Combined diabetes-renal multifactorial intervention in patients with advanced diabetic nephropathy: Proof-of-concept.

AIMS: To evaluate efficacy of a multifactorial-multidisciplinary approach in delaying CKD 3-4 progression to ESRD. METHODS: Two-year proof-of-concept stratified randomized control trial conducted in an outpatient clinic of a large public hospital system. This intervention, led by a team of endocrinologists, nephrologists, nurse practitioners, and registered dietitians, integrated intensive diabetes-renal care with behavioral/dietary and pharmacological interventions. 120 low-income adults with T2DM and CKD 3-4 enrolled; 58% male, 55% African American, 23% Hispanic. RESULTS: Primary outcome was progression rate from CKD 3-4 to ESRD. Fewer intervention (13%) than control (28%) developed ESRD, p<0.05. Intervention had greater albumin/creatinine ratio (ACR) decrease (62% vs. 42%, p<0.05) and A1C<7% attainment (50% vs. 30%, p<0.05) and trended toward better lipid/blood pressure control (p=NS). Significant differences between 25 ESRD and 95 ESRD-free patients were baseline eGFR (28 vs. 40ml/min/1.73m2), annual eGFR decline (15 vs. 3ml/min/year), baseline ACR (2362 vs. 1139mg/g), final ACR (2896 vs. 1201mg/g), and final A1C (6.9 vs. 7.8%). In multivariate Cox analysis, receiving the intervention reduced hazard ratio to develop ESRD (0.125, CI 0.029-0.54) as did higher baseline eGFR (0.69, CI 0.59-0.80). Greater annual eGFR decline increased hazard ratio (1.59, CI 1.34-1.87). CONCLUSIONS: The intervention delayed ESRD. Improved A1C and ACR plus not-yet-identified variables may have influenced better outcomes. Multifactorial-multidisciplinary care may serve as a CKD 3-4 treatment paradigm.

Lean versus obese diabetes mellitus patients in the United States minority population.

OBJECTIVE: To identify special characteristics in large group of lean diabetes minority patients in comparison to obese type 2 diabetes. METHODS: 1784 Lean (BMI <25) diabetes patients were identified and compared with 8630 obese (BMI ≥30) patients. Patients with Type 1 Diabetes (N=523) were excluded. Patient data, including demographics, psychosocial factors, insulin use, and complications was analyzed. RESULTS: In lean compared to obese, there was male predominance (62% vs 48%, p<0.001), higher prevalence of insulin use (49% vs 44%, p=0.001), lower TG/HDL (2.28 vs 3.4, p<0.001), and higher prevalence of alcoholism (5.7% vs 2.4%, p<0.001) and pancreatitis (3.6% vs 0.9%, p<0.001). In both groups, African Americans and Latinos were the prevalent ethnicities (38%, 34% vs. 53%,31%). When comparing patients within the lean group who were on insulin (49%) to those on oral medications, there were more males (65% vs. 59%, p<0.001), earlier age of onset (40±14 vs. 47±12, p<0.001), lower BMI (22.1±2 vs. 22.6±1.7, p<0.001) and lower TG/HDL (2.18 vs. 2.42, p=0.021). CONCLUSIONS: A subset of diabetes patients in the United States minority population are lean and may have rapid beta cell failure. The etiology is not clear and acquired factors, genetics, and autoimmunity may be contributory.

Insulin injections in relation to meals in the hospital medicine ward: comparison of 2 protocols.

OBJECTIVE: To investigate whether changing the prandial regular insulin to rapid-acting insulin analogue in hospital medicine wards improves the timing of insulin delivery in relation to meals and improves patient safety and glucose control. METHODS: This open-label randomized controlled trial in type 2 diabetic patients compared insulin lispro with meals and basal insulin glargine (intervention) vs regular insulin before meals and basal neutral protamine Hagedorn insulin twice daily (control). The primary endpoint was the rate of targeted timing of insulin to meals (target time). In the intervention group, target time was defined as insulin administered from 15 minutes before to 15 minutes after the patient started a meal. For the control group, target time was defined as insulin administered from 30 minutes before to 30 minutes after the patient started a meal. Hypoglycemic, hyperglycemic, and severe hyperglycemic patient-days were compared between groups. RESULTS: Twenty-seven patients in the intervention group and thirty-three patients in the control group were studied. The percentage of times that the insulin was given within target time was significantly higher in the intervention group as a whole (88.9% vs 70.1%, P<.001) and was higher for lunch and the evening meal (90% vs 66.7% and 94.7% vs 70.1%, P<.001). The rate of hypoglycemia was lower in the intervention group (1.85% vs 15%, P<.001). The rate of hyperglycemia was similar in both groups (68.2% vs 59.8%, P = .224), but the intervention group had a higher rate of severe hyperglycemia (28.9% vs 12.9%, P = .003). CONCLUSIONS: The use of prandial insulin analogues in medicine wards allows better timing with meals than regular insulin and results in better hypoglycemic outcomes. Higher rates of hyperglycemia with prandial analogues may need adjustment in insulin doses.

Early and later onset type 2 diabetes in uninsured patients: clinical and behavioral differences.

OBJECTIVE: The national burden of type 2 diabetes mellitus (T2DM) is increasing rapidly. This study investigated a) clinical differences between early onset and later onset T2DM; and b) if specific risk factors were associated with age at diagnosis or clinical outcomes among uninsured adults in a large urban setting. METHODS: We compared 417 adults diagnosed under age 30 with 968 adults diagnosed ages 50-58 on clinical and social measures using standard parametric tests. RESULTS: Early onset patients had higher hemoglobin A1c, were more likely to smoke and to be depressed, and had more emergency department visits. Insulin monotherapy was more common in early onset patients (32% vs. 11%). Complications were already present in 11% of early onset patients and 29% of later onset patients within one year of diagnosis. CONCLUSION: Early onset patients had more acute beta-cell failure and coped less well with their diabetes. It is crucial to expand specialized diabetes resources for young, medically indigent patients.