DIABETES

CARE

PATHWAY

VERSION 5 REVIEW

May May

2010 2011

CONTRIBUTORS Chris Baynes Paul Gouldstone Debbie Hicks Kit McAuley Dr Hilary Tindall Consultant Physician Head of Medicines Management Nurse Consultant Diabetes Diabetes Specialist Nurse Consultant Physician Barnet & Chase Farm Hospital NHS Enfield NHS Enfield Community Services NHS Enfield Community Services North Middlesex University Hospital

As endorsed by NHS Enfield NSF Implementation Group and NHS Enfield Commissioning Executive The printing of this document was supported by an unrestricted educational grant from the following companies: Abbott Laboratories Ltd Bayer Bristol Myers Squibb Pharmaceuticals Ltd Eli Lilly & Co Ltd GSK LifeScan (Johnson & Johnson) MSD Novo Nordisk Ltd Pfizer Ltd Sanofi Aventis Ltd Takeda UK Ltd

The following guidelines have been based on: NICE CG 66 Type 2 diabetes guidelines for Diabetes 2008 and NICE CG 87 Type 2 diabetes: partial update 2009 This document has been reviewed in its entirety in May 2010, however only some pages have required updating due to new evidence. These pages can be identified by the review date May 2010

DIABETES CARE PATHWAY TYPE 2 DIABETES

MILESTONE 1 Diagnostic phase

MILESTONE 2 Educative phase

MILESTONE 3 Treatment management phase

MILESTONE 4 Complication / risk management

MILESTONE 5 Maintenance phase

a. Lifestyle changes*

a. Check and recheck understanding b. Lifestyle issues* Inc Smoking and exercise c. Medication

a.

b. Patient given PCT information booklet c. Patient given PCT hand held record d.Referral to dietitian

- Offer dietary advice - Trial of lifestyle interventions including increased activity Treat all co existent pathology e.g. BP, lipids Arrange screening for complications See Milestone 4

a. Hypertension

a. Regular review if unstable 2 3 monthly

b. Lipid Management b.

b. 6 monthly review once stabilized

d. Complications e. Importance of regular review f. Driving

c. Anti-platelet therapy

c. Annual review (see Appendix 2)

d. Microalbuminuria d. Ongoing review of educational needs

e. Referral to group education sessions via Diabetes Referral & Triage f. Regular review see maintenance phase g. Assessment of emtional wellbeing h. People with severe mental health diagnosis should be checked annually for diabetes

c. See medication algorithm

g. Importance of good BP control h. Importance of good glycaemic control HbA1c / mmols/mol i. Eye examinations with dilated pupils & retinal camera j. Foot health k. Sexual health l. Travel m. Diabetes UK / support groups

e. Management of CKD

d. Continued education & support

f. Management of painful neuropathy

e. Review of dietary needs

e. 3 4 monthly HbA1c / mmols / mol

g. Retinopathy / Footcare

f. People with existing diabetes should be monitored for depression

f. Continue to follow medication algorithm

h. Erectile Dysfunction

g. Once stabilised, regular review See Maintenance phase

g. Information about monitoring and glucose meters where appropriate

i. Obesity

Reviewed May 09

n. Offer structured education programme

j. Peripheral arterial disease

See laminated version appendix 1 & 2

MILESTONE 1: DIAGNOSIS OF DIABETES MELLITUS

PRESENTING SYMPTOMS

1. Patient presents with signs and symptoms suggestive of Type 2 diabetes Excessive thirst Increased urination especially at night Lethargy Weight loss Blurred vision Infections e.g. Pruritis, balanitis None of the above 2. At routine /ad hoc health review patient has glycosuria 3. Increased suspicion due to risk factors e.g. Ethnicity Family history 40 years of age Previous gestational diabetes Existing severe mental illness such as schizophrenia

WHO DIAGNOSTIC CRITERIA FOR DIABETES MELLITUS IF RBG 6.0 11.0 mmols/ l FBG IF RBG 11.1 mmols / l Diabetes diagnosed ( OGTT NOT required) If FBG < 6 mmols / l, diabetes is unlikely If FBG is 6.1 7.0 mmols / l perform OGTT NB: In the absence of osmotic symptoms 2 consecutive venous samples are required to diagnose Diabetes Mellitus PLASMA DIABETES CONFIRMED IMPAIRED GLUCOSE IMPAIRED FASTING GLYCAEMIA TOLERANCE FBG < 7.0 7.0 6.1 < 7.0 OGTT Do OGTT to exclude diabetes 11.1 7.8 2 hour value or IGT <11.1 NB: In the elderly and some ethnic minority groups fasting glucose levels may not be a reliable indicator of diabetes
Reviewed May 09

MILESTONE 2: EDUCATION IN TYPE 2 DIABETES STEP 1 Assess learning needs STEP 2 Review understanding STEP 3 Discuss Lifestyle issues STEP 4 Discuss Complications STEP 5 Facilitate Dietetic referral STEP 6 Understanding the annual review
Height, weight, BMI, waist circumference

STEP 7 Review understanding

Is English the first language?

What is diabetes?

Diet Exercise

Eyes

Give stop gap dietary advice

Importance of regular diabetes checks

CVD Has patient been referred to dietitian? BP Routine blood tests / urine tests HbA1c/ mmols/mol U&E TFT LFT Lipid profile eGFR ACR Foot assessment Pedal pulses Neuropathy status Retinopathy status Enrolment onto NMUH Retinal Screening Programme Review concordance with medication Review concordance with healthy eating regimen

Is the patient literate in English?

Importance of regular diabetes checks

Smoking Kidney Alcohol

Is the patient literate in own language?

