Hypoglycemia in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease: A Prospective Observational Study.

Background: Glycemic management in patients with type 2 diabetes mellitus (T2DM) and CKD can become complicated. One factor that may affect treatment is hypoglycemia. Hypoglycemia risk may be increased by several biologic processes in CKD. The objective of this study was to determine the frequency, severity, and risk factors for hypoglycemia in patients with T2DM and CKD. Methods: The design was a prospective observational study. A continuous glucose monitor (CGM) was worn by 80 patients for up to 14 days; glucose was measured every 15 minutes. Patients with T2DM and eGFR <45 ml/min were enrolled. Patients on dialysis were excluded. The primary outcome was to assess the frequency of hypoglycemic episodes during the study period. Hypoglycemic episodes were defined as a reduced glucose concentration (<70 mg/dl) lasting ≥15 minutes. Secondary outcomes included assessment of severity of hypoglycemia and risk factors for its development. Results: A total of 80 patients wore the CGM for a mean of 12.7±2.9 days. Hypoglycemic events occurred in 61 of 80 patients (76%) with glucose <70 mg/dl, and 49 of 80 (61%) with glucose <60 mg/dl. Prolonged hypoglycemic events (CGM glucose <54 mg/dl for ≥120 consecutive minutes) occurred in 31 patients (39%) with 118 total events. Most hypoglycemic episodes occurred overnight, from 1:00 am to 9:00 am. By multivariate analysis, lower hemoglobin A1c and treatment with insulin were two modifiable risk factors for hypoglycemic events. Conclusions: Patients with T2DM and CKD have frequent periods of hypoglycemia that can be severe and prolonged. Hemoglobin A1c does not portray the full scope of hypoglycemia risk. This study illustrates the need for careful monitoring of glucose levels in patients with T2DM and CKD.

Continuous Glucose Monitoring and Glycemic Control in Patients With Type 2 Diabetes Mellitus and CKD.

RATIONALE & OBJECTIVE: The accuracy of glycated hemoglobin (HbA1c) level for assessment of glycemic control in patients with chronic kidney disease (CKD) is uncertain. This study assessed the accuracy of HbA1c level using continuous glucose monitoring. STUDY DESIGN: Diagnostic test study of HbA1c and serum fructosamine. The continuous glucose monitor was worn for 14 days. Glucose was measured every 15 minutes (up to 1,344 measurements). Average glucose concentration was calculated for each patient from the patient's continuous glucose monitor measurements. Linear regression was applied to estimate the relationship between average glucose concentration and HbA1c and serum fructosamine levels. The influence of patient characteristics on the relationship between HbA1c and average glucose concentrations was examined in a multivariate regression model. SETTING & PARTICIPANTS: Patients with type 2 diabetes and CKD (estimated glomerular filtration rate, 7-45 mL/min, not receiving dialysis) seen in an academic nephrology clinic. TESTS ANALYZED: The accuracy of HbA1c level for assessment of chronic glycemia. A secondary objective was to study serum fructosamine levels. OUTCOMES: The degree of correlation between continuous glucose monitoring-derived average glucose concentration and HbA1c level; serum fructosamine level was studied as a secondary outcome. RESULTS: 80 patients wore the continuous glucose monitor for a mean of 12.7 ± 2.9 days. Average glucose concentration of all patients was 151.5 ± 55.7 mg/dL. Mean HbA1c level was 7.2% ± 1.5%. HbA1c level was highly correlated with average glucose concentration, described by the equation: average glucose concentration = 30.48 × HbA1c - 68.48; r = 0.82; P < 0.001. Serum fructosamine level was also significantly correlated with average glucose concentration; r = 0.55; P < 0.001. The strong correlation between average glucose concentration and HbA1c level was not affected by the severity of CKD, whereas the performance of serum fructosamine level, in contrast, degraded among patients with more severe CKD. LIMITATIONS: Relatively small sample size. CONCLUSIONS: HbA1c is an accurate measure of glycemic status among patients with CKD and type 2 diabetes. This relationship appears to hold true among patients with more severe CKD.

Medication discrepancies in late-stage chronic kidney disease.

