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Original Authors WKCCG Medicines Optimisation Team

Ratified by NHS West Kent CCG Medicines Optimisation Group: 10/1/2019

Diabetes Implementation Group: 24/1/2019

MTW Drugs and Therapeutics Medicines Management Committee:

Version 8 (draft)

Date Issued

Review Date

Contact Point for Queries wkccg.medman@nhs.net

Type 1 and Type 2 Diabetes

Guidance document

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Table of Contents

Page 4-11: 1. West Kent CCG prescribing guidelines for the management of Adults withType 2 Diabetes Mellitus (T2DM)

Page 5-6: Summary of Implications of West Kent CCG Prescribing Guidelines for theManagement of Adults with Type 2 Diabetes Mellitus

Page 7: West Kent CCG Blood Glucose Management decision cycle for Adults withType 2 Diabetes Mellitus (T2DM)

Page 8: Management of hyperglycaemia in type 2 diabetesPage 9: Glucose-lowering medication in type 2 diabetes in those patients with

established atherosclerotic cardiovascular disease (ASCVD) or chronic kidneydisease (CKD)

Page 10: Glucose-lowering medication in type 2 diabetes with a compelling need tominimise hypoglycaemia

Page 11: Glucose-lowering medication in type 2 diabetes in those patients with acompelling need to minimise weight gain or promote weight loss

Pages 12-13: Insulin based treatment in type 2 diabetes Pages 14–20: 2. Type 2 diabetes medicines Pages 21-22 3. Dipeptidyl peptidase-4 (DPP-4) inhibitors initiation guidance in Type 2

diabetes for Primary Care Prescribers Pages 23-24: 4. Glucagon like peptide (GLP-1) initiation guidance in Type 2 Diabetes for

Primary Care Prescribers Pages 25-26: 5. Sodium-glucose co-transporter-2 (SGLT-2i) inhibitors in Type 2 Diabetes

guidance for primary care prescribers Pages 27-35: 6. Clinical area guidelines for clinicians;

Page 28: Blood Pressure in Type 1 & Type 2 Diabetic patients Page 29: Early Management of Diabetic Retinopathy in Type 1 & Type 2

Diabetes Algorithm Page 30: Renal Management in Type 1 and Type 2 diabetic patients Page 31: Management of cardiovascular disease risk in Type 1 and Type 2

Diabetic patients Page 32: Driving advice for Type 1 and Type 2 Diabetic patients Page 33: Management of Steroid (glucocorticoid) Induced Diabetes Page 34: Managing Glucose Control in People with known Type 1 or Type 2

Diabetes on Once Daily Steroids Page 35: End of Life Management in Type 1 and Type 2 Diabetic patients

Pages 36-45: 7. Diabetes UK Patient Information Prescriptions; Page 37: Being active Page 38: Eating well Page 39: Blood pressure Page 40: Mood Page 41: HbA1c Page 42: Foot care (low risk) Page 43: Foot care (moderate or high risk) Page 44: Kidneys Page 45: Contraception and Pregnancy

Page 46 -54: 8.Diabetes complications guidance flowcharts

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Page 47: Primary prevention of Cardiovascular Disease in diabetic patients Page 48: Management of obesity in diabetic patients Page 49: Management of hypoglycaemia in diabetic patients Page 50: Sick day rules for type 1 and type 2 diabetics treated with insulin Page 51-52: Management of diabetic foot problems and traffic light risk

assessment for the diabetic foot Page 53: Pre-conception care for women with diabetes Page 54: Management of erectile dysfunction in diabetic patients

Page 55-67: 9. Self-monitoring of Blood Glucose guidance document

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1. West Kent CCG prescribing guidelines for the management of Adults with Type 2 Diabetes Mellitus (T2DM)

At all appointments, reinforce lifestyle messages, check medication adherence and develop a collaborative care plan with the person who

has diabetes. Offer all patients structured education and integrate dietary advice with a personalised diabetes management plan, including other aspects of lifestyle modification, such as increasing physical activity and losing weight.

Please provide patients with the “Diabetes UK Patient Information Prescriptions” which outline further lifestyle and diabetes management advice to patients. These patient information prescriptions contain information on HbA1c, blood pressure, cholesterol, foot care, being active, eating well and much more.

Do not routinely offer self-monitoring of blood glucose levels unless the person is on insulin, on oral medication that may increase their risk of hypoglycaemia, is pregnant/planning to become pregnant or there is evidence of hypoglycaemic episodes. Please see West Kent CCG self-monitoring of blood glucose guidance document for more information.

Agree an individualised HbA1c target for every patient based on: the person’s needs and circumstances including preferences, comorbidities, risks from polypharmacy and tight blood glucose control and ability to achieve longer-term risk-reduction benefits. Encourage patients to achieve and maintain the target. Measure HbA1c levels at 3 to 6 monthly intervals, as appropriate. If the person achieves an HbA1c lower than target with no hypoglycaemia, encourage them to maintain it. Be aware that there are possible reasons for a lower than expected HbA1c level (e.g. haemoglobinopathies, haemolytic anaemia, splenomegaly, reticulocytosis, chronic liver disease, certain drugs - antiretrovirals)

Abbreviations of medicines used in this document; MET = Metformin SU = Sulphonylurea DPP-4i = Dipeptidylpeptidase-4 inhibitor SGLT-2i = Sodium Glucose co-transporter-2 inhibitor PIO = Pioglitazone TZD = Thiazolidinediones

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Summary of Implications of West Kent CCG Prescribing Guidelines for the

Management of Adults with Type 2 Diabetes Mellitus

Joint guidance from the American Diabetes Association (ADA) and the European Association

for the Study of Diabetes (EASD) on the management of hyperglycaemia in type 2 diabetes

was published in October 2018 (Davies, 2018). Their recommendations take into account a

systematic evaluation of the trials that have been published since 2014, many of which

assessed cardiovascular outcome and not simply impact on HbA1c. West Kent CCG

prescribing guidelines have adapted and amended these recommendations to fit in with the

West Kent Interface Formulary. There is a strong focus on a patient-centred approach with

the main goals of care to prevent diabetic complications and optimise quality of life. There

are key patient characteristics which need to be assessed from the outset and throughout

the decision-making cycle:

1. Current lifestyle

2. Comorbidities (specifically atherosclerotic cardiovascular disease, chronic kidney

disease and heart failure)

3. Clinical characteristics (namely age, HbA1c, and weight)

4. Issues such as motivation and depression

5. Cultural and socio-economic context

As the choice of treatment in the glycaemic management of type 2 diabetes continues to

expand, there are specific factors which may impact on that choice, including:

1. Individualised HbA1c target

2. Impact on weight and hypoglycaemia

3. Side-effect profile of medication

4. Complexity of the regimen (ie frequency, mode of administration) – this may impact

on adherence and persistence with the prescribed medication

The shared decision-making process to create a management plan must involve an educated

and informed patient (and their family/carers). Patient preferences should be sought and

patient empowerment should be encouraged. Effective consultation includes motivational

interviewing and goal-setting. There should be access to diabetes self-management

education and support. Patients not meeting goals generally should be seen at least every 3

months as long as progress is being made. Ongoing monitoring and support should include

checks on emotional well-being, lifestyle, tolerability of medication, self-blood glucose

monitoring (if applicable), weight, HbA1c, BP and lipid profile.

Management plans need to be agreed and reviewed at least once or twice a year. In the

event of a change in medication, the impact of this on HbA1c should take place 3 months

later. Clinical inertia should be avoided. If there is no significant impact on HbA1c following

the introduction of a specific medication despite good adherence for at least 3 months,

then that medication should be discontinued before considering the introduction of a

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different agent. However, if there has been a clinically relevant reduction in HbA1c, and the

patient is on the maximum tolerated dose of the drug without significant side-effects, then

it is reasonable to add in another agent if the individualised target has not been reached.

SGLT-2 inhibitors are the second line therapy of choice (after metformin) recommended by

the guidelines in a large number of clinical scenarios. Thus, it is important to be aware of

the situations when SGLT-2 inhibitors should be avoided:

Recurrent urinary tract infections

Recurrent uro-genital infections

eGFR < 60 ml/min – SGLT-2 inhibitors should not be commenced in patients with an

eGFR < 60 ml/min. However, if patients have an eGFR above this but subsequently

drop their renal function to < 60 ml/min, then the SGLT-2 inhibitor can be continued

down to an eGFR of 45 ml/min. Once the eGFR drops to < 45 ml/min, the SGLT-2

inhibitor should be stopped.

Patients at risk of volume depletion (eg on loop diuretics, elderly patients)

Those at risk of diabetic ketoacidosis (eg patients with normal or low BMI)

SGLT-2 inhibitors should be used with caution in the elderly. Many of these patients may

have a contraindication to therapy (eg eGFR < 60 ml/min, or may be at risk of volume

depletion). A higher risk of limb amputation and fractures were noted in a study using

canagliflozin compared to placebo.

References Davies, M.J et.al. (2018), Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), Diabetologia, 61(12):2461–2498

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Assess key patient characteristics;

- Current lifestyle

- Comorbidities e.g. atherosclerotic cardiovascular

disease , chronic kidney disease, heart failure

- Clinical characteristics i.e. age, weight, HbA1c

- Issues such as motivation and depression

- Cultural and socioeconomic context Consider specific factors that

impact choice of treatment;

- Individualised HbA1c target

- Impact on weight and hypoglycaemia

- Side effect profile of medication

- Complexity of regimen

- Choose regimen to optimize adherence and persistence

- Access, cost and availability of medication

Shared decision making to create a management plan;

- Involves an educated and informed patient

- Seek patient preferences

- Effective consultation includes motivational interviewing, goal

setting and shared decision making

- Empowers the patient

- Ensures access to DSMES

Agree on managemment plan;

- Specific

- Measurable

- Achievable

- Realisitc

- Time limited

Implement management plan;

- Patients not meeting goals generally should be seen at

least every 3 months as long as progress is being

made

Ongoing monitoring and support including;

- Emotional well-being

- Check tolerability of medication

- Monitor glycaemic status

- Biofeedback including SMBG, weight, step count, HBa1c,

blood pressure, lipids

Review and agree on management plan;

- Review management plan

- Mutual agreement on changes

- Ensure agreed modification of therapy is implemented in a timely fashion to avoid clinical

intertia

- Decision cycle undertaken regularly

West Kent CCG Blood Glucose Management decision cycle for Adults with Type 2 Diabetes Mellitus (T2DM)

GOALS OF CARE

- Prevent complications

- Optimise quality of life

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Management of hyperglycaemia in type 2 diabetes

Before using the algorithms on pages 7-9, the first step in the management of type 2 diabetes is to consider the presence of ASCVD, heart failure and chronic kidney disease. The evidence states there is benefit in

specific medications to reduce mortality, heart failure and progression of renal disease in the setting of established cardiovascular disease. It is therefore essential to assess individual patients for the presence of

Atherosclerotic cardiovascular disease (ASCVD). ASCVD is the leading cause of death in people with type 2 diabetes and as such ASCVD risk management is an essential part of diabetes treatment.

ASCVD is defined as patients with any evidence of established cardiovascular disease (eg angina, myocardial infarction, transient ischaemic attack, stroke, peripheral vascular disease, or any revascularisation procedure)

ADA and EASD evaluated evidence from a meta-analysis looking at the association between SGLT-2i, GLP-1 RA and DPP4i with all-cause mortality. The results suggest that SGLT-2i or GLP-1 RA were associated with

better all-cause mortality outcomes than DPP-4 inhibitors. When intensifying patient’s therapy to these newer agents, prescribers should consider the evidence for patients with established cardiovascular disease or

chronic kidney disease, that specific sodium-glucose cotransporter 2 inhibitors (SGLT-2i) or glucagon like peptide 1 receptor agonists (GLP-1 RA) have been shown to improve cardiovascular outcomes, as well as

secondary outcomes such as heart failure and progression of renal disease.

When considering intensification of medications, a reasonable HbA1c target for most non-pregnant adults with sufficient life expectancy to see microvascular benefits is around 53 mmol/mol (7%) or less.

