Canadian Diabetes Association 2013 Clinical …dnig.rnao.ca/sites/dnig/files/DNIG Talk CDA Essentials.pdftarget (2 -3 mos) Start / Increase metformin If not at glycemic targets L I

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.ca Copyright © 2013 Canadian Diabetes Association

The Essentials

Canadian Diabetes Association 2013 Clinical Practice Guidelines


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


www.guidelines.diabetes.ca


What is new in making the diagnosis of diabetes?


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

Presenter

Presentation Notes

Script: Diabetes can be diagnosed by many different cut-offs. The biggest change from the previous set of guidelines is that HbA1c > 6.5% is part of diagnostic cut-off if a standardized validated assay is used with absence of other factors that affect A1c and not suspecting Dm. So FBG >7, A1c >6.5%, or 2h PG > 11.1 or random PG >11.1 can be used to used to diagnose diabetes. Diagnosis of diabetes is based on thresholds of glycemia that are associated with microvascular disease


Diagnosis of Prediabetes* Test Result Prediabetes 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 – 11.0 Impaired glucose tolerance (IGT)

Glycated Hemoglobin (A1C) (%)

6.0 - 6.4

Prediabetes

* 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 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


Self-Monitoring of Blood Glucose (SMBG)

What should

we tell patients to do?


Regular SMBG is Required for:


Increased frequency of SMBG may be required:

Daily SMBG is not usually required if patient:


Individualize frequency of SMBG

• CDA SMBG tool - provides guidance on appropriate situations for SMBG utilization

http://guidelines.diabetes.ca

2013

http://www.diabetes.ca/documents/for- rofessionals/SMBG_HCP_Tool_9.pdf

http://guidelines.diabetes.ca



Medications for glycemia How do we choose?


Pharmacotherapy in T2DM checklist

CHOOSE initial therapy based on glycemia

START with Metformin +/- others

INDIVIDUALIZE your therapy choice based on

characteristics of the patient and the agent

REACH TARGET within 3-6 months of

diagnosis

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

L I F E S T Y L E

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

2013

Presenter

Presentation Notes

May start Metformin at the time of diagnosis Change to 8.5% as threshold Start metformin immediately as an option Concept of individualizing therapy based on patient and agent characteristics With that in mind, the next figure shows the characteristics of the agents ….

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 2013

L I F E S T Y L E

Presenter

Presentation Notes

Concept of RELATIVE A1c lowering – not absolute Concept of RELATIVE cost considerations Change to achieve target within 3-6 months.

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

L I F E S T Y L E

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

2013

Presenter

Presentation Notes

May start Metformin at the time of diagnosis Change to 8.5% as threshold Start metformin immediately as an option Concept of individualizing therapy based on patient and agent characteristics With that in mind, the next figure shows the characteristics of the agents ….

2013


Adapted from: Product Monographs as of March 1, 2013; CDA Guidelines 2008; and Yale JF. J Am Soc Nephrol 2005; 16:S7-S10.

Antihyperglycemic agents and Renal Function

Not recommended / contraindicated Safe Caution and/or dose reduction

Repaglinide

Metformin 30 60

Saxagliptin

Linagliptin

Glyburide 30 50

Thiazolidinediones 30

GFR (mL/min): < 15 15-29 30-59 60-89 ≥ 90 CKD Stage: 5 4 3 2 1

Gliclazide/Glimepiride 15 30 Liraglutide 50

Exenatide 30 50

Acarbose 25

Sitagliptin 50

50 15 2.5 mg

15

30 50 mg 25 mg


What are the options for Insulin?


Insulin Type (trade name) Onset Peak Duration

Bolus (prandial) Insulins Rapid-acting insulin analogues (clear): • Insulin aspart (NovoRapid®) • Insulin glulisine (Apidra™) • Insulin lispro (Humalog®)

10 - 15 min 10 - 15 min 10 - 15 min

1 - 1.5 h 1 - 1.5 h 1 - 2 h

3 - 5 h 3 - 5 h

3.5 - 4.75 h

Short-acting insulins (clear): • Insulin regular (Humulin®-R) • Insulin regular (Novolin®geToronto)

30 min

2 - 3 h

6.5 h

Basal Insulins Intermediate-acting insulins (cloudy): • Insulin NPH (Humulin®-N) • Insulin NPH (Novolin®ge NPH)

