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Standards of

Medical Care

Learning Objectives
Discuss the PERKENI Diabetes Mellitus
National Practice Guidelines/Standards of Care

Review a summary of the ADA Standards of


Care for preventing, diagnosing and treating
prediabetes and diabetes

Standards of Care:
PERKENI and ADA
PERKENI created Diabetes Mellitus National
Clinical Practice Guidelines (2011-revises)

ADA Standards of Medical Care in Diabetes


composes all current and key clinical
recommendations from the ADA

PERKENI: Standards of Care


Diabetes care must be:
Continuous, not episodic
Proactive, not reactive
Planned, not sporadic
Patient centered rather than provider centered
Population based, as well as individual based
Team care

PERKENI: Standards of Care


Ideal core team members:
A physician
A nurse
A dietician
at least one of whom is certified diabetes educator

Other team members will vary according to the patient


need, patient load, organization constraints, resources,
clinical setting and professional skills
e.g.: podiatrist, pharmacist, psychological or social workers
Mensing C. Diabetes Care 2000:23:682-9.

PERKENI: Screening
Screening is conducted on those who have diabetes
risks, but do not show any symptoms
of DM.

Screening seeks to capture undiagnosed DM


or prediabetes so it can be managed earlier
more appropriately.

and

Mass screening is not recommended considering the


costs, which are generally not followed by action plan
for those who were found abnormal.

Prevention/
Delay of T2DM

PERKENI: Diabetes Prevention


Management
Early Detection
High-risk population at
>30-year old

Family history of DM
Cardiovascular disorder
Overweight
Sedentary life style
Known IFG or IGT
Hypertension
Elevated triglyceride, low
HDL or both
History of Gestational DM
History of given birth
> 4000g
PCOS

2-hour OGTT is the most


sensitive method for early
detection and a
recommended screening
test procedure

Lifestyle Changes

Medical Nutritional
Therapy

Periodic Blood
Glucose & Risk
Factor Monitoring

Pharmacology
Therapy

Not yet
recommended

Hypertension

Dyslipidemia

Physical health

Body weight
control

Physical activity
Weight reduction

If overweight,
reduce body
weight by 5-10%

Physical exercise
for 30 minutes,
5 times/week, or
150 minutes/week

Diagnosis

Screening/Testing
for Diabetes in
Asymptomatic Patients

PERKENI Guidelines 2011


FBG = Fasting Blood Glucose
RBG = Random Blood Glucose
IGT = Impaired Glucose Tolerance
IFG = Impaired Fasting Glucose

Diabetes Symptoms

Diabetes Classic Symptoms (+)

126

FBG

<126

Diabetes Classic Symptoms (-)

FBG

atau

126

100-125

<100

atau

RBG

>200

<200

RBS

>200

140-199

<140

FBG and PPG


FBG

>126

<126

atau

RBG

OGTT 2 hour BG
200

<200
>200

Diabetes Mellitus

Evaluation of Nutritional Status


Evaluation Diabetic Complications
Evaluation Dietary Need and Dietary Planning

140-199
IGT

<140
IFG

Education
Dietary Planning
Physical Exercise
Achieving Ideal Body Weight

Normal

PERKENI: Diagnostic
Criteria for Diabetes Mellitus
Classic symptoms of diabetes + random glucose plasma level
200 mg/dL. Random glucose plasma level is a test which access
glucose plasma level at a single time without concerning about last
meal schedule.
or
Classical symptoms of diabetes + fasting plasma glucose
126 mg/dL. Fasting means patients not getting intake calories
for minimum 8 hours.
or
2-h plasma glucose at glucose tolerance test 200 mg/dL.
Glucose tolerance test done by the WHO standard using 75g
anhydrous glucose which solvent in the 100 cc water
or
HbA1c 6.5%
PERKENI GUIDELINES 2011-revices

PERKENI: Standard Values of Random Blood


Glucose and Fasting Blood Glucose for
Screening and Diagnosis of DM (mg/dL)
Non DM

Uncertain DM

DM

Random
Venous
blood glucose plasma
level
Capillary blood
(mg/dL)

<100

100-199

200

<90

90-199

200

Fasting blood
glucose level
(mg/dL)

Venous
plasma

<100

100-125

126

Capillary blood

<90

90-99

100

Note:
For high-risk groups which show no abnormal results, the test should be done
every year. For those aged > 45 years without other risk factors, screening can
be done every 3 years.

