Diabetes Mellitus Integrated Care Pathway · Diabetes Mellitus Integrated Care Pathway Bristol,...

Diabetes Mellitus Integrated Care

Pathway

Bristol, North Somerset and South Gloucestershire

Drug treatment pages 21st April 2009

(4th Edition, 2009)

Index (ignore page numbers 21.04.09)1. Diagnosis of diabetes ............................................................................................................ 1

2. Initial assessment and classification 1) in adults .......................................................................................................................3 2) in children and adolescents.....................................................................................4

3. Initial management of type 1 diabetes in adults.............................................................6

4. Initial management of type 2 diabetes .............................................................................7 1) Assessment or risk factors and complications...................................................8 2) Dietary advice ............................................................................................................9 3) Lifestyle and exercise advice............................................................................... 10 4) Structured education for people with diabetes ...............................................11

5. Continuing care of type 1 and type 2 diabetes.............................................................. 13 1) Glycaemic control and monitoring........................................................................ 15

a) Targets...................................................................................................... 15 b) Drug treatment ....................................................................................... 15 c) Monitoring................................................................................................. 19

2) CHD risk factor control and targets .................................................................. 21 d) Management of hypertension................................................................ 22 e) Management of dyslipidaemia ............................................................... 25 f) Anti-platelet agents ................................................................................ 27

6. Suggested specialist referrals ........................................................................................ 28

7. Appendices ................................................................................................................................. 1) Screening for complications

a) Foot assessment form .......................................................................... 29 b) Nephropathy screening ....................................................................... 30

2) Management of complications a) Problematic hypoglycaemia ................................................................... 31 b) Diabetes foot pathway ......................................................................... 34 c) Painful diabetic neuropathy ................................................................ 35 d) Persistent albuminuria or microalbuminuria..................................... 37 e) Erectile dysfunction ............................................................................. 39

3) Special situations a) Diabetes in women

i. From adolescence & throughout potential child-bearing Years ................................................................................................ 41

ii. Pre-pregnancy in women with type 1 or type 2 diabetes .... 42 iii. Confirmed pregnancy in women with type 1 or 2 diabetes 44 iv. Pregnancy in women at risk of gestational diabetes............ 45 v. Post natal care .............................................................................. 46

b) Diabetes in children & young people .................................................. 47 c) Diabetes in the elderly & housebound............................................... 48 d) Managing diabetes at the end of life ................................................ 49 e) Diabetes and steroid treatment ........................................................ 52

4) Treatment a) Starting insulin in type 2 diabetes .................................................... 54 b) Weight management advice ................................................................. 57 c) Weight loss surgery referral.............................................................. 58

8. The Diabetes Teams and other contacts ...................................................................... 59

Initial management of type 2 diabetes

symptoms improvedor asymptomatic

6 week review

• screen for risk factors and complications as at annual review • refer to dietitian as per local guidelines and provide interim general dietary advice• lifestyle and exercise advice• refer to structured education programme or ensure alternative provision•3 month trial of diet and exercise, shorter only if symptoms persist

Continuing care plan and targets agreed

Review diet and exerciseConsider starting oral hypoglycaemic agents

persistent symptoms

continue

12 week reviewReview fasting glucose results

(HbA1c not appropriate for monitoring treatment effect at this stage)

FBG < 7 mmol/l FBG 7-10 mmol/l FBG > 10 mmol/l

continue Review diet and exercise Start OHA

BMI ≥ 25 kg/m2

andno contraindications

BMI < 25 kg/m2

orrenal/cardiac/hepatic failure

Rx metforminstart with 500 mg od with/after food

for 7 days and increase stepwiseRx gliclazide

Continuing care of type 1 and type 2 diabetes

Annual review

Exploration of any concerns

Identification of risk factors for CHD and other complications2

• smoking • obesity, physical inactivity• hypertension • dyslipidaemia

Metabolic management• home blood glucose monitoring• HbA1c • dietary assessment • hypoglycaemia • injection sites

Surveillance for long termcomplications1

• eyes: retinal photograph or dilated fundoscopy, visual acuity

• kidneys: creatinine, eGFR, proteinuria/microalbuminuria

• feet: standard foot assessment, including painful neuropathy

• erectile dysfunction

Other issues:1. psychological or coping problems:

• depression • eating disorders etc.

2. pregnancy and contraception• pre-pregnancy counselling

3. lifestyle issues• work, leisure, travel• driving regulations

4. immunization• influenza• pneumococcus

Consider need for referral for specialist adviceand treatment

Agree care plan

Interim review• concerns• glycaemic control• control of risk factors• management options

Oral hypoglycaemic agents and insulin

Rx metforminstart with 500 mg od

with/after food for 7 days and increase stepwise

insulin(continue metformin if tolerated

and no contraindications)

BMI ≥ 25 kg/m2


BMI < 25 kg/m2


Rx gliclazide

add gliclazide

add metforminstart with 500 mg od


metforminintolerance1


orcontraindication

consider adding thiazolidinedione

(glitazone)or

DDP-4 inhibitor(gliptin)

Targets not achieved in spite of diet and lifestyle changes

high risk of hypoglycaemia

e.g. frail elderly

consider adding DPP-4 inhibitor

(gliptin)

insulin relatively contraindicated(e.g. employment reasons)

or high risk of weight gain

consider referralfor

exenatidetherapy

Starting insulin in type 2 diabetes





BMI ≥ 25 kg/m2


BMI < 25 kg/m2


Rx gliclazide

add gliclazide





orcontraindication


(glitazone)or




e.g. frail elderly


(gliptin)




exenatidetherapy






BMI ≥ 25 kg/m2


BMI < 25 kg/m2


Rx gliclazide

add gliclazide





orcontraindication


(glitazone)or




e.g. frail elderly


(gliptin)




exenatidetherapy


1. Glycaemic control and monitoring

a) Targets (NICE clinical guideline 66, 2008) Plasma glucose Fasting

≤ 7.0 mmol/l

Postprandial ≤ 8.5 mmol/l HbA1c 6.5 - 7.5 %

A higher target may be appropriate in patients with a limited prognosis or higher risk of iatrogenic hypoglycaemia (e.g. the elderly) and lower targets may be appropriate in certain circumstances e.g. pregnancy or early type 1 diabetes. It should be emphasised that any improvement in glycaemic control is associated with reduction in risk of microvascular disease, even if the targets are not achieved.

b) Drug treatment: oral hypoglycaemic agents and insulin i. Metformin 1st line OHA if BMI ≥25 Side effects:

Gastrointestinal symptoms (anorexia, nausea, vomiting, diarrhoea, abdominal pain, flatulence)

Lactic acidosis

Contraindications: Renal impairment – Creatinine ≥ 150 µmol/l or eGFR < 30ml/min.

