T2DM: NICE Guidelines

Dr Nemanja Stojanović

Consultant Endocrinologist Queen’s Hospital, Romford

The Talk

• Diabetes: Definition/ Classification

• A few cases

• NICE Guidelines

• New Developments

Definition

– Fasting plasma glucose 7mmol/l- 2 occasions

– 2 h plasma glucose or random glucose of 11.1 mmol/l

Case1: What is Your Next Question ?

• Is there family history of Diabetes?

• She should be referred and genetic counselling offered

DM Classification

• Type 1 DM

• Type 2 DM

• GDM

• ? Double Diabetes

• Type 1.5

• LADA

• Other subtypes

Genetic Diabetes

MODY

• HNF-4α (1)• Glucokinase (2)• HNF-1α (3)• IPF1   (4)• HNF-1β (5)• Neuro D1 (6)

• Neonatal Diabetes• Mitochondrial DNA

defects• Genetic defects of

insulin action

Drug Induced

• Steroids• Pentamidine• T4• β blockers• Dizoxide• Nicotinic Acid• Thiazides• α Interferon

Other Forms of DM

ENDOCRINOPATHIES

• Acromegaly• Cushing’s Disease• Glucagonoma• Hyperthyroidism• Somatostatinoma• Aldosteronoma• Pheochromocytoma• Others

Exocrine Pancreas

• Cystic Fibrosis• Hemochromatosis• Haemosiderosis• Cancer• Trauma/ surgery• Pancreatitis

NICE May 08

• Patient centred care

• Good communication is essential

• Support the care with evidence based medical information

• Allow patient is to reach informed decisions about their care

Self Monitoring

• Offer it only as a part of integral care • Discuss the purpose• Insulin treatment• OHA’s: to provide information on

hypoglycaemia• To assess changes in glucose control resulting

from medications and lifestyle change• To monitor glucose during intercurrent illness• To ensure safety during activities, including

driving.

Education

• Meet the national criteria laid down by DoH

• Meet the local cultural, linguistic, cognitive and literacy needs

• Provide appropriate resources to support the educators, who should be properly trained and allowed time to develop and maintain their skills.

Diet

• General advice for healthy eating:- Include high-fibre, low-glycaemic index sources

of carbohydrate- Include low-fat dairy products and oily fish- Control the intake of foods containing saturated

fats and trans fatty acids

HbA1c

• Target: 6.5%

• Discuss with the patient appropriate levels, set individual A1c targets

• Escalate treatment when HbA1c is> 7.5%

Metformin

• Start over several weeks

• Consider SR if GI side effects

• Stop if Cr> 150umol/l or GFR< 30ml/min

• In patient with moderate liver impairment /cardiac dysfunction discuss with the patient risk vs benefit

• Start low cost (not glibenclamide) when indicated

• Educate about the risk of hypoglycaemia

• PPGs

Sulphonylureas

Glitazones

• Warn about significant oedema and tell the person what to do if it happens

• Do not start if evidence of LVF or high risk of fracture

• When selecting a glitazone take into account most up-to-date advice, safety and cost issues

• HbA1c> 7.5%• BMI (Caucasian)> 35• Has specific psychological, biochemical or

physical problems arising from high body weight

• Would otherwise be starting TZD or insulin.

• Continue if of 1% in A1c over 6 months and BW of 5% over 12 months

Exenatide

Acarbose

• If unable to tolerate other medications

Insulin

• If HbA1c> 7.5%

• Structured programme

• Start once or twice daily NPH with SU + metformin

• Injection devices/ sharps

Glargine

• Patients who need help injecting

• BD insulin otherwise needed

• Significant hypoglycaemia including nocturnal hypos

Biphasic Insulin

• HbA1c > 9.0%.