What to expect at an Annual Review

Importance of medication

Erectile Dysfunction

YES Recheck understanding

Arrange appointments as necessary with interpreter Offer patient EPCT structured diabetes education programme

Diabetes UK / Enfield support group

Social adjustments Psychological well being Driving regulations

Neuropathy

NO Refer to dietitian

PVD

Assess gaps in knowledge and provide educateion as appropriate

Foot

Reviewed May 09

MILESTONE 3: TREATMENT MANAGEMENT IN TYPE 2 DIABETES = Usual approach = Alternative approach

IN THE FIRST INSTANCE, UNLESS THERE IS A CONTRA INDICATION AIM FOR HbA1c 6.5% or 48 mmols/mol This will need to be reviewed on an annual basis, as diabetes progresses, the HbA1c treatment target for intervention can be increased to 7.5% or 59 mmols/ml INITIATE HEALTHY EATING PLAN AND INCREASED ACTIVITY FOR AT LEAST 12 16 WEEKS UNLESS SYMPTOMATIC AGREE LEVEL OF HbA1C / MMOLS/MOL FOR INTERVENTION

Consider first

METFORMIN METFORMIN SHOULD NOT TO BE INITIATED IF SERUM CREATININE LEVEL IS > 150 umol / l OR eGFR < 30 Review response to medication using the step guidelines, within 28 days in the first instance, then 3 4 monthly using HbA1c/ mmols/mol Commence 500mgs BD / TDS Further increase as tolerated 1 gm BD / TDS. If unable to tolerate Metformin, or compliance issues, consider reducing current dose or change to slow release Metformin up to 2 gm OD Review Metformin dose if S.Creatinine >130 or eGFR < 45 SEE CKD PATHWAY FOR LONG TERM MONITORING

SULPHONYLUREAS If not overweight , or Metformin not tolerated, or a rapid therapeutic response is required because of hyperglycaemia Consider a rapid-acting secretagogue for people with erratic lifestyles GLICLAZIDE GLIPIZIDE GLIMEPIRIDE 80 mgs OD/ 40 mgs 5 mgs OD 1 mg OD BD 80 mgs BD 5 mgs BD 2 mgs OD 160 mgs AM / 10 mgs BD 4 mgsOD 80 mgs PM max 160 mgs BD max 6mgs max

Consider second when HbA1c > 6.5% or 48 mmols/mol if sulphonylurea is not appropriate 2nd line or risk of hypoglycaemia

THIAZOLIDINEDIONES (TZD) Can be added to Metformin or sulphonylurea Licensed for monotherapy use in patients who cannot tolerate Metformin Can be used with a sulphonylurea if control sub-optimal and cannot tolerate Metformin Not recommended in patients with evidence of heart failure*or a higher risk of fractures. Check LFT prior to starting treatment, 2 months after & annually thereafter ROSIGLITAZONE* *ONLY for patients currently taking this medication 4 - 8 mg mg OD Maximum 8 mg OD

PIOGLITAZONE* *Can be used with insulin, with caution 15 - 30 mg OD Maximum 45 mgs OD

CAUTION WHEN USED WITH SULPHONYLUREAS AS RESPONSE MAY NOT BE APPARENT FOR 6 12 WEEKS

DPP-4 INHIBITORS If significant risk of hypoglycaemia If sulphonylurea or Metformin is not tolerated or contraindicated Can be used combination with Metformin when Metformin plus diet and exercise, does not provide adequate glycaemic control. It can also be used in combination with either a sulphonylurea or a glitazone**. Continue only if > 0.5% reduction in HbA1c at 6 months which is maintained Saxagliptin may be recommended as further data becomes available SITAGLIPTIN VILDAGLIPTIN **has triple licence LFTs every 3/12 for 1st year Can be used as add-on to of treatment insulin 100MG OD 50 mg BD If on sulphonylurea dose may If on sulphonylurea 50mg OD need to be reduced

MILESTONE 3: TREATMENT MANAGEMENT IN TYPE 2 DIABETES

Consider third when HbA1c > 7.5% or 59 mmols/mol
TZD
See overleaf and If insulin is not acceptable or inappropriate

DPP-4 INHIBITOR
See above and If insulin is not acceptable or inappropriate Only Sitagliptin can be used in combination with Metformin and a Sulphonylurea

GLP-1

NPH INSULIN

OTHER INSULIN

If BMI 35 kg/m2 and other psychological/medical problem associated with raised BMI If BMI < 35kg/ m2 for whom insulin is unacceptable because of occupational implications or where weight loss would benefit other co-morbidities. Continue GLP-1 only if beneficial response seen and maintained (>1.0% reduction in HbA1C at 6 months and weight loss of at least 3% at 6 months) Check SPC for contraindications

Ensure injectables care pathway is completed

EXENATIDE Twice daily Meal related

LiRAGLUTIDE Once daily Not meal related Can be used with a TZD SBP

Ensure injectables care pathway is completed Can be considered if patient requires assistance from a carer/HCP to administer If lifestyle is restricted by recurrent hypoglycaemia If would otherwise need BD insulin and oral OHAs If cannot manage injection device for NPH

ALPHA GLUCOSIDASE INHIBITOR

ACARBOSE 50 mg OD Increase to 50 mg TDS after 6 weeks 100mg TDS 200 mg TDS

REFER TO INTERMEDIATE CARE TEAM FOR INITIATION The initiation of insulin or GLP-1 to people with diabetes should only be carried out by: A. Practices that are currently receiving enhanced diabetes payments or B. Have attended an appropriate training course on insulin initiation and management, and GLP-1 e.g. Exenatide / Liraglutide, within the last 2 years.

Consider fourth if HbA1c remains > 7.5% or 59 mmols/mol

NPH INSULIN Ensure injectables care pathway is completed OTHER INSULIN Ensure injectables care pathway is completed 1. Long acting insulin analogue See above and switch if: Target HbA1c not reached due to significant hypoglycaemia Cannot manage device for insulin Requires assistance from carer/ HCP to administer NOT to be initiated in pregnancy 2. Premix insulin Consider Pioglitazone or Sitagliptin with insulin if: Pioglitazone or Sitagliptin has previously had a marked glucose lowering effect or Blood glucose is inadequate without high dose insulin

