Improving clinical practice – a world of experience The Global Partnership for Effective Diabetes Management, including the development of this slide set, is supported by GlaxoSmithKline

Need for an early and intensive approach to type 2 diabetes management At diagnosis of type 2 diabetes: 50% of patients already have complications1 up to 50% of -cell function has already been lost2 Current management: two-thirds of patients do not achieve target HbA1c3,4 majority require polypharmacy to meet glycaemic goals over time5 1UKPDS Group. Diabetologia 1991; 34:877–890. 2Holman RR. Diabetes Res Clin Prac 1998; 40 (Suppl.):S21–S25. 3Saydah SH et al. JAMA 2004; 291:335–342. 4Liebl A et al. Diabetologia 2002; 45:S23–S28. 5Turner RC et al. JAMA 1999; 281:2005–2012.

Management of diabetes is evolving 7.0 6.5 6.0 Tighter HbA1c goals New global guidelines EVOLVING PRACTICE Comprehensive Standard Minimal Tailoring to health systems Treating to target vs. stepwise Individualised HbA1c goals

OAD monotherapy uptitration OAD + multiple daily insulin injections Stepwise approach: delays control and leaves patients at risk of complications OAD monotherapy uptitration OAD + multiple daily insulin injections Diet and exercise OAD monotherapy OAD combination OAD + basal insulin 10 Complications2 9 Mean HbA1c (%)1 8 7 6 Duration of diabetes OAD = oral anti-diabetic 1Adapted from Del Prato S et al. Int J Clin Pract 2005; 59:1345–1355. 2Stratton IM et al. BMJ 2000; 321:405–412.

OAD + multiple daily insulin injections Early, intensive intervention: reach glycaemic goals and reduce the risk of complications Diet and exercise 10 OAD monotherapy 9 OAD + multiple daily insulin injections OAD combination OAD uptitration OAD + basal insulin HbA1c (%)1 8 Complications2 Mean 7 6 Duration of diabetes OAD = oral anti-diabetic 1Adapted from Del Prato S et al. Int J Clin Pract 2005; 59:1345–1355. 2Stratton IM et al. BMJ 2000; 321:405–412.

The Global Partnership recommendations: Aim for good glycaemic control = HbA1c < 6.5%* < 6.5% Monitor HbA1c every 3 months in addition to regular glucose self-monitoring Treat patients intensively to achieve target HbA1c < 6.5%* within 6 months of diagnosis After 3 months, if patients are not at target HbA1c < 6.5%,* consider combination therapy *Or fasting/preprandial plasma glucose < 110 mg/dl (6.0 mmol/l) where assessment of HbA1c is not possible Del Prato S et al. Int J Clin Pract 2005; 59:1345–1355.

Paradigm for early combination treatment If HbA1c  9% at diagnosis Initiate combination therapy† or insulin in parallel with diet/exercise Treat to goal of HbA1c < 6.5%* by 6 months If HbA1c < 9% at diagnosis Initiate monotherapy in parallel with diet/exercise If HbA1c > 6.5%* at 3 months Initiate combination therapy† in parallel with diet/exercise 1 2 3 4 5 6 Months from diagnosis *Or fasting/preprandial plasma glucose < 110 mg/dl (6.0 mmol/l) where assessment of HbA1c is not possible †Combination therapy should include agents with complementary mechanisms of action Del Prato S et al. Int J Clin Pract 2005; 59:1345–1355.

Encouraging early treatment to glycaemic goal Happy 7 campaign, Korea Case Study

Encouraging early, intensive intervention: Happy 7, Korea Initiated in response to poor understanding of HbA1c and importance of quickly achieving glycaemic goals Objectives: Change doctors’ beliefs and behaviours towards HbA1c measurement Increase awareness of HbA1c among patients Most Korean patients with T2DM do not have good glycaemic control HbA1c > 8% HbA1c < 7% 32% 36% 32% HbA1c 7–8% Case Study

Happy 7: The campaign ~20,000 patients with type 2 diabetes in 300 clinics 2-day programme in each clinic, including: Patient and nurse education HbA1c measurement using portable testing equipment BMI, waist size and plasma glucose Detailed report generated for each clinic Case Study