PERKENI GUIDELINES 2011-revices

HbA1c

Check at first visit


Used as tool for diagnosis (6.5%)

Every 3 months later on (at least every 6 months)


For blood control evaluation

PERKENI GUIDELINES 2011-revices

Diabetes Care

Target of Treatment

BMI (kg/m2)

Risk CVD (-)

Risk CVD (+)

18.5 <23

18.5 <23

Blood Glucose

FPG (mg/dL)

<100

<100

Post Prandial BG (mg/dL)

<140

<140-180

<7.0

<7.0

<130/80

<130/80

Total Cholesterol (mg/dL)

<200

<200

Triglyceride (mg/dL)

<150

<150

HDL Cholesterol (mg/dL)

>40 / >50

>40 / >50

LDL Cholesterol (mg/dL)

<100

<70

A1C (%)
Blood Pressure
Lipid

PERKENI GUIDELINES 2011-revices

Strategies for Improving


Diabetes Care

Diabetes Self-Management

Team Care:
Physician
Nurse
Dietitian
Educator

Role of Team Members


To prepare people with
diabetes to make
self-management
decisions on their own
People with diabetes
are at the center of
the health team and
can learn to
self-manage
their diabetes

Whos teaching the diabetics? Etzwiler DD. Diabetes 1967:16:111-7.

PERKENI: Patient Education


Daily activities
Be active most of the time
Be productive

Self-management skills
Preparing pills, insulin
Follow drug schedule
Side effect awareness

Foot care
Daily foot care & appropriate shoes

Medical checkup

PERKENI: Patient Education


Healthy eating:
healthy food choices, food composition (carbs, protein,
fat, fiber)

Body weight maintenance:


achieved target of BMI or reduced 5 10% of body
weight

Exercise
Monitoring:

self-monitoring of blood glucose, A1C


Hypoglycemia: awareness & self-treatment

Self-Monitoring
of Blood Glucose (SMBG)
SMBG: one tool to assess therapy in diabetic patients that is
recommended especially in:

Patients that will undergo insulin therapy


Patients receiving insulin therapy
Patients with A1C level did not reach the target
Women planned for pregnancy / pregnant women with
hyperglycemia

Patients with recurrent hypoglycemia.

Diabetes Management DiabCare Asia


2008 Type of Management
Diabetes Management Variable

n (%)*

Type of Management
Diet only
OAD Insulin monotherapy
Insulin monotherapy
Insulin and OAD combination

1133 (61.88)
317 (17.31) 35
356 (19.44)

Herbal

5 (0.27)

None

20 (1.09)

*n = 1785

Soewondo P. Med J Indones 2010;19(4):235-244

Diabetes Management DiabCare Asia


2008 Type of OAD Therapy
Diabetes Management Variable

n (%)*

Type of OAD Therapy


Biguanides

1085 (59.26)

Sulphonylureas

1036 (56.58)

Meglinitides
Alpha glucosidase inhibitors

8 (0.44)
461 (25.18)

TZDs

51 (2.79)

Other OADs

48 (2.62)

Traditional herbal medicines

5 (0.27)

Double drug fixed dose combination

88 (4.81)

Soewondo P. Med J Indones 2010;19(4):235-244

PERKENI Guidelines 2011-revice


DM

Phase - I

Lifestyle
Modification

Phase - III

Lifestyle
Modification
+
OAD
Monotherapy

Phase - II

Alternative:
Insulin not available
Patient preference
Glucose control not
optimal

Lifestyle
Modification
+

Lifestyle
Modification

2 OADs
Combination

Lifestyle
Modification

2 OADs
Combination
+
Basal Insulin

+
Notes:
Fail: not achieving A1c target < 7% after 2-3 months of treatment
(A1c = average blood glucose conversion, ADA 2010)

3 OADs
Combination

Intensive Insulin

PERKENI Guidelines 2011-revice


< 7%

7 8%

Lifestyle
Modification

Lifestyle
Modification

8 - 9%

Lifestyle
Modification

Monotherapy

Met, SU, AGI,


Glinid, TZD,
DPP-IV

2 OADs
Combination
Met, SU, AGI,
Glinid, TZD,
DPP-IV

Notes:
Fail: not achieving A1c target < 7%
after 2-3 months of treatment
(A1c = average blood glucose conversion, ADA 2010)

> 9%

Lifestyle
Modification
+
3 OADs
Combination
Met, SU, AGI,
Glinid, TZD,
DPP-IV

9 - 10%

> 10%

Lifestyle
Modification
+
2 OADs
Combination
Met, SU, AGI,
Glinid, TZD,
DPP-IV

Lifestyle
Modification

Basal Insulin

+
Intensive
Insulin

Impact of Intensive Therapy


for Diabetes: Summary of
Major Clinical Trials
Study
UKPDS
DCCT /
EDIC*
ACCORD
ADVANCE
VADT

Microva
sc

CVD

Kendall DM, Bergenstal RM. International Diabetes Center 2009

UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:854.

