括 HbA 1c和范围内时间）沿着1型和2型糖尿病患者的患者报告结局。 然而，据我们所知，没有研究报告CGM对糖尿病并发症的影响。实时 CGM（rt-CGM）允许患者密切监测血糖模式，而无需频繁进行手指针刺 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R 03申请，我们提出了一项比较rt-CGM与标准CGM的随机对照试验 DFU患者的护理点手指针刺测试。我们将入组96例住院受试者， DFU从出院后开始随机分配至每个干预组，并持续12周随访 期我们将遵循务实的现实世界研究设计，患者自我管理和药物治疗 调整将由临床糖尿病专家指导，而不是由研究小组指导。我们的整体 假设rt-CGM将通过改善12周DFU愈合率（目标1主要结局） 血糖控制（目标2）。床旁监护组的参与者将接受设盲CGM，以便我们累积 血糖控制指标的稳健数据集（范围内的时间、高于和低于范围的时间以及血糖 变异性），以研究血糖控制和DFU愈合之间的关联。最后，我们将测试如果RT- CGM改善了患者报告的结局，如糖尿病痛苦和自我效能（目标3）。我们会进行 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，有250多人（80%是黑人） 每年因DFU住院。我们的研究结果将解决文献中的两个重要空白：（1）是否 血糖控制改善DFU愈合？(2)rt-CGM是否影响糖尿病并发症？重要的是，我们将 研究这些差距，在一个服务不足的人口，通常有较低的获得卫生技术，如 CGM。这个建议是我的K23的自然延伸，它实现了一个实用的设计，以医院 糖尿病的管理。在我的K培训期间，我与人共同创立了一个多学科的临床研究团队 总部设在格雷迪纪念医院，其使命是改善糖尿病足护理，以减少截肢。与 在这个团队的支持和我导师的持续支持下，这项研究将为成为一个 独立调查员R 03的发现将为我们未来的R 01提供信息，我将领导设计和 实施最先进的技术，以找到创新的解决方案，降低糖尿病相关截肢率。

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.