Biphasic Analogues

- Immediate injection before the meals is preferred

- Problems with hypos

- Postprandial hyperglycaemia is a problem

Blood Pressure

• Target 140/80 mmHg

• If macro/ microvascular damage: retinopathy, nephropathy, cerebrovascular disease: 130/80 mmHg

• Monitor for SE of therapy

Blood Pressure

• Monitor annually in normotensive patients without renal disease

• BP above the target:

- Repeat within a month if > 150/90mmHg

- Repeat within 2 months if > 140/80mmHg

- Repeat within 2 months if > 130/80mmHg & eye, kidney or cerebrovascular disease

Patients Not at High CVS Risk

• Normal weight

• BP< 140/80mmHg off treatment

• Normal ACR/ AER

• Non smokers

• Do not have high risk lipid profile

• No PMH of CVH

• No FH of CVDDO N

OT HAVE A

NY OF THESE

Effect of reduction of LDL by 1mmol/l by any means on coronary death and non-fatal MI:

meta-analysis of 58 trials0%

5%

10%

15%

20%

25%

30%

35%

40%

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6

Law MR BMJ 2003, 326: 1423-9

Equivalent Doses

Dose LDL Reduction %

Atorvastatin+ 10 39

Simvastatin 20-40 35-41

Pravastatin 40 34

Rosuvastatin 5-10 39-45

Fluvastatin 40-80 25-35

Ezetamibe 10 16-18 (12-21c)

+ + max dose decreases the LDL by additional 20%max dose decreases the LDL by additional 20%

Nephropathy

• Assess annually: ACR, Cr

• High ACR: repeat 2x within 3-4 months

• Treat with ACE/ ARB

• Aim for BP< 130/80mmHg

Suspect Intrinsic Renal Disease

• No retinopathy• BP resistant to treatment• Proteinuria in the face of previously normal

ACR• Rapid decline in ACR• Haematuria• Systemically ill patient

Eye Screening

• Annually

• Discuss the benefits

• Tropicamide and Driving

Referral to Ophthalmologist

• Maculopathy

• Unexplained loss of VA

• Pre-proliferative retinopathy

Studies/ Recommendations that followed the Guideline

ADVANCE

• 11140 patients: 5 years

• Intensive glycaemic control (A1c 6.5%) vs Conventional (A1c 7.3%)

• Intensive group: gliclazide MR 30 to 120 mg daily and other hypoglycamic agents including insulin

N Engl J Med 2008;10.1056/NEJMoa0802987

ADVANCE Primary Endpoints

• Composite of macro and microvascular events considered jointly and separately

• Macro: CVD death, non fatal CVA & MI

• Micro:new or worsening nephropathy ; doubling of the serum creatinine; the need for dialysis; death due to renal causes; worsening of retinopathy

N Engl J Med 2008;10.1056/NEJMoa0802987

ADVANCE Conclusion

• The main contributor to the 10% relative reduction in the primary outcome found with intensive control as compared with standard control was a 21% relative reduction in the risk of new or worsening nephropathy

• More modest but significant reduction in microalbuminura

ACCORD Trial

• 10,251 patients• Intensive glycaemic control and CVS outcomes• Primary outcomes : CVD death, Non fatal CVA &

MI• Intensive Treatment: HbA1c< 6%• Conventional Treatment HbA1c 7-7.9• Death rates begin to separate after 1 year…..

N Engl J Med 2008;10.1056/NEJMoa0802743

ACCORD

Intensive (%) Conventional(%)n 5128 5123

Hypoglycaemia 538 (10.5) 179 (3.5)

Weight gain> 10kg 1399 (27.8) 713 (14.1)

CVD Death 135 (2.6) 94 (1.8)

Non fatal MI 186 (3.6) 235 (4.6)

Non fatal CVA 67 (1.3) 61 (1.2)

Any Death 257 (5) 203 (4) N Engl J Med 2008;10.1056/NEJMoa0802743

HbA1c and Screening for T2DM

• <6%

• 6.1-6.5%

• 6.5-6.9%

• >7%

JCEM,2008; 93: 2447-53

Fasting Plasma Glucose and CVA/ Vascular Events: NOMAS

• 3298 participants

• 572 patients with DM

• DM patients: 338 elevated FPG > 7mmol/l

• In elevated FPG: CVA HR 2.7(95 CI: 2.0-3.8)

• Those with DM and normal FPG were not at increased risk

Dia Care 2008; 31:1132- 37

Conclusion

• A1c 6.5% ( ? 7.5%)

• BP 130/80mmHg (140/8o mmHg)

• Cholesterol 4mmol/l

• LDL 2mmol/l

• Triglycerides 4.5mmol/l

• Eyes, Kidneys, Nerves: Screen annually

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