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This bibliography contains defining clinical trials, behavioral and self-management support literature, as well as publications describing the Chronic Care Model. Links to the National Library of Medicine (NLM) site for the articles are provided when possible. The NLM site gives access to the article abstract when available, as well as other information. For information regarding the research methodology used to produce this bibliography, go to the Bibliography Overview.
Articles referencing clinicial guidelines may not reflect current standards.  For up-to-date clinical guidelines, please consult the National Guideline Clearinghouse (NGC), a public resource for evidence-based clinical practice guidelines. NGC is an initiative of the Agency for Healthcare Research and Quality.
Clinical Care
Sever PS, Dahlof B, Poulter NR, Wedel H, Beevers G, Caulfield M, Collins R, Kjeldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O'Brien E, Ostergren J. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomized controlled trial. Lancet. 2003 Apr 5;361(9364):1149-58. [Link]

These two clinical trials found substantial reductions in cardiovascular events with the use of a statin in patients with diabetes and that these benefits were independent of their baseline LDL-Cholesterol level. These findings suggest that most patients with diabetes will benefit from being put on a statin even when their LDL-C is naturally low.

Vijan S, Hayward RA. Treatment of hypertension in type 2 diabetes mellitus: blood pressure goals, choice of agents, and setting priorities in diabetes care. Ann Intern Med. 2003 Apr 1;138(7):593-602. [Link]

Review of the clinical trial literature that demonstrates that tight control of hypertension is of primary importance in preventing both microvascular and macrovascular complications of diabetes.

Harris R, Donahue K, Rathore SS, Frame P, Woolf SH, Lohr KN. Screening adults for type 2 diabetes: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Feb 4;138(3):215-29. [Link]

This paper discusses the rationale for why a screening program to identify undiagnosed type 2 diabetes should, or should not, be done.

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. 348(5. 5):383-93, 383-93. [Link]

A target-driven, long-term, intensified intervention aimed at multiple risk factors in Danish patients with type 2 diabetes and microalbuminuria reduced the risk of cardiovascular and microvascular events by about 50 percent.

U.S. Preventive Services Task Force. Screening for type 2 diabetes mellitus in adults: recommendations and rationale. Ann Intern Med 2003; 138. 138(3. 3):212-4, 212-4. [Link]

This paper discusses the rationale for why a screening program to identify undiagnosed type 2 diabetes should, or should not, be done.

Castaneda C, Layne JE, Munoz-Orians L et al. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care 2002; 25. 25(12. 12):2335-41, 2335-41. [Link]

This paper points out the value of increased exercise in improving blood glucose control in type 2 diabetes

The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care 2002; 25. 25(12. 12):2165-71, 2165-71. [Link]

This paper describes the behavior change in lifestyle in detail. Whether this degree of change is achievable outside of a research setting, and whether lesser degrees of change would be beneficial, remain to be shown.

Knowler WC, Barrett-Connor E, Fowler SE et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002; 346( 6):393-403. [Link]

This paper points out the effectiveness of intensive behavior change in lifestyle in delaying (or preventing) the onset of type 2 diabetes. It also has relevance to the management of patients with established type 2 diabetes.

MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomized placebo-controlled trial. Lancet. 2002 Jul 6;360(9326):7-22. [Link]

Tuomilehto J, Lindstrom J, Eriksson JG et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001; 344. 344(18. 18):1343-50, 1343-50. [Link]

This Finnish Study gives data similar to the DPP showing that lifestyle change prevents or delays type 2 diabetes.
Huang ES, Meigs JB, Singer DE. The effect of interventions to prevent cardiovascular disease in patients with type 2 diabetes mellitus. Am J Med 2001; 111. 111(8. 8):633-42, 633-42. [Link]

This points out the importance of cardiac risk reduction strategies.

Lustman PJ, Anderson RJ, Freedland KE, de Groot M, Carney RM, Clouse RE. Depression and poor glycemic control: a meta-analytic review of the literature. Diabetes Care. 2000 Jul;23(7):934-42. [Link]

Literature review suggests clear association between depression and worse glycemic control.

Heart Outcomes Prevention Evaluation Study Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Lancet. 2000 Jan 22;355(9200):253-9. [Link]

Treatment with the ACE-inhibitor, ramipril, decreased cardiovascular complications and progression of nephropathy and this benefit appeared to be greater than what would be predicted based upon improved blood pressure control alone.