Happy 7: the results A positive response… but more work to do Committed to more frequent HbA1c testing… …in the majority (~80%) of their patients… … but, HbA1c is only a supplementary test 10 20 30 40 50 60 70 80 90 100 % of doctors On follow-up, some clinics had not maintained changes and had reverted to old habits  Consistent, co-ordinated and complementary programme of activities needed to produce effective and enduring changes Case Study

Role of guidelines in encouraging early, intensive intervention Summarise scientific consensus Provide best advice available Objectives Define patients at risk, set goals for prevention/therapy Simplify management, improve quality of care Adapted from: Wood D et al. Eur Heart J 1998; 19:1434 1503. NCEP Expert Panel. JAMA 2001; 285:24862497. Erhardt L et al. Vascular Disease Prevention 2004; 1:167174.

Guidelines and the drive for tighter glycaemic control 7.5% ALAD 2000 CDA* ADA 2003 ADA 2004† ADA/ EASD‡ 7.0% IDF Global IDF Western Pacific HbA1c AACE Roadmap ALAD 2007§ 6.5% Global Partnership CDA* ADA 2004† 6.0% 1999 2000 2001 2003 2004 2005 2006 2007 *CDA: goal  7%, or < 6% in individuals “in whom it can be achieved safely”. †ADA: from 2004 onwards, goal for ‘patients in general’ is < 7%, while goal for ‘individual patients’ is ‘as close to normal (< 6%) as possible without significant hypoglycaemia. ‡ADA/EASD Consensus Statement: “Target HbA1c as close to the non-diabetic range as possible, minimum < 7%”. §ALAD 2007: unpublished.

For guidelines to work, they need to be implemented Guidelines are designed to improve the care of patients It takes a lot of time and effort to develop good management guidelines Despite this, guidelines are often not followed in routine clinical practice The barriers to guideline implementation must be understood and addressed if patient care is to improve

Common barriers to implementing guidelines Healthcare Systems Doctors Patients Organisational constraints Lack of awareness, familiarity and agreement Lack of awareness and understanding Lack of reimbursement Low motivation and/or outcome expectancy Limited access to care Inadequate staffing resource and specialist support Inability to reconcile guidelines with patient preferences Poor compliance; reluctance to take life-long medication Increased legal liability Insufficient time and/or resource Lack of adherence to lifestyle modifications Adapted from Erhardt L et al. Vascular Disease Prevention 2004; 1:167174 Cabana MD et al. JAMA 1999; 282:14581465.

Barriers to physician uptake Knowledge Attitudes Behaviour Improved outcomes “It’s all good in theory, but practice is different” “My patients are happy with their care as it is” “My patients are better controlled now” “I didn’t know there were guidelines” “I haven’t read the guidelines” “I know what’s best for my patients” “It takes time – time I haven’t got” “I’m more confident I’m doing the best for my patients” Adapted from Cabana MD et al. JAMA 1999; 282:14581465.

Improving implementation of treatment guidelines Canadian Diabetes Association guidelines, The GIANT Study & Project Ideal Case Study

Development and communication of guidelines: Canadian Diabetes Association 2003 Advocated early and intensive management Multi-disciplinary team approach Plans for dissemination integral to development Practical tool: cross-referencing, clinical tools, links Fed into government initiatives Partners in Progress: work with industry to disseminate CDA-verified materials Available online, with downloadable slides Case Study Canadian Diabetes Association. Can J Diabetes 2003; 27 (Suppl 2):S1152. Canadian Diabetes Association E-guidelines. http://www.diabetes.ca/cpg2003/

Does following guidelines impact patient care? The GIANT study General practitioner Implementation in Asia of Normoglycaemic Targets 100 family doctors Randomisation Education on guidelines* No education on guidelines Four subjects with T2DM for each doctor Primary outcome: HbA1c change at 6 months Secondary outcomes: FPG, blood pressure, adverse events, healthcare use, treatment escalation Study due to complete by end 2008 *Based on International Diabetes Federation  Western Pacific Region guidelines and involving: initial educational symposium and follow-up continuing medical education symposium at 3 months; reminders about guidelines sent to doctors every 3 months; desktop reminder cards; patient diary cards to prompt discussion/record information Case Study General Practitioner Implementation in Asia of Normoglycaemic Targets. http://www.clinicaltrial.gov/ct/show/NCT00499824?order=4

Improving Diabetes Education, Access to care, and Living Project IDEAL Improving Diabetes Education, Access to care, and Living Community-based initiative among low-income residents of North Carolina, USA Assessed the impact of 14 programmes designed to improve adherence to guidelines and quality of care Programmes included: New education/care programmes at existing healthcare facilities Mobile screening, education and healthcare units Advice in community pharmacies/physicians’ offices Diabetes educator/nurse practitioner visits to residential facilities Case Study Bell RA et al. NC Med J 2005; 66:96102.