However, HbA1c treatment targets should be individualized based on patient preferences and goals, risk of adverse effects of therapy (e.g. hypoglycaemia and weight gain) and patient characteristics including

frailty and comorbid conditions.

Local recommendations are for patients with clinical cardiovascular disease, heart failure or chronic kidney disease not meeting individualized glycaemia targets while treated with metformin (or in whom

metformin is contraindicated or not tolerated) should preferably be prescribed an SGLT-2i (or GLP-1 RA, if SGLT-2i contraindicated or not tolerated) with proven benefit for cardiovascular risk reduction

Prescribers should be aware SGLT-2i should not be initiated in patients with an eGFR < 60ml/min, should be stopped if eGFR falls below 45ml/min and should be avoided in patients with known history of diabetic

ketoacidosis,

Recent evidence and joint guidance from the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD), places a much greater emphasis on self-management, education and

support. Fundamentals of lifestyle management include physical activity, weight loss, counselling for smoking cessation and psychological support. For those with obesity, efforts targeting weight loss, including

lifestyle, medication and surgical interventions. There is also a large emphasis on clinicians to assess for atherosclerotic cardiovascular disease, heart failure and chronic kidney disease in individual patients.

Establishing and titrating treatment should be based on the risk assessments for the above conditions, following the algorithms adapted from ADA/EASD and working towards an agreed individualised target instead of

nominal HbA1c ‘cut offs’

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Glucose-lowering medication in type 2 diabetes in those patients with established atherosclerotic cardiovascular

disease (ASCVD) or heart failure (HF)/chronic kidney disease (CKD)

Use MET first line unless contraindicated/not-tolerated

If HbA1c target not met: continue metformin and remember to adjust dose/stop with declining eGFR. Add SGLT-2i or GLP-1 RA as below.

If HbA1c target is met: if patient is already on dual therapy or multiple glucose-lowering therapies and not on an SGLT-2i or GLP-1RA, consider switching to one of these agents with proven CV benefit OR reconsider/lower

individualised HbA1c target and add SGLT-2i or GLP-1RA OR reassess HbA1c at 3 month intervals and add SGLT-2i or GLP-1RA if HbA1c increases above target.

ASCVD predominates HF or CKD predominates

Preferably add SGLT-2i with proven CVD benefit, if eGFR adequate (empagliflozin > canagliflozin)

OR

If SGLT-2i not tolerated/contraindicated/eGFR less than adequate, add GLP-1 RA with proven CVD benefit

(strongest evidence for liraglutide)

Preferably add SGLT-2i with evidence of reducing HF and/or CKD progression, only in patients with CKD

stage 1 or 2 and eGFR>60ml/min (empagliflozin, canagliflozin, dapagliflozin all suitable).

OR

If SGLT-2i not tolerated/contraindicated/eGFR less than adequate, add GLP-1 RA with proven CVD benefit

(strongest evidence for liraglutide)

Second intensification: Consider intensification If HbA1c remains above agreed individualised targets after 3 months.

If further intensification is required or patient is unable to tolerate SGLT-2i.GLP-1 RAi, choose agents demonstrating CV safety;

• Consider adding the other class (GLP-1 RA or SGLT-2i) with proven CVD benefit • Basal insulin • TZD • SU

If further intensification required, avoid TZD in the setting of HF. Choose agents demonstrating CV safety;

Consider adding the other class (GLP-1 RA or SGLT-2i) with proven CVD benefit

Basal insulin

SU

First intensification: Consider intensification If HbA1c remains above agreed individualised targets after 3 months. Ensure only the use of combinations that fall within licensed uses for each specific medicine. See medication class flowcharts on page 19 onwards and the summary of product characteristics for each medicine available at

https://www.medicines.org.uk/emc

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First intensification: Consider intensification If HbA1c remains above agreed individualised targets after 3 months.

Glucose-lowering medication in type 2 diabetes in patients with a compelling need to minimise hypoglycaemia

Add DPP-4i

(Sitagliptin/Alogliptin) Add GLP-1 RA (Liraglutide) Add SGLT-2i Add TZD

Second intensification: Consider intensification If HbA1c remains above agreed individualised targets after 3 months.

Add;

- TZD

Add;

- SGLT-2i

OR

- TZD

Add;

- GLP-1 RA (Liraglutide)

OR

- TZD

Add;

- SGLT-2i

OR

- DPP-4i (Sitagliptin)/Alogliptin OR

- GLP-1 RA (Liraglutide)

Intensification: Consider intensification If HbA1c remains above agreed individualised targets after 3 months.

Continue with addition of other agents as outlined above. If further intensification required, consider the addition of either;

SU – choose a later generation SU with lower risk of hypoglycaemia (gliclazide)

Basal insulin

Use MET first line unless contraindicated/not-tolerated

Ensure only the use of combinations that fall within licensed uses for each specific medicine. See medication class flowcharts on page 19 onwards and the summary of product characteristics for each

medicine available at https://www.medicines.org.uk/emc

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Glucose-lowering medication in type 2 diabetes in those patients with a compelling need to

minimise weight gain or promote weight loss

Use MET first line unless contraindicated/not-tolerated

If HbA1c is > 17mmol/mol (1.5%) above individualised HbA1c target, consider early dual combination therapy.

Preferably add SGLT-2i if eGFR adequate Or

If SGLT-2i not tolerated/contraindicated/eGFR less than adequate,

consider adding GLP-1 RA with good efficacy for weight loss

(strongest evidence for liraglutide)

Second intensification: Consider intensification If HbA1c remains above agreed individualised targets after 3 months..

Add SGLT-2i if eGFR adequate Add GLP-1 RA with good efficacy for weight loss (strongest

evidence for liraglutide)

Further intensification: Consider intensification If HbA1c remains above agreed individualised targets after 3 months.

Continue with cautious addition of either;

SU

TZD

Basal insulin

See “management of obesity in diabetic patients” flow chart on page 46 for further information

First intensification: Consider intensification If HbA1c remains above agreed individualised targets after 3 months.

Ensure only the use of combinations that fall within licensed uses for each specific medicine. See medication class flowcharts on page 19 onwards and the

summary of product characteristics for each medicine available at https://www.medicines.org.uk/emc

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Once-daily basal insulin Intermediate or long-acting, usually at bedtime, in

addition to oral hypoglycaemic drugs. Choice – Isophane NPH insulin; Insulatard, Humulin

I, Insuman Basal

Twice daily bi-phasic insulin

Premixed biphasic human insulin or analogues are commonly used in twice daily regimens given before or at the time of eating.

Choice – Biphasic isophane insulin (soluble insulin + isophane insulin); Humulin M3, NovoMix 30, Humalog Mix 25, Humalog

Mix 50

Basal Bolus insulin Involves injection of both basal and prandial insulins. Recommended

regimen for intensification of treatment if glycaemic or symptoms control is not achieved on basal insulin alone.

Choice – Bolus: Soluble Insulin (Humulin S,NovoRapid, Humalog, Apidra)

Basal: Isophane NPH insulin (Insulatard, Humulin I, Insuman Basal)

Insulin therapy should be initiated from a choice of a number of insulin types and regimens by practitioner with the appropriate knowledge, competencies and experience to choose the most appropriate starting regimen tailored to each patient. When starting insulin therapy, use a structured programme employing active insulin titration that encompasses:

Injection technique, including rotating injection sites and avoiding repeated injections at same point within sites,

Continuing telephone support

Self-monitoring

Dose titration to target levels

Dietary understanding

DVLA guidance

Management of hypoglycaemia

Management of acute changes in plasma glucose control,

Support from an appropriately trained and experienced healthcare professional.

Long acting insulin analogues such as Insulin detemir or Insulin glargine should be considered as an alternative to NPH insulin only if:

The person requires assistance from a carer or health care professional to administer insulin and in whom use of a long-acting insulin analogue would reduce the frequency of injections from twice to once a day; or

The persons’ lifestyle is restricted by recurrent symptomatic hypoglycaemic episodes; or

The person would otherwise need twice daily isophane insulin (intermediate-acting) in combination with hypoglycaemic drugs; or

They are unable to use the device to inject isophane insulin

Insulin Based Treatments in Type 2 Diabetes

First line: As in line with NICE guidance, offer Human Isophane Insulin (NPH) insulin once or twice daily according to need. Begin with human NPH insulin (Isophane insulin e.g. Insulatard®, Humulin I®, Insuman Basal®) taken

at bedtime or twice daily according to need. Human NPH (isophane) insulin is used routinely in preference to a long acting human insulin analogue. It is the preferred first choice insulin recommended by NICE based on cost

effectiveness and its safety profile. There is limited evidence of a clinical benefit of insulin analogues over human NPH insulin for type 2 diabetes and they are considerably more expensive

Consider starting both NPH and short-acting insulin either separately or as pre-mixed (biphasic) human insulin (particularly if HbA1c is ≥ 75mmol/mol (9%).

Prescribe Insulin by brand name.

The word unit should not be abbreviated.

Ensure the type of insulin prescribed is reflected in patient’s insulin passport

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Insulin initiation dosage guidelines in Type 2 Diabetes

Intermediate or long-acting, usually at bedtime, in addition to oral hypoglycaemic drugs.

Choice – Isophane NPH insulin; Insulatard, Humulin I, Insuman Basal

Start with an evening/bed-time dose of up to 10 units

Self-test blood glucose before breakfast and increase insulin dose by 2 units (or 10%) every 3 days to achieve pre-breakfast

blood glucose target.

Also self-test 2-3 times a week once a day at different times AND 4 point profile every 5-6 weeks

If pre-evening meal blood glucose remains high OR HbA1c remains high despite good fasting blood glucose

Start morning dose of up to 10 units. Monitor and titrate morning dose as above to achieve pre-evening meal target

If blood glucose is less than 4mmol/L on consecutive days, reduce by 2 units or 10%

If fail to achieve individual targets or encountering challenges, seek advice from colleagues and/or consider changing regime to

twice daily biphasic or basal bolus

Premixed biphasic human insulin or analogues are commonly used in twice daily regimens given before or at the time of eating.

Choice – Biphasic isophane insulin (soluble insulin + isophane insulin);

Humulin M3, NovoMix 30, Humalog Mix 25, Humalog Mix 50

If transferring from once daily basal insulin, split the total daily units into 2 appropriate doses; pre-breakfast and pre-evening.

If starting on this regime, initiate at up to 10 units before breakfast and up to 8 units before evening meal.

Monitor blood glucose twice daily e.g. before breakfast and one other

appropriate time.

Monitor blood glucose twice daily .e.g. before breakfast and one other

appropriate time.

Adjust one dose at a time to achieve blood glucose target; - Pre-breakfast: Increase evening insulin by 2 units (or 10%) every 3

days - Pre-evening: Increasing morning insulin by 2 units (or 10%) every 3

days

If blood glucose is less than 4 mmol/L, decrease the preceding insulin dose

by 2 units or 10%

If fail to achieve individual targets or encountering challenges, seek advice

from colleagues, consider changing the pre-mix proportions or consider

changing regime to basal bolus.

Involves injection of both basal and prandial insulins. Recommended regimen for intensification of treatment if glycaemic or symptoms control is

not achieved on basal insulin alone. Choice –

Bolus: Soluble Insulin (Humulin S,NovoRapid, Humalog, Apidra) Basal: Isophane NPH insulin (Insulatard, Humulin I, Insuman Basal)

If transferring from once daily basal insulin, initiate bolus insulin at 2-6 units30 minutes before meals. Consider adjusting basal insulin dose if appropriateIf transferring from twice daily bi-phasic insulin, split the total daily units

Monitor blood glucose up to 4 times a day

Adjust bolus dose of insulin according to post meal target: increase or decrease by 2 units.

If blood glucose is less than 4mmol/L on 2 consecutive days, reduce by 2 units or 10%

Once-daily basal insulin

Twice daily bi-phasic insulin Basal Bolus insulin

Drug Licensed dose Safety information/Further information – (See BNF or Summary of Product characteristics at https://www.medicines.org.uk/emc for more information)

MET standard release tablets (£0.84 for 28 500mg tablets)

Start at a dose of 500mg daily. Increase by 500mg every 1-2 weeks to reach a maximum dose of 1g twice daily. Take with or after food to minimise the risk of gastrointestinal side effects.

