A Comparison of Different Statistical Methods Analyzing Hypoglycemia Data Using Bootstrap Simulations

REFERENCES

• American Diabetes Association. (2010). Standards of medical care in diabetes. Diabetes Care 33:S11 –S61.
   PubMed Web of Science ®Google Scholar
• Buse, J. B., Wolffenbuttel, B. H., Herman, W. H., Shemonsky, N. K., Jiang, H. H., Fahrbach, J. L., Scism-Bacon, J. L., Martin, S. A. (2009). DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results: Safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care 32:1007 –1013.
   PubMed Web of Science ®Google Scholar
• Cheung, Y. B. (2002). Zero-inflated models for regression analysis of count data: A study of growth and development. Statistics in Medicine 21:1461 –1469.
   PubMed Web of Science ®Google Scholar
• Cryer, P. E. (2002). Hypoglycaemia: The limiting factor in the glycaemic management of type I and type II diabetes. Diabetologia 45:937 –948.
   PubMed Web of Science ®Google Scholar
• Cryer, P. E., Davis, S. N., Shamoon, H. (2003). Hypoglycemia in diabetes. Diabetes Care 26: 1902 –1912.
   PubMed Web of Science ®Google Scholar
• Quade, D. (1967). Rank analysis of covariance. Journal of the American Statistical Association 62:1187 –1200.
   Web of Science ®Google Scholar
• Efron, B. (1979). Bootstrap methods: Another look at the Jackknife. Annals of Statistics 7:1 –26.
   Web of Science ®Google Scholar
• Efron, B., Tibshirani, R. J. (1993). An Introduction to the Bootstrap. New York: Chapman and Hall.
   Google Scholar
• Fleiss, J. L., Levin, B., Cho Paik, M. (2003). Statistical Methods for Rates and Proportions, 3rd ed. New York: John Wiley & Sons.
   Google Scholar
• Garg, S. K., Paul, J. M., Karsten, J. I., Menditto, L., Gottlieb, P. A. (2004). Reduced severe hypoglycemia with insulin glargine in intensively treated adults with type 1 diabetes. Diabetes Technology & Therapeutics 6:596 –600.
   PubMedGoogle Scholar
• Herbst, A., Bachran, R., Kapellen, T., Holl, R. W. (2006). Effects of regular physical activity on control of glycemia in pediatric patients with type 1 diabetes mellitus. Archives of Pediatrics and Adolescent Medicine 160:573 –577.
   PubMed Web of Science ®Google Scholar
• Hermansen, K., Davies, M., Derezinski, T., Martinez Ravn, G., Clauson, P., Home, P. (2006). A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naïve people with type 2 diabetes. Diabetes Care 29:1269 –1274.
   PubMed Web of Science ®Google Scholar
• Korytkowski, M. (2002). When oral agents fail: Practical barriers to starting insulin. International Journal of Obesity and Related Metabolic Disorders 26:S18 –S24.
   PubMed Web of Science ®Google Scholar
• Malone, J. K., Bai, S., Campaigne, B. N., Reviriego, J., Augendre-Ferrante, B. (2005). Twicedaily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with type 2 diabetes. Diabetic Medicine 22:374 –381.
   PubMed Web of Science ®Google Scholar
• Malone, J. K., Kerr, L. F., Campaigne, B. N., Sachson, R. A., Holcombe, J. H., Lispro Mixture-Glargine Study Group. (2004). Combined therapy with insulin lispro mix 75/25 plus metformin or insulin glargine plus metformin: A 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clinical Therapeutics 26:2034 –2044.
   PubMed Web of Science ®Google Scholar
• Maniatis, A. K., Klingensmith, G. J., Slover, R. H., Mowry, C. J., Chase, H. P. (2001). Continuous subcutaneous insulin infusion therapy for children and adolescents: An option for routine diabetes care. Pediatrics 107:351 –356.
   PubMed Web of Science ®Google Scholar
• Mullins, P., Sharplin, P., Yki-Jarvinen, H., Riddle, M., Haring, H. (2007). Negative binomial meta-regression analysis of combined glycosylated hemoglobin and hypoglycemia outcomes across eleven phase III and IV studies of insulin glargine compared with neutral protamine hagedorn insulin in type 1 and type 2 diabetes mellitus. Clinical Therapeutics 29:1607 –1619.
   PubMed Web of Science ®Google Scholar
• Olejnik, S. F., Algina, J. (1984). Parametric ANCOVA and the rank transform ANCOVA when the data are conditionally non-normal and heteroscedastic. Journal of Educational Statistics 9:129 –149.
   Google Scholar
• Ramaswamy, R., Koch, G. G., Amara, I. A. (1997). Application of rank analysis of covariance methods to analysis of multiple anatomical regions with treatment for seborrheic dermatitis. Journal of Biopharmaceutical Statistics 7:403 –416.
   PubMedGoogle Scholar
• Rosenstock, J., Ahmann, A. J., Colon, G., Scism-Bacon, J., Jiang, H., Martin, S. (2008). Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: Prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus glargine/lispro) therapy. Diabetes Care 31:20 –25.
   PubMed Web of Science ®Google Scholar