Ref: NICE CG 87 Type 2 diabetes: partial update May 2009

Reviewe

Reviewed & updated May 10

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT HYPERTENSION 1. Aim for Blood Pressure Information would be appreciated asap
Step 1 Offer ACE inhibitor Lisinopril 5mg initially, 10 20mg usual dose OD or Ramipril caps 2.5 5mg usual dose. IF BP REMAINS ABOVE TARGET Off If unable to tolerate ACE I, try A2RB For people of African Caribbean descent, offer ACE inhibitor plus Diuretic Bendroflumethiazide no more than 2.5mg OD as maximum dosage (check U&Es prior to commencing) Calcium Channel Blocker (CCB) Amlodipine 5 10 mg OD or Felodipine 5 10mg OD If there is a possibility of pregnancy, start with a CCB If continuing intolerance to ACE inhibitor (other than renal deterioration or hyperkalaemia) change to Angiotensin ll receptor blocker (A2RB) Losartan 50 to 100mg OD (Over 75s start with 25mg). This drug is now generic Irbesartan 150mg to 300mg OD (Over 75s start with 75mg) Licensed for use when micro/proteinuria present IF BP REMAINS ABOVE TARGET

measurement of: If NO renal complications are present aim for 140 / 80 mmHg If eye complications are present aim for <130/80 If renal complications are present aim for 125/75 mm Hg

2. Try non-pharmacological measures: Encourage healthy eating including salt reduction Increase physical activity Stop smoking Encourage weight reduction including reducing excess alcohol intake Stress management 3. Monitor patient monthly, titrating medication upwards to maximum dose, and adding next anti - hypertensive agent.

Step 2 Add CCB or diuretic Bendroflumethiazide 2.5 mg OD as maximum dosage Indapamide 2.5 mg IF BP REMAINS ABOVE TARGET

Step 3 Add diuretic or CCB (see above)

IF BP REMAINS ABOVE TARGET

Step 4
Add alpha blocker Doxazosin 2 - 16 mg OD, Add Beta blocker Metoprolol 50 200mg OD or Bisoprolol 2.5 20 mg OD

Reviewed & updated May 10

REFER TO SPECIALIST SERVICE IN CASES OF UNRESOLVED HYPERTENSION

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT CONTD LIPIDS RAISED LIPID PROFILE:

1. Statin should be offered to all those aged 40 or above with either Type 1 or Type 2 diabetes (If <40 start Statin if one complication* present see below) 2. Aim for TC 4 mmols/l and LDL 2 mmols/l, but consider each case for treatment on an individual basis. 3. If TC 4 mmols/l and LDL 2 mmols/l

Exclude hypothyroidism, excess alcohol intake, liver disease and pancreatitis

4. Encourage weight loss, healthy eating and increased activity 5. Tighten / optimise glycaemic control 6. Stop smoking *COMPLICATIONS ARE

Retinopathy of greater than background severity Nephropathy (including eGFR <90 or Microalbuminuria present) Poor glycaemic control (HbA1c > 9%) Elevated BP requiring antihypertensive medication Serum total cholesterol > 6.0 mmol / l Features of metabolic syndrome Family history of premature cardiovascular disease in a first degree relative

Step 1. Simvastatin 40mg nocte (if patient on Warfarin or is intolerant of Simvastatin, try Pravastatin up to 40mg nocte) NB Intolerance is typically muscle or liver related: myalgia and/or rhabdomyolysis, CK > 10x or LFTs (AST/ALT) >3x normal Step 2. Atorvastatin 40mg once daily Step 3. Atorvastatin 80 mg once daily Step 4. If target not reached, either add in Ezetimibe 10mg or switch to Rosuvastatin 10mg. Start at 5mg in Asian population (Increase Rosuvastatin slowly bi-monthly) Step 5. In patients who have not reached target, cannot tolerate statins, or who have high CV risk and TG = 2.3 4.5 mmol/l despite statin, consider addition of a fibrate, (Fenofibrate) on a case by case basis and consider referral to specialist services.

Reviewed & updated May 10

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT CONTD ANTI PLATELET THERAPY: Indications for low dose aspirin treatment in diabetes in the updated Joint British Societies (JBS 2) guidelines, British Cardiac Society et al, 2005. People with established macrovascular disease: IHD TIA / CVA PVD OR considered very high risk with 2 or more of the following: Raised BP Smoker Dyslipidaemia

1st line: Soluble aspirin 75 mg daily. This is to be given unless there is an absolute contraindication

2nd line: For patients who cannot tolerate soluble aspirin, or have a history of ulceration, add in either Lansoprazole Capsules 15mg OD or Omeprazole Capsules 20mg OD and continue with soluble aspirin 3rd line: If aspirin is still poorly tolerated, contra-indicated, has had a previous cardiovascular event, or compliance issues favour monotherapy, Clopidogrel 75mg daily
Reviewed & updated May 10

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT OBESITY ASSESSMENT

All patients with diabetes should have their BMI recorded annually Classification of BMI*: BMI <18.5 18.5 24.9 25.0 29.9 >30.0 30.0 34.9 35.0 39.9 >40 RISK OF CO-MORBIDITIES Low, but increased risk of other clinical problems Average Mildly increased Moderate High V High

CLASSIFICATION Underweight Desirable weight Overweight Obese Class i Class ii Class iii *DoH

Waist circumference: SEX Male Asian male Female Asian female

METRIC >102 cm 90cm 88 cm 80 cm

IMPERIAL 40 inches 35 35 31

Medical history e.g. Current glycaemic control, hypothyroidism, hypertension, hyperlipidaemia, CHD, PCOS, sleep apnoea, osteoarthritis, learning disabilities, mental health issues Family history Social history e.g. Alcohol, smoking status Drug history e.g. sulphonylureas, anti-psychotics, steroids Dietary history Physical activity status Readiness to change: Explore how person feels. Inform about solutions. Provide insight into risks

Active treatment of the obese person with diabetes should commence when BMI is greater than 28

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT OBESITY CONTD

TREATMENT OF OBESITY Aim of treatment is to: Reduce calorie intake <1,500 kcal/day) Increase physical activity Increase self awareness about day to day behaviours that affect calorie intake and activity levels Considerations: Discuss 5 10% reduction in weight in the first instance. Provide stop gap information* or relevant education / support materials for healthy eating See Appendix 1 Referral to health trainer Referral to dietetic department Encourage exercise to reduce sedentary behaviour: The goal being 30 minutes of moderately intensive activity (e.g. Brisk walking at least 5 times a week) Discuss behaviour strategies that will enable patient to sustain weight loss Review:

Review should be 1 3 monthly and assessment of weight loss carried out If patient has not reached target weight loss after 6 months, refer to Health Trainer Department using appropriate referral form. On discharge from Health Trainer department repeat HbA1c and BMI If Hba1c is not at target and BMI still greater than 30 see drug therapy recommendations below

DRUG THERAPY:

Drug treatment should be considered for patients who are unable to reach their target weight loss or have reached a plateau on dietary, activity and behavioural changes alone (NICE) after the 3 month point Discuss potential benefits, limitations, mode of action, adverse effects with patient:

Orlistat (lipase inhibitor) 120mg tds with meals GLP-1 agonist (Incretin Mimetic) Exenatide/Victoza to be considered if HbA1c > 7.5% or 59 mmols/mol and BMI >35 Refer to Diabetes Nursing Team using Referral and Triage form

IF BMI IS > 40, CONSIDER BARIATRIC SURGERY

Reviewed & updated May 10

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT CONTD MANAGEMENT OF PERIPHERAL ARTERIAL DISEASE

Patient presents with - Intermittent Claudication (IC): A cramp like pain in the legs when walking or exercising (Can be found in calf or thigh muscles and buttocks) - Known Arterial Disease (Coronary, Carotid or renal artery disease) - Absent or diminished Dorsalis Pedis or Posterior Tibial pulses - Rest pain or gangrene of leg / foot - Poorly healing / non healing wounds on leg or foot - People who have increased risk of arterial disease e.g smokers, dyslipidaemia, hypertension, Ankle:Brachial Pressure Index to be calculated.If this facility is not available in house please refer to EPCT Diabetes Nursing Team for neurovascular assessment using Referral and Triage form stating level of urgency

A:BPI < 0.9 **Actively treat risk factors**

A:BPI > 0.9

BP Aim to be < 130/ 80 Aim for good glycaemic control (see Milestone 3:Treatment management ) Commence antiplatelet therapy If Cholesterol > 4 commence statin (See Milestone 4: Complications / Risk management) Smoking cessation Weight loss Exercise therapy Keep walking If lifestyle impairment
SEVERE IMPAIRMENT Refer to Vascular Team via Choose and book

The A:BPI may be falsely elevated due to medial artery calcification. This will elevate the A:BPI to above 1.3 If IC symptoms present, patient will need to be referred for an exercise Doppler examination at NMUH Diabetes Centre via referral and triage form If drop in A:BPI post exercise occurs, PAD is diagnosed and patient to be treated as if A:BPI is < 0.9 See text box opposite If A:BPI shows no reduction other causes for painful symptoms may to be investigated

MILD IMPAIRMENT Exercise therapy Review 3/12 Consider Cilostazol 100mg bd if no improvement on exercise therapy alone (stop if ineffective after 3/12) Monitoring can be done in PCT Neurovascular clinic

Referral criteria to Specialist services

(6Ps) Rapid onset of symptoms: Pain, pulselessness, pallor, paraesthesia, paralysis, perishingly cold = Emergency referral Deterioration in chronic symptoms: Ischaemic rest pain, gangrene, non healing wound or ulceration, infection = Urgent referral NMUH offer a rapid access foot service Monday to Friday 0900 1700 hrs. If a patient has acute foot ulceration, infection, signs of acute ischaemia or penetrative foot injury contact Vascular Nurse on 020 8887 4257or 020 8887 2000 Bleep 324
References: SIGN, TASC II, Barnet and CFH guideline for management of PAD NMUH Diabetic foot protocol

Reviewed May 09

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT CONTD TREATMENT OF ERECTILE DYSFUNCTION (ED) Identify and treat curable causes of ED where possible:

Endocrine cause: Poor control of DM, Hypogonadism, Hyperprolactinaemia, Hypo / Hyperthyroidism, Cushings syndrome (will need Endocrine referral) Vascular cause: PVD, CKD Urological: Previous injury, Pelvic / Prostatic surgery or radiation therapy (may need urology referral) Neurological cause: MS, Alzheimers, Parkinsons, spinal cord injury (may need neurology referral) Medications: Beta-blockers, Alpha Adrenergic Antagonists, Diuretics, Sedatives, tranquilizers, anxiolytics, antidepressants, antipsychotics, Corticosteroids, digoxin, NSAIDs, H2 Antagonists etc Lifestyle / habit / addiction: Substance abuse, smoking, alcoholism, anabolic steroids, Heroin, Marijuana Psychological

Lifestyle changes and risk factor modification Send blood for hormone levels

Education for patients and partners Describe treatments available Assess current CV risk & medication history (e.g.nitrates)

Counselling for patients and partners Refer for psychosexual therapy

PRESCRIBE PDE5 INHIBITORS TRIAL:

The prescribing physician should be aware of mode of action, cautions, contraindications, side effects as per BNF Frequency of treatment needs to be considered on a case by case basis. One treatment per week is usually appropriate (DoH)
DRUG DOSE 50 100 mg Start at 50 mg and titrate according to response and side effects 5 20 mg Start at 10mg and titrate according to response and side effects 5 20mg Start at 10mg and titrate according to response and side effects MINIMUM INFORMATION FOR PATIENTS Effective 30-60 mins in presence of sexual stimulation Effect reduced by fatty meal Half life 4 hours Effective after 25 60 mins in presence of sexual stimulation (can be as early as 10 mins) Effect reduced by fatty meal Half life 4.5 hours Effective after 30 mins in presence of sexual stimulation Effect not reduced by food and alcohol Half life 17.5 hours