Project IDEAL: Overcoming barriers to guideline implementation Baseline (1998) Patients (%) Follow-up (2001) 10 20 30 40 50 60 70 80 90 100 HbA1c tested < 8.0% HbA1c control: < 7.0% Blood pressure tested Blood pressure control* Lipids tested LDL-c control† Nephropathy assessed Dilated eye exam Complete foot exam *Blood pressure < 140 mmHg systolic and < 90 mmHg diastolic; †LDL-c < 100 mg/dL Case Study Bell RA et al. NC Med J 2005; 66:96102.

The benefits of the multidisciplinary approach

Key function of the multidisciplinary team To provide: Continuous, accessible and consistent care focused on the needs of individuals with type 2 diabetes

Additional functions of a multidisciplinary team Provide input at diagnosis of condition and continually thereafter to: agree standards of care discuss rational therapeutic suggestions monitor guideline adherence and short-term outcomes avoid early complications or provide timely intervention to decrease diabetes-related complications Enable long-term patient self-management Codispoti C et al. J Okla State Med Assoc 2004; 97:201–204.

The multidisciplinary team: core members Physician Diabetes specialist nurse Patient Dietician Podiatrist National Diabetes Education Program. Team care: comprehensive lifetime management for diabetes. www.ndep.nih.gov/resources/health.htm.

The multidisciplinary team: additional members Other specialists Physician Diabetes specialist nurse Patient Diabetologist/ endocrinologist Dietician Podiatrist Pharmacist National Diabetes Education Program. Team care: comprehensive lifetime management for diabetes. www.ndep.nih.gov/resources/health.htm.

Benefits of the multidisciplinary approach Kaiser Permanente & PEDNID LA studies Case Study

Improvements in patient care: Kaiser Permanente Medical Care Program, California Individuals with poorly controlled diabetes randomised to outpatient care from: multidisciplinary nurse led team (diabetes nurse educator, psychologist, nutritionist and pharmacist) (n=97) or primary care physician (n=88) After 6 months, multidisciplinary team approach associated with: significant improvements in glycaemic control significant reductions in hospital admissions and outpatient visits –0.2 HbA1c –0.4 Change in HbA1c from baseline (%) –0.6 –0.8 –1.0 –1.2 –1.4 Control Multidisciplinary team 30 25 Hospitalisation 20  Hospitalisations/ 1000 person-months 15 10  5 Multidisciplinary team Control Sadur CN et al. Diabetes Care 1999; 22:2011–2017 Copyright © 1999 American Diabetes Association Adapted with permission from The American Diabetes Association Case Study

Cost of pharmacotherapy/year (US$) Improved cost-effectiveness: Co-operative Latin American implementation study (PEDNID LA) Educational model designed/adapted to local conditions by multidisciplinary team in 10 Latin American countries (n = 446) Four weekly teaching units plus reinforcement session at 6 months Family members and spouses encouraged to attend Significant improvements in FPG, HbA1c, body weight, blood pressure, cholesterol, triglycerides Reduction in pharmacotherapy → 62% decrease in treatment costs 120,000 Costs ↓ 62% 100,000 80,000 Cost of pharmacotherapy/year (US$) 60,000  40,000 20,000  Baseline 12 months Case Study Gagliardino JJ & Etchegoyen G. Diabetes Care 2001; 24:1001–1007.

Key steps for improving clinical practice  Disease management programmes can improve management of chronic disorders, including type 2 diabetes Achieve glycaemic goals as quickly as possible using early, intensive intervention Tailor education about the importance of achieving glycaemic goals to the target audience Make recommendations practical and engage all relevant parties Use co-ordinated and complementary campaigns to build long-term improvements in care    