United Kingdom Prospective Diabetes Study Group. Cost effectiveness analysis of improved blood pressure control in hypertensive patients with type 2 diabetes: UKPDS 40. BMJ. 1998;317:720-26. [Link]

The UKPDS is a landmark study demonstrating the effectiveness of improved glycemic control on decreasing complications of Type II diabetes. Additional studies in the same population demonstrated even greater benefits for maximizing blood pressure control.
United Kingdom Prospective Diabetes Study Group. UKPDS 28: A Randomized Trial of Efficacy of Early Addition of Metformin in Sulfonylurea-Treated Type 2 Diabetes. Diabetes Care. 1998;21(1):87-92. [Link]

Paradoxical findings that metformin treatment was associated with improved outcomes (compared to those treated with sulfonylurea alone), but that combination metformin/sulfonylurea treatment was associated with worse outcomes.
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;329:977-86. [Link]

This is the definitive trial of tight glucose control in patients with Type I diabetes, demonstrating decreased complications with improved glucose control.

Litzelman DK, Slemenda CW, Langefeld CD, et al. Reduction of lower extremity clinical abnormalities in patients with non-insulin-dependent diabetes mellitus. A randomized, controlled trial. Ann Intern Med. 1993 July 1;119(1):36-41. [Link]

An intervention designed to reduce risk factors for lower-extremity amputations positively affected patient self-foot-care behavior, as well as the foot care given by health care providers, and reduced the prevalence of lower-extremity clinical disease in patients with diabetes.
Primary Care Interventions
Younis N, Broadbent DM, Vora JP, Harding SP. Incidence of sight-threatening retinopathy in patients with type 2 diabetes in the Liverpool Diabetic Eye Study: a cohort study. Lancet 2003; 361. 361(9353. 9353):195-200, 195-200. [Link]

Norris SL, Nichols PJ, Caspersen CJ et al. The effectiveness of disease and case management for people with diabetes. A systematic review. Am J Prev Med 2002; 22. 22(4 Suppl 1. 4 Suppl 1):15-38, 15-38. [Link]

Concludes that there is good evidence supporting the effectiveness of case management in managed care settings, but that the amount of benefit reported has varied substantially between studies and that further evaluations are needed in other patient populations.
Renders CM, Valk GD, Franse LV, Schellevis FG, van Eijk JT, van der Wal G. Long-term effectiveness of a quality improvement program for patients with type 2 diabetes in general practice. Diabetes Care. 2001 Aug;24(8):1365-70. [Link]

A review of multifaceted professional interventions and organizational interventions found that structural and systems changes and regular review of patients was effective in improving the process of care. The addition of patient education to these interventions and the enhancement of the role of nurses in diabetes care led to improvements in patient outcomes and the process of care.

Wagner EH, Grothaus LC, Sandhu N, Galvin MS, McGregor M, Artz K, Coleman EA. Chronic care clinics for diabetes in primary care: a system-wide randomized trial. Diabetes Care. 2001 Apr;24(4):695-700. [Link]

Periodic primary care sessions organized to meet the complex needs of diabetic patients improved the process of diabetes care and was associated with better health outcomes.

Piette JD, Weinberger M, Kraemer FB, McPhee SJ. Impact of automated calls with nurse follow-up on diabetes treatment outcomes in a Department of Veterans Affairs Health Care System: a randomized controlled trial. Diabetes Care. 2001 Feb;24(2):202-8. [Link]

Intervention uses automated calls technology to improve the efficiency of phone follow-up.

Olivarius N, Beck-Nielsen H., Andreasen A, Horder M., and Pedersen P. Randomized controlled trial of structured personal care of type 2 diabetes mellitus. BMJ. 2001, 323(7319): 970-5. [Link]

Individualized goals with educational and surveillance support may for at least six years bring risk factors of patients with type 2 diabetes to a level that has been shown to reduce diabetic complications but without weight gain.

Stratton IM, Kohner EM, Aldington JS, Turner RC, Holman RR, Manley SE, Matthews DR, for the UKPDS Group. UKPDS 50: Risk factors for incidence and progression of retinopathy in Type II diabetes over 6 years from diagnosis. Diabetologia 2001; 44: 156-163. [Link]

Vijan S, Hofer TP, Hayward RA. Cost-utility analysis of screening intervals for diabetic retinopathy in patients with type 2 diabetes mellitus. JAMA 2000 Feb 16;283(7):889-96. [Link]

These three studies all suggest that patients whose last retinal exam was normal are at very low risk of needing laser therapy within the following 3 years, suggesting that every 2-3 year eye screening for those with previous normal retinal examinations may be more than adequate.