ALTERNATIVE THERAPIES:
NB: PATIENT NEEDS TO BE REFERRED TO UROLOGIST / ED CLINIC TO BE TRAINED IN USE OF THESE PRODUCTS

SILDENAFIL
Viagra

Intracavernosal injections: Caverject, Viridal Duo Intraurethral alprostadil: Muse Vacuum devices Penile implants
ASSESS THERAPEUTIC OUTCOMES IT IS ESSENTIAL IN DIABETES TO ADVISE PATIENTS TO TAKE ORAL MEDICATION APPROXIMATELY 4 HOURS PRIOR TO SEXUAL ACTIVITY AS IT HAS BEEN OBSERVED THAT ONSET OF ACTION MAY BE DELAYED IN MEN WITH DIABETES. IF SILDENAFIL IS INEFFECTIVE CHANGE TO ANOTHER PDE5 INHIBITOR IF INEFFECTIVE, REFERRAL TO ED CLINIC VIA DIABETES REFERRAL & TRIAGE

VARDENAFIL
Levitra

TADALAFIL
Cialis

Reviewed May 09

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT CONTD RENAL COMPLICATIONS / MICROALBUMINURIA SCREENING

** PLEASE NOTE THAT THESE TESTS ARE IN ADDITION TO THE eGFR **

DIPSTICK URINE FOR PROTEIN USING MULTISTIX / ALBUSTIX

IF NEGATIVE Refer to local laboratory guidelines for EMU collection protocol Collect EMU for Albumin / Creatinine ratio Normal A : C Ratio Males < 2.5 mg / mmol Females < 3.5 mg / mmol If specimen is within normal range retest annually

IF POSITIVE If 1st specimen is abnormal exclude UTI (collect MSU) If 2nd specimen is abnormal quantify proteinuria by albumin / creatinine ratio (A:CR). Treat to target 1. BP (Aim < 125 / 75) 2. Glycaemic control HbA1c 6.5% or 48 mmols/mol. 3. Commence ACE inhibitor or ARB if intolerant to ACEI (Irbesartan has licence in microalbuminuria) Repeat ACR after 6 months If specimen is abnormal, refer to specialist care according to local CKD guidelines

NICE Clinical Guideline 66 Management of Type 2 diabetes mellitus, May 2008

SEE eGFR GUIDELINES

Reviewed May 09

MILESTONE 4: COMPLICATIONS AND RISK MANAGEMENT REFERRAL FOR CKD USING eGFR IN DIABETES MELLITUS Chronic Kidney Disease(CKD) and the estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease (CKD) is common. It affects approx 10% of the population and is often asymptomatic until renal function is severely reduced. Serum creatinine has traditionally been the mainstay for the initial identification of renal disease. Serum creatinine on its own does not detect minor degrees of kidney impairment and is not directly related to the GFR. eGFR forms the basis for the classification and management of CKD. CKD is an important risk factor for Cardiovascular problems. eGFR makes it easier to tell who should be offered treatment. DoH has recommended a formula-based eGFR calculation which is used for the identification and initial staging and monitoring of CKD patients being mls / minute / 1.73 m2. Both NMUH and CFH laboratory will calculate the eGFR using the following variables: creatinine, age, sex. Ethnicity should be factored in by multiplying the result by 1.212 in patients of African Caribbean origin. This should be done by a clinician. eGFR is not applicable in people < 18 years, acute renal failure, pregnancy, amputees, extremes of body weight, 1 kidney. Stage 1 2 3A 3B 4 5 eGFR result > 90 60 - 89 45 - 59 30 - 44 15 - 29 < 15 Severity of CKD Normal Mild impairment
60 90 % renal function

Frequency of testing Annually Annually 3 - 6 monthly 3 6 monthly 3 monthly 3 monthly

Referral to renal team Only if specifically indicated See table 1 As for stage 1 See table 1 NO ONLY if deteriorating function See table 2 Yes See table 3 Yes See table 4 Yes See table 4

Type of referral See below See below Routine referral See below Referral or discussion Urgent referral or discussion Immediate referral or discussion

Moderate impairment
45 - 59% renal function

Moderate impairment
30 44% renal function

Severe impairment
15 30 % renal function

Established CKD

YOU HAVE FOUND THAT YOUR PATIENT HAS A HIGH CREATININE (LOW eGFR)

In all cases initial assessment of high creatinine / low eGFR should include:

Is the patient well? Is there a history of significant disease? History of significant associated disease: Referral may need to be considered if indicators present e.g. urinary abnormalities Review previous results: Assess whether stable or deteriorating. If patient appears well repeat within 2 weeks, sooner if there is any doubt. NB: Slight changes in eGFR may move patients frequently from one stage to another. Look at average readings Clinical assessment: Look for signs of sepsis, heart failure, hypovolaemia, bladder enlargement Medication review: Look for recent additions e.g. ACE inhibitors, ARBs, NSAIDS, Antibiotics, diuretics, Mesalazine, PPIs Blood tests: HbA1c, Ca2+, PO4, FBC, CRP. Hypercalcaemia may cause acute renal impairment or deterioration Urine tests: Dipstick for blood and protein BP/ Cardiovascular assessment (including peripheral circulation) : Malignant hypertension and Grade 4 retinopathy needs immediate referral to on call medical team Imaging: Required if function is deteriorating and of unknown origin. Urgency will be ascertained by speed of deterioration

REFER TO APPROPRIATE TABLE: Stage 1 & 2 Stage 3A Stage 3B Stage 4 & 5 Table 1 Table 2 Table 3 Table 4

Table 1 Management of Stage 1 and 2 CKD in Diabetes Mellitus GENERAL POINTS EXCEPTIONS MANAGEMENT Patient can be managed in Primary Care Referral to joint diabetes / renal clinic is not setting required unless: Patients have normal / near normal Nephrotic range proteinuria > 3g/ 24 hours eGFR but have other evidence of renal or PCR > 300 mg /ml. disease e.g polycystic or reflux See below nephropathy or microalbuminuria in diabetes

Initial assessment to include: - Blood tests: , HbA1c, TFTs, Ca2+, PO4, FBC, CRP - Urinalysis: Dipstick for blood and protein - BP/ Cardiovascular assessment (including peripheral circulation) : Ensure BP within target range (<130/80 mm/ Hg) Ongoing management: Blood tests annually for: - HbA1c/mmol/mol - Creatinine - Potassium - Cholesterol. Urinalysis: Annually for blood and protein Meticulous control of BP 130/ 80 Smoking, exercise and lifestyle advice (see Diabetes Care Pathway Appendix 1) Aspirin (see anti platelet therapy Milestone 4: Diabetes Care Pathway) Cholesterol lowering therapy (Milestone 4 Diabetes Care Pathway)

GENERAL POINTS Patient can be managed in Primary Care setting or on a shared care basis

Table 2 Management of Stage 3A CKD in Diabetes Mellitus EXCEPTIONS

MANAGEMENT Referral to joint diabetes/renal clinic is not required unless eGFR is 40 mls / min.

