Canadian Diabetes Association
2013 Clinical Practice Guidelines
The Essentials
John MacFadyen, MD FRCPC, MHPE
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CDA Guidelines - Essentials
•
Diagnostic Criteria
–
–
Diabetes
Pre-Diabetes
•
Gylycemic Goals
• Approach to Glycemic Therapies
• Vascular Prevention Strategies
• What is not included in the guidelines
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Diagnosis of Diabetes
2013
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
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Diagnosis of Prediabetes*
2013
Test
Result
Prediabetes Category
Fasting Plasma
Glucose
(mmol/L)
6.1 - 6.9
Impaired fasting glucose
(IFG)
7.8 – 11.0
Impaired glucose tolerance
(IGT)
6.0 - 6.4
Prediabetes
2-hr Plasma Glucose in
a 75-g Oral Glucose
Tolerance Test (mmol/L)
Glycated
Hemoglobin
(A1C) (%)
* Prediabetes = IFG, IGT or A1C 6.0 - 6.4%  high risk of developing T2DM
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A1C Level and Future Risk of Diabetes:
Systematic Review
A1C Category (%)
5-year incidence of
diabetes
5.0-5.5
<5 to 9%
5.5-6.0
9 to 25%
6.0-6.5
25 to 50%
Zhang X et al. Diabetes Care. 2010;33:1665-1673.
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2013
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
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Please indicate your recommended A1C target for the
following patient profiles:
45 yo female with newly diagnosed DM on Metformin therapy
< 6.5 7.0 7.5 8.0 8.5 >9.0
65 yo male with DM x 15 years, on Metformin and Diamicron MR with
history of prev. PCI and stable angina Class II
< 6.5 7.0 7.5 8.0 8.5 >9.0
45 yo female from a group home, DM x 10 years on maximal oral agents
< 6.5 7.0 7.5 8.0 8.5 >9.0
84 yo male from Nursing home, on Metformin, Diamicron MR and Lantus
insulin
< 6.5 7.0 7.5 8.0 8.5 >9.0
ACCORD
ADVANCE
VADT
OUTCOME (INTENSIVE VS STANDARD)
Median A1c
(%)
6.4 vs 7.5
6.4 vs 7.0
6.9 vs 8.4
CV death (%)
2.6 vs 1.8
4.5 vs 5.2
2.1 vs 1.7
Nonfatal MI
3.6 vs 4.6
2.7 vs 2.8
6.1 vs 6.3
Nonfatal
stroke
1.3 vs 1.2
3.8 vs 3.8
2.0 vs 3.1
All-cause
mortality
5.0 vs 4.0
8.9 vs 9.6
11.4 vs
10.6
Major
hypoglycemia
(requiring
assistance)
3.1 vs 1.0
%/yr
0.7 vs 0.4
%/yr
3 vs 9 /100
pt-yr
Individualizing A1C Targets
2013
Consider 7.1-8.5% if:
which must be
balanced against
the risk of
hypoglycemia
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2013
Among frail elderly
Parameter
A1C
Target
≤ 8.5%
FPG or
preprandial
glucose
5.0-12.0 mmol/L
(depending on level of frailty)
AVOID HYPOGLYCEMIA
FPG= fasting plasma glucose
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A1c
Average glucose
6%
7.0
7%
8.6
8%
10.1
9%
11.7
10%
13.3
11%
14.9
12%
16.5
ABG in mmol/L = (1.583 * A1c) – 2.52 Nathan D, et al. Diab Care 31(8):1473-8, 2008.
Individualized Target A1C
Miller’s Rule: if patient > 70 years old
then target A1C = age / 10
eg – age 85 – Target A1C 8.5
Individualized Target A1C
MacFadyen’s Corollary – added to Miller’s Rule
If Advanced Vascular Complications
Cognitive Impartment/Poor Self Care
Significant Hypoglycemia
Disease Duration > 20-25 yrs
then add 0.5 each – max 9.0
Eg Age 75 + MI + prev episode hypoglycemic seizure
= Target – 8.5
Individualized Target Blood Glucoses
MacFadyen’s Rule
Goal Glucose = Goal A1C -2 /+ 3
Eg. If target A1c is 8.5
most sugars should be between 6.5 – 11.5
Self-Monitoring of
Blood Glucose (SMBG)
What should
we tell patients to do?