BACKGROUND: Late-stage chronic kidney disease (LS-CKD) can be defined by glomerular filtration rate (GFR) 0-30 mL/min. It is a period of risk for medication discrepancies because of frequent hospitalizations, fragmented medical care, inadequate communication and polypharmacy. In this study, we sought to characterize medication discrepancies in LS-CKD. METHODS: We analyzed all patients enrolled in Northwell Health's Healthy Transitions in LS-CKD program. All patients had estimated GFR 0-30 mL/min, not on dialysis. Medications were reviewed by a nurse at a home visit. Patients' medication usage and practice were compared with nephrologists' medication lists, and discrepancies were characterized. Patients were categorized as having either no discrepancies or one or more. Associations between patient characteristics and number of medication discrepancies were evaluated by chi-square or Fisher's exact test for categorical variables, and two-sample t-test or Wilcoxon text for continuous variables. RESULTS: Seven hundred and thirteen patients with a median age of 70 (interquartile range 58-79) years were studied. There were 392 patients (55.0% of the study population) with at least one medication discrepancy. The therapeutic classes of medications with most frequently occurring medication discrepancies were cardiovascular, vitamins, bone and mineral disease agents, diuretics, analgesics and diabetes medications. In multivariable analysis, factors associated with higher risk of discrepancies were congestive heart failure [odds ratio (OR) 2.13; 95% confidence interval (CI) 1.44-3.16; P = 0.0002] and number of medications (OR 1.29; 95% CI 1.21-1.37; P < 0.0001). CONCLUSIONS: Medication discrepancies are common in LS-CKD, affect the majority of patients and include high-risk medication classes. Congestive heart failure and total number of medications are independently associated with greater risk for multiple drug discrepancies. The frequency of medication discrepancies indicates a need for great care in medication management of these patients.

Augmented Nurse Care Management in CKD Stages 4 to 5: A Randomized Trial.

BACKGROUND: Outcomes for patients with late-stage chronic kidney disease (CKD) in the United States are suboptimal. There is poor education and preparation for end-stage kidney disease, as well as a high rate of hospitalization in this group of patients. STUDY DESIGN: A randomized, parallel-group, 2-arm, controlled trial. SETTING & PARTICIPANTS: The study was conducted at 3 sites: a clinic of an academic medical center, a public hospital academic clinic, and a community-based private practice. All participants had late-stage CKD (stages 4-5 CKD). Patients were excluded only if they had significant cognitive impairment. INTERVENTION: The care management intervention involved nurse care manager coordination aided by the use of a disease-based informatics system for monitoring patients' clinical status, enhancing CKD education, and facilitating preparation for end-stage kidney disease. The comparison control group received usual late-stage CKD care alone. OUTCOMES: The primary outcome was rate of hospitalization. MEASUREMENTS: Rates of preemptive transplantation, home dialysis, hemodialysis (HD) starts without a hospitalization, and HD therapy initiation rates with catheters or with functioning accesses. RESULTS: 130 patients were randomly assigned. The hospitalization rate was significantly lower in the intervention group versus controls: 0.61 versus 0.92 per year, respectively (incidence rate ratio, 0.66; 95% CI, 0.43-0.99; P=0.04). Peritoneal dialysis or preemptive transplantation was the initial end-stage kidney disease treatment in 11 of 30 (37%) participants receiving the intervention versus 3 of 29 (10%) receiving usual care. Among HD starts, treatment was initiated without hospitalization in 11 of 19 (58%) participants in the intervention group versus 6 of 26 (23%) in the control group. At the time of HD therapy initiation, a catheter was present in 7 of 19 (37%) participants in the intervention group versus 18 of 26 (69%) in the control group. A functioning arteriovenous access was in place in 10 of 19 (53%) participants in the intervention group and 7 of 26 (27%) in the control group LIMITATIONS: Moderate sample size, limited geographic scope. CONCLUSIONS: The augmented nurse care management intervention resulted in reduced hospitalizations in late-stage CKD and there were suggestions of improved end-stage kidney disease preparation. Given suboptimal outcomes in late-stage CKD, care management interventions could potentially improve patient outcomes.

Longitudinal predictors of uremic pruritus.

OBJECTIVE: Pruritus is a common problem among hemodialyzed patients. Its causes are poorly understood, and, as a result, itching is often attributed to elevated serum phosphorus and other disorders of bone and minerals. The primary purpose of this study was to analyze the relationship between pruritus and common tests of bone and mineral disease. METHODS: This study was a post hoc analysis of data from a randomized controlled trial of 3 months of ergocalciferol versus placebo treatment in 50 hemodialysis patients with uremic pruritus. A pruritus survey was administered at baseline and then every 2 weeks for 12 weeks. Concurrent serum phosphorus, intact parathyroid hormone (PTH), serum calcium, and calcium-phosphate product were measured. RESULTS: Pruritus score was not found to be associated or correlated with serum phosphate, intact PTH, serum calcium, or calcium-phosphate product at each time interval or over time. Likewise, when analyzed by original study group (placebo or ergocalciferol), no association or correlation between the mineral and bone indicators and itching were found. CONCLUSION: Neither serum phosphate nor other tests of bone and mineral status were found to be significant predictors of pruritus at any point in time or over time.