Patients have stable renal function (eGFR or **A diabetes referral form will be required** creatinine) See below for general management Initial assessment to include: Review previous results: Assess whether stable or deteriorating. Repeat within 2 weeks if patient appears well. If patient is unwell repeat within 2 days. NB: Slight changes in eGFR may move patients frequently from one stage to another. Look at average readings Assess for the following: - Is the patient well? Is there a history of significant associated disease which involves kidneys e.g. urinary abnormalities - Clinical assessment for heart failure, sepsis, hypovolaemia, examination for bladder enlargement ( may need imaging if obstruction) and rectal examination for prostate enlargement - Medication review. Look for recent additions e.g. ACE inhibitors, ARBs, NSAIDS, Mesalazine, Antibiotics, Diuretics - Blood tests: HbA1c, Ca2+, Phosphate, Hb, Cholesterol, PTH - Urinalysis: Dipstick urine for blood and protein - Cardiovascular assessment: BP and peripheral vascular disease. - Imaging. Exclusion of obstruction Ongoing management: IF CREATININE IS > 150 MICROMOLS/L OR THE eGFR < 30 STOP METFORMIN* IF DISCREPANCY BETWEEN 2 VALUES USE eGFR: REFER TO PRIMARY CARE DIABETES TEAM VIA DIABETES REFERRAL AND TRIAGE FORM IF NECESSARY Blood tests initially to be done 3 monthly then 6 12 monthly when stable for: - HbA1c/ mmol/mol - Creatinine and Potassium - Ca2+ - Phosphate - Hb - Cholesterol Urine tests: - Protein estimation if proteinuria - If MICROSCOPIC haematuria Urology referral if > 50 years old, if < 50 years old Nephrology referral. All MACROSCOPIC haematuria needs urology referral Blood pressure. Meticulous control of BP 125/ 75 (see Milestone 4: Diabetes Care Pathway) Smoking, exercise and lifestyle advice (see Diabetes Care Pathway Appendix 1) Aspirin (see anti platelet therapy Milestone 4: Diabetes Care Pathway) Cholesterol lowering therapy (Milestone 4 Diabetes Care Pathway) Immunisation for influenza and pneumococcus Medication review: Regular review of medication to minimise nephrotoxic drugs (particularly NSAIDs). Please exercise caution in bisphosphonates

Table 4 Management of Stage 3B, 4 and 5 CKD in Diabetes Mellitus GENERAL POINTS EXCEPTIONS MANAGEMENT Referral to Dr H Tindall / Dr D Jayaseena If severe renal impairment is part of another Patient will be cared for on a shared care joint diabetes / renal clinic at NMUH terminal illness basis Those patients for whom further Referral in first instance to Dr H Tindall / Dr investigation and management is clearly D Jayaseena joint diabetes / renal clinic at inappropriate NMUH There is a clear and understood pathway of care already in place Assess for the following: - Clinical Assessment and Medication Review as per stage 3 CKD - Assess whether values are stable or deteriorating. Repeat within 2 weeks if patient appears well. If patient is unwell repeat within 2 days. - Is the patient well? / Clinical assessment: Is there significant associated disease? If yes, consider urgent referral - Blood tests: HbA1c, Ca2+ Phosphate ,Hb, cholesterol, PTH - Urinalysis: Dipstick urine for blood and protein - BP/ Cardiovascular assessment - Dietary assessment Ongoing management: METFORMIN SHOULD BE STOPPED IN ALL PATIENTS WITH eGFR 30 Blood tests 3 monthly for: - HbA1c / mmols/mol - Creatinine, Potassium and bicarbonate - Ca2+ - Phosphate - Hb, Ferritin, B12 and folate - Cholesterol - PTH Urine tests: - Protein estimation if proteinuria - Haematuria as in Stage 3 Correction of acidosis. Oral bicarbonate after discussion with joint diabetes / renal team Blood pressure. Meticulous control of BP120/ 70 (see Milestone 4: Diabetes Care Pathway) Smoking, exercise and lifestyle advice (see Diabetes Care Pathway Appendix 1) Aspirin (see anti platelet therapy Milestone 4: Diabetes Care Pathway) Cholesterol lowering therapy (Milestone 4 Diabetes Care Pathway) Immunisation for influenza and pneumococcus. In stage 4&5 CKD Hepatitis B is also added Medication review: Regular review of medication to minimise nephrotoxic drugs (particularly NSAIDs). Please exercise caution in bisphosphonates

INDICATIONS FOR REFERRAL TO UROLOGY: All macroscopic haematuria should be referred to the Urology Department o Isolated microscopic haematuria (after excluding UTI) should be sent to Urology if patient > 50 years o Isolated microscopic haematuria (after excluding UTI) should be sent to Nephrology if patient < 50 years o Microscopic haematuria and proteinuria refer to Nephrology if < 50 years, if If > 50 years refer to Nephrology only if Urology investigations negative.

