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（DFUs）是糖尿病的一种破坏性并发症，其影响不成比例

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.