Treating to Target: Implementing an Effective Diabetes Care Paradigm for Managed Care

Jan E. Berger, MD;Andrew J. Ahmann, MD;Donald C. Balfour, MD;Robert Beltran, MD, MBA;Michael A. Bush, MD;Larry Culpepper, MD, MPH;Glenda S. Owens, RPh;Marc Ringel, MD;Francine K. Welty, MD;

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Treating to Target: Implementing an Effective Diabetes Care Paradigm for Managed Care

March 17, 2010

Jan E. Berger, MD
Andrew J. Ahmann, MD

Publication

Article

Supplements and Featured PublicationsTreating to Target: Implementing an Effective Diabetes Care Paradigm for Managed Care

Volume 16

Issue 1 Suppl

Author Affiliations: From Division of Endocrinology, Diabetes, and Clinical Nutrition, Oregon Health and Science University, Portland (AJA); Sharp Rees-Stealy Medical Group, San Diego, CA (DC B); Outpatient Services, Monarch Healthcare, Irvine, CA (RB); Health Intelligence Partners, Chicago, IL (JEB); Division of Endocrinology, Cedars-Sinai Medical Center, Los Angeles, CA (MAB); Department of Family Medicine, Boston University School of Medicine, Boston (LC); Pharmacy Service, Arcadian Health Plan, San Dimas, CA (GSO); Brush, CO (MR ); Beth Israel Deaconess Medical Center, Boston, MA (FKW).

Funding Source: Financial support for this work was provided by Novo Nordisk.

Author Disclosures: Dr Ahmann reports being a consultant/advisory board member for Biodel, MannKind, and Novo Nordisk, grants from Amylin, Lilly, MannKind, and Medtronic, and receiving honoraria from and paid lectureship for Amylin, Lilly, Merck, and Sanofi. Dr Balfour reports being an advisory board member for GlaxoSmithKline, Lilly, Merck, Novartis, Novo Nordisk, Ortho-McNeil, Sanofi, Takeda, and Teva. Dr Bush reports being a consultant/advisory board member for Novo Nordisk and on the speakers' bureau for Lilly, Merck, and Novo Nordisk. Dr Culpepper served on the advisory board for AstraZeneca, Lilly, Pfizer, Sanofi, Takeda, and Wyeth. Drs Beltran, Berger, Ringel, and Welty and Ms Owens report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this supplement.

Authorship Information: Concept and design (DCB, MAB, LC, GSO, FKW); acquisition of data (DCB); analysis and interpretation of data (AJA, RB, MAB, LC); drafting of the manuscript (AJA, DCB, RB, MAB, LC, GSO, FKW); critical revision of the manuscript for important intellectual content (AJA, RB, MAB, LC, MR , GSO, FKW); and administrative, technical, or logistic support (JEB, GSO).

Address correspondence to: Jan E. Berger, MD, President & CEO, Health Intelligence Partners, 3842 Monticello Ave, Chicago, IL 60618. E-mail: janberger@comcast.net.

Section 1

1. Mokdad AH, Ford ES, Bowman BA, et al. Diabetes trends in the U.S.: 1990-1998. Diabetes Care. 2000;23:1278-1283.

2. Cowie CC, Rust KF, Ford ES, et al. Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care. 2009;32:287-294.

3. Centers for Disease Control and Prevention. Early release of selected estimates based on data from the January-June 2005 National Health Interview Survey. http://www.cdc.gov/nchs/data/nhis/earlyrelease/200512_14.pdf. Accessed September 10, 2009.

4. Centers for Disease Control and Prevention. National diabetes fact sheet, 2007. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf. Accessed September 10, 2009.

5. Centers for Disease Control and Prevention. Maps of trends in diabetes and obesity. CDC Division of Diabetes Translation; National Diabetes Surveillance System; May 2008. http://www.cdc.gov/diabetes/statistics/slides/maps_diabetesobesity_trends.pdf. Accessed September 10, 2009.

6. Stratton IM, Adler AI, Neil AW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405-412.

7. DECODE Study Group; European Diabetes Epidemiology Group.

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1999;354:617-621.

8. American Heart Association. Diabetes. http://www.americanheart.org/presenter.jhtml?identifer=3044745. AccessedNovember 5, 2009.

9. American Heart Association. Diabetes and cardiovascular disease. http://www.americanheart.org/presenter.jhtml?identifier=3044762. Accessed November 5, 2009.

10. Wandell PE. Quality of life of patients with diabetes mellitus. An overview of research in primary health care in the Nordic countries. Scand J Prim Care. 2005;23:68-74.

11. Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev. 1999;15:205-218.

12. Tabaei BP, Shill-Novak J, Brandle M, et al. Glycemia and the quality of well-being in patients with diabetes. Qual Life Res. 2004;13:1153-1161.

13. Cox D, Gonder-Frederick L, McCall A, et al. The effects of glucose fluctuations on cognitive function and QOL: the functional costs of hypoglycaemia and hyperglycaemia among adults with type 1 or type 2 diabetes. Int J Clin Pract. 2002;12(9 suppl):20-26.

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17. American Diabetes Association. Third-party reimbursement for diabetes care, self-management education, and supplies. Diabetes Care. 2007;30(suppl 1):S86-S87.

18. Gerich JE. Contributions of insulin-resistance and insulin-secretory defects to the pathogenesis of type 2 diabetes mellitus. Mayo Clin Proc. 2003;78:447-456.

19. Virally M, Blickle JF Girard J, et al. Type 2 diabetes mellitus: epidemiology, pathophysiology, unmet needs and therapeutical perspectives. Diabetes Metab. 2007;33:231-244.

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22. Simonson GD, Kendall DM. Diagnosis of insulin resistance and associated syndromes: the spectrum from the metabolic syndrome to type 2 diabetes mellitus. Coron Artery Dis. 2005;16:465-472.

23. Utzschneider KM, Carr DB, Hull RL, et al. Impact of intra-abdominal fat and age on insulin sensitivity and β-cell function. Diabetes. 2004;53:2867-2872.

24. Elbein SC. The genetics of human noninsulin-dependent (type 2) diabetes mellitus. J Nutr. 1997;127:1891S-1896S.

25. van Dam RM, Rimm EB, Willett WC, et al. Dietary patterns and risk for type 2 diabetes mellitus in U.S. men. Ann Intern Med. 2002;136:201-209.

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28. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977-986.

29. UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837-853.

30. UK Prospective Diabetes Study Group. Effect of intensive bloodglucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) [published correction appears in Lancet. 1998;352:1557]. Lancet. 1998;352:854-865.

31. Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995;28:103-117.

32. American Diabetes Association. Standards of medical care in diabetes-2010. Diabetes Care. 2010;33(suppl 1):S11-S61.

33. American Diabetes Association. Standards of medical care in diabetes-2009. Diabetes Care. 2009;32(suppl 1):S13-S61.

34. International Expert Committee. International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care. 2009;32(7):1344-1345.

35. Ford ES, Li C, Little RR, Mokdad AH. Trends in A1C concentrations among U.S. adults with diagnosed diabetes from 1999 to 2004. Diabetes Care. 2008;31:102-104.

36. Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003;348(5):383-393.

37. Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med. 2008;358(6):580-591.

38. Spann SJ, Nutting PA, Galliher JM, et al. Management of type 2 diabetes in the primary care setting: a practice-based research network study. Ann Fam Med. 2006;4(1):23-31.

Section 2

1. American Diabetes Association. Standards of medical care in diabetes-2009. Diabetes Care. 2009;32(suppl 1):S13-S61.

2. American Diabetes Association. Standards of medical care in diabetes-2010. Diabetes Care. 2010;33(suppl 1):S11-S61.

3. Rodbard HW, Blonde L, Braithwaite SS, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007;13(suppl 1):1-68.

4. IDF Clinical Guidelines Task Force. Global guideline for type 2 diabetes. Brussels: International Diabetes Federation; 2005. http://www.idf.org/webdata/docs/IDF%20GGT2D.pdf. Accessed December 16, 2009.

5. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009;32:193-203.

6. Look AHEAD Research Group; Pi-Sunyer X, Blackburn G, Brancati FL, et al. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the Look AHEAD trial. Diabetes Care. 2007;30:1374-1383.

7. Wing R. Reduction in weight and cardiovascular disease (CVD) risk factors in subjects with type 2 diabetes (T2DM): four-year results of Look AHEAD. Obesity 2009; October 25, 2009;Washington, DC. Abstract 06-OR.

8. Funnell MM, Brown TL, Childs BP, et al. National standards for diabetes self-management education. Diabetes Care. 2009;32(suppl 1):S87-S94.

9. National Diabetes Education Program. Fact Sheet. Changing the way diabetes is treated. http://www.ndep.nih.gov/media/NDEP_FactSheet.pdf. Accessed February 23, 2010.