Use metformin only with caution if eGFR 30-59 ml/min. Ensure renal function is stable before starting treatment, monitor eGFR regularly and discontinue metformin if the eGFR is falling or in the event of any intercurrent illness likely to be associated with dehydration.

Cardiac failure not controlled by minimal doses of loop diuretic (furosemide 40 mg o.d or equivalent without digoxin) and/or ACE inhibitor (ramipril 10mg od or equivalent without digoxin)

Significant chronic pulmonary disease with potential for hypoxia (exercise tolerance less than one flight of stairs)

Liver disease with LFT ≥ 3 x upper limit of normal range (if pre-treatment results raised but < 3 x upper limit, recheck LFT after 1-2 months of treatment and investigate according to local guidelines if still abnormal)

Treatment schedule: Start at low dose (500mg o.d. with or after food) increase by

500mg per day each week to highest tolerated dose up to usual maximum 1g b.d.

Always advise patient to take tablets with or after food

If gastrointestinal side effects, reduce back to previously tolerated dose

Modified release metformin should not be used routinely but may be better tolerated compared to immediate-release metformin formulations by some patients. If patients have persistent GI side effects in spite of slow introduction of the standard formulation, a short trial of modified release metformin should be considered before using alternative treatments

ii. Gliclazide and other sulphonylurea drugs

1st line OHA if BMI < 25 kg/m2

Cautions: Warn patient of potential risk of hypoglycaemia if meals omitted or

activity increased Drivers need to notify the DVLA on starting treatment Glibenclamide should be avoided and a short acting agent (e.g.

gliclazide or tolbutamide) used if Renal function deteriorates (creatinine ≥ 150 µmol/l) Patient ≥ 60 years

Treatment schedule: Start gliclazide 40 - 80 mg o.d. and adjust according to response.

Increase at fortnightly intervals if necessary Maximum dose 160 mg b.d.

iii. Metformin/gliclazide combinations 2nd line if single agent treatment fails to achieve target

iv. Acarbose Sometimes useful if metformin intolerance Associated with GI side effects and should be taken with food at the start of the meal If tolerated can reduce HbA1c by ~0.5%

v. Prandial glucose regulators e.g. repaglinide and nateglinide Short acting agents potentially used in place of sulphonylureas Their role currently lacks a clear evidence base and their use is not therefore recommended.

vi. Thiazolidinediones/glitazones Pioglitazone or rosiglitazone can be used as alternative 2nd line OHA if one of the standard agents is not tolerated No proven advantage over metformin/gliclazide combinations Associated with weight gain ++

Rosiglitazone and pioglitazone are associated with fluid retention. Avoid if current or previous heart failure, ischaemic heart disease or high CVD risk. If initiation of glitazone treatment is indicated, use pioglitazone but discontinue if the patient develops heart failure or ischaemic heart disease, no treatment effect is seen or weight gain and other adverse effects are unacceptable. If ongoing rosiglitazone treatment is effective and the patient is not at high risk discuss the evidence and continue if patient agrees. ‘Routine’ switching to pioglitazone is not justified on the current evidence. Glitazones may be considered for use in conjunction with metformin and sulphonylurea only in patients in whom insulin is relatively contraindicated because of occupation (e.g. HGV licence holders) or other factors

vii. GLP-1 mimetic (exenatide) Exenatide (given by s.c. injection) may be considered for use in patients whose diabetes is not controlled on maximum tolerated OHA (metformin and sulphonylurea) in whom insulin conversion is being considered but • insulin is relatively contraindicated for employment reasons (e.g.

HGV licence holders) or other factors

• there is a particularly high risk of weight gain identified by a) previous weight loss (from maximum remembered weight), b) HbA1c > 8.5%, c) inability to increase activity levels due to comorbidity etc.

• BMI ≥ 35 kg/m2 with specific psychological or medical problems associated with high body weight

• Contraindications to exenatide therapy are type 1 diabetes, severe renal impairment (CrCl <30 ml/min), pancreatitis, severe gastrointestinal disease including gastroparesis, child-bearing potential without adequate contraception.

• Severe pancreatitis (sometimes fatal), including haemorrhagic or necrotising pancreatitis, has been reported rarely. Patients or their carers should be told how to recognise signs and symptoms of pancreatitis and advised to seek prompt medical attention if symptoms such as abdominal pain, nausea, and vomiting develop; discontinue permanently if pancreatitis is diagnosed. Exenatide should be used with caution in patients with risk factors for pancreatitis such as hyperlipidaemia and gallstones.

Exenatide is an ‘amber light’ drug that is initiated only by the diabetes teams in BNSSG. Patients in whom it is being considered should therefore be referred for consultant review. The drug should be discontinued in the absence of fall of at least 1.0% in HbA1c achieved within 6 months and sustained thereafter.

viii. DPP-4 inhibitors (gliptins) DPP-4 inhibitors (sitagliptin, vildgliptin) may be suitable second-line therapy instead of sulphonylurea if a patient is considered to be at significant risk of iatrogenic hypoglycaemia e.g. frail older people living alone. Their role otherwise currently lacks a clear evidence base. As they are novel agents with potential effects upon multiple tissues and have not yet been widely used, their use in other situations is not recommended.

ix. anti-obesity drugs and obesity surgery Orlistat and sibutramine may be considered as part of a weight-

loss strategy for people with type 2 diabetes and BMI ≥ 28 kg/m2 accordance with NICE guidance. Treatment should generally be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of drug therapy.

Patients with type 2 diabetes with body mass index ≥ 35 kg/m2 may be suitable for gastric banding or other bariatric surgery in accordance with NICE guidance. Referrals to the service are accepted only from secondary care and patients who are potentially suitable should therefore be referred to the diabetes specialist team in the first instance (see Appendix 4c)

x. Insulin Use if treatment with combined oral hypoglycaemic agents fails to achieve targets. If metformin has previously been tolerated, it should generally be continued in patients with type 2 when starting insulin. See Appendix 4a for guidelines.

