2015 PDCI Core Kit 3b PERKENI Standards of Medical Care -
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Transcript of 2015 PDCI Core Kit 3b PERKENI Standards of Medical Care -
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 and more appropriately.
• 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
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
• Medical Nutritional Therapy
• Physical activity
• Weight reduction
• If overweight, reduce body weight by 5-10%
• Physical exercise for 30 minutes,
5 times/week, or 150 minutes/week
• Not yet recommended
Early Detection Lifestyle ChangesPharmacology
Therapy
Periodic Blood Glucose & Risk
Factor Monitoring
• Hypertension
• Dyslipidemia
• Physical health
• Body weight control
• 2-hour OGTT is the most sensitive method for early detection and a recommended screening test procedure
Management
Diagnosis
Screening/Testing for Diabetes in
Asymptomatic Patients
PERKENI Guidelines 2011
Diabetes Symptoms
Diabetes Classic Symptoms (+) Diabetes Classic Symptoms (-)
FBG ≥126 <126
RBG >200 <200
FBG and PPG
FBG >126 <126
RBG ≥200 <200
Diabetes Mellitus
FBG ≥126 100-125
RBS >200 140-199
<100
<140
OGTT 2 hour BG
Evaluation of Nutritional StatusEvaluation Diabetic Complications
Evaluation Dietary Need and Dietary Planning
>200 140-199
IGT IFG Normal
<140
EducationDietary Planning
Physical ExerciseAchieving Ideal Body Weight
atau atau
atau
FBG = Fasting Blood GlucoseRBG = Random Blood GlucoseIGT = Impaired Glucose ToleranceIFG = Impaired Fasting Glucose
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 blood glucose level(mg/dL)
Venous plasma
<100 100-199 ≥200
Capillary blood <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
Risk CVD (-) Risk CVD (+)
BMI (kg/m2) 18.5 – <23 18.5 – <23
Blood Glucose
• FPG (mg/dL) <100 <100
• Post Prandial BG (mg/dL) <140 <140-180
A1C (%) <7.0 <7.0
Blood Pressure <130/80 <130/80
Lipid
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
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
Who’s 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 1133 (61.88)
• Insulin monotherapy 317 (17.31) 35
• Insulin and OAD combination 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 8 (0.44)
• Alpha glucosidase inhibitors 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
DM Phase - I Phase - II Phase - III
Lifestyle Modification
+
Intensive Insulin
Alternative:• Insulin not available• Patient preference• Glucose control not
optimal
Lifestyle Modification
OAD Monotherapy +
Lifestyle Modification
2 OADs Combination
+
Lifestyle Modification
2 OADs Combination
Basal Insulin
+
+
Lifestyle Modification
3 OADs Combination
Notes:Fail: not achieving A1c target < 7% after 2-3 months of treatment(A1c = average blood glucose conversion, ADA 2010)
PERKENI Guidelines 2011-revice
< 7% 7 – 8% 8 - 9% > 9% 9 - 10% > 10%
Lifestyle Modification
Lifestyle Modification
+
Monotherapy
Met, SU, AGI, Glinid, TZD,
DPP-IV
Lifestyle Modification
+
2 OADs Combination
Met, SU, AGI, Glinid, TZD,
DPP-IV
Lifestyle Modification
+
3 OADs Combination
Met, SU, AGI, Glinid, TZD,
DPP-IV
Lifestyle Modification
+
2 OADs Combination
Met, SU, AGI, Glinid, TZD,
DPP-IV
+
Basal Insulin
Lifestyle Modification
+
Intensive Insulin
Notes:Fail: not achieving A1c target < 7% after 2-3 months of treatment(A1c = average blood glucose conversion, ADA 2010)
PERKENI Guidelines 2011-revice
Study Microvasc CVD Mortality
UKPDS DCCT / EDIC*
ACCORD ADVANCE
VADT
Long Term Follow-up
Initial Trial
* in T1DM
Kendall DM, Bergenstal RM. © International Diabetes Center 2009
UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:854.
Holman RR et al. N Engl J Med. 2008;359:1577. DCCT Research Group. N Engl J Med 1993;329;977.
Nathan DM et al. N Engl J Med. 2005;353:2643. Gerstein HC et al. N Engl J Med. 2008;358:2545.
