Guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association The Case of Victor Canadian Diabetes Association.

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association The Case of Victor Canadian Diabetes Association 2013 Clinical Practice Guidelines (Updated July 2015) 2015

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Learning Objectives By the end of this session, participants will be able to: 1.Understand the major changes within the 2013 CDA clinical practice guidelines 2.Understand the rationale behind these changes 3.Apply the recommendations in clinical practice

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Faculty for slide deck development Jonathan Dawrant, BSc, MSc, MD, FRCPC Zoe Lysy, MDCM, FRCPC Geetha Mukerji, MD, FACP, FRCPC Dina Reiss, MD, FACP, FRCPC Steven Sovran, BSc, MD, MA, FRCPC Alice Y.Y. Cheng, MD, FRCPC Peter J. Lin, MD, CCFP Catherine Yu, MD, FRCPC, MHSc

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association FPG ≥7.0 mmol/L Fasting = no caloric intake for at least 8 hours or A1C ≥6.5% (in adults) Using a standardized, validated assay, in the absence of factors that affect the accuracy of the A1C and not for suspected type 1 diabetes or 2hPG in a 75-g OGTT ≥11.1 mmol/L or Random PG ≥11.1 mmol/L Random= any time of the day, without regard to the interval since the last meal 2hPG = 2-hour plasma glucose; FPG = fasting plasma glucose; OGTT = oral glucose tolerance test; PG = plasma glucose Diagnosis of Diabetes 2013

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Diagnosis of Prediabetes* TestResultPrediabetes Category Fasting Plasma Glucose (mmol/L) 6.1 - 6.9 Impaired fasting glucose (IFG) 2-hr Plasma Glucose in a 75-g Oral Glucose Tolerance Test (mmol/L) 7.8 – 11.0Impaired glucose tolerance (IGT) Glycated Hemoglobin (A1C) (%) 6.0 - 6.4Prediabetes * Prediabetes = IFG, IGT or A1C 6.0 - 6.4%  high risk of developing T2DM 2013

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Diabetes Prevention Program (DPP) Diabetes Prevention Program (DPP) Research Group. N Engl J Med 2002;346:393-403. Years Benefit of diet and exercise or Metformin on diabetes prevention in at-risk patients N = 3234 with IFG and IGT, without diabetes 0 0 10 20 30 40 1.02.03.04.0 Placebo Metformin Lifestyle Cumulative incidence of diabetes (%)  31%  58% P* < 0.001 *vs placebo IFG = impaired fasting glucose, IGT = impaired glucose tolerance

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Physical Activity Checklist DO a minimum of 150 minutes of moderate-to vigorous-intensity aerobic exercise per week INCLUDE resistance exercise ≥ 2 times a week SET physical activity goals and INVOLVE a multi- disciplinary team ASSESS patient’s health before prescribing an exercise regimen 2013

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Pre-exercise Assessment Assess for conditions that can predispose to injury before prescribing an exercise regimen: – Neuropathy (autonomic and peripheral) – Retinopathy – Coronary artery disease – resting ECG +/- exercise stress test (see CPG Chapter 23) – Peripheral arterial disease

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Age >40 years Duration of DM >15years + Age >30 years End organ damage – Microvascular – Macrovascular Cardiac risk factors Baseline resting ECG Repeat every 2 years Who Should be Screened with ECG?

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Exercise ECG stress testing If cannot exercise or resting ECG abnormality present: – Pharmacologic stress echo – Pharmacologic stress nuclear imaging Typical or atypical cardiac symptoms Associated diseases: – PAD – Carotid bruits – TIA – Stroke Resting ECG abnormalities (e.g. Q waves) Who Should have Stress Testing and/or Functional Imaging to Screen for CAD?

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Macronutrient Distribution (% Total Energy) CarbohydratesProteinFat % of total energy 45-60%15-20% (or 1-1.5g / kg BW) 20-35% Calories per gram 449 Grams for 2000 calorie/day diet 225-30075-10044-78 BW = body weight

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Victor Lost to follow up and shows up 3 years later FBS 9.0 mmol/L A1C 8.3% What are the A1C targets for Victor?

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Targets Checklist A1C ≤ 7.0% for MOST people with diabetes A1C ≤ 6.5% for SOME people with T2DM A1C 7.1-8.5% in people with specific features 2013

diabetes.ca | 1-800-BANTING (226-8464) Macro and Microvascular Benefits?

