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

连续血糖监测与出院后护理点血糖测试对 12 周糖尿病足溃疡愈合率的随机对照试验

• 批准号: 10727731
• 负责人: Maya Fayfman
• 金额: $ 19.17万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10727731
• 关键词: Address; Adult; Amputation; Black race; Blinded; Blood Glucose; Blood Vessels; Caring; Cessation of life; Client satisfaction; Clinical; Complex; Complications of Diabetes Mellitus; Continuous Glucose Monitor; Country; Data; Data Set; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Ulcer; Enrollment; Event; Fingers; Foot Diseases; Future; General Population; Glucose; Glycosylated hemoglobin A; Health Technology; Hospital Administration; Hospitalization; Hospitals; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Immune system; Impaired healing; Impaired wound healing; Impairment; Incidence; Insulin; Intervention; Intervention Trial; Legal patent; Leukocytes; Life; Limb structure; Link; Literature; Malignant Neoplasms; Measurement; Measures; Mediating; Mental Depression; Mentored Patient-Oriented Research Career Development Award; Mentors; Mission; Monitor; Non-Insulin-Dependent Diabetes Mellitus; Oral; Osteomyelitis; Outcome; Participant; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Pattern; Perioperative; Personal Satisfaction; Persons; Pharmaceutical Preparations; Postoperative Period; Prevalence; Prospective Studies; Provider; Randomized; Randomized, Controlled Trials; Reactive Oxygen Species; Recurrence; Reporting; Research; Research Design; Research Personnel; Risk; Self Efficacy; Self Management; Site; Specialist; Study Subject; Surgical Wound Infection; Technology; Testing; Therapeutic Intervention; Time; Training; Ulcer; Underserved Population; United States; Visit; angiogenesis; arm; clinically significant; comparison control; design; diabetes distress; diabetes management; experience; follow-up; glucose monitor; glycemic control; healing; high risk; improved; innovation; innovative technologies; insight; limb loss; mortality; multidisciplinary; neural; point of care; point of care testing; primary endpoint; primary outcome; real time monitoring; recruit; safety net; satisfaction; standard of care; treatment arm; trial comparing; type I and type II diabetes; wound; wound healing

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.

糖尿病足溃疡（DFUS）是糖尿病的破坏性并发症，不成比例地影响 服务不足的人群。 DFU通常是住院的原因，是肢体损失的主要原因 美国。 DFU和由此产生的截肢是与高抑郁症相关的改变生命的事件 率，独立性丧失和死亡。虽然改善血糖控制的好处良好 出现其他糖尿病并发症的证明，对DFU愈合的影响尚未充分 调查。连续葡萄糖监测器（CGM）已显示可改善血糖指标（包括 HBA1C和范围内的时间）以及1型和2型糖尿病患者的患者报告结果。 但是，据我们所知，尚无对CGM对糖尿病并发症的影响的研究。即时的 CGM（RT-CGM）允许患者密切监测血糖模式，而不会燃烧频繁的手指棒 并提供了详细的措施，可以帮助自我管理和临床指导治疗 干预措施。对于此R03应用，我们提出了一个随机对照试验，将RT-CGM与标准进行了比较 DFU的患者的护理点手指棒测试。我们将注册96名受试者 DFU随机分配到每个干预臂开始入院后，并继续进行12周的随访 时期。我们将遵循务实的现实研究设计设计，患者自我管理和药物 调整将由临床糖尿病专家而不是研究团队指导。我们的整体 假设是RT-CGM通过改善而提高12周的DFU愈合率（AIM 1主要结果） 血糖控制（AIM 2）。护理小组的参与者将有一个盲目的CGM，使我们能够累积 血糖控制的稳健数据集（范围内的时间，范围以下和以下时间）以及血糖 可变性）研究血糖控制与DFU愈合之间的关联。最后，我们将测试RT- CGM改善了患者报告的结果，例如糖尿病困扰和自我效能感（AIM 3）。我们将进行 该试验在亚特兰大安全网医院格雷迪纪念医院，> 250人（黑色80％） 每年在DFU住院。我们的发现将解决文献中的两个重要差距：（1）确实 血糖控制改善了DFU愈合？ （2）RT-CGM是否影响糖尿病并发症？重要的是，我们会的 研究这些差距在服务欠缺的人群中，通常较低的健康技术（例如 CGM。该提议是我的K23的自然扩展 糖尿病的管理。在我的K培训期间，我共同创立了一个临床研究者的多学科团队 总部位于Grady Memorial Hospital，其任务是改善糖尿病足护理以减少截肢。和 这支团队的支持以及我心理的持续支持，这项研究将为成为一名 独立研究者。此R03的发现将为我们的未来R01提供我将导致设计和 实施艺术技术的状态，以找到创新的解决方案，以降低与糖尿病相关的距离的速度。