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2012 SEMDSA Guideline for the Management of Type 2 Diabetes Mellitus. Aslam Amod 1st FCPSA Congress 19 May 2012, Cape Town. The Guideline & Steering Committee. The Guideline & Steering Committee (2). The Guideline & Steering Committee (3). The Guideline & Steering Committee (4).
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2012 SEMDSA Guideline for the Management of Type 2 Diabetes Mellitus Aslam Amod 1st FCPSA Congress 19 May 2012, Cape Town
Amod A et al. The 2012 SEMDSA guideline for the management of type 2 diabetes. JEMDSA. 2012;17(1):S1-S94. Available at http://www.jemdsa.co.za
Introduction • Target Audience • All healthcare professionals (medical & allied) • Focus on primary care, but also general physician • Funders of healthcare • Undergraduates and postgraduates • Not for “experts” • Self-proclaimed or otherwise • Disclaimer International Diabetes Federation. IDF Diabetes Atlas [cited 2012 Mar 18]. Available from: http:// www.idf.org/diabetesatlas
Disclaimer • This guideline is not intended to replace professional judgement, experience and appropriate referral. • These guidelines are intended to inform general patterns of care, to enhance diabetes prevention efforts and to reduce the burden of diabetes complications in people living with this disease. • They reflect the best available evidence at the time, and practitioners are encouraged to keep updated with the latest information in this rapidly changing field. • While every care has been taken to ensure accuracy, reference to product information is recommended before prescribing. • SEMDSA assumes no responsibility for personal or other injury, loss or damage that may result from the information in this publication. • Unless otherwise specified, these guidelines pertain to the care of adults with type 2 diabetes at primary care level.
Epidemiology / Prevalence • Type 2 > 90% • Local studies using 1985 WHO criteria • Rural African: 3.5% • Urban Coloured: 10.8% • Urban Indian: 13% • 30-85% undiagnosed • >90% are obese • IDF Atlas 5th edition • 6.5% of adults aged 20-79 years International Diabetes Federation. IDF Diabetes Atlas [cited 2012 Mar 18]. Available from: http:// www.idf.org/diabetesatlas
Diagnosis (WHO criteria) World Health Organization. Definition and diagnosis of diabetes mellitus and intermediate hyperglycaemia [cited 2011 Sep 20]. Available from: http://whqlibdoc.who.int/publications/2006/9241594934_eng.pdf.
Diagnosis (WHO criteria) • For clinical purposes, the diagnosis of diabetes should always be confirmed by repeating the test on another day (preferably the same test), unless there is unequivocal hyperglycaemia with acute metabolic decompensation or obvious symptoms (polyuria, polydipsia and weight loss).
Diagnosis (WHO criteria) • a “Fasting” is defined as no caloric intake for at least eight hours • bThe test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in 250 ml water ingested over five minutes
Diagnosis (WHO criteria) dThe classic symptoms of hyperglycaemia include polyuria, polydipsia and weight loss. “Hyperglycaemic crisis” refers to diabetic ketoacidosis or hyperosmolarnonketotichyperglycaemia.
Diagnosis (WHO criteria) cProvidedthat: -The test method meets stringent quality assurance criteria -The assay is NGSP certified and standardised to the DCCT assay -There are no conditions present which preclude its accurate measurement
Screening • Diagnosis vs. screening • Targeted screening advocated • High rate of undiagnosed diabetes • Age > 45 or any age with multiple risk factors • Repeat every 3 yrs or more frequently • Use FPG, OGTT or HbA1C • Exclude diabetes • FPG < 5.6 mmol/L; if not do OGTT • RPG < 5.6 mmol/L; if not do FPG or OGTT • HbA1C – do OGTT if 6.0 to 6.4%
Random PG <5.6 mmol/L • 5.6 – 11.0 • mmol/L ≥ 11.1 mmol/L + Symptoms Diabetes excluded Inconclusive Do FPG or OGTT Diabetes
Fasting PG <5.6 mmol/L • 5.6 – 5.9 • mmol/L • 6.0 – 6.9 • mmol/L • ≥ 7.0 • mmol/L Diabetes excluded Inconclusive Do OGTT IFG (Repeat) Diabetes (Repeat)
HbA1C Normal Normal – 5.9 % 6.0 – 6.4 % ≥ 6.5 % Diabetes excluded Clinical judgement Inconclusive Do FPG/OGTT Diabetes (Repeat)
2hr OGTT < 7.8 mmol/L • 7.8 – 11.0 • mmol/L ≥ 11.1 mmol/L Diabetes excluded IGT (Repeat) Diabetes (Repeat)
Translating HbA1C into estimated average glucose (eAG) Nathan DM et al for the A1c-Derived Average Glucose (ADAG) Study Group. Translating the A1C assay into estimated average glucose values. Diabetes Care 2008; 31: 1473– 1478
General Considerations • Type 2 diabetes is not a homogeneous disease • Try to understand the pathophysiology in each individual patient • Majority of patients treated at PHC level • Poor access to / use of laboratory testing esp. HbA1C and renal function • Increase number of agents that can be prescribed safely by PHC doctors and nurses without complex monitoring • Accumulating data on dangers of hypoglycaemia as a risk marker for CV death • Potential remission / cure in obese patients with substantial weight loss
Glycaemic control: SEMDSA 2012 algorithm for type 2 diabetes Use this algorithm only if the patient does NOT have features of severe decompensationa. Progress down this algorithm within 3 months if HbA1C remains above 7% (or individualised target). Choose therapies that are likely to produce the HbA1c reduction required to achieve the targetb Do not proceed with drug therapy without annual serum eGFR measurement Lifestyle measures plus Preferred therapies Alternative therapies for special circumstancesc STEP 1: INITIATE AT LEAST ONE ORAL DRUG AT DIAGNOSIS Metformin SU DPP-4i Acarbose Metformin SU Incretin Acarbose Basal Insulin STEP 2: COMBINE ANY 2 DRUGSd STEP 3: COMBINE 3 DRUGS Metformin + SU + Basal Insulin (or Metformin + Pre-mix) Metformin + SU + Incretin Metformin + SU + Acarbose STEP 4: MORE ADVANCED THERAPIES Refer to specialist for Basal + mealtime insulin ± Metformin ± Acarbose ± Incretin Metformin + Pre-mix insulin (if not used yet) SU = sulphonylurea. Not glibenclamide ; DPP-4i = Dipeptidyl peptidase inhibitor; eGFR = estimated glomerular filtration rate aSeveredecompensation includes any of: FPG > 15mmol/L, HbA1C > 11%, marked polyuria & polydipsia, weight loss > 5% or ketoacidosis. Refer the patient for specialist care (Step 4). bRefer to Table I for expected HbA1C reductions. cRefer to text dIf at diagnosis, the patient’s HbA1C is >9% without features of severe decompensation, consider initiating therapy at STEP 2.