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Regular SMBG is Required for:
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Increased frequency of SMBG may be required:
Daily SMBG is not usually required if patient:
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Physical Activity Checklist
2013
 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 multidisciplinary team
 ASSESS patient’s health before prescribing an
exercise regimen
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1. Modest weight loss CAN make a difference
•
Goal is to prevent weight gain, promote
weight loss and prevent weight re-gain
• Weight loss of only 5-10% improves:
–
–
–
–
Insulin sensitivity
Glycemic control
Blood pressure
Lipid levels
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Pharmacotherapy in T2DM checklist
2013

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
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AT DIAGNOSIS OF TYPE 2 DIABETES
Start lifestyle intervention (nutrition therapy and physical activity) +/- Metformin
L
I
F
E
S
T
Y
L
E
A1C <8.5%
If not at glycemic
target (2-3 mos)
Start / Increase
metformin
A1C 8.5%
Symptomatic hyperglycemia with
metabolic decompensation
Start metformin immediately
Consider initial combination with
another antihyperglycemic agent
Initiate
insulin +/metformin
If not at glycemic targets
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
Agent Characteristics
BG lowering efficacy and durability
Risk of inducing hypoglycemia
Effect on weight
Contraindications & side-effects
Cost and coverage
Other
2013
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See next
Copyright © 2013 Canadian Diabetes Association
page…
From prior page…
L
I
F
E
S
T
Y
L
E
If not at glycemic target
• Add another agent from a different class
• Add/Intensify insulin regimen
2013
guidelines.diabetes.ca
| 1-800-BANTING
(226-8464) | diabetes.ca
Make
timely adjustments
to attain
Copyright © 2013 Canadian Diabetes Association
target A1C within 3-6 months
Consider weight effects when selecting
antihyperglycemic medications
Weight Gain
Weight Effect (kg)
Insulin
+4.5 to 5.0
Thiazolidenediones (TZDs)
+4.2 to 4.8
Sulfonylureas
+1.6 to 2.6
Meglitinides
+ 0.7 to 1.8
Weight Neutral or Decrease Weight
Weight Effect (kg)
Metformin
-4.6 to 0.4
α-Glucosidase inhibitors
+0.0 to 0.2
Dipeptidyl peptidase-4 (DPP-4) inhibitors
+0.0 to 0.4
Glucagon-like peptide-1 (GLP-1) receptor
agonists
-1.3 to 3.0
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Hollander, P. Diabetes Spectrum 2007; 20(3): 159-165
Antihyperglycemic agents and Renal Function
CKD Stage:
GFR (mL/min):
5
< 15
4
15-29
3
30-59
30
Metformin
Linagliptin
15
Saxagliptin
15
Sitagliptin
25 mg
Exenatide
2.5 mg
≥ 90
60
50
30 50 mg
50
30
50
50
Liraglutide
Glyburide
1
25
Acarbose
Gliclazide/Glimepiride
2
60-89
15
30
30
50
Repaglinide
Thiazolidinediones
30
Not recommended / contraindicated
Caution and/or dose reduction
Safe
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Adapted
from:©Product
Monographs
as ofAssociation
March 1, 2013; CDA Guidelines 2008; and Yale JF. J Am Soc Nephrol 2005; 16:S7-S10.
Copyright
2013 Canadian
Diabetes
Measure Lipids at Diagnosis
•
Repeat yearly if treatment not started
•
Repeat q3-6mos if on treatment
•
Fasting (8-hr) profile:
–
•
Total cholesterol, triglycerides, HDL-C, LDL-C
or
Non-fasting profile:
–
–
ApoB
Non-HDL-C
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Who Should Receive Statins?
2013
•
≥40 yrs old or
•
Macrovascular disease or
•
Microvascular disease or
•
DM >15 yrs duration and age >30 yrs or
•
Warrant 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.
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If on therapy, target
LDL ≤2.0 mmol/L
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Second line agents :
Only if LDL-C target not reached with statin
•
Bile acid sequestrants
•
Cholesterol absorption inhibitors
•
Fibrates
•
Nicotinic acid
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2013
If Triglycerides > 10.0 mmol/L …
•
Use a FIBRATE to reduce the risk of pancreatitis
• Optimize glycemic control
• Implement lifestyle interventions
– Weight loss
– Optimal dietary strategies
– Reduce alcohol
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2013
Who Should Receive ACEi or ARB Therapy?
•
≥55 years of age or
•
Macrovascular disease or
•
Microvascular disease
At doses that have shown vascular protection (ramipril 10 mg daily,
perindopril 8 mg daily, telmisartan 80 mg daily)
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
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Hypertension Checklist
2013

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
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ADA 2013
• Hypertension/Blood Pressure Control has
been revised to suggest that the systolic blood
pressure goal for many people with diabetes
and hypertension should be <140 mmHg, but
that lower systolic targets (such as <130
mmHg) may be appropriate for certain
individuals, such as younger patients, if it can
be achieved without undue treatment burden.