Actively titrate the dose of MET (i.e. increase to the maximum tolerated dose). This must be done over several weeks to minimise risk of gastrointestinal (GI) side effects. (NICE CG87). Renal impairment (NICE CG87):

Review the dose of MET if estimated glomerular filtrationrate (eGFR) is below 45 ml/ minute/1.73-m2.

Stop MET if eGFR is below 30 ml/minute/1.73-m2.

“For those patients with an eGFR of 30-45 ml/min, advisethem to discontinue MET temporarily if suffering from anacute illness associated with dehydration (eggastroenteritis).”Liver or cardiac impairment (NICECG87):

The benefits of MET therapy should be discussed with a person with mild to moderate liver dysfunction or cardiac impairment so that:

Due consideration can be given to the cardiovascular-protective effects of the drug

An informed decision can be made on whether tocontinue or stop the MET

CV safety – considered to be safe (UKPDS)

MET modified release (£4.00 for 56 500mg MR tablets £6.40 for 56 1000mg MR tablets. Sukkarto is WKCCG brand of choice)

Consider a trial of modified release MET tablets where GI tolerability prevents continuation of MET therapy. (NICE CG87)

Sulphonylureas (SU); SU’s should be used as first line therapy if rapid response is required due to symptomatic hyperglycaemia or if a person is not overweight (BMI < 25)

Educate the person about the risk of hypoglycaemia, especially in the presence of renal impairment

Educate the person SU’s can cause weight gain• Caution is advised in patients who are elderly, housebound and in certain occupations (e.g. operating heavy

machinery)

SU’s can cause weight gain of 1.5-3kg on average.• Check HbA1c after patient has been on SU for 3 months

SU’s may NOT be suitable in the following patients due to the increased risk of hypoglycaemic attacks: • Group 2 drivers (those who hold a licence to drive heavy goods vehicles or public service vehicles)• Professional drivers (e.g. taxi drivers)• Occupations where safety is critical, e.g. construction workers, steeplejacks• Frail, elderly patients who live alone• Those with severe renal impairment (eGFR less than 30ml/min)

Advice for drivers on an SU’s: For Group 1 drivers (car/motorcycle) it may be appropriate to monitor blood glucose regularly and at times relevant to driving to enable the detection of hypoglycaemia. Group 2 drivers (bus/lorry) on SU’s are required by law to monitor glucose level at least twice daily and at times relevant to driving. For more information about driving with diabetes see the Government guidance for drivers with diabetes and advice for drivers on the Diabetes UK website and West Kent CCG self-monitoring of blood glucose guidance.

2. Medications – Background information

The table below outlines information regarding some of the common medications used in type 2 diabetes. The

information below is not exhaustive, for comprehensive up to date clinical information please refer to the Summary

of Product Characteristics (SmPC) for each individual medication, available at https://www.medicines.org.uk/emc.

Prices stated are subject to change, please consult the most recent drug tariff for up to date prices

CV safety – SU’s are considered safe however avoid aggressive up titration which may lead to hypoglycaemia and cardiovascular risk (ACCORD)

Gliclazide (preferred SU locally, £0.78 for 28 80mg tablets)

Start at a dose of 40-80mg daily before meals (higher doses divided). The pros and cons of self-testing blood glucose should be discussed with each individual patient being commenced on an SU. Maximum dose 160mg bd

Renal impairment:

SUs should be used with care in those with mild to moderate renal impairment (corrected eGFR 30-60 mL/min) due to the increased risk of hypoglycaemia. Avoid in severe renal impairment (corrected eGFR <30mL/min) unless under specialist guidance

Liver impairment: Avoid in severe hepatic impairment due to an increased risk of hypoglycaemia

Glipizide (£2.73 for 28 5mg tablets)

Start at 5 mg, given before a meal. Elderly patients or those with liver disease start on 2.5 mg. Dosage adjustments should be in increments of 2.5 mg or 5 mg. The maximum recommended single dose is 15 mg. Doses above 15 mg should be divided. Max dose 10mg twice a day.

Contraindicated in patients with severe renal or hepatic dysfunction

Glimepiride (£1.56 for 30 1mg tablets; £1.98 for 30 2mg tablets; £2.61 for 30 3mg tablets; £2.56 for 30 4mg tablets)

Start at 1 mg per day. If control is unsatisfactory, the dosage should be increased, based on the glycaemic control, in a stepwise manner with an interval of about 1 to 2 weeks between each step, to 2mg, 3mg, or 4mg per day. The maximum recommended dose is 6mg glimepiride per day.

Contraindicated in severe renal or hepatic disease

Glibenclamide (£3.35 for 28 5mg tablets)

Start at 5mg daily with or immediately after breakfast or the first main meal. If control is satisfactory 5mg is continued as the maintenance dose. If control is unsatisfactory, the dose can be adjusted by increments of 2.5mg or 5mg at weekly intervals. The maximum daily dosage shouldn’t exceed 15mg

Avoid glibenclamide in the elderly, as it is longer acting. If required, use a shorter acting alternative Contraindicated in Severe impairment of renal function. And Hepatic impairment.

PIO (£1.84 for 28 15mg tablets; £2.52 for 28 30mg tablets; £3.14 for 28 45mg tablets)

Start at 15-30mg once daily, increased to 45mg once daily according to response. Start with lowest possible dose in the elderly and increase gradually. Where applicable, dose of concurrent SU or insulin may need to be reduced

PIO is contraindicated in those with a history of heart failure (including treated heart failure macroscopic haematuria, previous or active bladder cancer, diabetic ketoacidosis, hepatic impairment.

Caution is advised when considering use in cardiovascular disease or in combination with insulin, or in those with an increased risk of bone fractures or risk factors for bladder cancer

PIO may cause weight gain of 2-3kg on average over 12 months, so not recommended in overweight patients.

Liver impairment:

Avoid in hepatic impairment

Monitor liver function before treatment and periodically thereafter. Advise patients to seek immediate medical attention if symptoms such as nausea, vomiting, abdominal pain, fatigue and dark urine develop. Discontinue if jaundice occurs

The safety and efficacy of PIO should be reviewed after 4-6 months. The effects on blood glucose levels can be delayed. Thus checking HbA1c after 3 months, this may still be on the way down but not reached maximal effect (leading to an unnecessary up-titration of the dose). It should be stopped in patients not responding adequately. Efficacy and safety should be reviewed (e.g. 3-6 monthly) in patients continuing therapy. See MHRA advice (Aug 2011) for further details and the summary of product characteristics (SPC) CV safety – PIO has been shown to improve cardiovascular outcomes in type 2 patients (PROactive)

Sodium-Glucose co-transporter 2 inhibitors (SGLT-2i’s) - Dapagliflozin, Canagliflozin, Empagliflozin (See SGLT-2i initiation flowchart for further details) When treating patients who are taking a SGLT-2i; SGLT-2i should only be started if baseline eGFR > 60. Monitor renal function prior to initiation and then 6 monthly to annually thereafter. Test for urinary ketones in patients with symptoms of diabetic ketoacidosis (DKA) e.g. unwell, abdominal pain, vomiting (beware some patient may have normal or mild hyperglycaemia) ; omitting this test could delay diagnosis of DKA • If you suspect DKA, stop SGLT-2i treatment. If DKA is confirmed, refer to on-call medical team. Inform patients of the symptoms and signs of DKA (see below); advise them to get immediate medical help if these occur - SGLT-2 inhibitors: updated MHRA advice on the risk of diabetic ketoacidosis • SGLT-2i;s are NOT approved for treatment of type 1 diabetes • Due to its mechanism of action, patients taking SGLT-2i’s are at increased risk of urinary tract infection and will test positive for glucose in their urine. •Interrupt treatment with the SGLT-2i in patients who are hospitalised for major surgery or acute serious illnesses; treatment may be restarted once the patient’s condition has stabilised. • Continue to report suspected side effects to SGLT-2i’s inhibitors or any other medicines on a Yellow Card

SGLT-2i can cause a 2-3kg reduction in weight on average over a 12 month period

Any patient diagnosed with type 2 diabetes and a previous CV event or risk factors of Cv disease and with a baseline eGFR > 60, consider empagliflozin.

Empagliflozin (preferred choice if history of CV disease or CV risk factors, £36.59 for 28 10mg & 25mg tablets))

10mg once daily increasing to 25mg once daily if tighter glycaemic control is required.

Renal impairment:

If eGFR falls below 60, adjust or maintain dose at 10mg once. Stop if eGFR is <45 ml/min.

CV safety: EMPA-REG OUTCOME study showed improved cardiovascular endpoints in patients treated with empagliflozin.

Dapagliflozin £36.59 for 28 5mg & 10mg tablets)

10mg once daily

Renal impairment:

Avoid initiating if eGFR <60.

Stop treatment if eGFR < 45 ml/min/1.73 m2).

CV safety – DECLARE study showed non-inferiority for 3 point MACE was demonstrated. The main benefits were in relation to HF and renoprotection

Canagliflozin (£39.20 for 30 100mg & 300mg tablets)

100mg once daily increasing to 300mg once daily if tighter glycaemic control is required.

Renal impairment: . • If eGFR falls below 60, adjust or maintain dose at: 100mg once daily. Stop if eGFR is <45 ml/min. CV safety: CANVAS and CANVAS-R study showed improved cardiovascular outcomes in patients treated with canagliflozin. However, there was a small increased risk of amputations and fractures in the canagliflozin-treated group.

Glucagon-like Peptide-1 receptor (GLP-1) agonists - Dulaglutide, Liraglutide (See GLP-1 initiation flowchart for further details) GLP-1 agonists are licensed for the treatment of Type 2 diabetes mellitus in combination with insulin and oral hypoglycaemic agents, in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these therapies • Consider if BMI ≥ 35 (adjust accordingly for ethnicity) and specific psychological or other medical problems associated with obesity OR if BMI < 35 and where insulin would have significant occupational implications or weight loss would benefit other significant obesity related co-morbidities • Local guidelines recommend to continue GLP-1 agonist therapy if significant metabolic benefit after 6-12 months of therapy e.g. HBa1C reduction and/or weight loss/stability. Some patients will show a metabolic benefit that may not reach certain parameters, consider continuing treatment on an individual basis.

Liraglutide 6mg/ml injection (preferred first line choice, £78.48 for 28 days supply)

Starting dose - 0.6 mg liraglutide daily. After at least one week, increase dose to 1.2 mg. Daily doses

Renal impairment:

Not recommended for use in severe renal impairment (eGFR <

higher than 1.2 mg are not recommended locally.

15ml/min) CV safety - LEADER study showed improved cardiovascular outcomes in patients treated with liraglutide.

Dulaglutide 0.75mg & 1.5mg pre-filled pen (£73.25 for 28 days supply)

Monotherapy: 0.75mg once weekly Add-on therapy: 1.5mg once weekly

Renal impairment:

Not recommended for use in severe renal impairment (eGFR < 15ml/min)

CV safety – study ongoing

Exenatide injection MR 2mg (£73.36 for 28 days supply)

2mg once weekly preferably on the same day each week.

Renal impairment:

Not recommended for use in moderate to severe renal impairment (eGFR < 50ml/min)

DURATION-1 study has shown sustained beneficial effects on HbA1c for 6 years.

CV safety - EXSCEL, considered safe

Lixisenatide 10mcg/20mcg injection (£57.93 for 28 days supply at maintenance)

Starting dose is 10 mcg lixisenatide once daily for 14 days.