Mortality

Initial Trial

Long Term Follow-up


* in T1DM

Individualized target of therapy

Suggested goals for Glycemic Treatment in Patients with Type-2


Diabetes
Suggested goals for Glycemic
Treatment in Patients with Type-2
GlycatedDiabetes
Hemoglobin Range
Most Intensive Level
Approximately 6.0%
Highly motivated,
adherent,
knowledgeable, strong
self-care capability

Factors

Psychosocial
considerations

Least Intensive Level


Approximately 8.0%
Less motivated, nonadherent, less
knowledge, weak selfcare capability

Adequate

Resources or support
systems

inadequate

Low

Risk of hypoglycemia

High

Short

Duration of type-2 DM

long

Long

Life expectancy

Short

None

Microvascular disease

Advances

None

Cardiovascular disease

Established

None

Coexisting conditions

Multiple, severe, or both

Ismail-Beigi. N Engl J Med 366:1319, 2012

Profiles of Antidiabetic Medications


METF

DPP-4 I

GLP1 RA

TZD

AGI

COL
SVL

BCR
OR

HYPOs
Neutral

Neutral

Neutral

Neutral

Neutral

Neutral

SU/glini
de

INSULIN

Moderate
to severe

Moderate
to severe

Neutral

SGLT2

PRAML

Neutral

Neutral

Mild

Weight

Slight loss

Neutral

Loss

Gain

Neutral

Neutral

Neutral

Gain

Gain

Loss

Loss

Renal / GU

Contra
indicated
grd 3B,4,5

Neutral ?

Exenaitide
contra
indicate in
clr crt<30%

May
worsen
fluid
retention

Neutral

Neutral

Neutral

More
hypoglyce
mia

More hypo
risk & fluid
retention

Infection

Neutral

GI Sx

Moderate

Neutral

Moderate

Neutral

Moderate

Mild

Moderate

Neutral

Neutral

Neutral

Moderate

CHF

Neutral

Neutral

Neutral

Moderate

Neutral

Neutral

Neutral

Neutral

Neutral

Neutral

Neutral

CVD

Benefit

Neutral

Neutral

Neutral

Neutral

Neutral

Benefit

Neutral

Neutral

Neutral

BONE

Neutral

Neutral

neutral

Moderate
bone loss

Neutral

Neutral

Neutral

Neutral

Neutral

Bone
loss?

Neutral

Few adverse events or possible


benefits

Used with caution

Likelihood of adverse
events

Treatment Approach
Other drugs than metformin can be used as initial treatment in some cases
Type-2 Diabetic Patients

Lifestyle intervention + 1st initial drug


A1c not at target
Stringent group
A1c target <7%

Less Stringent group


A1c target 8%

Existing A1c and A1c Target of Tx


Gap between existing A1c
and target of Tx > 2%

insulin

Comorbid
Recurrent HYPOs
Overweight / Obese

Gap between existing A1c


and target of Tx < 2%
Drugs
Metformin / GLP-1RA / DPP4-inh / AGI / TZD
GLP-1RA / DPP4-I / Metformin / AGI

Cardiovascular Diseases

Metformin / TZD / incretin Tx (?)

Congestive Heart Failure

Insulin / Metformin () / Incretin Tx

Chronic Kidney Disease

Insulin / DPP4-I or AGI (adjust dose)

Liver diseases

Insulin, TZD (hepatosteatosis), DPP4-I (?)