Patel A et al. N Engl J Med 2008;358:2560. Duckworth W et al. N Engl J Med 2009;360:129. (erratum:
Moritz T. N Engl J Med 2009;361:1024)
Impact of Intensive Therapy for Diabetes: Summary of Major Clinical Trials
Individualized target of therapy
Most Intensive Level Approximately 6.0%
Factors Least Intensive Level Approximately 8.0%
Highly motivated, adherent,
knowledgeable, strong self-care capability
Psychosocial considerations
Less motivated, non-adherent, less
knowledge, weak self-care 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
Glycated Hemoglobin Range
Suggested goals for Glycemic Treatment in Patients with Type-2 Diabetes
METF DPP-4 I GLP1 RA TZD AGI COL SVL
BCR OR
SU/glinide
INSULIN SGLT2 PRAML
HYPOs
Neutral Neutral Neutral Neutral Neutral Neutral Neutral
Moderate to severe
Mild
Moderate to severe
Neutral Neutral
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
hypoglycemia
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
Profiles of Antidiabetic Medications
Comorbid Drugs
Recurrent HYPOs Metformin / GLP-1RA / DPP4-inh / AGI / TZD
Overweight / Obese 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 (?)
Type-2 Diabetic Patients Lifestyle intervention + 1st initial drug
A1c not at target
Existing A1c and A1c Target of Tx
Stringent group A1c target <7%
Less Stringent group A1c target ±8%
Gap between existing A1c and target of Tx > 2% Gap between existing A1c
and target of Tx < 2%
insulin
Other drugs than metformin can be used as initial treatment in some cases
Treatment Approach
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.
40
Thank You
41
Oral Diabetes Drugs in Indonesia
Class Generic name
Trade name mg/tab Daily dose (mg) Duration of action (hrs)
Freq/day Taking time
Sulfonylurea
Glibenclamid Daonil 2.5 – 5 2.5 – 15 12 – 24 1 – 2
Before meal
GlipizidMinidiab 5 – 10 5 – 20 10 – 16 1 – 2
Glucotrol-XL 5 – 10 5 – 20 12 – 16** 1
GliklazidDiamicron 80 80 – 320 10 – 20 1 – 2
Diamicron-MR 30 – 60 30 – 120 24 1
Glikuidon Glurenorm 30 30 – 120 6 – 8 2 – 3
Glimepirid
Amaryl 1-2-3-4 0.5 – 6 24 1
Gluvas 1-2-3-4 1 – 6 24 1
Amadiab 1-2-3-4 1 – 6 24 1
Metrix 1-2-3-4 1 – 6 24 1
GlinideRepaglinid Dexanorm 1 1.5 – 6 3
Nateglinid Starlix 120 360 – 3
Thiazolidinedione Pioglitazone
Actos 15 – 30 15 – 45 24 1Not depend on meal
Deculin 15 – 30 15 – 45 24 1
Pionix 15 – 30 15 – 45 18 – 24 1
Gluckosidase alpha inhibitor
AcarboseGlucobay 50 – 100 100 – 300 3
First spoonEclid 50 – 100 100 – 300 3
Biguanide
MetforminGlucophage 500 – 850 250 – 3000 6 – 8 1 – 3
With/after meal
Glumin 500 500 – 3000 6 – 8 2 – 3
Metformin XRGlucophage XR 500 – 750 24 1
Glumin XR 500 500 – 2000 24 1
Oral Diabetes Drugs in Indonesia
Class Generic name
Trade name mg/tab Daily dose (mg) Duration of action (hrs)
Freq/day Taking time
DPP-IV inhibitors
Vildagliptin Galvus 50 50 – 100 12 – 24 1 – 2Not depend on meal
Sitagliptin Januvia 25, 50, 100 25 – 100 24 1
Saxagliptin Onglyza 5 5 24 1
Fixed combintaion
Metformin + Glibenclamid
Glucovance
250/1.25Max dose of
glibenclamid 20 mg/day12 – 24 1 – 2
With / after meal
500/2.5
500/5
Glimepirid + Metformin
Amaryl-Met FDC1/250 2/500 2
2/500 4/1000
Pioglitazone + Metformin
Pionix M15/500 Max dose of
pioglitazone 45 mg/day18 – 24 1
30/850
Sitagliptin + Metformin
Janumet50/500 Max dose of sitagliptin