Maintenance dose: a fixed maintenance dose of 20 mcg lixisenatide once daily is started on Day 15

Renal impairment: Not recommended for use in severe renal impairment. CV safety – ELIXA, considered safe

Exenatide 250microgram/ml injection (£81.89 for 28 days supply)

Starting dose is 5micrograms twice daily for at least 1 month then increased if necessary up to 10micrograms twice daily, dose to be taken within 1 hour before 2 main meals (at least 6 hours apart)

Renal impairment: Use with caution in moderate renal impairment (eGFR 30-50ml/min). Avoid in severe renal impairment (eGFR <30ml/min)

Dipeptidyl peptidase-4 inhibitors (DPP-4i) - Sitagliptin, Alogliptin, Linagliptin Saxagliptin, Vildagliptin (See DPP-4i initiation flowchart for further details) In 2012 the MHRA issued an alert regarding reports of acute pancreatitis associated with the dipeptidylpeptidase-4 inhibitors (DPP-4i). It states that DPP-4i’s should be discontinued if symptoms of acute pancreatitis occur (persistent, severe abdominal pain). DPP-4i’s should be avoided in those at high risk of pancreatitis e.g. previous acute pancreatitis, triglycerides >5.6mmol/L or heavy alcohol use. DPP-4i are weight neutral.

Sitagliptin (preferred first line choice, £33.26 for 28 25mg & 50mg tablets))

100mg once daily 50mg in moderate renal impairment (eGFR 30-44ml/min) 25mg in severe renal impairment (eGFR < 30ml/min)

Not recommended for use in severe hepatic impairment. Cardiovascular safety – safe , (TECOS) Licensed for use as;

- Monotherapy - Dual therapy with MET, SU or TZD - Triple therapy with MET + SU or MET + TZD

Alogliptin (£26.60 for 28 6.25mg, 12.5mg & 25mg

25 mg once daily 12.5mg once daily in moderate renal impairment (eGFR 30-44ml/min) 6.25mg once daily in severe renal impairmen (eGFR

Not recommended for use in severe hepatic impairment. Cardiovascular safety – safe (EXAMINE) Licensed for use as;

- Dual therapy with MET, SU or TZD

<30ml/min) - Triple therapy with MET + TZD

Linagliptin (£33.26 for 28 5mg tablets)

5mg once daily No dose adjustment required in renal or hepatic impairment. Cardiovascular safety – safe (CAROLINA) Licensed for use as;

- Monotherapy - Dual therapy with MET - Triple therapy with MET + SU or MET + SGLT-2i

Saxagliptin (£31.60 for 28 2.5mg & 5mg tablets)

5mg once daily 2.5mg once daily in moderate & severe renal impairment (eGFR 15-44ml/min)

Not recommended for use in end-stage renal disease, severe hepatic impairment. Cardiovascular safety – Safe for primary outcome (SAVOR-TIMI 53), but an increased risk of hospitalisation for heart failure was noted. Licensed for use as;

- Monotherapy - Dual therapy with MET, SU or TZD - Triple therapy with MET + SU or MET + SGLT-2i

Vildagliptin (£33.35 for 28 50mg tablets)

50mg twice daily (or 50mg once daily in combination with a sulphonylurea) 50mg once daily in moderate and severe renal impairment (eGFR < 50ml/min)

Monitor liver function before treatment and every 3 months for the first year, periodically thereafter. Should not be used in patients with hepatic impairment, including those with pre-treatment ALT or AST ≥3x upper limit of normal. Cardiovascular safety - no comparable CV safety study. However, VIVIDD study showed slight increase risk but was non-inferior Licensed for use as;

- Monotherapy - Dual therapy with MET, SU and TZD - Triple therapy with MET + SU

Alpha-glucosidase inhibitor

Acarbose (£11.51 for 90 50mg tablets; £19.03 for 90 100mg tablets)

The recommended initial dose is 50mg three times a day. However, some patients may benefit from a more gradual initial dose titration to minimise gastrointestinal side-effects.

Consider for a person unable to use other oral glucose-lowering medications. Acarbose delays the digestion and absorption of starch and sucrose. It has a small but significant effect in lowering blood glucose and is used either on its own or as an adjunct to metformin or to sulfonylureas when they prove inadequate. Flatulence deters some from using acarbose although this side effect tends to decrease with time. Timing of doses is crucial; tablets should be chewed or swallowed whole with the first mouthful of food.

Metiglinides- If insulin secretagogue is indicated and patient has erratic meal patterns (especially skipped meals), then they can be helpful.

Nateglinide (£26.12 for 84 60mg tablets; £29.76 for 84

60mg three times a day, to be taken within 30minutes before main meals. Licensed only for use in combination with

Dose adjustment may be required in moderate to severe renal impairment (15-15ml/min)

120mg & 180mg tablets)

metformin in type 2 diabetes

Repaglinide (£9.05 for 90 500mcg tablets; £10.42 for 90 1mg tablets; £5.88 for 90 2mg tablets)

500micrograms (0.5mg) to be taken within 30 minutes before main meals (1mg if transferring from another oral antidiabetic). Licensed for use as monotherapy or combination with metformin.

Caution is required in patients with renal impairment

*NOT RECOMMENDED BY NICE

3. Dipeptidyl peptidase-4 (DPP-4) inhibitors initiation guidance in Type 2 diabetes for Primary Care Prescribers

Sitagliptin, saxagliptin, linagliptin, alogliptin and vildagliptin are licensed and approved by NICE for use in Type 2 diabetes as;

First-line monotherapy if MET is contraindicated or not-tolerated

Second-line therapy to first-line MET monotherapy when control of blood glucose remains or becomes inadequate (HbA1c ≥7.5% [≥58 mmol/mol], if

the person is at significant risk of hypoglycaemia or its consequences for example, older people and people in certain jobs (those working at heights or

with heavy machinery or people in certain social circumstances e.g. those living alone), or the person does not tolerate a SU or a SU is contraindicated.

Second-line therapy to first-line SU* monotherapy if the person does not tolerate MET, or MET is contraindicated and when control of blood glucose

remains or becomes inadequate

Third-line therapy to first-line MET and a second-line SU*/PIO when control of blood glucose remains or becomes inadequate and insulin is

unacceptable or inappropriate.

*Prescribers should be aware, if adding a DPP-4 inhibitor to SU/insulin therapy, consider decreasing the sulfonylurea/insulin dose, to reduce hypoglycaemia risk.

NICE recommends that treatment must be assessed at 6 months and to only continue DPP-4i therapy if the person has had a beneficial

metabolic response classified as a reduction of at least 0.5 percentage points [5.5 mmol/mol] in HbA1c in 6 months.

Most common side effects are: GI disturbances (see below), reflux, headache, pruritus, rash.

In 2012 the MHRA issued an alert regarding reports of acute pancreatitis associated with the DPP-4i’s. It states that DPP-4i’s should be

discontinued if symptoms of acute pancreatitis occur (persistent, severe abdominal pain). DPP-4i’s should be avoided in those at high risk of

pancreatitis e.g. previous acute pancreatitis, triglycerides >5.6mmol/L or heavy alcohol use.

Saxagliptin (Onglyza®) usual

dose 5mg once daily – Full

prescribing information

available in SPC at

https://www.medicines.org.u

k/emc/search?q=saxagliptin

Cost = £31.60 for 28 tablets

of 2.5mg and 5mg

Vildagliptin (Galvus®) usual

dose 50mg twice a day – Full

prescribing information

available in SPC at

https://www.medicines.org.u

k/emc/search?q=vildagliptin

Cost = £33.35 for 56 tablets

of 50mg

Linagliptin (Trajenta®) usual

dose 5mg once daily – Full

prescribing information

available in SPC at

https://www.medicines.org.u

k/emc/search?q=Linagliptin

Cost = £33.26 for 28 tablets

of 5mg

Alogliptin (Vipidia®)▼ usual dose 25mg once daily – Full

prescribing information available in SPC at

https://www.medicines.org.uk/emc/search?q=alogliptin

Cost = £26.60 for 28 tablets

of 6.25mg, 12.5mg and

25mg

Sitagliptin (Januvia®) usual

dose 100mg once daily - Full

prescribing information

available in SPC at

https://www.medicines.org.u

k/emc/search?q=sitagliptin

Cost = £33.26 for 28 tablets

of 25mg, 50mg and 100mg

Licensed for;

Monotherapy

Dual therapy with MET/

SU/PIO

Triple therapy with MET +

SU

Add on to insulin +/- MET*

Licensed for;

Monotherapy

Dual therapy with

MET/SU/

PIO.

Triple therapy with MET +

SU (50mg once daily with

SU)

Add on to insulin +/-

MET*

Licensed for;

Monotherapy

Dual therapy with MET only

Triple therapy with MET +

SU.

Add on to insulin +/- MET*

Licensed for;

Dual therapy with MET,

PIO, SU or insulin*

Triple* therapy with MET

+ PIO/insulin*.

Licensed for;

Monotherapy

Dual therapy with MET/SU/

PIO.

Triple therapy with MET +

SU

/PIO*

Add on to insulin +/- MET*

Monitor renal function

before treatment and

periodically thereafter.

Monitor liver function

before treatment and every

3 months for the first year,

periodically thereafter

Monitor renal function before

treatment and periodically

thereafter.

Monitor renal function

before treatment and

periodically thereafter

No renal or liver monitoring

required

When eGFR 15-44ml/min reduce dose to 2.5mg daily. Not recommended in end

stage renal disease requiring haemodialysis.

When eGFR 15-49ml/min, reduce dose to 50mg and

use with caution when eGFR <15mL/min.

5mg daily is the standard

dose

When eGFR 30-49ml/min reduce dose to 12.5mg. When eGFR <30ml/min

reduce dose to 6.25mg and use with caution.

When eGFR 30-44ml/min, reduce dose to 50mg and when eGFR <30ml/min, reduce dose to 25mg.

No dose adjustment in mild

hepatic impairment. Caution

in moderate impairment. Not

recommended in severe

impairment.

Should NOT be used in

patients with hepatic

impairment, including those

with pre-treatment ALT or

AST ≥3x upper limit of

normal.

No dose adjustment in

hepatic impairment.

Avoid in severe hepatic

impairment

No dose adjustment for mild –

moderate hepatic impairment.

Avoid in severe impairment,

due to lack of experience

. Cardiovascular safety – Safe (SAVOR-TIMI 53)

Cardiovascular safety – Safe (VIVIDD)

Cardiovascular safety – Safe (CAROLINA)

Cardiovascular safety – Safe (EXAMINE)

Cardiovascular safety – Safe (TECOS)

References for DPP-4 flow chart

1. Alogliptin summary of product characteristics updated 29/1/15. Available at

http://www.medicines.org.uk/emc/medicine/28513

2. British national formulary 72, pages 625 -629

3. Linagliptin summary of product characteristics updated 1/8/17. Available at

http://www.medicines.org.uk/emc/medicine/25000

4. NICE clinical knowledge summary Diabetes - type 2. Last revised July 2016

5. Type 2 diabetes in adults: management NICE guideline [NG28] Published date: December 2015 Last updated: May 2017

6. Type 2 diabetes: alogliptin Evidence summary [ESNM20] Published date: May 2013 Last updated: October 2014 7. Saxagliptin summary of product characteristics updated 12/7/17. Available at

http://www.medicines.org.uk/emc/medicine/22315

8. Sitagliptin summary of product characteristics updated 8/8/17. Available at

http://www.medicines.org.uk/emc/medicine/19609

9. Vildagliptin summary of product characteristics updated 12/6/17. Available at

http://www.medicines.org.uk/emc/medicine/20734

10. All costs included are taken from the June 2018 Drug Tariff

4. Glucagon like peptide (GLP-1) initiation guidance in Type 2 Diabetes for Primary Care Prescribers

AND Weight, BMI and HbA1c must be

measured before initiating GLP-1

agonists

*NOT RECOMMENDED

Individualised target not achieved from current dual oral anti-diabetic therapy?

GLP-1 agonists are licensed for the treatment of Type 2 diabetes mellitus in combination with insulin and oral hypoglycaemic agents, in patients

who have not achieved adequate glycaemic control on maximally tolerated doses of these therapies.

Initiation and dose titration can be carried out by Primary care teams experienced and confident in the management of type 2 diabetes. Those who

wish to initiate GLP-1 therapy are recommended to attend specific workshop training before starting.

In the case of secondary care initiation, prescribing is transferred to primary care after 3 months, only if GLP-1 is well tolerated and the patient is

stable.