Detection and Diagnosis


Gestational Diabetes
(GDM)

Gestational Diabetes Mellitus (GDM)


Diagnosis of GDM based on OGTT (75 g glucose orally)
Diagnose:
FBG 95 mg/dl; 1 hr PP 180 mg/dl; 2 hr PP 150 mg/dl

Manage by team care


Objective: to reduce morbidity and mortality of the mother and
the baby

Target of treatment
FBG : 95 mg/dl
2hrPP : 120 mg/dl

Assessment of Common
Comorbid Complications

Dyslipidemia
Dyslipidemia increases cardiovascular risk
Check lipid profile in first visit newly diabetic patient
and repeat at least every 1 year
Target of treatment:
LDL:
Without CVD < 100 mg/dl
With
CVD < 70 mg/dl

HDL:
Men > 40 mg/dl; women > 50 mg/dl

TG:
<150 mg/dl

Therapy:
Non pharmacology
Pharmacology: statin, fibrate, niacin

Hypertension
Initiation therapy when BP: >130/80 mmHg
Target of treatment: 130/80 mmHg
Therapy:
Non pharmacology

Reduce BW
Exercise
Stop smoking and alcohol
Reduce salt intake

Pharmacology:

ACE-I
ARB
CCB
Low dose diuretic
Alpha-receptor blocker

Anti Platelet coagulation


Low dose aspirin (75-160 mg/day), is used for:

Diabetic patients with cardiovascular risk


Patient > 40 years old
Not recommended for patient < 21 years old
Combination with other anti-platelet use for
patient with high risk
Other anti-platelet is used for patient with
intolerance to aspirin

Nephropathy
Assess urine albumin excretion annually
Persistence micro-albuminuria (30-299 mg/24 hrs)
indicated DN

Measure albumin/creatinine ratio annually


Control blood glucose
Control blood pressure

Recommendations: Hypoglycemia
Glucose (15 20g) preferred treatment for conscious
individual with hypoglycemia

Check blood glucose 15 minute after glucose therapy


(oraly/iv)

Glucagon should be prescribed for all individuals at


significant risk of severe hypoglycemia and
caregivers/family members instructed in administration

Those with hypoglycemia unawareness or 1 episodes


of severe hypoglycemia should raise glycemic targets to
reduce risk of future episodes

ADA. V. Diabetes Care. Diabetes Care 2012;35(suppl 1):S27.

Summary

According to the most recent PERKENI and


ADA Standards of Care:
optimal diabetes care requires appropriate and
evidence-based prevention, screening, diagnosis,
treatment and educational strategies.

Thank You

40

41

Oral Diabetes Drugs in Indonesia


Class

Generic
name
Glibenclamid
Glipizid

Gliklazid
Sulfonylurea

Glikuidon

Glimepirid

Glinide

Repaglinid
Nateglinid

Thiazolidinedione

Gluckosidase
alpha inhibitor

Pioglitazone

Acarbose

Metformin
Biguanide

Trade name

mg/tab

Daily dose (mg)

Duration of
action (hrs)

Freq/day

Daonil

2.5 5

2.5 15

12 24

12

Minidiab

5 10

5 20

10 16

12

Glucotrol-XL

5 10

5 20

12 16**

80

80 320

10 20

12

30 60

30 120

24

30

30 120

68

23

Amaryl

1-2-3-4

0.5 6

24

Gluvas

1-2-3-4

16

24

Amadiab

1-2-3-4

16

24

Metrix

1-2-3-4

16

24

1.5 6

Starlix

120

360

Actos

15 30

15 45

24

Deculin

15 30

15 45

24

Pionix

15 30

15 45

18 24

Glucobay

50 100

100 300

Eclid

50 100

100 300

500 850

250 3000

68

13

500

500 3000

68

23

24

Diamicron
Diamicron-MR
Glurenorm

Dexanorm

Glucophage
Glumin
Glucophage XR

500 750

Taking
time

Before
meal

Not depend
on meal

First spoon

With/after

Oral Diabetes Drugs in Indonesia


Class

DPP-IV
inhibitors

Generic
name

Trade name

mg/tab

Daily dose (mg)

Duration of
action (hrs)

Freq/day

50

50 100

12 24

12

Januvia

25, 50, 100

25 100

24

Onglyza

24

Max dose of
glibenclamid 20 mg/day

12 24

12

Vildagliptin

Galvus

Sitagliptin
Saxagliptin

Taking
time
Not depend
on meal

250/1.25
Metformin +
Glibenclamid

Glucovance

500/2.5
500/5

Glimepirid +
Metformin
Fixed
combintaion

Amaryl-Met FDC

Pioglitazone +
Metformin

Pionix M

Sitagliptin +
Metformin

Janumet

1/250

2/500

2/500

4/1000

15/500
30/850
50/500
50/1000

Max dose of
pioglitazone 45 mg/day

With / after
meal
18 24

Max dose of sitagliptin


100 mg/hari

50/500
Vildagliptin +
Metformin

Galvusmet

50/850
50/1000

Max dose of
vildagliptin 100 mg/hari

12 24

Insulin in Indonesia
Insulin

Onset of action

Peak of action

Duration of action

30-60 minute

30-90 minute

3-5 hrs

Vial, pen/cartridge

Insulin Lispro (Humalog)