100 mg/hari1
50/1000
Vildagliptin + Metformin
Galvusmet
50/500Max dose of
vildagliptin 100 mg/hari12 – 24 250/850
50/1000
Insulin in Indonesia
Insulin Onset of action Peak of action Duration of action
Insulin Prandial (Meal Related)
Insulin Short Acting
Reguler (Actrapid®, Humulin® R) 30-60 minute 30-90 minute 3-5 hrs Vial, pen/cartridge
Insulin Analog Rapid Acting
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
Insulin Intermediate Acting
NPH (Insulatard®, Humulin® N) 2-4 hrs 4-10 hrs 10-16 hrs Vial, Pen/cartridge
Insulin Long Acting
Insulin Glargine (Lantus®) 2-4 hrs No Peak 20-24 hrs Pen
Insulin Detemir (Levemir®) 2-4 hrs No Peak 16-24 hrs Pen
Insulin Campuran
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
75% Insulin Lispro Protamin30% Insulin Lispro (HumalogMix® 25)
5-15 minute Dual 16-18 hrs Pen/cartridge
Class Mechanism Advantages Disadvantages CostBiguanides • Activates AMP-
kinase• Hepatic glucose production
• Extensive experience• No hypoglycemia• Weight neutral• ? CVD
• Gastrointestinal• Lactic acidosis• B-12 deficiency• CKD
Low
SUs / Meglitinides
• Closes K-ATP- channels• Insulin secretion
• Extensive experience• Microvasc. risk
• Hypoglycemia• Weight gain• Low durability• ? Ischemic preconditioning
Low
TZDs • PPAR-g activator• insulin sensitivity
• No hypoglycemia• Durability• TGs, HDL-C • ? CVD (pio)
• Weight gain• Edema / heart failure• Bone fractures• ? MI (rosi)• ? Bladder ca (pio)
High
Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print]
DPP-4inhibitors
• Inhibits DPP-4• Increases GLP-1, GIP
• No hypoglycemia• Well tolerated
• Modest A1c • ? Pancreatitis• Urticaria
High
Properties of anti-hyperglycemic agents
Class Mechanism Advantages Disadvantages Costa-GIs • Inhibits -a
glucosidase• Slows carbohydrate absorption
• No hypoglycemia• Nonsystemic• Post-prandial glucose• ? CVD events
• Gastrointestinal• Dosing frequency• Modest A1c
Mod.
GLP-1 receptor agonists
• Activates GLP-1 R• Insulin, • glucagon• gastric emptying• satiety
• Weight loss• No hypoglycemia• ? Beta cell mass• ? CV protection
• GI• ? Pancreatitis• ? Medullary cancer • Injectable
High
Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print]
Insulin • Activates insulin receptor• peripheral glucose uptake
• Universally effective• Unlimited efficacy• Microvascular risk
• Hypoglycemia• Weight gain• ? Mitogenicity• Injectable• Training requirements• “Stigma”
Variable
Properties of anti-hyperglycemic agents
First Line of Drugs
IDF 2012
AACE 2012
ADA – EASD 2014
NICE 2009
GSH
+
Intensive Insulin *
+
2 drugs combination
Met, SU,AGI, Glinid,
TZD
+
Basal Insulin
+
3 drugs combination
Met, SU,AGI, Glinide,TZD, DPP IV
+
2 drugs combination
Met, SU,AGI, Glinid,TZD, DPP IV
+
Monotherapy
Met, SU,AGI, Glinid,TZD, DPP IV
HLS
Healthy Lifestyle
• Reduced BW•Healthy Diet • Exercise
HbA1c
<7% <7-8% <8-9% 9-10% >10%
* Intensive insulin : basal bolus approach
HLS
HLS
HLS
HLS
HLS
Indonesian Society of Endocrinology , 2011
Type-2 DM Drug Treatment Guideline
DIABETES
TARGET of TREATMENT< 7%
(more stringent)± 8%
(less stringent)
CO-CONDITIONS DRUGS CHOICES
Recurrent HYPOs
Cardio Vascular Disease
Congestive Heart Failure
Chronic Kidney Disease
Liver disease
Overweight / obese
?
?
?
?
?
?
Gap of A1c to target ?
Treatment approach