10. Welchol (colesevelam hydrochloride) [prescribing information]. Daiichi Sankyo, Inc; January 2008.

11. Cycloset (bromocriptine mesylate) [prescribing information]. VeroScience LLC; April 2009.

12. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). Diabetes Care. 2003;26:881-885.

13. Kahn SE, Haffner SM, Keise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy [published correction appears in N Engl J Med. 2007;356:1387-1388]. N Engl J Med. 2006;355:2427-2443.

14. Alvarez Guisasola F, Tofe Povedano S, Krishnarajah G, et al. Hypoglycaemic symptoms, treatment satisfaction, adherence and their associations with glycaemic goal in patients with type 2 diabetes mellitus: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) Study. Diabetes Obes Metab. 2008;10(suppl 1):25-32.

15. Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The Treat-to-Target Trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetes. Diabetes Care. 2003;26:3080-3086.

16. Horvath K, Jeitler K, Berghold A, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2007;(2):CD005613.

17. Nesto RW, Bell D, Bonow RO, et al. Thiazolidinedione use, fluid retention, and congestive heart failure. A consensus statement from the American Heart Association and American Diabetes Association. Circulation. 2003;108:2941-2948.

18. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group [published correction appears in Lancet. 1998;352:1558]. Lancet. 1998;352:854-865.

19. Drucker DJ. The biology of incretin hormones. Cell Metab. 2006;3:153-165.

20. De Leon DD, Crutchlow MF, Ham JY, Stoffers DA. Role of glucagon-like peptide-1 in the pathogenesis and treatment of diabetes mellitus. Int J Biochem Cell Biol. 2006;38:845-859.

21. Nauck MA. Unraveling the science of incretin biology. Am J Med. 2009;122(6 suppl):S3-S10.

22. Drucker DJ. Enhancing incretin action for the treatment of type 2 diabetes. Diabetes Care. 2003;26:2929-2940.

23. Holloway AC, Petrik JJ, Bruin JE, Gerstein HC. Rosiglitazone prevents diabetes by increasing beta-cell mass in an animal model of type 2 diabetes characterized by reduced beta-cell mass at birth. Diabetes Obes Metab. 2008;10(9):763-771.

24. Degn KB, Juhl CB, Sturis J, et al. One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Diabetes. 2004;53:1187-1194.

25. Nauck MA, Kleine N, Orskov C, et al. Normalization of fasting hyperglycaemia by exogenous glucagon-like peptide 1 (7-36 amide) in type 2 (non insulin-dependent) diabetic patients. Diabetologia. 1993;36:741-744.

26. Ahren B, Landin-Olsson M, Jansson PA, et al. Inhibition of dipeptidyl peptidase-4 reduces glycemia, sustains insulin levels, and reduces glucagon levels in type 2 diabetes. J Clin Endocrinol Metab. 2004;89:2078-2084.

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30. Hermansen K, Kipnes M, Luo E, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007;9:733-745.

31. Aschner P, Kipnes MS, Lunceford JK, et al. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006;29:2632-2637.

32. Charbonnel B, Karasik A, Liu J, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006;29:2638-2643.

33. Goldstein BJ, Feinglos MN, Lunceford JK, et al. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes [published correction appears in Diabetes Care. 2008;31:1713]. Diabetes Care. 2007;30:1979-1987.

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37. Dore DD, Seeger JD, Arnold Chan K. Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. Curr Med Res Opin. 2009;25:1019-1027.

38. Williams-Herman D, Round E, Swern AS, et al. Safety and tolerability of sitagliptin in patients with type 2 diabetes: a pooled analysis. BMC Endocr Disord. 2008;8:14.

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41. DeFronzo RA, Ratner RE, Han J, et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005;28:1092-1100.

42. Buse JB, Henry RR, Han J, et al. Effects of exenatide (exendin-4) on glycemic control over 20 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004;27:2628-2635.

43. Kendall DM, Riddle MC, Rosenstock J, et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005;28:1083-1091.

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47. Noel RA, Braun DK, Patterson RE, Bloomgren GL. Increased risk of acute pancreatitis and biliary disease observed in patients with type 2 diabetes: a retrospective cohort study. Diabetes Care. 2009;32:834-838.

48. Victoza (liraglutide) [prescribing information]. Bagsvaerd, Denmark: Novo Nordisk; January 2010. http://www.victoza.com/pdf/PI_(1_Column_Format).pdf. Accessed February 24, 2010.

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51. Marre M, Shaw J, Brandle M, et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with type 2 diabetes (LEAD-1 SU). Diabet Med. 2009;26:268-278.