These guidelines are based on: CG73 NICE Guideline: Early Identification and management of Chronic Kidney Disease in adults in primary and secondary care, September 2008

Reviewed May 09

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT CONTD - PAINFUL NEUROPATHY

DIAGNOSIS HISTORY - Consider differential diagnosis (alcohol excess, B12 deficiency, malignancy) - Sometimes acute, sometimes insidious onset and progressive - Paraesthesia in toes, feet and shins - Anaesthesia - Hyperaesthesia Symptoms often worse at night or at rest PAIN - A wide variety of descriptions of peripheral symptoms can be present. - Careful patient questioning is necessary as symptoms can be confusing - Consider use of Pain Pictures or S-LANNS assessment questionnaire Symptoms may include: - Numbness - Tingling - Prickling - Pins and Needles - Aching - Dull pain - Burning - Buzzing - Cold - Sharp - Knife like - Electric shocks The severity of individual patient symptoms will influence which step of the care pathway is appropriate for commencement of treatment

SIGNS WEAKNESS - Distal and/or proximal - Loss of reflexes NEUROPATHIC EXAMINATION - 10 g Monofilament - Vibration perception (tuning fork 128 Hz), calibrated tuning fork, Bio / Neurothesiometer) - Proprioception - Light touch - Sensory loss glove and stocking distribution

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT CONTD - PAINFUL NEUROPATHY

PERIPHERAL NEUROPATHY HAS BEEN DIAGNOSED

STEP 1
Improve glycaemic control. Liaise with diabetes nursing team / dietician if appropriate. Aim for normoglycaemia Prescribe Duloxetine 60mg daily (child and adolescent under 18 years not recommended) If patient is experiencing night time cramps only, consider prescribing: - Quinine sulphate 200 300 mg nocte (Inform patient that it may take up to 1 month to see an improvement) - May benefit from low calorie Indian tonic water (not available on FP10) Reassure. (Use of pain diary may be useful) Review in 1 month If patient is reluctant to take oral medication consider Capsaicin cream 45 g, noting that initially there may be an intense burning sensation.

STEP 2 Review symptoms, pain and glycaemic control If pain still present, reassure Check concordance with Duloxetine previously prescribed in Step 1 If pain is still present, add in: - Amitryptyline 25 mg 75mg at night (unlicensed for this indication) Review in 1 month

STEP 3 Review symptoms, pain and glycaemic control If pain still present / no improvement in symptoms, refer for specialist input Monitor therapy, and increase, up to maximum licensed dosage. Consider prescribing in place of previous medication: Pregabalin 150 600 mg in divided doses Consider addition of Tramadol 50mg 150 mg tds

STEP 4 Review symptoms, pain and glycaemic control If pain is not controlled referral to specialist pain clinic

Updated NICE Guidance May 2010 Reviewed & updated May 10

MILESTONE 4: COMPLICATIONS / RISK MANAGEMENT CONTINUED

RETINOPATHY: 1. Ensure that patient understands the importance of annual retinopathy screening 2. Ensure that patient is enrolled on the Enfield & Haringey Community Retinopathy Screening Programme for digital photography. Please contact NMUH Diabetes Centre Retinopathy team on 0208 887 2352 or fax 020 8887 4414. 3. At annual review, check that a result is present in the patient records dated within the last 12 months 4. Results of retinal screening should be discussed with patient 5. If retinopathy is present ensure appropriate referral is made re: NICE guidelines

FOOT CARE: 1. Ensure that feet are assessed including foot pulses, vibration, sensation by a competent practitioner annually (See also Milestone 4: Peripheral Arterial Disease [PAD]) 2. Record results on diabetes template 3. Ensure that principles of good foot care are reiterated at each review 4. Refer for podiatry treatment as appropriate 5. Refer URGENTLY TO RAPID ACCESS CLINIC if any of the following problems occur: Acute foot injury (including any penetrating foot injury) Foot ulcer present Signs of infection Evidence of ischaemia noted This service is available Monday to Friday 9 4 only. Please telephone 020 8887 4257 and ask to speak to the Vascular Nurse Specialist or telephone 020 8887 2000 and ask for Bleep 324. DO NOT SEND PATIENTS TO THIS SERVICE UNLESS CONTACT HAS BEEN MADE WITH THE DIABETES TEAM 6. Refer to Painful Neuropathy Care Pathway if symptoms of painful neuropathy are present or referral to EPCT Neurovascular assessment clinic via Diabetes Referral and Triage form.

Reviewed May 09

MILESTONE 5: MAINTENANCE
1. Regular review if unstable 2- 3 monthly BP Lipids Glycaemic control (there is no benefit to repeating HbA1c reading more frequently than 3 monthly) Diet Lifestyle 2. 6 monthly review As above 3. Annual review Weight / BMI BP Review of medication Review of diet Review of glycaemic control Review of investigations - HbA1c - Lipids - U&E including eGFR - TFT - LFT if taking Glitazone or Statin - Albumin / Creatinine ratio (ACR) Foot examination - Shoes, socks, stockings MUST be removed - Observation of colour, warmth, sensation, symptoms, general appearance of nails, skin, callus etc. - Pedal pulses at Dorsalis Pedis and Posterior Tibial points -10gm Monofilament on BOTH feet Lifestyle issues - Driving - Activity levels - Smoking - Alcohol - Sexual activity - Stress (Assess for depression)

Reviewed May 09

APPENDIX 1

LIFESTYLE CHANGES

HEALTHY EATING (STOP GAP INFORMATION) ADVICE TO BE GIVEN Regular meals that include carbohydrates This will help to control blood glucose levels* EXAMPLES High fibre low salt and low fat breakfast cereals Wholemeal / whole grain breads, including pitta, crackers, crispbreads Pasta and noodles Potatoes Rice Beans Lentils Bran Wholemeal and wholegrain breads and cereals Fruit and vegetables Less animal fats and fatty foods Choose olive oil, rapeseed oil or other vegetable oils Grill, steam ,bake food Use less butter, margarine, cheese and fatty meats Use low fat dairy foods like skimmed or semi skimmed milk, low fat yoghurt Less processed food Leave out salt in cooking Buy reduced salt versions of food Use herbs and spices instead of salt Try to eat five portions of fruit or vegetables a day, but limit fruit intake to no more than 3 4 portions a day A portion is a handful of fruit or vegetables This does NOT mean a sugar free diet Sugar can be used as an ingredient in foods in small quantities Use sugar free, diet or low sugar squashes and fizzy drinks

