Diabetes affects up to 40% of patients with end-stage renal disease (ESRD). Diabetes management in the context of existing ESRD is challenging due to alterations on glucose metabolism, insulin sensitivity, and also renal clearance of several medications. Thus, most patients with diabetes on dialysis are treated with insulin therapy, resulting in increased risk for hospitalizations for hypoglycemia, mortality, length-of-stay and hospitalization costs at a national level. In many instances, clinicians and patients need to make treatment decisions based on few point-of-care blood glucoses (POC BG) per day, which fails to detect asymptomatic and nocturnal hypoglycemia and are not a good indicator of the 24-hours glycemic excursions. Novel factory-calibrated continuous glucose monitoring (CGM) devices have shown improved accuracy and could fill the critical need for better glycemic monitoring systems in dialysis patients. In this proposal, the PI, Dr. Galindo, will use CGM (Aim 1a) to examine the prevalence of hypoglycemia, hyperglycemia and estimate glycemic variability patterns among patients with type 2 diabetes (DM2), treated with insulin and receiving hemodialysis, (Aim 1b) to assess the accuracy of the CGM in this specific cohort, (Aim 2a) to assess the efficacy of real-time CGM data in preventing hypoglycemia and hyperglycemia, and (Aim 2b) to examine the relationship between glycemic variability and inflammatory/oxidative stress markers in patients participating in Aim 2a. We anticipate that this study will provide novel insights into the glycemic exposure patterns among dialysis patients and will provide preliminary data for future outcomes-based studies determining the best glycemic targets for this group. Dr. Galindo has created a multidisciplinary mentorship team with track record of NIH funding, led by Dr. Umpierrez, with expertise in glucose monitoring and research methodology, and Dr. Tuttle, who is an expert on clinical and translational studies in diabetic kidney disease. His scientific advisory committee includes experts in biostatistics and bioinformatics (Dr. Limin Peng, PhD), and in CGM technology for (Dr. Beck). Dr. Galindo will test the proposed aims within the vast resources available at Emory University - a world-known research institution. The career development plan includes didactic classes, mentored-based training on clinical research and hands-on experience on CGM use and large database analyses. This innovative proposal and formal training plan, will provide Dr. Galindo with the bases for future R01 applications, and an independent career in patient-oriented clinical research.
/Public Health Relevance Statement Diabetes management in patients with ESRD represent a challenge for clinicians and patients. These patients are exposed to wide glycemic exposures, and high risk for hypoglycemia and glycemic variability. Current glucose control measures lack accuracy and validation in ESRD patients. Continuous glucose monitoring (CGM) provides a comprehensive, real-time 24-hours glucose profile, but no prior study has included ESRD patients. The proposed research intends to fill this critical knowledge gap by testing a new strategy with novel factory-calibrated CGMs.