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60. Jellinger PS, Davidson JA, Blonde L, et al. Road maps to achieve glycemic control in type 2 diabetes mellitus: ACE/AACE Diabetes Road Map Task Force. Endocr Pract. 2007;13:260-268.

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Section 3

1. American Diabetes Association. Standards of medical care in diabetes-2009. Diabetes Care. 2009;32(suppl 1):S13-S61.

2. Ford ES, Li C, Little RR, Mokdad AH. Trends in A1C concentrations among U.S. adults with diagnosed diabetes from 1999 to 2004. Diabetes Care. 2008;31:102-104.

3. Spann SJ, Nutting PA, Galliher JM, et al. Management of type 2 diabetes in the primary care setting: a practice-based research network study. Ann Fam Med. 2006;4:23-31.

4. Massi-Benedetti M, Orsini-Federici M. Treatment of type 2 diabetes with combined therapy: what are the pros and cons? Diabetes Care. 2008;31(suppl 2):S131-S135.

6. Rodbard HW, Blonde L, Braithwaite SS, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007;13(suppl 1):1-68.

7. Jellinger PS, Davidson JA, Blonde L, et al. Road maps to achieve glycemic control in type 2 diabetes mellitus: ACE/AACE Diabetes Road Map Task Force. Endocr Pract. 2007;13:260-268.

8. Grant RW, Wexler DJ, Watson AJ, et al. How doctors choose medications to treat type 2 diabetes: a national survey of specialists and academic generalists. Diabetes Care. 2007;30:1448-1453.

9. Peyrot M, Rubin RR, Lauritzen T, et al. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care. 2005;28:2673-2679.

10. Centers for Disease Control and Prevention. Team care: comprehensive lifetime management for diabetes. Atlanta, GA: US Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, 2001. National Diabetes Education Program: http://www.ndep.nih.gov/media/TeamCare.pdf. Accessed November 2, 2009.

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12. Kuritzky L. Overcoming barriers to insulin replacement. J Fam Pract. 2009;58(8 suppl):S25-S31.

13. Austin MM. Diabetes educators: partners in diabetes care and management. Endocr Pract. 2006;12(suppl 1):138-141.

14. American Association of Diabetes Educators. Diabetes education fact sheet. http://www.diabeteseducator.org/export/sites/aade/_resources/pdf/Diabetes_Education_Fact_Sheet_2009.pdf. Accessed November 2, 2009.

15. American Diabetes Association. Third-party reimbursement for diabetes care, self-management education, and supplies. Diabetes Care. 2009;32(suppl 1):S85-S86.

16. American Association of Diabetes Educators. Role of the diabetes educator. http://www.diabeteseducator.org/export/sites/aade/_resources/pdf/Definition_Diabetes_Educator.pdf. Accessed November 2, 2009.

17. Daly A, Kulkarni K, Boucher J. The new credential: advanced diabetes management. J Am Diet Assoc. 2001;101:940-943.

18. Robbins JM, Thatcher GE, Webb DA, Valdmanis VG. Nutritionist visits, diabetes classes, and hospitalization rates and charges: the Urban Diabetes Study. Diabetes Care. 2008;31:655-660.

19. Boren SA, Fitzner KA, Panhalkar PS, Specker JE. Costs and benefits associated with diabetes education: a review of the literature. Diabetes Educ. 2009;35:72-96.

20. Lieder TR. Rhode Island insurers pick up tab for diabetes self-management education. Am J Health Syst Pharm. 2001;58:751-752, 754, 756.

21. American Pharmacists Association. Medication therapy management: MTM Central. http://www.pharmacist.com/AM/Template.cfm?ContentID=11481&Section=Pharmacist_Practitioners&TPLID=96&Template=TaggedPage/TaggedPageDisplay.cfm. Accessed October 2, 2009.

22. Shapiro KB. New opportunities in medication therapy management. Medscape Pharmacists; May 16, 2007. http://cme.medscape.com/viewarticle/556492. Accessed October 1, 2009.

23. Karkashian C, Schlundt D. Diabetes. In: Sabate E, ed. Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization; 2003:71-85. http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf. Accessed September 30, 2009.

24. Cramer JA. A systematic review of adherence with medications for diabetes. Diabetes Care. 2004;27:1218-1224.

25. Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence on hospitalization risk and healthcare cost. Med Care. 2005;43:521-530.

26. Odegard PS, Capoccia K. Medication taking and diabetes: a systematic review of the literature. Diabetes Educ. 2007;33:1014-1029.

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