Foods that are high in fibre*

Cut down / Eat less saturated fat*

Reducing salt*

Five a day* Cut down on sugar / sugary foods*

Reviewed May 09

APPENDIX 1

LIFESTYLE CHANGES CONTD

INCREASING ACTIVITY ADVICE TO BE GIVEN Increase exercise levels gradually until exercising for at least 30 minutes a day 5 x week* EXAMPLES Walking daily Increase distance and speed Once exercising regularly, try cycling, swimming etc. If heart problems Heart Throbs Exercise class Housework / gardening if mobility is limited If immobile teach armchair exercises

STOPPING SMOKING ADVICE TO BE GIVEN Assess smoking status Advise to stop* WHAT TO DO Give information about smoking cessation service Give patient information card / leaflet Contact Quit Smoking Service on FREEPHONE 0800 085 6258 or EMAIL www.quitsmoking.uk.com

ALCOHOL ADVICE ADVICE TO BE GIVEN There is no harm in drinking in moderation* EXAMPLE 1 unit of alcohol = half a pint of beer or lager, 1 small glass of wine or 1 single measure Men should drink no more than 3 units a day Women should drink no more than 2 units a day

*Diabetes UK Patient information www.diabetes.org.uk

Reviewed May 09

APPENDIX 2

PATIENT EDUCATION

After diagnosis it is essential that education is given at a level appropriate to individual needs. EDUCATION CHECKLIST INFORMATION TO BE GIVEN Patient information booklet given Patient held record given What is diabetes Causes of diabetes The Annual Review - what care to expect HbA1c normal ranges Lifestyle issues: Diet Exercise Smoking Alcohol Medication relevant information about current medication Hypoglycaemia Hyperglycaemia Driving What / when to report to DVLA Sick day rules Possible complications associated with poor control: Retinopathy and importance of annual screening Renal problems Arterial problems Neuropathy Foot problems / foot care Travel Fasting / feasting Blood glucose monitoring Sexual Health - women Sexual Health men (Erectile Dysfunction) Diabetes UK info / Enfield support group Psychological well-being
Reviewed May 09

SIGN OFF WHEN GIVEN

Appendix 3: Blood glucose monitoring in Primary Care

Enfield PCT has standardised blood glucose meters available for patient use to the following range: Lifescan One Touch range ** This range of meters are currently in use across PCT by Community Nursing and some GP surgeries (EQA system available for these meters). Further enquiries to kit.mcauley@enfield.nhs.uk Abbott Optium Xceed Ascensia Contour Sensocard Plus (Talking meter available from EPCT Diabetes Nursing Team on 0208 344 3184) All patients monitoring blood glucose levels should be advised to check the accuracy (Quality Assurance) of the blood glucose meter on a monthly basis. Control solutions used to carry out this procedure are, in most cases, available free of charge from the manufacturer. 15 pharmacies in Enfield offer patients free Quality Assurance see next page

FREQUENCY OF TESTING
Type 1 diabetes Type 2 diabetes If on diet and exercise Patients do not need to monitor blood glucose levels on a daily basis. Ensure 3/12 HbA1c If people want to test, testing can be done 2 3 times a week at different times*

Blood glucose testing is essential for ALL people with type 1 diabetes If taking basal bolus regimen this could be up to 6 times a day Frequency may be increased during intercurrent illness Ketone testing equipment should be available for times of acute illness Drivers should maintain a record (as per DVLA recommendations) and test prior to all journeys Pre Pregnancy and pregnancy - may be necessary to test up to 6 times daily

If on diet, exercise and Metformin (+/- Glitazone) - As above If on sulphonylurea / Insulin secretagogue Increased risk of hypoglycaemia. Testing may be necessary to confirm or avoid this

Approximate usage Type 2 on conventional insulin therapy

Six tests per day One test per day Three tests per week

= 48 boxes (50 strips each) per year = 4 boxes per month = 8 boxes per year = 4 boxes per year

If stable, 2 3 times a week at different times If unstable, once daily testing at different times of the day until stability achieved See Type 1 diabetes for DVLA recommendations

Type 2 on intensive insulin therapy May be necessary up to 6 times daily See Type 1 for DVLA recommendations

(This includes extra strips for testing when ill & accidental wastage) An annual assessment of self-monitoring skills, quality and frequency of testing, the use made of results, impact on quality of life and equipment used is essential.
*NICE CG66 Management of Type 2 diabetes, May 2008

Pre Pregnancy and pregnancy May be necessary up to 6 times daily PTO

Appendix 3: Blood glucose monitoring in Primary Care contd When considering suitability for blood glucose monitoring the following points should be considered: Visual acuity Manual dexterity Ability to use blood glucose meter Willingness of patient to perform tests

When initiating blood glucose monitoring the following process should take place: Offer choice from standardised range of meters ONLY according to patient needs Demonstrate chosen meter and finger pricking device, identifying procedure for patient to follow Give information on the safe disposal of sharps Issue blood glucose monitoring diary indicating agreed individual target range and frequency of testing (See previous page) Give information to patient regarding what to do with self testing results Ensure patient has a contact number for access to HCP advice Arrange to review self testing results at a suitable interval

Atkinson Chemist Atkinson Chemist Co-op Pharmacy Co-op Pharmacy Co-op Pharmacy Co-op Pharmacy Co-op Pharmacy Forest Pharmacy Hayward Pharmacy Lloyds Pharmacy Lloyds Pharmacy Lloyds Pharmacy Lloyds Pharmacy Lloyds Pharmacy Lloyds Pharmacy Sainsbury Pharmacy
Reviewed and updated May 10

PHARMACIES INVOLVED IN EQA PROJECT FOR BLOOD GLUCOSE METERS IN ENFIELD 20, The Grangeway N21 2HG 750, Green Lanes N21 3RE 255-257 Hertford Road EN3 5JL 247 High Rd EN3 4DR 417 Hertford Rd EN3 5PT 66, Silver St EN1 3EP 670, Hertford Rd EN3 6LZ 308a Hertford Road N9 7HD 10, Queen Anne Place, EN1 2HB 261 Fore St N18 2TY Florey Sq N21 1UJ 44, Cannon Hill N14 6LH 98A South St EN3 4QA 304, Baker St EN1 3LD 614 616 Hertford Rd EN3 5TD 681, Green Lanes N21 3RS