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This study extends nutritional intervention results reported by short-term clinical trials of a diabetes-specific nutritional meal replacement by assessing the ten-year impact of the interventions on patient outcomes and costs compared to usual care. We developed and validated a computer simulation of type 2 diabetes based on published data from major clinical trials. The model tracks patients through microvascular and macrovascular health states and reports cumulative costs and quality adjusted life years. We modeled different scenarios that include a diabetes-specific nutritional meal replacement as part of a structured lifestyle intervention, and also as the only difference between the intervention and usual care treatment groups, and compared them to usual care with diet and physical activity recommendations. We used sensitivity analysis to explore the robustness of results. When a diabetes-specific nutritional meal replacement is the only treatment difference and is considered an equal cost meal replacement, the diabetes-specific nutritional meal replacement interventions are less costly and more effective than usual care. As an added cost meal replacement, the diabetes-specific nutritional meal replacement has an incremental cost-effectiveness ratio between $50,414 and $55,036 depending on improvement in percent glycated hemoglobin. A hypothetical lifestyle intervention using a diabetes-specific nutritional meal replacement has an incremental cost-effectiveness ratio of $47,917. The diabetes-specific nutritional meal replacement was found to be cost-effective under the various conditions simulated. [ABSTRACT FROM AUTHOR]

This study evaluated a structured and integrated intervention program on diabetes management in individuals with type 2 diabetes in Shanghai, China. Men and women with type 2 diabetes and body mass index > 23 kg/m2 were randomized into a 24-week, prospective, randomized clinical trial. The Reference Group (n=50) received diabetes education including diet and physical activity instruction only; the Intervention Group (n=100) received more intensive intervention, including diabetes education with frequent blood glucose monitoring, nutritional counseling, meal plans with diabetes-specific nutritional meal replacement, and weekly progress updates with study staff. Major study assessments were obtained at baseline, and after 12 and/or 24 weeks of intervention. The Intervention Group improved fasting blood glucose, insulin, systolic and diastolic blood pressures compared to Reference Group ( p <0.05). Importantly, HbA1c was lower ( p <0.001) in the Intervention Group at 12 weeks (-0.6 +/- 0.1%) and 24 weeks (-0.8 +/- 0.1%). Weight loss was modest, but significant differences were observed between groups ( p <0.05). Weight change from baseline after 12 and 24 weeks was -2.8 +/- 0.2% and -3.7 +/- 0.3%, respectively, in the Intervention Group vs -1.8 +/- 0.4% and -2.5 +/- 0.4% in the Reference Group. Additionally, waist and hip circumferences and waist:hip ratio decreased in the Intervention compared to the Reference Group ( p <0.05). In conclusion, this study demonstrates that Chinese men and women with type 2 diabetes following an integrated intervention program including diabetes education, frequent blood glucose monitoring and daily use of a diabetes-specific meal replacement, can achieve significant improvements in glycemic control and markers of cardiovascular health. [ABSTRACT FROM AUTHOR]