References: NICE clinical guideline 66: Management of type 2 diabetes (update) (2008)

(http://www.nice.org.uk/nicemedia/pdf/CG66NICEGuideline.pdf) NICE clinical guideline 43: Obesity (2006)

(http://www.nice.org.uk/nicemedia/pdf/CG43NICEGuideline.pdf )

c) Monitoring

i. Home blood glucose monitoring

Diabetes type Treatment group Monitoring regimen Type 1 All people with

type 1 diabetes Blood glucose monitoring should be an integral

part of treatment People with type 1 diabetes should receive

education to enable them to monitor BG and adjust treatment appropriately

The majority of people with type 1 diabetes should consider testing ≥ 4 times per day to optimise control and prevent acute complications

The frequency and timing of tests should be tailored according to the targets and stability of glycaemic control

Diabetes in pregnancy

All women with diabetes in pregnancy

Blood glucose monitoring essential during pregnancy and when planning pregnancy

The frequency and timing of tests as recommended by the joint diabetes/antenatal team

Type 2 Intensive insulin therapy/titration of insulin

As with type 1 diabetes, monitoring should be according to the individual’s need to optimise control and prevent acute complications

Fasting blood glucose should be tested daily during basal insulin dose titration

Type 2 Insulin (with or without oral agents)

Wherever possible all patients on insulin or their relatives should be taught to perform BGM, to interpret results and adjust treatment

The frequency and timing of tests should be tailored according to the targets and stability of glycaemic control

People using conventional insulin regimens and have less stable control should test at least once daily, varying the time between fasting, pre-meal and bedtime tests

Those with stable control should test 2-3 times per week, varying the times as above

Type 2 Diet & exercise People with good control do not need to monitor

unless they are destabilised by other factors HbA1c should be monitored 3-6 monthly If individuals choose to perform BGM as a

method of monitoring lifestyle changes, then they should be advised on the most appropriate meter and monitoring advice as below

Offer BGM to a person newly diagnosed only as an integral part of a self-management plan and advise as below

Type 2 Metformin +/- glitazones or gliptins

As for diet and exercise

Type 2 Sulphonylurea alone or in combination with other agents

BGM should be available to provide information on hypoglycaemia e.g. due to variable food intake or activity levels

BGM should be available to ensure safety during activities including driving

BGM should be considered for those with poor or deteriorating control particularly those on maximum oral agents who are likely to require insulin in the near future

Type 2 Incretins There is no evidence to support BGM unless on sulphonylurea

Special circumstances

Driving Illness Changes of

treatment Steroid

therapy

People on insulin and sulphonylureas must be made aware of the DVLA regulations

‘Sick day’ guidance should be available for patients regarding the frequency of testing

BGM may be indicated during changes in treatment

People should be advised to test or increase testing to adjust diabetic treatment if taking steroids (see Appendix 3e)

Discuss urine glucose monitoring if blood monitoring is found to be unacceptable

Monitoring advice

Assess BGM at least annually and include in the discussion: the purpose of monitoring, how to interpret and

act on the results self-monitoring skills, the equipment used,

quality and frequency of testing how the results are used, the impact on quality

of life and the continued benefit

References: Consensus guidelines: Recommendations regarding self-monitoring of blood glucose (Appendix 2) Diabetes and Primary Care. 2005; 7: 9-21 NICE clinical guideline 66 The Management of type 2 diabetes May 2008

ii. Glycated haemoglobin (HbA1c) HbA1c should be monitored 3-6 monthly. As the results reflect glycaemic control over a period of 6-8 weeks, tests performed at intervals of less than 3 months are uninformative and should be avoided. The frequency of testing depends on the target for glycaemic control, stability of blood glucose control and changes in therapy.

iii. Fructosamine Use for monitoring glycaemic control in haemoglobinopathies

2. CHD risk factor control and targets

Targets (NICE clinical guideline 66, 2008) Total cholesterol

< 5.0 mmol/l

(<4.0 mmol/l if vascular disease or CVD risk > 20%)

Blood pressure

Smoking

≤140/80 mmHg

(≤ 130/80 mmHg if microalbuminuria or proteinuria, retinopathy or

cerebrovascular disease)

Non-Smoker

It should be emphasised that any improvement in the level of control of BP and cholesterol is associated with reduction in risk of macrovascular disease, even if the targets are not achieved.

References: NICE guideline 66: Management of type 2 diabetes (update) (2008)

Management of hypertension Steps (1)-(6) indicate sequential additional treatment given if targets

not achieved

Check creatinine & electrolytes before and

1-2 weeks after startingACE inhibitor

Urine ACR <2.5M/3.5W mg/mmolTarget <140/80

Urine ACR ≥ 2.5M/3.5W mg/mmolTarget <130/80

(1) LIFESTYLE CHANGESReduce salt

Lose weight and ↑ activity

(2) ACE INHIBITOR

hypertension alonetitrate over 2-3 wk to

achieve target BP or maximum

licensed dose

microalbuminuria/proteinuriatitrate to maximum dose

over 2-3 wk unless

symptomatic hypotension

STOP ACEI or ARB if:• K+ ≥ 6.0 mmol/l (at lower levelsameliorate with addition of diuretic)• Creatinine rises by >25%

ANGIOTENSIN II RECEPTOR BLOCKER

if ACEI induced cough

(3) DIURETIC6

(4a) β BLOCKER7 (4b) CALCIUM CHANNELBLOCKER8

(5) α BLOCKER9

(6) REVIEW TREATMENT• May need to add centrally acting agent

(eg monoxidine or methyl dopa)• Consider secondary care referral

ACE inhibitor and AIIR blocker

CONTRAINDICATEDSee next figure

Alternative treatment pathway if ACE inhibitor and angiotensin II receptor blocker contraindicated

n.b. patients with CKD 1, 2 or 3 whose creatinine has risen >25% on starting ACE inhibitors or angiotensin II receptor blockers should be referred to the

nephrologists

(2) Diuretic6

(3) β blocker7

monitor pulse rate if also on diltiazem

(1) non-dihydropyridone calcium channel blocker (eg diltiazem modified release preparation)

(4) α blocker9

(5) review treatment• May need to add centrally acting agent

(eg monoxidine or methyl dopa)• Consider secondary care referral

Notes:

1. Salt intake should be reduced in all patients (patient advice is available on the websites of NHS direct and and the Food Standards Agency: http://www.nhs.uk/Livewell/Goodfood/Pages/salt.aspx http://www.eatwell.gov.uk/healthydiet/fss/salt/ )

2. Patients with ACR ≥ 3 mg/mmol should be started on an ACEI irrespective of blood pressure in line with guidelines for the management of proteinuria or persistent microalbuminuria

3. Check eGFR and potassium before and 1-2 weeks after commencing ACEI or ARB.

• Stop ACEI/ARB if potassium > 6.0 mmol/l with no modifiable cause. • Stop ACEI/ARB if eGFR falls >25% unless modifiable cause • If eGFR falls >5% but less than 25%, recheck eGFR in 1-2 weeks • Refer to nephrologists if eGFR falls >15% in patients with CKD 3 or

CKD 1 & 2

4. Consider stopping ACEI or ARB 1 week prior to elective surgery or during intercurrent illness (especially if fluid depleted) to reduce risk of acute kidney injury

5. Antihypertensive medication should be reviewed in all women planning pregnancy. If clinically acceptable ACEI and ARB should be stopped in all women planning pregnancy and replaced with alternative antihypertensive medication eg methyl dopa or nifedipine

6. Diuretics: bendroflumethiazide 2.5 mg od (maximum effect after 4-6 wk). Use furosemide 40 mg bd if the patient has oedema or GFR <60 ml/min/1.73m2

7. β blockers: Atenolol 50 mg od (avoid in critical limb ischaemia)

8. Calcium channel blockers: Long acting dihydropyridone CCB (e.g. amlodipine, nifedipine, felodipine) or non-dihydropyridone CCB (e.g. diltiazem modified release preparation or verapamil). Long acting dihydropyridone CCB and β blockers may be combined. Caution should be used if prescribing diltiazem and β blockers. Verapamil should not be prescribed with β blockers

9. α blockers: e.g. doxazosin 1 mg od for one wk → 2 mg od for one wk → 4 mg od for one wk. Increase dose further if target not achieved (max 16 mg od)

Management of dyslipidaemia

Rx statin

Evidence of vascular disease

Simvastatin40 mg

High risk(type 1 or type 2 diabetes)

• age >40 yr • age 18-39 yr with additional risk factor1

TargetTot. cholesterol < 4 mmol/l

&LDL <2 mmol/l

Increase to Simvastatin 80 mg if low risk of side effects (no elevation in ALT or CK, no muscle symptoms

and no predisposing factor for myositis). Otherwise substitute Atorvastatin 20 mg or Rosuvastatin 10 mg

Accept if LDL 2-3 & TC 4-5, and judged to be at moderate risk.

if LDL > 3, TC > 5 or clinically judged to be at very high risk consider

Atorvastatin 40-80 mg OR Rosuvastatin 20 mg OR

Add Ezetimibe 10 mg

Consider addingFenofibrate MR 160 mg

(caution ↑ risk of myositis)

Refer to secondary carelipid clinic

target not achieved after 6 wk

LDL > target HDL <1 OR fasting trigs >2.3


TargetTot. cholesterol < 5 mmol/l

&LDL <3 mmol/l

Vascular disease OR CVD risk >20%

No evidence of vascular disease AND

CVD risk < 20%


Notes:

1. Additional risk factor:

One or more of the following:

– Evidence of microvascular complications (retinopathy and/or microalbuminuria)

– hypertension on treatment,

– family history of premature cardiovascular disease,

– metabolic syndrome

– HbA1c ≥ 9.0%

– total cholesterol ≥ 6.0 mmol/l

2. Women who are considering pregnancy should stop statins prior to conception as there is a suggestion that statins may affect CNS and limb formation if taken during 1st trimester.

References:

NICE clinical guideline 66. The management of Type 2 diabetes (update) (May 2008)

NICE clinical guideline 67. Cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease (May 2008).

Anti-platelet agents National guidance on the use of antiplatelet agents for primary prevention of cardiovascular disease in people with diabetes is currently under review. The most recent NICE recommendations are to treat any person with type 1 or type 2 diabetes who meets any of the following criteria:

• Age ≥ 50

or

• Age < 50 and significant other cardiovascular risk factors

o hypertension on treatment,

o family history of premature cardiovascular disease,

o metabolic syndrome

o smoking

o microalbuminuria

o existing cardiovascular disease (MI or angina, stroke or TIA, or PVD) Start treatment after systolic blood pressure has been reduced to ≤145 mmHg.

Blood pressure should be kept at 145 mmHg or lower while aspirin is being taken as anti-platelet therapy.

Prescribe dispersible aspirin 75 mg od unless contraindicated (see below)

Consider use of combined dipyridamole/aspirin for 24 months in patients who have experienced a vascular event whilst on aspirin.

Contraindications to anti-platelet agents Aspirin allergy defined by anaphylaxis - rash or wheeze directly

attributable to aspirin ingestion. Consider use of clopidogrel for secondary prevention

Previous cerebral haemorrhage (ever)

Active peptic ulceration. In previous peptic ulcer disease, aspirin can be started in conjunction with a proton pump inhibitor

Bleeding tendency

Active hepatic disease

Concomitant warfarin therapy, unless indicated and carefully monitored

Uncontrolled hypertension (systolic BP ≥145 mmHg)

References: NICE clinical guideline 66: Management of type 2 diabetes (update) (2008) NICE clinical guideline 37: Type 1 diabetes (July 2004)

Appendix 2a: Management of problematic hypoglycaemia

Problematic hypoglycaemia

Explore possible reasons• food• activity• alcohol• medication

Exclude underlying causes• weight loss

• renal function• endocrine causes

(thyroid, adrenal etc)• coeliac diseasePatient on

insulinPatient on

sulphonylurea

Adviseq.d.s.

self BG monitoring

Hypos requiringassistance from

a third party

Review • injection sites• insulin doses

(inc. patient’s own adjustments)

• hypo treatment• driving safety

Reduced warning(results <3.5 mmol/lwithout symptoms)

Consider urgentreferral to

SpecialistTeame.g DRAC

Move sites and/or

adjust insulin doseas appropriate

Rx glucagon andGlucogel

Night hypos

Advise regular low GIbedtime snack

Consider change to • short acting insulin analogue(esp. if hypos 1.00 – 3.00 am)• long acting insulin analogue

Day time hypos

Consider change to basal bolus

insulin regimen

If T1DM, refer to dietitian for training

in carbohydrate counting

Continued problemRefer to secondary care

specialist team

Review carbohydrate counting

dose adjustmentetc

ConsiderCSII

in T1DM patients

substitute gliclazide

or tolbutamide

Patient on glibenclamide

Consider • stopping or reducing dose

• starting CBGM by patient or carer

Patient frail orelderly

consider low dosetolbutamideor a gliptin

If medication required

Continued problemRefer to secondary care

specialist team

Notes: Blood glucose levels of < 4 mmol/L should be treated as hypos whether or not accompanied by symptoms. 1. Possible reasons to be considered • Changes in food intake – reduced carbohydrate, delayed or missed meals or snacks.