Glycaemic control: SEMDSA 2012 algorithm for type 2 diabetes Use this algorithm only if the patient does NOT have features of severe decompensationa. Progress down this algorithm within 3 months if HbA1C remains above 7% (or individualised target). Choose therapies that are likely to produce the HbA1c reduction required to achieve the targetb Do not proceed with drug therapy without annual serum creatinine / eGFR measurement aSeveredecompensation includes any of: FPG > 15mmol/L, HbA1C > 11%, marked polyuria & polydipsia, weight loss > 5% or ketoacidosis. Refer the patient for specialist care (Step 4). bRefer to Table for expected HbA1C reductions.
Glycaemic control: SEMDSA 2012 algorithm Lifestyle measures plus Preferred therapies Alternative therapies for special circumstances Metformin SU DPP-4i Acarbose STEP 1: INITIATE AT LEAST ONE ORAL DRUG AT DIAGNOSIS
Glycaemic control: SEMDSA 2012 algorithm Lifestyle measures plus Preferred therapies Alternative therapies for special circumstances Metformin SU DPP-4i Acarbose STEP 1: INITIATE AT LEAST ONE ORAL DRUG AT DIAGNOSIS Metformin SU Incretin Acarbose Basal Insulin STEP 2: COMBINE ANY 2 DRUGSd dIf at diagnosis, the patient’s HbA1C is >9% (but without features of severe decompensation), consider initiating therapy at STEP 2
Glycaemic control: SEMDSA 2012 algorithm Lifestyle measures plus Preferred therapies Alternative therapies for special circumstances Metformin SU DPP-4i Acarbose STEP 1: INITIATE AT LEAST ONE ORAL DRUG AT DIAGNOSIS Metformin SU Incretin Acarbose Basal Insulin STEP 2: COMBINE ANY 2 DRUGSd STEP 3: COMBINE 3 DRUGS Metformin + SU + Basal Insulin (or Metformin + Pre-mix) Metformin + SU + Incretin Metformin + SU + Acarbose
Glycaemic control: SEMDSA 2012 algorithm Lifestyle measures plus Preferred therapies Alternative therapies for special circumstances Metformin SU DPP-4i Acarbose STEP 1: INITIATE AT LEAST ONE ORAL DRUG AT DIAGNOSIS Metformin SU Incretin Acarbose Basal Insulin STEP 2: COMBINE ANY 2 DRUGSd STEP 3: COMBINE 3 DRUGS Metformin + SU + Basal Insulin (or Metformin + Pre-mix) Metformin + SU + Incretin Metformin + SU + Acarbose STEP 4: MORE ADVANCED THERAPIES Refer to specialist for Basal + mealtime insulin ± Metformin ± Acarbose ± Incretin Metformin + Pre-mix insulin (if not used yet)
Metformin in the 2012 SEMDSA algorithm • Step 1: Monotherapy • Initial therapy of choice • Start at time of diagnosis in all patients (overweight and normal weight) unless specifically contra-indicated. • Step 2: Dual therapy • Can be added as a second-line agent in patients where treatment has been initiated with any other class of anti-diabetic drug. • It is recommended that metformin therapy continue even when other classes of anti-diabetic agents (including insulin) are added subsequently.
SU in the 2012 SEMDSA algorithm • Step 1: Monotherapy • at diagnosis in persons intolerant of metformin, or in normal weight individuals or those with marked symptoms of hyperglycaemia. • Step 2: Dual therapy • Add as 2nd drug to metformin, or any other drug used at Step 1 • Step 3: Triple therapy • with metformin and basal insulin, or metformin and incretin. • In gestational diabetes, glibenclamide is the sulphonylurea of choice (for specialist use only)
Meglitinides in the 2012 SEMDSA algorithm • Instead of SU • If FPG is at target but HbA1C and PPG levels are elevated