HbA1C greater than 58mmol/mol (7.5%)

BMI of 35kg/m2 or higher (adjust for other ethnic

groups) OR

BMI of less than 35kg/m2 and whom insulin therapy

would have significant occupational implications OR

weight loss would benefit other significant obesity

related comorbidities.

Dulaglutide (Trulicity®)

Once weekly - Full

prescribing information

available in SPC at

https://www.medicines.org

.uk/emc/search?q=trulicity

Cost = £73.25 for 4 x pre-

filled pen

Liraglutide (Victoza®)

Once daily - Full prescribing

information available in

SPC at

https://www.medicines.org

.uk/emc/product/6585

Cost = £78.48 for 2 x

6mg/mL, 3mL pen

Lixisenatide (Lyxumia®)

Once daily - Full prescribing

information available in SPC

at https://www.medicines.org.u

k/emc/search?q=lyxumia

Cost = £31.67 for

10microgram pen or £57.93

for 2 x 20microgram pen

Exenatide (Byetta®)

Twice daily - Full

prescribing information

available in SPC at

https://www.medicines.org

.uk/emc/search?q=byetta

Cost = £81.89 for

10micrograms/0.04mL,

2.4mL pen

Exenatide (Bydureon®) MR

Once weekly - Full

prescribing information

available in SPC at

https://www.medicines.org

.uk/emc/product/3650

Cost = £73.36 for 4 x pre-

filled pens

0.75mg once weekly as

monotherapy* or 1.5mg

once weekly when in

combination

0.6 mg once daily for at least one week, then increased to 1.2 mg.

1.8mg dose not

recommended locally*

10 micrograms once daily

60mins before a meal for at

least 14 days, then increased

to 20 micrograms once daily

5 micrograms 60 mins

before morning &evening

meal for at least 1 month,

then increased to 10

micrograms twice daily

2mg once weekly

Licensed for

monotherapy*, dual

therapy with insulin and

triple therapy with MET &

SU

Licensed for use with

insulin or with metformin

and a sulfonylurea or MET

and a thiazolidinedione

Licensed for dual therapy

with oral medicines (e.g.

MET, PIO, or a SU or basal

insulin, or both

Licensed for triple therapy

with MET and a SU

Licensed for triple therapy

with MET and a SU or MET

and a thiazolidinedione.

MONITORING

Must review patients after initiation: Follow-up in primary care will be by telephone at 2 weeks and in person at 4 and 8 weeks to check patient’s progress,

especially any possible adverse events or persistent nausea and vomiting. At 12 weeks if GLP-1 treatment is well tolerated and the patient is stable continue

therapy

Most common side effects are: nausea, vomiting, diarrhoea, constipation, abdominal pain*, dyspepsia – these reactions are mostly mild and transient.

*There has been concern about the possibility of an increase in the incidence of acute pancreatitis. It is recommended to advise patients that they should

stop taking GLP-1 therapy if they experience continued severe abdominal pain and seek medical assistance.

Treatment must be assessed at 6 months. Local guidelines recommend to continue GLP-1 agonist therapy if significant metabolic benefit after 6-12 months

of therapy e.g. HBa1C reduction and/or weight loss/stability. Often patients lose weight but their HbA1c rises, if this occurs, clinicians should be aware this

may indicate beta cell failure and uncontrolled diabetes.

Avoid if eGFR is less than

15ml/min

Avoid if eGFR is less than

15mL/min

Avoid if eGFR is less than

30ml/min

Avoid if eGFR is less than

30ml/min. Cautiously

increase dose if eGFR 30-

50ml/min

Avoid if eGFR is less than

50ml/min

Cardiovascular safety –

study ongoing

Cardiovascular safety – safe

(LEADER)

Cardiovascular safety – safe

(ELIXA)

- Cardiovascular safety – safe

(EXSCEL)

References

1. British national formulary72 pages 657-660

2. Type 2 diabetes: dulaglutide Evidence summary [ESNM59] Published date: June 2015

3. Type 2 diabetes: lixisenatideEvidence summary [ESNM26] Published date: September 2013

4. Type 2 diabetes in adults: management NICE guideline [NG28] Published date: December 2015 Last updated:

May 2017

5. Exenatide (Byetta) Summary of product characteristics, updated 30/3/17. Available at:

https://www.medicines.org.uk/emc/product/8617/smpc

6. Dulaglutide (Trulicity) Summary of product characteristics, updated 2/7/18. Available at

https://www.medicines.org.uk/emc/product/3634/smpc

7. Liraglutide (Victoza) Summary of product characteristics, updated 1/7/17. Available at

https://www.medicines.org.uk/emc/product/6585/smpc

8. Exenatide MR (Bydureon) Summary of product characteristics, updated 10/11/17. Available at

https://www.medicines.org.uk/emc/product/3650/smpc

9. Lixisenatide (Lyxumia) Summary of product characteristics, updated 18/9/17. Available at

https://www.medicines.org.uk/emc/product/2966/smpc

10. WKCCG interface formulary. Available at http://www.formularywkccgmtw.co.uk/default.asp#bodytext

11. All costs included are taken from the June 2018 Drug Tariff

5. Sodium-glucose co-transporter-2 (SGLT-2) inhibitors in Type 2 Diabetes guidance for primary care prescribers

Dapagliflozin, empagliflozin and canagliflozin, are licensed and approved by NICE for use in type 2 diabetes as;

Monotherapy: If MET is contraindicated and when diet and exercise alone do not provide adequate glycaemic control, only if; i) a DDP-4i would

otherwise be prescribed and ii) a SU or PIO is not appropriate.

Dual therapy with MET If a SU is contraindicated/not tolerated or the person is at significant risk of hypoglycaemia or its consequences.

Triple therapy (all): in combination with metformin and a SU or insulin with or without other diabetic drugs. Triple therapy (canagliflozin and empagliflozin ONLY): in combination with MET and PIO*

Consider the use of SGLT-2 inhibitors as per NICE guidance 28 above where a patient is uncontrolled and would benefit from weight loss.

*While a causal relationship between dapagliflozin and bladder

cancer is unlikely, as a precautionary measure dapagliflozin is not

recommended for use in patients concomitantly treated with

pioglitazone.

Reduce current dose to 10mg once daily if eGFR

≤60ml/min. Stop treatment if eGFR falls below

45ml/min. Monitor renal function at least

annually

Do not initiate if eGFR <60ml/min. Stop treatment

if eGFR falls below 45ml/min. Monitor renal

function annually and at least twice a year when

eGFR <60ml/min

Reduce current dose to 100mg once daily if eGFR

≤60ml/min. Stop treatment if eGFR falls below

45ml/min. Monitor renal function at least twice a

year in moderate renal impairment

eGFR MUST be above 60 before treatment. Repeat renal function before initiation of concomitant drugs that may reduce renal function, then at least every

6 months thereafter.

Cautions

Patients at risk of volume depletion e.g. cardiovascular disease; elderly; antihypertensive therapy and loop diuretics

Due to its mechanism of action, patients will test positive for glucose in their urine and as a result are at an increased risk of urinary tract infections.

Patients and carers should be informed of the signs and symptoms of

diabetic ketoacidosis (see MHRA warning at the bottom of page)

NICE recommends only continuing SGLT-2i therapy if the person has had a beneficial metabolic response classified as a reduction

of at least 0.5 percentage points [5.5 mmol/mol] in HbA1c in 6 months.

Most common side effects: Constipation, dyslipidaemia, dysuria, pruritus, hypoglycaemia (caution in combination with insulin or

sulfonylurea), polyuria, thirst, urinary frequency, volume depletion.

In 2017 the MHRA issued an alert regarding reports canagliflozin may increase the risk of lower-limb amputation (mainly toes) in

patients with type 2 diabetes: Evidence does not show an increased risk for dapagliflozin and empagliflozin, but be aware this risk

may be a class effect. Preventative foot care is important for all patients with diabetes The FDA issued a warning regarding SGLT-

2i’s being linked to a rare, but serious, Fournier’s Gangrenene

In 2015 the MHRA issued an alert regarding reports of an increased risk of diabetic ketoacidosis with SGLT-2i’s. When treating

patients who are taking an SGLT-2i, test for raised ketones in patients with symptoms of diabetic ketoacidosis (DKA) (e.g. unwell,

abdo pain and/ or vomiting). STOP SGLT-2i treatment if DKA is confirmed, inform patients of the symptoms and signs of DKA and

advise them to get immediate medical help if these occur. Be aware that SGLT-2i are not approved for treatment of type 1

diabetes.

Cardiovascular safety – superior (CANVAS and CANVAS-R)

Cardiovascular safety – DECLARE study showed

non-inferior

Cardiovascular safety – superior (EMPA-REG)

Empagliflozin (Jardiance®)▼- Usual dose 10mg

once daily increased to 25mg once daily if tighter

glycaemic control is required - Full prescribing

information available in SPC at https://www.medicines.org.uk/emc/search?q=em

pagliflozin

Cost = £36.59 for 28 tablets of 10 mg or 25 mg.

Dapagliflozin (Forxiga®)▼- Usual dose 10mg once

daily (5mg once daily in hepatic impairment) – Full

prescribing information available in SPC at

https://www.medicines.org.uk/emc/search?q=da

pagliflozin

Cost = £36.59 for 28 tablets of 5mg or 10mg

Canagliflozin (Invokana®)▼- Usual dose 100mg

once daily, increased to 300mg once daily if

tighter glycaemic control is required. Dose to be

taken before breakfast - Full prescribing

information available in SPC at

https://www.medicines.org.uk/emc/search?q=ca

nagliflozin

Cost = £39.20 for 30 tablets of 100 mg or 300 mg.

Avoid in severe hepatic impairment

Use initial dose of 5mg in severe hepatic

impairment, increased according to response

Avoid in severe hepatic impairment

Contraindications: Diabetic ketoacidosis Contraindications: Diabetic ketoacidosis; Over 75

years, combination with pioglitazone

Contraindications: Diabetic ketoacidosis; Over 85

years

References for SGLT-2i flow chart

1. British national formulary72 pages 633 – 636 2. Canagliflozin in combination therapy for treating type 2 diabetes. TA315. June 2014 3. Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes Technology appraisal

guidance [TA390]published date: 25 May 2016 4. Canagliflozin summary of product characteristics updated 8/5/17. Available at

http://www.medicines.org.uk/emc/medicine/28400

5. Dapagliflozin in combination therapy for treating type 2 diabetes. TA288. Published date: 26 June 2013 Last

updated: 23 November 2016

6. Dapagliflozin summary of product characteristics updated 28/7/17. Available at

http://www.medicines.org.uk/emc/medicine/27188

7. Empagliflozin in combination therapy for treating type 2 diabetes. TA336. March 2015 8. Type 2 diabetes in adults: management NICE guideline [NG28] Published date: December 2015 Last updated:

May 2017 9. Empagliflozin summary of product characteristicsupdated 9/8/17. Available at

http://www.medicines.org.uk/emc/medicine/28973 10. https://www.gov.uk/drug-safety-update/sglt2-inhibitors-canagliflozin-dapagliflozin-empagliflozin-risk-of-

diabetic-ketoacidosis 11. Type 2 diabetes in adults: management NICE guideline [NG28] Published date: December 2015 Last updated:

May 2017 12. WKCCG interface formulary. Available at http://www.formularywkccgmtw.co.uk/default.asp#bodytext 13. All costs included are taken from the June 2018 Drug Tariff

6. Clinical area guidelines for clinicians

The following guidelines are aimed to help clinicians decide on the most appropriate action in specific clinical

circumstances that are relevant to diabetes and may be commonly seen in both Type 1 and Type 2 diabetic

patients.