Varying carbohydrate intake at meals may also cause hypos. • Physical activity – this can include activity such as housework, ironing, shopping and

gardening as well as exercise. Hypos may be delayed following intensive exercise • Medication/ insulin – incorrect or too much. Oral hypoglycaemic agents (eg

gliclazide, glibenclamide) can cause hypos • Alcohol - the effects can often be delayed until the following day, particularly if

large amounts of alcohol are consumed. Advise bedtime snack and blood glucose monitoring following day

2. Potential underlying causes • Renal impairment • Weight loss • Endocrine disorders (eg hypothyroidism, Addison’s disease) • Coeliac disease • Pregnancy • Injection sites (especially if the patient has moved sites) • Cessation/reduction of steroids without reduction in diabetes medication

3. Symptoms • Usual symptoms include sweating, trembling, weakness/fatigue, hunger,

palpitations, speech problems • Recurrent hypos will cause a change/reduction in hypo symptoms.

4. Immediate advice • Advise patients to test BG levels if possible in event of further hypos, and to

ingest 20g of quick acting carbohydrate – eg Lucozade, glucose tablets. Once blood glucose levels are above 4mmol/l to have a snack containing approx 15-20g of longer acting carbohydrate.

• Further information/patient information sheet is available at www.avondiabetes.nhs.uk

5. Assessment and management • Identify the BG level at which the patient’s warning symptoms occur – if

significant reduction in warning or symptoms occur only when BG less than 3.5mmol/l, refer to the diabetes specialist team: the Diabetes Rapid Access Clinic (DRAC) at NBT, the DSNs at UHBristol or the diabetes team at Weston General Hospital

• Encourage patient to test BG levels pre-meals, bed and around the time that hypos most commonly occur

• Explore timing of medication and food. Ensure insulin or sulphonylurea is being taken at recommended times in relation to meals

• Identify patterns in hypos, advise adjustment in insulin/medication accordingly • Review injection sites – lipohypertrophy can cause erratic absorption of insulin. If

patient advised to move sites reduce insulin by 10-20% initially. • Recheck HbA1c. HbA1c < 6.5% in insulin treated patients or HbA1c <6% on

sulphonylureas is suggestive of significant hypoglycaemia.

6. Hypo unawareness • If the patient experiences no symptoms until blood glucose is <3.5mmol/l, he/she

is considered to have hypo unawareness • Unawareness is potentially dangerous, especially if driving or operating machinery • Often the patient has no adrenergic symptoms, and therefore presents with

confusion or other neurological problems • Patients with hypo unawareness should be referred for specialist team review

complete avoidance of low BG levels for around 3 months can help restore warning symptoms. This requires intensive multiprofessional input

7. Indications for referral to secondary care • Hypo unawareness • Any unconscious episodes of hypoglycaemia • More than 3 hypos per week • Consider referral of any patient having hypos requiring assistance from a third

party

8. Driving and Hypoglycaemia • Patients with hypoglycaemia unawareness should be advised not to drive until

warnings return • Always check blood glucose levels before driving, and every 2 hours during the

journey • Do not drive if feeling hypoglycaemic or if blood glucose less than 4 mmol/l • Do not resume driving until 45 minutes after blood glucose has returned to normal.

It takes up to 45 minutes for the brain to fully recover. • If blood glucose ≤ 5mmol/l snack before driving • Ensure the patient knows to have a blood glucose meter and fast acting

carbohydrate in the car Ref: ‘A guide to insulin treated diabetes and driving’ http://www.dvla.gov.uk/media/pdf/medical/aagv1.pdf

Appendix 2c: Management of painful diabetic neuropathy

Assess pain on Likert scale(0 no pain – 10 worst possible pain)

Foot examination and assessment of risk (see Appendix 1a)

Discuss causeand prognosis

AddPregabalin

(max 300 mg/day)

≥ 30% pain relief

Neuropathic symptoms?Burning, pain, hyperaesthesia, numbness, difficulty walking

Optimise glycaemic controlDrug treatment

Amitriptyline(max 75 mg)

SubstituteDuloxetine

(max 60 mg/day)stop amitriptyline

Consider trial of opiatesOxycodone MR (10 – 60 mg bd) or

Tramadol (50 – 100mg qds)and/or

Pain clinic referral

Consider otherpossible causes

Unable to tolerateamitriptyline

or <30% pain relief

<30% pain relief with duloxitene alone

Alternative pathway if persistent pain on amitriptylineand pregabalin

Notes:

1. Review patient regularly and increase dose of drugs 1-2 weekly depending on the response Use Likert scale to guide for dose adjustment (daily scoring by patient and the weekly mean of pain score)

• If ≥30 % or more improvement but on maximal dose of a drug, add next drug.

• If < 30 % improvement on maximum dose, stop drug.

Starting dose Suggested increment interval Maximum dose

Amitriptyline 10 mg nocte 10 mg 2 weeks 80 mg nocte

Pregabalin 50 mg 50 mg 1 week 150 mg b.d.

Duloxetine 15 mg nocte 15 mg 1 week 30 mg b.d.

A painful diabetic neuropathy score record and information sheets for patient prescribed amitriptyline/nortriptyline, pregabalin or duloxetine are available to be downloaded from www.avondiabetes.nhs.uk

2. Titrate down the dose of drugs over 1-2 weeks when stopping them.

3. If other factors equal, select 2nd line treatment on cost. (January 2009: duloxetine < pregabalin)

4. Warn patient about sedative effects of drugs especially while driving or operating hazardous machinery.

5. When combining drugs. • Consider the sedative effects • If combining duloxetine and pregabalin, lower the doses. • The following should not be combined

• amitriptyline and duloxetine • pregabalin and gabapentin • tramadol and amitriptyline or duloxetine.