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association After median 8.5 years post-trial follow-up Aggregate Endpoint 19972007 Any diabetes related endpoint RRR: 12%9% P: 0.029 0.040 Microvascular disease RRR: 25%24% P: 0.00990.001 Myocardial infarction RRR: 16%15% P: 0.0520.014 All-cause mortality RRR: 6%13% P: 0.440.007 Legacy Effect of Earlier Glucose Control Holman R, et al. N Engl J Med 2008;359.

diabetes.ca | 1-800-BANTING (226-8464)

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association ADVANCE: Glucose Control Follow-up (months) Mean A1C (%) Standard control 7.3% Intensive control 6.5% 10.0 9.0 8.0 7.0 6.0 5.0 0.0 0612182430364248546066 p < 0.001 ADVANCE Collaborative Group. N Engl J Med 2008;358:24.

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association ADVANCE: Treatment Effect on the Primary Microvascular Outcomes New/worsening nephropathy, retinopathy 66 Cumulative incidence (%) Follow-up (months) HR 0.86 (0.77-0.97) p = 0.01 Standard control Intensive control 25 20 15 10 5 0 06121824303642485460 ADVANCE Collaborative Group. N Engl J Med 2008;358:24.

diabetes.ca | 1-800-BANTING (226-8464)

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Consider A1C 7.1-8.5% if … Limited life expectancy High level of functional dependency Extensive coronary artery disease at high risk of ischemic events Multiple co-morbidities History of recurrent severe hypoglycemia Hypoglycemia unawareness Longstanding diabetes for whom is it difficult to achieve an A1C ≤ 7%, despite effective doses of multiple antihyperglycemic agents, including intensified basal-bolus insulin therapy 2013

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Individualizing A1C Targets which must be balanced against the risk of hypoglycemia Consider 7.1-8.5% if: 2013

Start metformin immediately Consider initial combination with another antihyperglycemic agent Start lifestyle intervention (nutrition therapy and physical activity) +/- Metformin A1C <8.5% Symptomatic hyperglycemia with metabolic decompensation A1C  8.5% Initiate insulin +/- metformin If not at glycemic target (2-3 mos) Start / Increase metformin If not at glycemic targets LIFESTYLELIFESTYLE Add an agent best suited to the individual: Patient Characteristics Degree of hyperglycemia Risk of hypoglycemia Overweight or obesity Comorbidities (renal, cardiac, hepatic) Preferences & access to treatment Other See next page… AT DIAGNOSIS OF TYPE 2 DIABETES Agent Characteristics BG lowering efficacy and durability Risk of inducing hypoglycemia Effect on weight Contraindications & side-effects Cost and coverage Other 2015

If not at glycemic target From prior page… Add another agent from a different class Add/Intensify insulin regimen Make timely adjustments to attain target A1C within 3-6 months LIFESTYLELIFESTYLE 2015

Start metformin immediately Consider initial combination with another antihyperglycemic agent Start lifestyle intervention (nutrition therapy and physical activity) +/- Metformin A1C < 8.5% Symptomatic hyperglycemia with metabolic decompensation A1C  8.5% Initiate insulin +/- metformin If not at glycemic target (2-3 mos) Start / Increase metformin If not at glycemic targets LIFESTYLELIFESTYLE Add an agent best suited to the individual: Patient Characteristics Degree of hyperglycemia Risk of hypoglycemia Overweight or obesity Comorbidities (renal, cardiac, hepatic) Preferences & access to treatment Other See next page… AT DIAGNOSIS OF TYPE 2 DIABETES Agent Characteristics BG lowering efficacy and durability Risk of inducing hypoglycemia Effect on weight Contraindications & side-effects Cost and coverage Other 2015

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Adapted from: Product Monographs as of July 2015; Harper W et al. Can J Diab 2015;39:250-252; and Yale JF. J Am Soc Nephrol 2005; 16:S7-S10.. Antihyperglycemic agents and Renal Function 2015

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Victor’s friend passed out because of low sugars What do you tell Victor about Hypoglycemia?

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Recognize Risk Factors for Severe Hypoglycemia Risk factors in Type 1 DM patients Risk factors in Type 2 DM patients AdolescenceElderly Children unable to detect and/or treat mild hypoglycemia Poor health literacy, Food insecurity A1C <6.0%Increased A1C Long duration of diabetesDuration of insulin therapy Prior episode of severe hypoglycemia Severe cognitive impairment Hypoglycemia unawarenessRenal impairment Autonomic neuropathyNeuropathy

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Steps to Address Hypoglycemia 1.Recognize autonomic or neuroglycopenic symptoms 2.Confirm if possible (blood glucose <4.0 mmol/L) 3.Treat with “fast sugar” (simple carbohydrate) (15 g) to relieve symptoms 4.Retest in 15 minutes to ensure the BG >4.0 mmol/L and retreat (see above) if needed 5.Eat usual snack or meal due at that time of day or a snack with 15 g carbohydrate plus protein