The guidelines below cover the following clinical areas;

- Blood Pressure in Type 1 & Type 2 Diabetic patients

- Early Management of Diabetic Retinopathy in Type 1 & Type 2 Diabetes

- Renal Management in Type 1 and Type 2 diabetic patients

- Management of Heart Failure/Ischaemic Heart in Type 1 and Type 2 Diabetic patients

- Driving advice for Type 1 and Type 2 Diabetic patients

- Management of Steroid (glucocorticoid) Induced Diabetes

- Managing Glucose Control in People with known Type 1 or Type 2 Diabetes on Once

Daily Steroids

- End of Life Management in Type 1 and Type 2 Diabetic patients

Blood Pressure in Type 1 & Type 2 Diabetic patients .

This algorithm is for patients with confirmed hypertension

Blood Pressure Target All patients with diabetes (Type 1 or Type 2) should be treated to an individualised target with a combination

of lifestyle intervention and drug therapy.

If patients have kidney, eye or cerebrovascular damage, ideal target <130/80mmHg (individualise target based on patient

circumstances)

All other patients should be ideally treated to a blood pressure target of <140/80mmHg

(individualise target based on patient circumstances)

Lifestyle Interventions Interventions are encouraged in the following areas:

Smoking Assess smoking status and refer to Smoking

Cessation Team e.g. OneYou Kent

Exercise Explain benefit of regular aerobic exercise.

Dietary Intervention and weight loss Advise patients of the following: (also see eating well / BP information prescriptions on page 30 and 31) Reduce salt intake Moderate alcohol intake Reduce saturated fats in diet Eat plenty of fruit and vegetables Cut down on sugar intake

Assessment Assess blood pressure at least 3 monthly until

targets are achieved, and monitor every 4-6 months once targets are achieved.

Patients who are on maximal therapy (more than 3 agents) and don’t achieve target should

be referred for further management.

Nephropathy ACE inhibitors or ARBs are preferred first line

therapy in people with any degree of nephropathy (raised albumin/creatinine ratio).

In all patients measure renal function and electrolytes 1-2 weeks after initiation of ACE inhibitors or ARBs and with each increase in

dose.

Drug Therapy Up to half the patients with Type 2 diabetes will need three (3) or more anti-hypertensive agents.

Ensure to check drug compliance.

For lifestyle interventions, clinicians could also consider signposting suitable patients to other

services as well such as OneYou Kent.

Early Management of Diabetic Retinopathy in Type 1 & Type 2 Diabetes Algorithm

a Use screening tests that achieve at least 80% sensitivity and 95% specificity b Those at high risk of progression are those with rapid improvement in blood glucose control, presence of raised blood pressure or renal disease

Is retinopathy present? NO

Routine Care Arrange recall and annual review via Kent & Medway Diabetes Eye

Screening Service 0333 456 0122.

Provide stop smoking advice if applicable

YES

Maintain good blood glucose control (HbA1c below 48-58 mmol/mol [6.5-7.5%], according to individual’s

target) and good blood pressure control (below 130/80 mmHg). Manage retinopathy as follows:

• Sudden loss of vision • Retinal detachment

• New vessels • Pre-retinal and/or vitreous haemorrhage

• Rubeosis iridis

• Unexplained drop in visual acuity (which may indicate macular oedema)

• Hard exudates within 1 disc diameter of fovea • Macular oedema • Unexplained retinal findings • Pre-proliferative or severe retinopathy

Emergency (same day) referral to Ophthalmology specialist / eye casualty

Urgent referral to ophthalmology specialist.

Arrange referral within one week.

Referral Arrange referral for specialist opinion

within 4 weeks.

• New or worsening lesions since previous examination • Scattered exudates >1 disc diameter from fovea • People at high risk of progression (b)

Early Review Arrange recall and review

every 3-6 months

• Minimal or background retinopathy • Low risk background retinopathy

Routine Care Arrange recall and annual review via

Kent & Medway Diabetes Eye Screening Service

0333 456 0122

Avoid sudden improvement in glycaemic control in those patients with severe retinopathy, as this

may worsen disease and precipitate a bleed

Renal Management in Type 1 and Type 2 diabetic patients

Assess Classify the stage of Chronic Kidney Disease as follows:

Monitor in Primary care

Stage 1 - Normal eGFR; eGFR >90 ml/min/1.73 m

2 with other evidence of

chronic kidney damage

Stage 2 - Mild impairment; eGFR 60-89 ml/min/1.73 m

2 with other evidence of

chronic kidney damage

Stage 3 - Moderate impairment;

eGFR 30-59 ml/min/1.73 m2

Stage 3 CKD should be split into two subcategories defined by (2):

eGFR 45-59 ml/min/1.73 m2 (stage 3A)

eGFR 30-44 ml/min/1.73 m2 (stage 3B)

Stage 4: Severe impairment:

eGFR 15-29 ml/min/1.73 m2

eGFR every 6 months Annual- Haemoglobin/Potassium/Calcium/PhosphateBicarbonate if needs nephrology referral.

Refer if: • Sustained decrease in eGFR of ≥ 25%, and

a change in eGFR category

• Sustained decrease in eGFR of ≥ 15ml/min within 12 months

Most patients with CKD 4 should be referred to secondary care. Repeat Renal profile / eGFR every 3 months Stop Metformin

Stage 5: Kidney failure:

eGFR < 15 mL/min/1.73 m2

Should be under the care of a renal specialist or previous decision made for conservative treatment (i.e. not for renal replacement therapy)

Management of Cardiovascular Disease Risk

in Type 1 and Type 2 Diabetic patients

From NICE CG 181 - Assessment of Cardiovascular Disease (CVD) Risk Does the patient have Type 1 or Type 2 Diabetes?

Use the current QRISK assessment tool to assess CVD risk.

Do not use a risk assessment tool to assess CVD risk.

Type 1 Type 2

Lifestyle Modifications Do not advise patients with type 1 or type 2 diabetes to take plant stenols or sterols for

the prevention of CVD

Offer statin treatment for the primary prevention of CVD to adults with type 1 diabetes who: • are older than 40 years or • have had diabetes for more than 10 years or • have established nephropathy or • have other CVD risk factors. Start treatment for adults with type 1 diabetes with atorvastatin 20 mg

Primary Prevention – Statins Does the patient have Type 1 or Type 2 Diabetes?

Type 1 Type 2

Estimate the level of risk using the current QRISK assessment tool. Offer atorvastatin 20 mg for the primary prevention of CVD to people with type 2 diabetes who have a 10% or greater 10 year risk of developing CVD.

Monitoring Manage adverse effects of statin treatment as follows:

Do not stop statins. (See NICE guideline PH38)

Intolerance with Statin treatments Blood glucose level or HbA1c increases

Seek specialist advice about options for treating people who are intolerant to 3 different statins. Do not routinely offer Fibrates Do not offer: - Nicotinic acid or Bile acid sequestrants - Omega 3 fatty acid compounds

For information on aspirin treatment please refer to flowchart

on page45)

Driving advice for Type 1 and Type 2 Diabetic

patients

DVLA Guidance is updated regularly. Please visit the DVLA website (https://www.gov.uk/diabetes-driving) for the specific requirements for different groups drivers of drivers. Advise patients the following:

Treatment Group 1 (Car/M’bike

Group 2 (LGV/PCV)

Diet alone No No

Tablets at low risk of causing hypos

No* Yes

Non-insulin injections No* Yes

Tablets that carry a risk of hypos**

No* Yes

Insulin Yes Yes

Temporary Insulin (eg following a heart attack or gestational diabetes

No* Yes

* Visit https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/670819/assessing-fitness-to-drive-a-guide-for-medical-professionals.pdf for specific reporting requirements to the DVLA or see Appendix A of WKCCG Guidelines on self-monitoring of Blood Glucose. ** Tablets which carry a risk of hypos include: Sulphonylureas such as Gliclazide, and Glinides (Repaglinide and Nateglinide)

DVLA Notification • To visit the DVLA website

(https://www.gov.uk/diabetes-driving) to determine whether the DVLA need to be notified.

• That they can be fined if they do not tell DVLA about a medical condition or prosecuted if they are involved in an accident.

Preparing to Drive • The DVLA recommends that blood glucose levels

should always be at least 5 mmol/L. • Always test before driving due to risk of hypos whilst

driving. • Plan for long journeys and take regular breaks and

test 2 hourly. • Carry easily accessible glucose treatments in the car.

Hypo whilst driving • Stop car as soon as possible. • Remove keys. • Move to the passenger seat if safe. • Treat the hypo. • Do not drive for at least 45 minutes following a

hypo.

Doctor’s Responsibility • When any doctor is aware that a patient is not fit to drive, they should advise the person not to drive and to notify

the DVLA. The doctor may also want to inform the patient that their insurance is no longer valid. • If a doctor becomes aware that someone in their care does not notify the DVLA, or refuses to do so, the doctor is

allowed under General Medical Council guidelines to notify the DVLA (ref: www.gmc-uk.org/news/27477.asp). • It is up to the DVLA to revoke/renew a licence • If the doctor has concerns but are not sure if the person is fit to drive, they should advise the individual to notify the

DVLA. • For the avoidance of doubt, the advice should be confirmed in writing and documented in the notes.

Management of Steroid (glucocorticoid) Induced Diabetes

Is the patient “high risk” or with symptoms suggestive of “hyperglycaemia”?

YES

Check HbA1C prior to commencement of steroid and recommend Capillary Blood Glucose (CBG) once daily

pre or post lunch or evening meal.

If CBG greater than 12mmol/L, increase testing to 4 times a day. If CBG is found to be consistently greater

than 12mmol/L (i.e. on 2 occasions during a 24hr period), manage the patient as follows:

Consider patient to be low risk and record the CBG daily post breakfast or post lunch. If CBG consistently below 10mmol/L consider

cessation of CBG testing.

CBG readings above desired target (6-10mmol/L – acceptable range 4-12mmol/L)

Add in gliclazide 40mg with breakfast and increase the dose by 40mg increments daily

if targets are not reached.

If no symptoms of hypoglycaemia are experienced by the patient despite being on 160mg of gliclazide

Consider titration to 240mg in the morning. (You may wish to seek specialist advice on

dose titration at this stage via Kinesis).

If no improvement on maximum dosage

Consider adding an evening dose of gliclazide or add morning human NPH

insulin e.g. Humulin I / Insulatard / Insuman Basal

For NPH – commence 10 units daily in the morning and titrate every 24hrs by 10-20%

to achieve desired CBG target

Patients remaining on glucocorticoids

CBG<12mmo

l/L

CBG>12mmo

l/L

Continue monitoring

If steroid treatment discontinued.

If hyperglycaemia has resolved, CBG can be discontinued

If hyperglycaemia persists, continue monitoring until normal glycaemia returns

or until a definitive test for diabetes is undertaken

Any dose greater than prednisolone 5mg once daily (or equivalent) and any length of high dose glucocorticoid use would facilitate the use of this algorithm

Managing Glucose Control in People with known Type 1 or Type 2 Diabetes on Once Daily Steroids

Assessment: Reassess glucose control and current therapy

Set target blood glucose e.g. 6-10mmol/L (see glycaemic targets box below)

Check capillary blood glucose (CBG) 4 times a day and use this flowchart to adjust diabetes medication accordingly.

In Type 1 diabetes also check daily for ketones if CBG>12mmol/L

Diet controlled (Type 2) OHAA +/- GLP-1

Test for ketones. If ketones >3mmol/L or urinary ketones >++

assess for DKA.

Insulin Controlled Type 1

Insulin Controlled Type 2

Test for ketones if CBG levels>12mmol/L and the patient has

osmotic symptoms.

Current regimen- Once daily night time

insulin;

Transfer this injection to morning

Titrate by 10-20% daily according to pre-evening meal CBG readings.

If targets not achieved consider twice daily or basal bolus regimen.

Current regimen - Basal bolus insulin;

Consider transferring evening basal dose insulin to the morning and increase short/fast acting insulin by 10-20% daily until glycaemic target reached.

Aim for agree CBGs target to patients need pre-meal, unless patient has hypo despite snacks or has long gaps between meals.

Current regimen - Twice daily insulin;

Morning dose will need to increase 10-20% daily according to pre-evening mean CBG readings

Aim for CBGs to individual needs as stated above, unless patient experiences “hypo” despite snacks.