McCulloch DK, Price MJ, Hindmarsh M, Wagner EH. Improvement in Diabetes Care Using an Integrated Population-based approach in a Primary Care Setting. Disease Management 2000; 3(2):75-82. [Link N/A]

Scott J, Gade G, McKenzie M, Venohr I. Cooperative health care clinics: A group approach to individual care. Geriatrics. 1998;53(May):68-81. [Link]

Provides a how-to description of the cooperative health care clinic, a group visit model used in primary care. Initial efforts were with geriatric patients. This model has been successfully used with patients with diabetes.

Aubert R, Herman W, Waters J, et al. A randomized controlled trial of nurse case management within an HMO to improve glycemic control in patients with diabetes. Ann Int Med. 1998 Oct 15;129(8):605-12. [Link]

This trial found using care managers within a primary care setting significantly improved glycemic control, although high rate of subjects lost to follow-up in the care management group raises the possibility that the study may over-estimate the amount of benefit.
Friedman NM, Gleeson JM, Kent MJ, Foris MF, Rodriguez DJ. Management of diabetes mellitus in the Lovelace Health Systems; EPISODES OF CARE program. Effective Clinical Practice. 1998;1:5-11. [Link]

This article describes the comprehensive diabetes program used in a managed care setting that resulted in improved diabetes care.

Wagner EH. Chronic disease management: What will it take to improve care for chronic illness? Effective Clinical Practice. 1998;1:2-4. [Link]

This editorial introduces an entire issue devoted to chronic illness care and is the first article publishing the model for improvement of chronic illness.

Beck A, Scott J, Williams P, et al. A randomized trial of group outpatient visits for chronically ill older HMO members: The cooperative health care clinic. JAGS. 1997;45:543-49. [Link]

Evidence that group visits can provide clinical care and result in beneficial outcomes for patients and providers. 
Von Korff M, Gruman J, Schaefer J, Curry SJ, Wagner EH. Collaborative management of chronic illness. Ann Inter Med. 1997;127:1097-102. [Link]

This review article with an extensive bibliography describes the elements of collaborative care.

Gohdes D, Rith-Najarian S, Acot K, Shields R. Improving diabetes care in the primary health setting: The Indian Health Service experience. Ann Intern Med. 1996 Jan 1;124(1 Pt 2):149-52. [Link]

The Indian Health Service provides a model of using standards and feedback to improve care of patients with diabetes.

Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Mil Quarterly. 1996;74(4):511-44. [Link]

Comprehensive discussion of the model for improving chronic illness care. Behavioral Medicine Symposium. HMO Practice. 1995;9. [Link N/A]

This issue is devoted to assisting primary care clinicians in caring for patients with behavioral problems. It includes brief descriptions of programs that work and how providers integrate behavioral techniques into their practice.
Wagner EH. Population-based management of diabetes care. Patient Educ Couns. 1995;26:225-30. [Link]

This article provides an overview of the steps involved in population-based care.

Weinberger M, Kirkman MS, Samsa GP, et al. A nurse-coordinated intervention for primary care patients with non-insulin-dependent diabetes mellitus: impact on glycemic control and health-related quality of life. J Gen Int Med. 1995;10:59-66. [Link]

This study demonstrates a pragmatic, low-intensity adjunct to care delivered by physicians that improved glycemic control.
Wasson J, Gaudette C, Whaley F, Sauvigne A, Baribeau P, Welch HG. Telephone care as a substitute for routine clinic follow-up. JAMA. 1992;267:1788-93. [Link]

The first randomized clinical trial demonstrating cost savings and satisfactory care from substituting regularly scheduled, proactive phone calls for some clinic visits.
Sadur CN, Moline N, Costa M, Michalik D, Mendlowitz D, Roller S, Watson R, Swain BE, Selby JV, Javorski WC. Diabetes management in a health maintenance organization. Efficacy of care management using cluster visits. Department of Medicine, Kaiser Permanente Medical Care Program, Northern California, Pleasanton 94588, USA. [Link N/A]

Diabetes Care Intervention uses a clustered visit approach to care.
Self-management Support
Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001 Mar;24(3):561-87. [Link]

Canga N, De Irala J, Vara E, Duaso MJ, Ferrer A, Martinez-Gonzalez MA. Intervention study for smoking cessation in diabetic patients: a randomized controlled trial in both clinical and primary care settings. Diabetes Care. 2000 Oct;23(10):1455-60. [Link]

Lorig KR, Sobel DS, Stewart AL, et al. Evidence suggesting that a chronic disease self-management program can improve health status while reducing utilization and costs: A randomized trial. Med Care. 1999 Jan;37(1):5-14. [Link]

Research basis for the Chronic Disease Self-Management Program developed by the Stanford Patient Education Research Center.