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Hypoglycemia and Driving If BG <5.0 mmol/L prior to driving: – Take 15 g carbohydrate – Re-check in 15 minutes – When BG >5 mmol/L for at least 45 minutes  safe to drive Need to re-check BG every 4 hours of continuous driving and carry simple carbohydrate snacks Iain S. Begg et al. Canadian Journal of Diabetes. 2003;27(2):128-140. Safe blood glucose (BG) prior to driving BG ≥ 5.0 mmol/L

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Increased frequency of SMBG may be required: Daily SMBG is not usually required if patient:

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Vascular Protection Checklist 2013 A A1C – optimal glycemic control (usually ≤7%) B BP – optimal blood pressure control (<130/80) C Cholesterol – LDL ≤2.0 mmol/L if decided to treat D Drugs to protect the heart A – ACEi or ARB │ S – Statin │ A – ASA if indicated E Exercise / Eating healthily – regular physical activity, achieve and maintain healthy body weight S Smoking cessation

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association ≥40 yrs old or Macrovascular disease or Microvascular disease or DM >15 yrs duration and age >30 years or Warrants therapy based on the 2012 Canadian Cardiovascular Society lipid guidelines Among women with childbearing potential, statins should only be used in the presence of proper preconception counseling & reliable contraception. Stop statins prior to conception. 2013 Who Should Receive Statins? (regardless of baseline LDL-C)

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association What if baseline LDL-C ≤2.0 mmol/L? Within CARDS and HPS, the subgroups that started with lower baseline LDL-C still benefited to the same degree as the whole population If the patient qualifies for statin therapy based on the algorithm, use the statin regardless of the baseline LDL-C and then target an LDL reduction of ≥50% HPS Lancet 2002;360:7-22 Colhoun HM, et al. Lancet 2004;364:685.

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Who Should Receive ACEi or ARB Therapy? (regardless of baseline blood pressure) ≥55 years of age or Macrovascular disease or Microvascular disease At doses that have shown vascular protection [p erindopril 8 mg daily (EUROPA), ramipril 10 mg daily (HOPE), telmisartan 80 mg daily (ONTARGET)] Among women with childbearing potential, ACEi or ARB should only be used in the presence of proper preconception counseling & reliable contraception. Stop ACEi or ARB either prior to conception or immediately upon detection of pregnancy 2013 EUROPA Investigators, Lancet 2003;362(9386):782-788. HOPE study investigators. Lancet. 2000;355:253-59. ONTARGET study investigators. NEJM. 2008:358:1547-59

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Recommendation ASA should not be routinely used for the primary prevention of cardiovascular disease in people with diabetes [Grade B, Level 2] ASA may be used in the presence of additional cardiovascular risk factors [Grade D, Consensus] 2013

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Hypertension Checklist ASSESS for hypertension (≥ 130/80 mmHg) TREAT to target < 130/80 mmHg USE multiple antihypertensive medications if needed to achieve target (often necessary) USE initial combination therapy if systolic blood pressure > 20 mmHg or diastolic blood pressure > 10 mmHg above target 2013

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Summary of Pharmacotherapy for Hypertension in Patients with Diabetes Threshold equal or over 130/80 mmHg and Target below 130/80 mmHg With Nephropathy, CVD or CV risk factors ACE Inhibitor or ARB Diabetes Without the above 1. ACE Inhibitor or ARB or 2. Thiazide diuretic or DHP-CCB Monitor serum potassium and creatinine carefully in patients with CKD prescribed an ACEI or ARB Combinations of an ACEI with an ARB are specifically not recommended in the absence of proteinuria More than 3 drugs may be needed to reach target values If Creatinine over 150 µmol/L or creatinine clearance below 30 ml/min ( 0.5 ml/sec), a loop diuretic should be substituted for a thiazide diuretic if control of volume is desired Combination of 2 first line drugs may be considered as initial therapy if the blood pressure is >20 mmHg systolic or >10 mmHg diastolic above target > 2-drug combinations

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association ER = extended release; IR = immediate release; LA=long acting; TG=triglycerides; FCT=film coated tablet; SR=sustained release

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Chronic Kidney Disease (CKD) Checklist SCREEN regularly with random urine albumin creatinine ratio (ACR) and serum creatinine for estimated glomerular filtration rate (eGFR) DIAGNOSE with repeat confirmed ACR ≥ 2.0 mg/mmol and/or eGFR < 60 mL/min DELAY onset and/or progression with glycemic and blood pressure control and ACE inhibitor or angiotensin receptor blocker (ARB) PREVENT complications with “sick day management” counselling and referral when appropriate 2013