No. of events/No. in group
ASA for 1⁰
Prevention in
Diabetes
Meta analysis of 6 studies
(n = 10,117)
No overall benefit for:
• Major CV events
• MI
• Stroke
• CV mortality
• All-cause mortality
JPAD = Japanese Primary Prevention of Atherosclerosis
with Aspirin for Diabetes
POPADAD = Prevention of Progression of Arterial
Disease and Diabetes
PPP = Primary Prevention Project
ETDRS = Early Treatment Diabetic Retinopathy Study
PHS = Physicians’ Health Study
WHS = Women’s Health Study
ASA Control/placebo
Major CV events
JPAD
68/1262
86/1277
POPADAD
105/638
108/638
WHS
58/514
62/513
PPP
20/519
22/512
ETDRS
350/1856
379/1855
Total
601/4789
657/4795
RR (95% CI)
RR (95% CI)
0.80 (0.59-1.09)
0.97 (0.76-1.24)
0.90 (0.63-1.29)
0.90 (0.50-1.62)
0.90 (0.78-1.04)
0.90 (0.81-1.00)
Myocardial infarction
JPAD
28/1262
POPADAD
90/638
WHS
36/514
PPP
5/519
ETDRS
241/1856
PHS
11/275
Total
395/5064
14/1277
82/638
24/513
10/512
283/1855
26/258
439/5053
0.87 (0.40-1.87)
1.10 (0.83-1.45)
1.48 (0.88-2.49)
0.49 (0.17-1.43)
0.82 (0.69-0.98)
0.40 (0.20-0.79)
0.86 (0.61-1.21)
Stroke
JPAD
POPADAD
WHS
PPP
ETDRS
Total
32/1277
50/638
31/513
10/512
78/1855
201/4795
0.89 (0.54-1.46)
0.74 (0.49-1.12)
0.46 (0.25-0.85)
0.89 (0.36-2.17)
1.17 (0.87-1.58)
0.83 (0.60-1.14)
Death from CV causes
JPAD
1/1262
POPADAD
43/638
PPP
10/519
ETDRS
244/1856
Total
298/4275
10/1277
35/638
8/512
275/1855
328/4282
0.10 (0.01-0.79)
1.23 (0.80-1.89)
1.23 (0.49-3.10)
0.87 (0.73-1.04)
0.94 (0.72-1.23)
All-cause mortality
JPAD
34/1262
POPADAD
94/638
PPP
25/519
ETDRS
340/1856
Total
493/4275
38/1277
101/638
20/512
366/1855
525/4282
0.90 (0.57-1.14)
0.93 (0.72-1.21)
1.23 (0.69-2.19)
0.91 (0.78-1.06)
0.93 (0.82-1.05)
12/1262
37/638
15/514
9/519
92/1856
181/4789
De Beradis G, et al. BMJ 2009; 339:b4531.
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0.03 0.125
Favors ASA
0.5 1
2
8
Favors control/placebo
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2013
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
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2013
ACR ≥ 2.0 mg/mmol
CKD
in diabetes
and/or
eGFR < 60 mL/min
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Reducing progression of diabetic nephropathy
•
Optimal glycemic control
•
Optimal blood pressure control
•
ACE-inhibitor or Angiotensin receptor blocker (ARB)
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Counsel all
Patients
About
Sick Day
Medication
List
2013
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2013
Bariatric Surgery is Appropriate in Select
Refractory Cases
•
Class III (BMI ≥ 40 kg/m2), or class II (BMI 35.0-39.9 kg/m2)
obesity with comorbidities
•
Assessment by interdisciplinary team
–
Medical, surgical, psychiatric, and nutritional
•
Laparoscopic Roux-en-Y gastric bypass or
biliopancreatic diversion with duodenal switch
•
Long-term medical follow up
•
Be aware of any provincial regulations with respect
to bariatric surgery
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What isn’t in the CDA Guidelines but still
important to consider
Exenatide: 68% of 3-Year Completers Both
Lost Weight and Had Reduced HbA1c
Weight Change from Baseline (kg)
15
10
10%
6%
68%
16%
5
0
-5
-10
-15
-20
-25
-30
-5
-4
-3
-2
-1
0
1
2
3
HbA1c Change from Baseline (%)
4
5
N=217
Adapted from Klonoff DC, et al. Curr Med Res Opin 2008;24:275-286.
43
What is not included in the CDA
Guidelines
• Ensure that evidence for glycemic benefit
with incretin agents
• Consider adding back oral agents to patients
on insulin if no previous exposure
• Identify “super-responders”
“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)
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CDA Clinical Practice Guidelines
www.guidelines.diabetes.ca – for professionals
1-800-BANTING (226-8464)
www.diabetes.ca – for patients
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