Glasgow RE, Eakin EG. Issues in Diabetes Self-Management. In: Shumaker S, Schron E, Ockene J, McBee WL, eds. The Handbook of Health Behavior Change. New York, NY: Springer Publishing Company; 1997: 53-62.  [Link N/A]

This chapter reviews barriers and determinants to self-management behaviors for persons with diabetes from the personal to the environmental levels, reviews key studies in self-management regimen areas (dietary, smoking, foot care, exercise) and the implications of the DCCT.

Glasgow RE, La Chance PA, Toobert DJ, Brown J, Hampson SE, Riddle MA. Long term effects and costs of brief behavioral dietary intervention for patients with diabetes delivered from the medical office. Patient Educ Couns. 1997;32:175-84. [Link]

This study evaluates the effectiveness of a single session intervention involving touchscreen computer-assisted assessment the provided feedback on key barriers to dietary self-management.

Brown JE, Glasgow RE, Toobert DJ. Integrating dietary self-management counseling into the regular office visit. Practical Diabetol. 1996 Dec;16-22. [Link N/A]

Examines the successes, difficulties, and implications of integrating patient self-management support, particularly dietary self-care regimens, into primary-care office visits.
Anderson RM, Funnell MM, Arnold MS. Using the empowerment approach to help patients change behavior. In: Anderson B, and Rubin R, eds. Practical Psychology for Diabetes Clinicians. Alexandria, VA: American Diabetes Association; 1996. [Link N/A]

Based on sound principles of counseling and educational psychology, this chapter examines the roles of provider and patient based on the significant differences between the treatment of acute diseases and diabetes.
Glasgow RE, Eakin EG. Dealing with complexity: the case of diabetes self-management. In: Anderson B and Rubin R, eds. Practical Psychology for Diabetes Clinicians. Alexandria, VA: American Diabetes Association; 1996. [Link N/A]

Provides a framework and practical suggestions for facilitating diabetes self-management.
Anderson RM, Funnell MM, Butler PM, Arnold MS, Fitzgerald JT, Feste CC. Patient empowerment. Results of a randomized controlled trial. Diabetes Care. 1995;18:943-49. [Link]

This wait-listed trial of empowerment techniques for patients with diabetes demonstrated improved self-efficacy and blood glucose control favoring the intervention.

Community Based Interventions
Goldhaber-Fiebert JD, Goldhaber-Fiebert SN, Tristan ML, Nathan DM. Randomized controlled community-based nutrition and exercise intervention improves glycemia and cardiovascular risk factors in type 2 diabetic patients in rural costa rica.
Diabetes Care 2003; 26. 26(1. 1):24-9, 24-9. [Link]

Although only a short-term study with a small number of patients, this paper does show what can be achieved in a community setting.

Norris SL, Nichols PJ, Caspersen CJ et al. Increasing diabetes self-management education in community settings. A systematic review. Am J Prev Med 2002; 22. 22(4 Suppl. 4 Suppl):39-66, 39-66. [Link]

Leatherman S, Berwick D, Iles D et al. The business case for quality: case studies and an analysis. Health Aff 2003; 22. 22(2. 2):17-30, 17-30. [Link]

Wagner EH, Sandhu N, Newton KM, McCulloch DK, Ramsey SD, Grothaus LC. Effect of improved glycemic control on health care costs and utilization. JAMA. 2001 Jan 10;285(2):182-9. [Link]

Bibliography Editors
Rodney A. Hayward, M.D.
Dr. Hayward received his training in epidemiological methods and biostatistics as a Robert Wood Johnson Clinical Scholar at UCLA and at the RAND Corporation, Santa Monica. He joined the faculty at the University of Michigan in 1988, where he is currently a Professor of Internal Medicine at the Medical School and a Professor of Public Health in the Department of Health Management and Policy. He joined the VA as the Director of the VA Ann Arbor Healthcare System's Center for Practice Management & Outcomes Research in 1996. He is a general internist with expertise in quality monitoring and improvement and in chronic disease management, especially for type 2 diabetes.

David K. McCulloch, M.D., F.R.C.P.

Dr. McCulloch obtained his medical education at Edinburgh University, Scotland with additional postgraduate training at the University of Nottingham, England, and University of Washington, Seattle. He has worked in the field of clinical diabetes innovation for over twenty years and has over 70 publications on a wide variety of diabetes-related topics. He is a Clinical Professor of Medicine at the University of Washington and works as a diabetologist and Medical Director of Clinical Improvement at Group Health.