1 - 3 h 5 - 8 h Up to 18 h

Long-acting basal insulin analogues (clear) • Insulin detemir (Levemir®) • Insulin glargine (Lantus®)

90 min Not applicable

Up to 24 h (glargine 24 h,

detemir 16 - 24 h)

Types of Insulin


Insulin Type (trade name) Time action profile

Premixed Insulins Premixed regular insulin – NPH (cloudy): • 30% insulin regular/ 70% insulin NPH (Humulin® 30/70) • 30% insulin regular/ 70% insulin NPH (Novolin®ge 30/70) • 40% insulin regular/ 60% insulin NPH (Novolin®ge 40/60) • 50% insulin regular/ 50% insulin NPH (Novolin®ge 50/50)

A single vial or cartridge contains a fixed ratio of insulin

(% of rapid-acting or short-acting insulin to % of intermediate-acting

insulin)

Premixed insulin analogues (cloudy): • 30% Insulin aspart/70% insulin aspart protamine crystals (NovoMix® 30) • 25% insulin lispro / 75% insulin lispro protamine (Humalog® Mix25®) • 50% insulin lispro / 50% insulin lispro protamine (Humalog® Mix50®)

Types of Insulin (continued)


Seru

m In

sulin

Lev

el

Time

Analogue Bolus: Apidra, Humalog, NovoRapid

Human Basal: Humulin-N, Novolin ge NPH Analogue Basal: Lantus, Levemir

Human Bolus: Humulin-R, Novolin ge Toronto


Time

Seru

m In

sulin

Lev

el

Human Premixed: Humulin 30/70, Novolin ge 30/70 Analogue Premixed: Humalog Mix25, NovoMix 30


What about Hypoglycemia?


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

Presenter

Presentation Notes

Teaching patients to recognize and treat hypoglycemia can be done in 3 steps 1) It is important to teach patients to recognize the common autonomic and neuroglycopenic symptoms associated with hypoglycemia including: Trembling, Palpitations, Sweating, Anxiety, Hunger, Nausea, Tingling which are common autonomic symptoms and Difficulty concentrating, Confusion, Weakness, Vision change, and Headache are common neuroglycopenic symptoms.


Macrovascular Disease

Vascular Protection: Who and When?


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 (regardless of baseline BP or LDL)

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


• ≥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)


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

[perindopril 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

Presenter

Presentation Notes

ACE inhiibitor or ARB therapy should be offered to people with diabetes age ≥55 years, or in the presence of macrovasular disease or microvascular disease. This recommendation is regardless of blood pressure. It is important that the ACEi or ARB be titrated to the doses that have been shown to provide vascular protection since low dose ACE-inhibitor or ARB may not result in any benefit (DIABHYCAR study). These vascular protection benefits have been shown to be present irrespective of baseline blood pressure. Since it is not proven that low dose ACEi or ARB confers the same vascular protection, it is recommended that the ACEi or ARB dose be increased to the vascular protective doses (peripdopril 8mg, ramipril 10 mg, telmisartan 80 mg daily). Given that not all ACEi or ARB have conducted “vascular protection” type of studies and of those that have, not all have been positive, it is justified to titrate to doses shown to have vascular protection.


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



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

Presenter

Presentation Notes

1. Persons with diabetes mellitus should be treated to attain systolic blood pressure of lower than130 mmHg (Grade C) and diastolic blood pressure of less than 80 mmHg (Grade A). (These target blood pressure levels are the same as the blood pressure treatment thresholds.)�Combination therapy using two first-line agents may also be considered as initial treatment of hypertension (Grade B) if the SBP is 20 mmHg above the target or if DBP is 10 mmHg above the target. However caution should be exercised in patients in whom a substantial fall in blood pressure is more likely or poorly tolerated (e.g. elderly patients, patients with autonomic neuropathy). 2. For persons with cardiovascular or kidney disease, including microalbuminuria or with cardiovascular risk factors in addition to diabetes and hypertension, an ACE inhibitor or an ARB is recommended as initial therapy (Grade A). 3. For persons with diabetes and hypertension not included in the above recommendation, appropriate choices include (in alphabetical order): ACE inhibitors (Grade A), angiotensin receptor blockers (Grade B), dihydropyridine CCBs (Grade A) and thiazide/thiazide-like diuretics (Grade A). 4. If target blood pressures are not achieved with standard-dose monotherapy, additional antihypertensive therapy should be used. For persons in whom combination therapy with an ACE inhibitor is being considered, a dihydropyridine CCB is preferable to hydrochlorothiazide (Grade A).