6. In renal impairment doses may need to be adjusted depending on eGFR

7. Pregabalin should be used with caution in patients with pre-existing oedema. The usual dose is up to 300 mg/day. A dose of 600 mg /day may give some additional pain relief but is associated with increased side effects. Consider a trial of the higher dose in patients who have partial benefit from 300 mg/day and tolerate this dose without problems.

8. Gabapentin has not been recommended because of its higher cost at the recommended doses and more complex dose titration compared with pregabalin

9. Patients who cannot tolerate amitriptyline sometimes have fewer side effects on alternative tricyclic antidepressants such as nortriptyline.

Appendix 2e: Management of erectile dysfunction

Evidence of significant relationship/ psychosexual & lifestyle problems

Consider referrral for relationship/ psychosexual

counselling

No nitrate use & fit for sex (can climb 2 flights of stairs without

SOB or chest pain)

Trial of oral phosphodiesterase inhibitor

consider stopping beta-blockers Medications2

exclude endocrine cause3Loss of or low libido

Urological cause1 refer urology andrology clinic

effective & no adverse effects

Continue

not sufficient for intercoursetry tadalafil 20 mg

on ≥8 occasions

not sufficient for intercoursetry another PDE5 inhibitor5

Patient tries tadalafil 10 mgon 4 occasions

adverse effects

not sufficient for intercoursetry tadalafil 10 mg

on further 4-8 occasions4

try tadalafil

5 mg

Fails to respond to proper trial of PDE5 inhibtorsor unacceptable side effects at effective doses

refer to urology andrology clinic

Notes:

• Erectile dysfunction is usually multifactorial • Organic cause likely if: gradual onset, present in all situations (inc waking

& self stimulation), lack of tumescence, normal ejaculation, risk factors. • Psychogenic cause likely if: sudden onset, early collapse of erection,

normal spontaneous/ waking/ self stimulated erections, premature or absent ejaculation.

Identify treatable causes if possible Notes:

1. Urological causes: e.g. curved penis (Peyronie’s disease), pelvic injury, pelvic/prostatic surgery or radiation treatment.

2. Many drugs can theoretically cause ED but medication changes rarely result in improvement apart from stopping β blockers.

3. Check testosterone, SHBG, LH, FSH, prolactin and thyroid function. Refer for endocrine opinion if appropriate.

4. Effective erections occur after a mean of 8-12 doses of oral phosphodiesterase inhibitors. If any appears ineffective, patient should try the drug on at least 8 occasions at the maximum or maximum tolerated dose before abandoning.

5. Other PDE5 inhibitors: sildenafil (Viagra) 25-100mg or vardenafil (Levitra) 5-20mg. Start at sildenafil 50 mg or vardenafil 10 mg and titrate to response and adverse effects as above. If either appears ineffective, try on at least 8 occasions before abandoning.

Appendix 3a: Diabetes in women

From adolescence and throughout potential child-bearing years

The following methods of contraception are generally most suitable for women with diabetes:

• Mirena coil • Cerazette • Implanon • Combined hormonal contraceptives

n.b. Avoid combined hormonal contraceptive if BMI >39.0, or over age 35 yr or diabetic complications present

The importance of avoiding unplanned pregnancyshould be an essential component of diabetes education and

must be discussed (and documented) at every opportunity with all women

with type 1 and type 2 diabetesfrom adolescence and while of child-bearing age

Not currently planningpregnancy

• Ensure most effective contraceptionpossible

• Explain (and document) risks of unplanned pregnancy and the need to optimise glycaemic control beforestopping contraception

• Explain (and document) the need to plan pregnancy when the time is right

Pre-pregnancy in women with type 1 or type 2 diabetes

The importance of avoiding unplanned pregnancyshould be an essential component of diabetes education and

must be discussed (and documented) at every opportunity with all women

with type 1 and type 2 diabetesfrom adolescence and while of child-bearing age

Not currently planningpregnancy

• Ensure most effective contraceptionpossible

• Explain (and document) risks of unplanned pregnancy and the need to optimise glycaemic control beforestopping contraception

• Explain (and document) the need to plan pregnancy when the time is right

Consideringpregnancy

• Refer for pre-pregnancy counsellingin antenatal clinics at St Michael’s or Southmead 1,2

• Prescribe 5mg folic acid od 3

• Aim for HbA1c ≤ 6.1% 4

• Ensure retinal screening and urine ACR in the past 6 months 5

• Medication review 6

Notes: 1. All women with type 1 or type 2 diabetes planning to become pregnant

must be referred for preconception counselling delivered by a specialist antenatal medical clinic

2. Referrals should be sent to:

• For Southmead Hospital – fax to Dr Andrew Johnson’s secretary 0117 323 6379

• For St Michael’s Hospital - fax to Diabetes Specialist Nurses 0117 3423945 and to the secretary to the obstetric team (Miss Sellers/Miss Trinder/Miss Treloar) 0117 342 5250

• For Weston General Hospital - fax to Dr Kurien John’s secretary 01934 647209 and to St Michael’s 0117 342 5250

3. There is an increased risk of neural tube defects in babies of women

with diabetes. All women planning pregnancy should be given folic acid 5mg once daily (not 400 micrograms) prior to conception and up to 12 weeks gestation.

4. Advise women to aim for an HbA1c below 6.1%, if safe.

Inform women that any reduction in HbA1c may reduce risks. Advise women with HbA1c above 10% to avoid pregnancy.

5. Diabetic retinopathy can worsen in pregnancy, therefore all women

must have retinal assessment by digital imaging with mydriasis using tropicamide within the 6 months prior to conceiving

6. Medication review:

• Oral hypoglycaemic agents may need to be stopped and insulin started if required. However, NICE guidance allows the use of metformin (and exceptionally, with informed consent, glibenclamide) in pregnancy under specialist antenatal care.