5-15 minute

30-90 minute

3-5 hrs

Pen/cartridge

Insulin Glulisine (Apidra)

5-15 minute

30-90 minute

3-5 hrs

Pen

Insulin Aspart (Novorapid)

5-15 minute

30-90 minute

3-5 hrs

Pen, Vial

2-4 hrs

4-10 hrs

10-16 hrs

Vial, Pen/cartridge

Insulin Glargine (Lantus)

2-4 hrs

No Peak

20-24 hrs

Pen

Insulin Detemir (Levemir)

2-4 hrs

No Peak

16-24 hrs

Pen

70% NPH 30% Reguler


(Mixtard, Humulin 30/70)

30-60 minute

Dual

10-16 hrs

Pen/cartridge

70% Insulin Aspart Protamin


30% Insulin Aspart (Novomix 30)

10-20 minute

Dual

15-18 hrs

Pen

Insulin Prandial (Meal Related)

Insulin Short Acting


Reguler (Actrapid, Humulin R)
Insulin Analog Rapid Acting

Insulin Intermediate Acting


NPH (Insulatard, Humulin N)
Insulin Long Acting

Insulin Campuran

Properties of anti-hyperglycemic agents


Class

Mechanism

Advantages DisadvantageCost
s

Biguanide
s

Activates AMPkinase
Hepatic glucose
production

Extensive
experience
No hypoglycemia
Weight neutral
? CVD

Gastrointestinal
Lactic acidosis
B-12 deficiency
CKD

Low

SUs /
Meglitinid
es

Closes K-ATPchannels
Insulin secretion

Extensive
experience
Microvasc. risk

Hypoglycemia
Weight gain
Low durability
? Ischemic
preconditioning

Low

TZDs

PPAR- activator
insulin
sensitivity

High

DPP-4
inhibitors

Inhibits DPP-4
Increases GLP-1,
GIP

No hypoglycemia
Well tolerated

Weight gain
Edema / heart
failure
Bone fractures
? MI (rosi)
Modest
A1c
? Bladder
ca (pio)
? Pancreatitis
Urticaria

No hypoglycemia
Durability
TGs, HDL-C
? CVD (pio)

High

Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of


print]

Properties of anti-hyperglycemic agents


Class

Mechanism

Advantages DisadvantageCost
s

-GIs

Inhibits
glucosidase
Slows
carbohydrate
absorption

No hypoglycemia
Nonsystemic
Post-prandial
glucose
? CVD events

Gastrointestinal
Dosing frequency
Modest A1c

Mod.

GLP-1
receptor
agonists
Insulin

Activates GLP-1 R
Insulin,
glucagon
Activates
gastric insulin
receptor
emptying
peripheral
satiety
glucose
uptake

Weight loss
No hypoglycemia
? Beta cell mass
? CV protection
Universally
effective
Unlimited efficacy
Microvascular
risk

GI
? Pancreatitis
? Medullary
Hypoglycemia
cancer
Injectable
Weight
gain
? Mitogenicity
Injectable
Training
requirements
Stigma

High

Vari
able

Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of

First Line of Drugs

ADA EASD 2014

AACE 2012

NICE 2009

IDF 2012

Type-2 DM Drug Treatment


HbA1c
Guideline
<7%

<7-8%

HLS

HLS

Healthy Lifestyle

>10%

+
HLS

Monotherapy
Reduced
BW
Healthy Diet
Exercise

9-10%

<8-9%

Met, SU,
AGI, Glinid,
TZD, DPP IV

+
2 drugs
combination

HLS

Met, SU,
AGI, Glinid,
TZD, DPP IV

3 drugs
combination

Met, SU,
AGI, Glinide,
TZD, DPP IV

HLS
+
2 drugs
combination
Met, SU,
AGI, Glinid,
TZD
+
Basal Insulin

HLS
GSH
+
Intensive
Insulin *

* Intensive insulin : basal bolus approach

Indonesian Society of Endocrinology , 2011

Treatment approach
DIABETES
TARGET of TREATMENT

< 7%
(more stringent)

8%
(less stringent)

CO-CONDITIONS

DRUGS CHOICES

Gap of A1c to target

Recurrent HYPOs

Overweight / obese

Cardio Vascular Disease

Congestive Heart Failure

Chronic Kidney Disease

Liver disease

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