Chronic, progressive loss of kidney function ACR persistently >60 mg/mmol eGFR <30 mL/min Unable to remain on renal-protective therapies due to adverse effects such as hyperkalemia or a >30% increase in serum Cr within 3 months of starting ACEi or ARB Unable to achieve target BP (could be referred to any specialist in hypertension) When to Refer….. guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Retinopathy Checklist SCREEN regularly DELAY onset and progression with glycemic and blood pressure control ± fibrate TREAT established disease with laser photocoagulation, intra-ocular injection of medications or vitreoretinal surgery 2013

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Delaying Retinopathy 1. Glycemic control: target A1C ≤7% 2. Blood pressure control: target BP <130/80 3. Lipid-lowering therapy: fibrates have been shown to decrease progression and may be considered 2013

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Victor heard that amputations are highest in people with diabetes What do you tell Victor?

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Public Health Agency of Canada (August 2011); using 2008/09 data from the Canadian Chronic Disease Surveillance System (Public Health Agency of Canada). Patients with DM are 20X More Likely to be Hospitalized for Non-traumatic Limb Amputation

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Educate patients on proper foot care – The “DO’s” DO … Check your feet every day for cuts, cracks, bruises, blisters, sores, infections, unusual markings Use a mirror to see the bottom of your feet if you can not lift them up Check the colour of your legs & feet – seek help if there is swelling, warmth or redness Wash and dry your feet every day, especially between the toes Apply a good skin lotion every day on your heels and soles. Wipe off excess. Change your socks every day Trim your nails straight across Clean a cut or scratch with mild soap and water and cover with dry dressing Wear good supportive shoes or professionally fitted shoes with low heels (under 5cm) Buy shoes in the late afternoon since your feet swell by then Avoid extreme cold and heat (including the sun) See a foot care specialist if you need advice or treatment

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Educate patients on proper foot care – The “DON’Ts” DO NOT … Cut your own corns or callouses Treat your own in-growing toenails or slivers with a razor or scissors. See your doctor or foot care specialist Use over-the-counter medications to treat corns and warts Apply heat with a hot water bottle or electric blanket – may cause burns unknowingly Soak your feet Take very hot baths Use lotion between your toes Walk barefoot inside or outside Wear tight socks, garter or elastics or knee highs Wear over-the-counter insoles – may cause blisters if not right for your feet Sit for long periods of time Smoke

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association 40-50% of people with DM will have detectable neuropathy within 10 years Sensorimotor poly- or mono-neuropathy Increased risk for:  Foot ulceration and amputation  Neuropathic pain  Significant morbidity  Usage of health care resources

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Neuropathy Checklist PREVENT with blood glucose control SCREEN with monofilament or tuning fork TREAT pain symptoms with anticonvulsants or antidepressants 2013

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association 4.The following agents may be used alone or in combination for relief of painful peripheral neuropathy: – Anticonvulsants (pregabalin [Grade A, Level 1], gabapentin ‡, valproate ‡ ) [Grade B, Level 2] – Antidepressants (amitriptyline ‡, duloxetine, venlafaxine ‡ ) [Grade B, Level 2] – Opioid analgesics (tapentadol ER, oxycodone ER, tramadol) [Grade B, Level 2] – Topical nitrate spray [Grade B, Level 2] ‡ This drug is not currently approved by Health Canada for the management of neuropathic pain associated with diabetic peripheral neuropathy. 2013 Recommendation 4

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Serum Insulin Level Time Analogue Bolus: Apidra, Humalog, NovoRapid Human Basal: Humulin-N, Novolin ge NPH Analogue Basal: Lantus, Levemir Human Bolus: Humulin-R, Novolin ge Toronto

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Time Serum Insulin Level Human Premixed : Humulin 30/70, Novolin ge 30/70 Analogue Premixed: Humalog Mix25, NovoMix 30

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association Intensive Group had Improved CV Outcomes 1224364860728496 0 10 20 30 40 50 60 P = 0.007 Conventional therapy Intensive therapy Months of Follow-up RRR= relative risk reduction 53 % RRR Any CV event NNT = 5 Gaede et al. NEJM. 2003: 348;383-393

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association “Neither evidence nor clinical judgment alone is sufficient. Evidence without judgment can be applied by a technician. Judgment without evidence can be applied by a friend. But the integration of evidence and judgment is what the healthcare provider does in order to dispense the best clinical care.” (Hertzel Gerstein, 2012)

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association CDA Clinical Practice Guidelines www.guidelines.diabetes.cawww.guidelines.diabetes.ca – for professionals 1-800-BANTING (226-8464) www.diabetes.ca www.diabetes.ca – for patients

Guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association The Case of Victor Canadian Diabetes Association.

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Guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association The Case of Victor Canadian Diabetes Association.

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