• Angiotensin-converting enzyme inhibitors and angiotensin-II receptor antagonists should be stopped and alternative antihypertensives started (methyldopa)

• Statins should be stopped Reference: NICE clinical guideline 63: Diabetes in Pregnancy (July 2008) http://www.nice.org.uk/nicemedia/pdf/CG063NICEGuideline.pdf

Confirmed pregnancy Women with type 1 or type 2 diabetes

1. Advise women to aim for an HbA1c below 6.1%, if safe.

Inform women that any reduction in HbA1c may reduce risks.

2. Prescribe folic acid and review medication as indicated in pre-pregnancy section

Reference: NICE clinical guideline 63: Diabetes in Pregnancy (July 2008)

If unplanned pregnancy

• prescribe 5mg Folic acid od 3

• aim for HbA1c ≤ 6.1% 4

• medication review 6

Southmead Hospital St Michael’s Hospital

• Urgent referral (same day) faxed toDr Johnson’s secretary 0117 959 6379

and

• Phone referral to DSNs07500 027385

• Urgent referral to Peggy WoodwardDiabetes Specialist Midwife 0117 3425577 or fax 0117 3425523

• Phone referral to DSN’s BRI 0117 342 2892 orWeston General Hospital 01934 647213

Confirmed pregnancy(planned or unplanned) in a woman with type 1

or type 2 diabetes

Pregnancy in women at risk of gestational diabetes

Screen at booking

Previous gestational diabetes • BMI > 30 kg/m2

• Previous macrosomic baby (birth weight ≥ 4.5 kg)

• 1st degree relative with diabetes

• Family origin with high prevalence of diabetes(South Asian, black Caribbean/

African, Middle Eastern)

Offer 75g oral glucose tolerance test at 16-18 weeks

and repeat at 28 weeks if first test normal

or offer early self-monitoring

of blood glucose

See local guidelines for referral to specialist

maternity services

Southmead Hospital St Michael’s Hospital Weston General Hospital

Refer to DSNs 07500 027385

Refer to Peggy Woodward Diabetes Specialist Midwife

Tel: 0117 342 5577or Fax 0117 342 5523

Refer to DSNs01934 647213

Offer 75g oral glucose tolerance test at 24-28 weeks

Post natal care

General:

• Breastfeeding - continue to avoid drugs discontinued for safety reasons

• Advise on the importance of contraception and pre-conception care when planning future pregnancies

Gestational diabetes:

• Advise on

o weight control, diet / exercise

o symptoms of hyperglycaemia

o Risks of gestational diabetes and need for screening when planning pregnancy

• FBG at the 6-week postnatal appointment, then annually

Insulin-treated pre-existing diabetes:

• Encourage frequent monitoring as insulin requirements may change

• Risk of hypoglycaemia, especially while breastfeeding

• Food available before / during breastfeeding

• Refer back to routine diabetes care

Type 2 diabetes:

• Resume or continue metformin or insulin while breastfeeding. Other oral hypoglycaemic agents to be avoided

• Refer back to routine diabetes care Ophthalmological follow-up:

• Women with preproliferative diabetic retinopathy diagnosed in pregnancy should be offered ophthalmological follow-up for at least 6 months post partum

Appendix 3d: Managing diabetes at the end of life

i. Type 1 diabetes

Type 1 diabetes

Last weeks of life

Will still need some insulin until end of life

Consider change to basal bolus regimenwith reduced dose

eating some small meals

eating minimalamount

give short actinginsulin after meals

titrated to amount eaten

discontinue usual insulin regimen and commence

insulin glarginenocte

final days of life

b.d. insulin regimen

basal-bolus insulin regimen

Discontinue insulin and BG monitoringwhen clinical team and carers agree consequences ofuncontrolled hyperglycaemia are less burdensome

for patient than process of monitoring and injections .

Type 1 diabetes

Last weeks of life

Will still need some insulin until end of life

Consider change to basal bolus regimenwith reduced dose

eating some small meals

eating minimalamount

give short actinginsulin after meals

titrated to amount eaten

discontinue usual insulin regimen and commence

insulin glarginenocte

final days of life

b.d. insulin regimen

basal-bolus insulin regimen



ii. Type 2 diabetes

Type 2 diabetes

last weeksof life

may or may not need some insulinas oral intake reduces

and through the dying process

needs insulinRx insulin

glargine o.d.

final daysof life

Discontinue usual insulin regimen and monitor capillary BG b.d. for 2 days

BG ≥ 20 mmol/lor

BG ≥ 15 mmol/land symptoms

of hyperglycaemia

insulin treated tablet treated

BG < 20 mmol/lor

no symptoms

no insulin or

monitoring required.

BG ≥ 20 mmol/land

symptoms

considerinsulin

glargine o.d.



Discontinue OHA and monitor capillary BG o.d. for 2 days

usually need to discontinue oralhypoglycaemic agents

to avoid hypoglycaemia

BG ≥ 20 mmol/lor


of hyperglycaemia

Consider Restarting OHAat reduced dose.

last weeksof life

final daysof life

orBG < 20 mmol/l

orno symptoms

no OHAor


Type 2 diabetes

last weeksof life

may or may not need some insulinas oral intake reduces

and through the dying process

needs insulinRx insulin

glargine o.d.

final daysof life

Discontinue usual insulin regimen and monitor capillary BG b.d. for 2 days

BG ≥ 20 mmol/lor


of hyperglycaemia

insulin treated tablet treated

BG < 20 mmol/lor

no symptoms

no insulin or


BG ≥ 20 mmol/land

symptoms

considerinsulin

glargine o.d.



Discontinue OHA and monitor capillary BG o.d. for 2 days

usually need to discontinue oralhypoglycaemic agents

to avoid hypoglycaemia

BG ≥ 20 mmol/lor


of hyperglycaemia

Consider Restarting OHAat reduced dose.

last weeksof life

final daysof life

orBG < 20 mmol/l

orno symptoms

no OHAor


Notes: 1. Objectives of care

• To prevent symptomatic hyperglycaemia • To prevent diabetic ketoacidosis (DKA) or hyperosmolar non-ketotic state

(HONK) • To prevent iatrogenic hypoglycaemia • To prevent unnecessarily invasive interventions in the last weeks to days

of life • To recognise that strict glycaemic control and dietary restrictions are

not desirable and aim for blood glucose range 5 – 20 mmol/l.

