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 (DFU) 是糖尿病的一种破坏性并发症，对人体造成不成比例的影响 医疗服务不足的人群中，DFU 是导致住院的常见原因，也是导致肢体丧失的主要原因。 在美国，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。 虽然改善血糖控制的好处是显而易见的。 对于其他糖尿病并发症，其对 DFU 愈合的影响尚未得到充分证明 研究表明，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）以及 1 型和 2 型糖尿病患者报告的结果。 然而，据我们所知，还没有研究报告 CGM 对糖尿病并发症的实时影响。 CGM (rt-CGM) 允许患者密切监测血糖模式，而无需频繁进行手指穿刺 并提供有助于自我管理和临床医生指导治疗的详细措施 对于此 R03 应用，我们提出了一项比较 rt-CGM 与标准的随机对照试验。 我们将招募 96 名因 DFU 住院的受试者。 从出院后开始，DFU 被随机分配到每个干预组，并继续进行 12 周的随访 期间我们将遵循务实的现实世界研究设计，其中患者的自我管理和药物治疗。 调整将由临床糖尿病专家而不是我们的整体研究团队指导。 假设 rt-CGM 将通过改善 12 周 DFU 治愈率（目标 1 主要结局）来提高 血糖控制（目标 2）。护理点组的参与者将进行盲法 CGM，使我们能够累积血糖。 血糖控制指标的强大数据集（范围内时间、高于和低于范围的时间以及血糖 变异性）来研究血糖控制和 DFU 愈合之间的关联。最后，我们将测试 rt- 是否有效。 CGM 改善患者报告的结果，例如糖尿病困扰和自我效能（目标 3）。 这项试验在格雷迪纪念医院进行，这是一家亚特兰大安全网医院，该医院有超过 250 人（80% 是黑人） 每年因 DFU 住院的患者，我们的研究结果将解决文献中的两个重要空白：(1) 确实如此。 血糖控制可改善 DFU 愈合吗？ (2) rt-CGM 会影响糖尿病并发症吗？ 研究服务不足的人群中的这些差距，这些人群通常获得卫生技术的机会较少，例如 这个建议是我的K23的自然延伸，它对医院实施了务实的设计。 在我的 K 培训期间，我与他人共同创立了一个由临床医生兼研究人员组成的多学科团队。 总部位于格雷迪纪念医院，其使命是改善糖尿病足部护理以减少截肢。 在这个团队的支持和我的导师的持续支持下，这项研究将为成为一名 R03 的研究结果将为我们未来的 R01 提供支持，我将领导 R01 的设计和开发。 实施最先进的技术，寻找创新的解决方案来降低糖尿病相关截肢率。