If no “hypo” symptoms and NOT on a sulfonylurea:

Commence gliclazide 40mg in morning; titrate daily until a maximum dose of 240mg in morning or glycaemic targets are reached.

Seek specialist advice if you are concerned about dose titration in those taking 160mg with no improvement in glycaemic control.

If on twice daily gliclazide and targets not reached consider referral to specialist care for titration to 240mg morning dose plus 80mg in the evening

If no “hypo” symptoms and

taking maximum dose (320mg/day):

Add Insuman Basal, Humulin I or Human Insulatard

Aim for CBG appropriate to patients needs

If CBG remains > desired target before the evening meal:

Increase insulin by 4 units or 10-20%

Review daily

If remains above target titrate daily by 10-20% until glycaemic target reached

If steroids are reduced or discontinued:

Blood glucose monitoring may need to be continued for inpatients and in discharged patients by their GP

Any changes made should be reviewed and consideration given to reverting to previous therapy or doses.

If unsure at any stage about next steps, or want specific advice on how to meet with patients’ needs or expectations please discuss with the team who usually looks after their diabetes (GP/Specialist Team via Kinesis)

Glycaemic Targets:

Aim for 6-10mmol/L (acceptable range 4-12mmol/L)

End of Life care: Aim for 6-15mmol/L and symptom relief.

End of Life Management in Type 1 and Type 2 Diabetic

patients

Discuss Discuss changing the approach to diabetes management with patient and/or family if not already explored. If the patient remains on insulin ensure the diabetes specialist nurses (DSNs) are involved and agree monitoring strategy. Manage diabetes as follows:

Type 2 Diabetes Diet controlled or

Metformin treated

No need to monitor blood sugars unless on oral steroid therapy

Type 2 diabetes on other tablets and/or insulin / or

GLP-1 RA#

Type 1 diabetes always on insulin

If insulin/injectable stopped: • Urinalysis for glucose daily – If over 2+ check capillary

blood glucose (CBG) • If CBG over 20 mmol/L give 6 units rapid acting insulin

* • Recheck CBG after 2 hours

If patient requires rapid acting insulin* more than twice consider daily isophane insulin^ or long-acting insulin analogue

+.

Principles • Keep tests to a minimum. It may be necessary to perform some

tests to ensure unpleasant symptoms do not occur due to low or high blood glucose levels.

• It is difficult to identify symptoms due to “hypo” or hyperglycaemia in a dying patient.

• If symptoms are observed it could be due to abnormal CBG levels.

• Test urine or blood for glucose if the patient is symptomatic

• Observe for symptoms in previously insulin-treated patient where insulin has been discontinued.

If insulin to continue: • Prescribe once daily morning dose of isophane

insulin^ or long acting insulin analogue+ based on

25% less than total previous daily insulin dose

Check CBG once a day at teatime: • If below 8 mmol/L reduce insulin by 10-20% • If above 20 mmol/L increase insulin by10-20% to reduce

risk of symptoms or ketosis

Key

# Byetta (Exenatide) /Victoza,

(Liraglutide), Lyxumia (Lixisenatide)

* Humalog/Novorapid®/Apidra

^ Humulin I /Insulatard/ Insuman Basal

+ Lantus/Levemir

7. Diabetes UK Patient Information Prescriptions

Patient information prescriptions are included in the following pages and can be supplied to patients when

suitable. Patient information prescriptions are designed to give people with diabetes the information they need

to understand and improve on their health targets. They aim to target areas that are usually covered during

routine appointments and can put people at high risk of complications if not managed correctly:

- Being active (Can be used in patients at risk of developing type 2 diabetes)

- Eating well (Can be used in patients at risk of developing type 2 diabetes)

- Blood pressure

- Mood

- HbA1c

- Foot care - low risk

- Foot care - moderate or high risk

- Kidneys

- Contraception and Pregnancy

By empowering patients with an information prescription, the patient and clinician can identify steps the patient

can take towards a better future with diabetes. By improving their results and taking control of their diabetes in

this way, patients can dramatically lower their risk of complications.

All of the below patient information prescriptions also available online at the following link

https://www.diabetes.org.uk/professionals/resources/resources-to-improve-your-clinical-practice/information-

prescriptions-qa

The link above also provides guidance to help clinicians use the patient information prescriptions through their

primary care IT systems (EMIS or Vision), allowing simple linkage with patients’ medical records.

8. Diabetes complications guidance flowcharts

The flowcharts on the following pages are aimed to help guide and support

clinicians on the most appropriate steps to take when a patient with diabetes

presents with the following clinical complications;

Primary prevention of Cardiovascular Disease in diabetic patients

Management of obesity in diabetic patients

Management of hypoglycaemia in diabetic patients

Sick day rules for type 1 and type 2 diabetics treated with insulin

Management of diabetic foot problems

Pre-conception care for women with diabetes

Management of erectile dysfunction in diabetic patients

References for flowcharts

- NICE clinical guideline 189 – Obesity: identification, assessment and

management

- NICE clinical guideline 28 – Type 2 diabetes in adults: management

- NICE guideline 19 – Diabetic foot problems: prevention and

management

- Joint Formulary Committee. British National Formulary 74, page 680.

London: BMJ Group and Pharmaceutical Press; 2017

- NICE guideline 3 – Diabetes in pregnancy: management from

preconception to the postnatal period

- TREND-UK (2013) Managing diabetes during intercurrent illness in the

community. Available at: http://trend-uk.org/wp-

content/uploads/2017/02/TREND-consensus.pdf (accessed 8.08.2018)

- NICE clinical guideline 181 – Lipid modification: cardiovascular risk

assessment and the modification of blood lipids for the primary and

secondary prevention of cardiovascular disease

Primary cardiovascular disease (CVD) prevention in people with Type 2 diabetes –

Covers all type 2 diabetic patients without known CVD, familial hypercholesterolemia

or other disorders of lipid metabolism

Estimate a 10 –year risk of CVD using current QRisk risk calculator.

If current QRisk < 10% over the

next 10 years = give lifestyle advice

If current QRisk > 10% over the next 10

years

Identify and address all modifiable risk factors e.g. smoking, diet, obesity, alcohol, exercise, blood pressure and blood glucose/HbA1c

Reassess CVD risk after a trial of lifestyle

modification, and if current QRisk remains

>10% over the next 10 years, offer

Atorvastatin 20mg daily in addition to

lifestyle modification. (If potential drug

interactions, high risk of adverse effects,

patient preference or 20mg not tolerated,

use a lower dose of atorvastatin or consider

an alternative generic agent)

Offer Atorvastatin 20mg daily in addition to lifestyle

modification. (If potential drug interactions, high risk

of adverse effects, patient preference or 20mg not

tolerated, use a lower dose of atorvastatin or consider

an alternative generic agent)

People with Type 1 diabetes, who;

Are > 40 years old or

Have had Type 1 diabetes for > 10 years or

Have established nephropathy or

Have other CVD risk factors

Reinforce lifestyle interventions and check

adherence to medication. There are no

specific lipid treatment targets for primary

prevention, but for those patients

considered at risk, consider increasing statin

dose if necessary to reduce non-HDL

cholesterol by >40% from baseline.

Once statin therapy has been initiated, continue to reinforce lifestyle interventions and checks adherence to medication. Repeat lipid profile at 3 months. Aim for a reduction in non-HDL cholesterol by 40% from baseline;

If baseline cholesterol is not known, patients should

be treated to achieve at least a total cholesterol of <

5mmol/L and non-HDL cholesterol <3.8mmol/L

Increase dose if started on < 80mg atorvastatin and

not achieving adequate reductions in cholesterol or

at higher risk due to their co-morbidities, or using

clinical judgement – seek specialist advice in renal

disease (eGFR < 30ml/min/1.73m2)

Anti-platelet agents Aspirin 75mg daily is

indicated for all patients

with diabetes who have

any form of

cardiovascular disease. In

those who are

hypertensive the blood

pressure should be

controlled to 145/90 or

below before

commencement of

aspirin. If aspirin is not

tolerated or is

contraindicated,

clopidogrel 75mg daily

should be considered

Do not routinely offer

fibrates, nicotinic acid, bile

acid sequestrants or

omega-3 fatty acids to

diabetes patients

If a patient is not able to tolerate a high intensity statin aim to treat with the maximum tolerated dose. Discuss stopping the statin and restart when symptoms are resolved, reducing the dose of statin or changing the statin to a lower intensity group. Seek specialist advice for those who are intolerant of 3 different statins

Primary prevention of Cardiovascular Disease in diabetic patients

Management of obesity in diabetic patients

Obesity is a major modifiable risk factor in the development of type 2 diabetes. It is important to counsel patients

that weight loss alone can sometimes be effective enough to reverse type 2 diabetes.

Those people with diabetes whose weight is likely to contribute to the progression of their diabetes control should

be offered the opportunity to discuss this. The benefits of weight loss should be made clear.

Lifestyle interventions –

Advice on reducing caloric

intake and increasing

exercise is the mainstay of

obesity management

Targets – Realistic targets should be agreed between the patient and healthcare professional. These will vary depending on the individual.

Aim for a maximum weekly weight loss of 0.5-1kg, with a target to lose 5-10% of original weight.

Individuals should be encouraged to partake in 30 to 45 minutes of exercise, 5 times a week.

Drug Therapy - Consider

drug therapy only after

dietary, exercise and

behavioural approaches

have been tried. See NICE

guidance 189.

Only prescribe orilistat as part of an overall plan for managing obesity in patients with diabetes who have;

- a BMI of 28kg/m2 or more

Continue orlistat beyond 3 months only if the patient has lost at least 5% of their initial body weight since starting drug treatment.

Obesity surgery (Bariatric surgery)

Kent and Medway Policy Recommendation and Guidance Committee recommend bariatric surgery is funded locally for adults diagnosed with diabetes where all of the following criteria are fulfilled:

The patient has either: a BMI of > 35 OR Asian family origin, recent onset type 2 diabetes mellitus and

a BMI of >32.5

All appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss.

The individual has recently received and complied with a local specialist weight management programme (tier 3 please refer to “4 healthy weight” referral form) for a duration considered appropriate by the multi-disciplinary team (MDT).

The person is generally fit for anaesthesia and surgery.

The person commits to the need for long-term follow-up.

A formalised MDT led process for the screening of co-morbidities and the detection of other significant diseases has been completed. This is mandatory prior to entering a surgical pathway.

The specialist hospital bariatric MDT agrees surgery is indicated; for each patient a risk:benefit evaluation should favour bariatric surgery.

Blood glucose/CBG < 4mmol/L with or without symptoms – Pale, sweating, trembling/anxiety/irritability, palpitations, poor concentration, confused, convulsions, coma

Patient conscious, orientated

and able to swallow Patient conscious and able to swallow but confused,

disorientated, unable to co-operate and aggressive

Patient is unconscious, having

seizures, very aggressive or

uncooperative

Give 15-20g of fast acting

carbohydrate (glucose) by

mouth. Approximately 15-

20g of glucose is available

from; 150-200ml pure fruit

juice e.g. orange juice; 5-7

Dextrosol® tablets; 4-5

Glucotabs®; 3-4 heaped

teaspoons of sugar

dissolved in water; 4 jelly

babies; 90-120ml of original

Lucozade® (sugar content in

soft drinks may change,

please check individual

product labels)

Check blood glucose after 10-15 minutes

Blood glucose > 4mmol/L

Following initial treatment for hypoglycaemia and once blood glucose is > 4mmol/L, the patient must eat a snack or meal containing a long acting carbohydrate e.g. a sandwich, fruit, milk, toast, or biscuits or the next meal (if it is

due). This can prevent blood-glucose concentration from falling again. Once stable, clinicians should try to determine the cause for the hypoglycaemic episode and provide hypoglycaemia education to the patient. Ensure

that regular blood glucose monitoring is conducted for 24-48 hours following the hypoglycaemic episode

Blood glucose < 4mmol/L

Check ABCDE;

Give 1.5-2 tubes of Glucogel squeezed into mouth or

between teeth or

(if this is ineffective or patient unable to swallow)

give glucagon 1mg IM (may be

less effective in patients prescribed

sulphonylurea therapy)

Dial 999 Check ABCDE;

Give Glucagon 1mg IM or

75ml 20% dextrose IV

infusion over 15 minutes (in

hospital)

Carbohydrates should be

given as soon as possible to

restore liver glycogen

Patient conscious and able to swallow

– Repeat 15-20g of oral glucose

Patient unconscious/oral

route not possible – If

Glucagon not effective in 10

minutes intravenous glucose

should be given.