What about Microvascular Disease? • Nephropathy

• Retinopathy • Neuropathy


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

Presenter

Presentation Notes

Use same check marks as Geetha

Counsel all Patients About

Sick Day

Medication List 2013


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

Presenter

Presentation Notes

Use same check marks as Geetha


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


Neuropathy Checklist

PREVENT with blood glucose control

SCREEN with monofilament or tuning fork

TREAT pain symptoms with anticonvulsants or antidepressants

2013

Presenter

Presentation Notes

Use Geetha’s check marks


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


Foot Care: What are the

DO’s and DON’Ts of foot care?


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


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


Special populations …


Diabetes in the Elderly Checklist ASSESS for level of functional dependency (frailty)

INDIVIDUALIZE glycemic targets based on the above (A1C ≤ 8.5% for frail elderly) but if otherwise healthy, use the same targets as younger people

AVOID hypoglycemia in cognitive impairment

SELECT antihyperglycemic therapy carefully caution with sulfonylureas or thiazolidinediones Basal analogues instead of NPH or human 30/70

insulin Premixed insulins instead of mixing insulins separately

GIVE regular diets instead of “diabetic diets” or nutritional formulas in nursing homes

2013



Add an agent best suited to the individual (agents listed in alphabetical order):

Class Relative A1C

Lowering

Hypo-glycemia

Weight Other therapeutic considerations Cost

α-glucosidase inhibitor (acarbose)

↓ Rare Neutral to ↓

Improved postprandial control, GI side-effects

$$

Incretin agents: DPP-4 Inhibitors GLP-1 receptor agonists

↓↓

↓↓ to↓↓↓

Rare Rare

neutral

↓

GI side-effects

$$$

$$$$

Insulin ↓↓↓ Yes ↑↑ No dose ceiling, flexible regimens $-$$$$

Insulin secretagogue: Meglitinide Sulfonylurea

↓↓ ↓↓

Yes* Yes

↑ ↑

*Less hypoglycemia in context of missed meals but usually requires TID to QID dosing Gliclazide and glimepiride associated with less hypoglycemia than glyburide

$$ $

Thiazolidinediones ↓↓ Rare ↑↑ CHF, edema, fractures, rare bladder cancer (pioglitazone), cardiovascular controversy (rosiglitazone), 6-12 weeks required for maximal effect

$$

Weight loss agent (orlistat)

↓ None ↓ GI side effects $$$

• CAUTION in the elderly • Initial doses = HALF of usual dose • Avoid glyburide • Use gliclazide, gliclazide MR,

glimepiride, nateglinide or repaglinide instead

• CAUTION in the elderly • Increased risk of fractures • Increased risk of heart failure

• May use detemir or glargine instead of NPH or human 30/70 for less hypos

• Premixed insulins and prefilled insulin pens instead of mixing insulin to reduce dosing errors


Need a PRECONCEPTION checklist for women with pre-existing diabetes

1. Attain a preconception A1C of ≤ 7.0% (if safe)

2. Assess for and manage any complications

3. Switch to insulin if on oral agents

4. Folic Acid 5 mg/d: 3 mo pre-conception to 12 weeks post-conception

5. Discontinue potential embryopathic meds: Ace-inhibitors/ARB (prior to or upon detection of pregnancy) Statin therapy

2013

Presenter

Presentation Notes

Script:


How can we keep track of all the parameters for our patients with Diabetes?


Tools to help us keep track of our patients


Tools to help us keep track of our patients


Back Page: “Cheat Sheet” of Targets and Goals


Back Page: “Cheat Sheet” of Targets and Goals


“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)


CDA Clinical Practice Guidelines

www.guidelines.diabetes.ca – for professionals 1-800-BANTING (226-8464) www.diabetes.ca – for patients

http://guidelines.diabetes.ca/

http://guidelines.diabetes.ca/

http://diabetes.ca/

Documents

Canadian Diabetes Association 2013 Clinical …dnig.rnao.ca/sites/dnig/files/DNIG Talk CDA Essentials.pdftarget (2 -3 mos) Start / Increase metformin If not at glycemic targets L I