2. Clinical teams should recognise and communicate with the patient, carers and staff that the patient with diabetes is entering the final weeks or days of their life, so that care and medical management can be planned

3. The consensus clinical guideline to manage diabetes at the end of life is

available on www.avondiabetes.nhs.uk 4. The appropriate clinical guidance should be selected on the patient’s

expected prognosis and diabetes type.

Appendix 3e: Diabetes and steroid treatment

Diet controlled diabetes/not known diabetes with symptoms that may be related to

hyperglycaemia

Monitor BG for 2 days

BG < 15 mmol/l BG ≥ 15 mmol/l

Stop monitoring,

no Rx required Start

gliclazide 80mg

Continue monitoringfor 2 days

BG < 5 mmol/l

Reduce gliclazide to

40 mg odor

stop if hypoglycaemia

BG <15 mmol/l

asymptomatic stop

monitoring

BG ≥ 15mmol/l or symptoms

start morning isophaneinsulin &continue OHAs

Known diabetestablet/insulin treated

Monitor BG for 2 days

BG ≥ 15 mmol/lBG < 15 mmol/l

Tablet treated

Continue current

treatment

Insulin treated

Increase OHAs

BG ≥ 15Mmol/l

BG < 15mmol/l

Continue current dose

stop monitoring

unless symptomatic

Start morning isophaneinsulin

& continue OHAs

Increase insulin and continue monitoring if BG ≥11 mmol/l

If on b.d. insulin regimen, consider adding short acting insulin with lunch or switching to basal-

bolus regimen

Effect of steroids on blood glucose levels

• Steroids induce a state of relative insulin resistance, most patients will not have significantly different FBG but postprandial hyperglycaemia is exaggerated

• BG levels can start to rise within a few days of commencing oral steroids & subside within 48 hours of stopping the medication. Injected steroids may cause BG levels to rise soon after administration & last 3 - 10 days

• Controlling BG levels will improve hyperglycaemic symptoms, reduce the risk of infections and hyperglycaemic emergencies

Managing diabetes and steroid therapy

• Start BG monitoring (BGM) or increase the frequency – check fasting and post-prandial levels for 2 days

• Diet/tablet controlled – if BG ≥ 15mmol/l add gliclazide for people normally controlled on diet alone or with metformin

• If BG remains ≥ 15mmol/l after increasing OHAs, add isophane insulin, initially at breakfast time

• Frail or elderly patients may benefit from other regimens suited to their glucose profile and circumstances contact the community DSN or specialist team for advice if in doubt any of these situations

• Insulin treated – increase insulin if BG ≥ 11mmol/l consider a basal bolus regimen or adding short acting insulin to a bd regimen and adjust as per sick day guidance (www.avondiabetes.nhs.uk)

• Not known to have diabetes but displaying symptoms that may be related to hyperglycaemia, initiate BGM for 2 days and treat as for diabetes if BG ≥ 15mmol/l

General advice

Patients on steroids often have additional causes for the increase in BG level, such as decrease in activity, increased appetite & weight gain

• Follow a healthy eating plan & see a dietitian if indicated

• Refer to DSN for ongoing education and support if indicated

Appendix 4a: Starting insulin in type 2 diabetes • Who should initiate insulin in type 2 diabetes?

Insulin can be initiated in primary care by GP and practice nurse teams who have undergone recognized training (locally or nationally), attend CPD in diabetes care and when the practice nurse has a recognized diabetes qualification (e.g. diabetes diploma).

If in doubt contact the secondary care team or primary care DSN

• How is it done?

1. Ensure the patient understands the relationship between insulin and BG, this helps when increasing the dose of insulin (those unable to monitor BG levels will require support from community nursing team)

2. Become familiar with the use of a limited range of insulins. For example:

a) isophane insulin (Insulatard, Humulin I or Insuman Basal) for overnight regimens,

b) 30/70 biphasic pre-mixed soluble/isophane insulins (e.g. Mixtard 30 or Humulin M3) for bd regimens.

Randomised controlled trials published to date do not show any advantage to using analogue insulins in type 2 diabetes in terms of HbA1c or risk of hypoglycaemia.

twice daily insulin(continue metformin if tolerated)add bedtime insulin to oral therapy

start isophane insulin• 10 units od if previously on metformin only or if sulphonylureacontinued• 20 units od if previously on combined treatment and SU is stopped. Use lower dose if BMI < 20 kg/m2 or patient is frail/elderly

start biphasic 30/70 premixedsoluble/isophane insulin• 10 units bd if BMI > 20 kg/m2. Use lower dose if BMI < 20 kg/m2

or patient is frail/elderly• continue metformin if tolerated

Decision to start insulinInvolve patient in choice of regimen

and device to suit lifestyle and ability

Assess lifestyle issues and refer to dietitian

In general, addition of a single dose of bedtime insulin to oral therapy is only likely to control BG if the patient is asymptomatic and HbA1c <9.5%.

Continue metformin in combination with the insulin if tolerated in order to minimize weight gain. If unable to tolerate metformin, consider switch to modified release or reduced dose.

3. Hypoglycaemia is unlikely because of the nature of type 2 diabetes and the low starting dose – however, patients need to be clear on how to recognize symptoms and what corrective action to take – refer to hypoglycaemia guidelines/patient information sheet available on www.avondiabetes.nhs.uk

4. Implications for DVLA need to be discussed.

5. Telephone support and an emergency contact are needed with regular follow up.

• Adjusting the dose of insulin

Targets may need to be modified for patients who are frail and elderly or have cognitive impairment

Once the target is achieved, avoid making changes too frequently.

If BG levels remain elevated check factors such as injection technique, diet, lifestyle and the patient’s understanding of what he/she is doing.

Bedtime insulinadjust dose every 3 days to achieve

fasting BG 4.0 – 5.5 mmol/lunless symptoms of hypoglycaemia

occur

Twice daily insulinadjust dose every 3 days to achieve

fasting and pre-evening mealBG 4.0 – 5.5 mmol/l

unless symptoms of hypoglycaemia occur

determine whether fasting orpre-evening meal test is highest and

adjust the appropriate insulin to bring this down

fasting BG5.5 - 10.0 mmol/l

fasting BGconsistently>10.0 mmol/l

increase dose by 4 units

increase doseby 2 units

BG5.5 - 10.0 mmol/l

BGconsistently>10.0 mmol/l

increase doseby 2 units

increase dose by 4 units

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