Blood

glucose >

4mmol/L

Blood glucose

< 4mmol/L -

Review

Blood

glucose >

4mmol/L

Blood

glucose <

4mmol/L –

Review

Management of hypoglycaemia in diabetic patients

Insulin treated patient with diabetes

feeling unwell

Type 2 diabetes Type 1 diabetes

Test blood glucose

Blood

glucose

less than

13mmol/L

Take insulin as

normal. Take

carbohydrates as

meal

replacement and

sip sugar-free

liquids, at least

100mL/hour

Blood

glucose

more than

13mmol/L

Test blood glucose and ketones

Blood

glucose

less than

13mmol/L

Take insulin as normal.

Carbohydrates as meal

replacement and sip sugar-

free liquids, 100ml/hour

Blood glucose more than

13mmol/L and ketones

present (more than

1.5mmol/L in blood or

+/++ in urine)

Blood glucose more than

13mmol/L and no

ketones present (less

than 1.5mmol/L in blood)

Blood Glucose Insulin dose

13-17mmol/L Add 2 extra units to each dose

17-22mmol/L Add 4 extra units to each dose

More than 22mmol/L Add 6 extra units to each dose

All patients should be taught how to adjust their insulin. Once

the initial increased dose has been administered, patients

should contact their GP or specialist nurse if unsure.

Test blood glucose level every 4 hours

Blood glucose

more than

13mmol/L –

repeat process

Blood glucose

less than

13mmol/L

Total daily insulin dose Give additional 10% of rapid acting or mixed insulin every 4 hours

Give an additional 20% of rapid acting or mixed insulin every 2 hours

Up to 14 units 1 unit 2 units

15-24 units 2 units 4 units

25-34 units 3 units 6 units

35-44 units 4 units 8 units

45-54 units 5 units 10 units

All patients should be taught how to adjust their insulin

Urine ketones + to ++ or

Blood ketones 1.5-3mmol/L

Urine ketones +++ to ++++ or Blood ketones

>3mmol/L

Blood glucose more than 13mmol/L and

ketones present – repeat process

Test blood glucose and

blood/urine ketone

levels every 4 hours

Test blood glucose and

blood/urine ketone

levels every 2 hours

Blood glucose less than 13mmol/L - As the

patient’s illness resolves, they should adjust

their insulin dose back to normal

As the patient’s illness

resolves, they should

adjust their insulin dose

back to normal

If the patient starts vomiting, is unable to keep fluids down or unable to control their blood glucose or ketone

levels, advise them to seek urgent medical advice. Patients must NOT stop taking their insulin, even if they

are unable to eat.

Sick day rules for insulin treated type 1 and type 2 diabetic patients

Patients with diabetes are at increased risk of developing lower limb complications. This risk can be reduced by

healthcare professionals advising patients to adhere to a foot care programme that provides education, podiatry and

advice on protective footwear.

The risk of developing a diabetic foot problem should be assessed at the following times;

When diabetes is diagnosed and at least annually thereafter

If any foot problems arise

On any admission to hospital and if there is a change in status while they are in hospital.

Risk factors for diabetic foot problems;

Neuropathy, Callus, Infection/inflammation, Deformity, Charcot arthopathy, peripheral artery disease

Low risk = normal

sensation and

palpable pulses. No

risk factors present

Moderate risk = one

risk factor present

e.g. loss of sensation

or signs of peripheral

vascular disease

without callus or

deformity

High risk = Previous

ulcer or amputation

or more than one risk

factor e.g. loss of

sensation or signs of

peripheral vascular

disease with callus or

deformity

Active diabetic foot

problem = active

ulceration,

spreading infection,

critical ischaemia,

gangrene

Classify risk as below

In the absence of

any foot pathology,

patient can be seen

routinely. Must

agree a

management plan

including foot care

education.

Review annually by

a suitably trained

healthcare

professional

Enhance foot care

education for the

patient. Podiatrist or

member of foot

protection team must

inspect feet 3-6

monthlyds provide

advice on

appropriate

footwear, review

need for vascular

assessment regularly.

Refer to foot

protection service to

be seen within 6-8

weeks

Refer to foot

protection service to

be seen within 2-4

weeks

Arrange frequent

review, 1-2 monthly,

from specialist

podiatry/foot care

team.

At each annual

diabetes review,

provide intensified

foot care education.

Urgently refer to

specialist

multidisciplinary

foot clinic. See

antibiotic guidance

for active foot

infections for

initiation of

treatment

Arrange very

frequent review,

every 1-2 weeks.

Provide information and clear explanations as part of the individualised treatment plan for people with a diabetic foot problem. Information should be oral and written, and include the following:

A clear explanation of the person's foot problem; Pictures of diabetic foot problems, care of the other foot and leg, foot

emergencies and who to contact, footwear advice, wound care, information about diabetes and the importance of

blood glucose control

Management of diabetic foot problems

Traffic light risk assessment for the diabetic foot

Ensure that the importance of avoiding an unplanned pregnancy is an essential component of diabetes education from adolescence for women with diabetes.

Women with diabetes who are planning a pregnancy should be advised that the risks associated with pregnancy increase with how long the woman has had diabetes. They

should have a medical, dietetic, educational, drug, obstetric and gynaecological history taken and should be advised to remain on contraception until good blood glucose

control has been established before conception and continue this throughout pregnancy – this will help to reduce the risk of complications (but not eliminate them).

Diet Monitoring Medication safety Retinal

Advise women to take 5mg folic

acid once daily for at least 3

months prior to conception, and

then until 12 weeks gestation.

Offer women with a BMI >

27kg/m2, advice on how to lose

weight

Offer women monthly

measurement of their HbA1c level

and a meter for self-monitoring of

blood glucose

Advise women to aim for blood glucose targets as agreed by

specialist diabetes team

Strongly advise women whose HbA1c is > 86mmol/mol (10%), not to get pregnant due to the associated risks.

Women with diabetes may be

advised to use metformin as an

adjunct or alternative to insulin. All

other oral blood glucose-lowering

agents should be discontinued

before pregnancy and

metformin/insulin substituted

If the woman is taking medication

that is NOT recommended in

pregnancy – e.g. ACE inhibitors,

statins, diuretics or beta-blockers,

and certain diabetes drugs – steps

should be taken to remedy this

before conception, or as soon as

pregnancy is confirmed.

Women with diabetes should

be made aware that

retinopathy can accelerate

during pregnancy and the

requirement for regular retinal

exams during pregnancy.

Women should have access to members of the multidisciplinary team appropriate to their needs, including but not limited to: diabetologist, obstetrician, psychologist,

specialist diabetes dietitians, specialist diabetes nurses and special diabetes midwives

Preconception care for women with diabetes

1. Take a full medical history, including sexual and psychosexual history.

Note: Patients with diabetes are at an increased risk of erectile dysfunction and men with diabetes should

be asked about erectile dysfunction at their annual diabetes check.

2. Examination covering the following:

Cardiovascular risk assessment including measurement of BMI, BP, waist circumference.

Testicular atrophy, penile abnormalities e.g. Peyronie’s disease, hypogonadism, reduced body

hair, gynaecomastia

3 .First Investigations: 9am Testosterone; if less than 12, repeat 9am testosterone and also check gonadotrophin,

SHBG and prolactin and refer to endocrinology if abnormalities detected

1. Provide lifestyle advice on; smoking cessation, weight loss, increasing physical activity, reducing alcohol

consumption, reducing stress.

2. Prescribing; Consider a phosphodiesterase-5 inhibitor to treat problematic erectile dysfunction in men

with type 2 diabetes, initially choosing the drug with the lowest acquisition cost and taking into account

any contraindications. Generic Sildenafil is the cheapest medicine in this class and is now available for all

patients who need it, not just under SLS restrictions.

(If a patient does not respond to Sildenafil, ensure the patient has taken into account that fatty food and

alcohol reduce the effect of sildenafil)

Following discussion, refer men with type 2 diabetes to a service offering other medical, surgical or psychological

management of erectile dysfunction if treatment (including a phosphodiesterase-5 inhibitor, as appropriate) has

been unsuccessful

Repeat 9am testosterone and check LH, FSH,

SHBG and PSA. Treat the underlying condition or

refer to local endocrinology service

Results

normal

Results

abnormal

Patient does not

respond to

treatment

Management of erectile dysfunction in diabetic patients

9. Guidelines on Self-Monitoring of Blood Glucose (SMBG) in people with

Type 1 and Type 2 Diabetes

Aims:

To help clinicians and patients draw up management plans together with the full agreement of the patient, taking into account their lifestyle and personal preferences. This guidance is in addition to NICE guidance and aims to specifically address frequency of SMBG.

To direct resources to where they are needed for best possible patient care, whilst reducing waste as much as possible, taking account of the best available evidence.

This document aims to provide guidance: there will be occasions when a patient and their clinicians

will agree to differ from this guidance e.g. risk of hypoglycaemia or if occupation or lifestyle require

more frequent SMBG for justifiable reasons. Current guidelines from the Driver and Vehicle Licensing

Agency (DVLA) should always be observed (See Appendix A and refer to the link

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file

/670819/assessing-fitness-to-drive-a-guide-for-medical-professionals.pdf for most up to date

guidance).

1. Type 1 Diabetes:

SMBG is an integral part of treatment.

Most individuals should be able to monitor four or more times a day to help self-manage their

diabetes appropriately (control hyperglycaemia and prevent hypoglycaemia). Active or changeable

lifestyles &/or frequent driving, confirmation of hypoglycaemia, and application of sick day rules

require additional testing. The DVLA advise that drivers treated with insulin take precautions which

includes amongst others, testing blood glucose levels before driving and every 2 hours on long

journeys(see Appendix C).

Please note: Freestyle Libre® users will still need to do finger-prick blood tests prior to and during

driving to meet current DVLA requirements, as Freestyle Libre®, like continuous glucose monitoring,

measures interstitial fluid levels and not capillary blood glucose levels.

“NICE guidance 17 – Type 1 diabetes in adults: diagnosis and management” (available at

https://www.nice.org.uk/guidance/ng17) states;

Routine self-monitoring of blood glucose levels for all adults with type 1 diabetes, and recommend testing at least 4 times a day, including before each meal and before bed

Support to test up to 10 times a day if any of the following apply: The desired target for blood glucose control measured by HbA1c is not achieved The frequency of hypoglycaemia episodes increases In relation to driving as per DVLA requirements. Click here to access the DVLA

Assessing fitness to drive – a guide for medical professionals During periods of illness Before, during and after sport When planning pregnancy, during pregnancy and while breastfeeding

If there is a need to know blood glucose levels more than 4 times a day for other reasons (e.g. impaired awareness of hypoglycaemia, high-risk activities)

2. Type 2 Diabetes:

“NICE guidance 28 – Type 2 diabetes in adults: management” (available at

https://www.nice.org.uk/guidance/ng28/resources/type-2-diabetes-in-adults-management-pdf-

1837338615493) states that clinicians should not routinely offer SMBG levels for adults with type 2

diabetes unless:

The patient is on insulin or

There is evidence of hypoglycaemic episodes or

The person is on oral medication that may increase their risk of hypoglycaemia while driving or operating machinery or

The person is pregnant, or is planning to become pregnant. For more information, see the NICE guideline on diabetes in pregnancy (https://www.nice.org.uk/guidance/ng3)

Consider short-term self-monitoring of blood glucose levels in adults with type 2 diabetes (and

review treatment as necessary):

When starting treatment with oral or intravenous corticosteroids or

To confirm suspected hypoglycaemia .

If adults with type 2 diabetes are self-monitoring their blood glucose levels, carry out a structured

assessment at least annually. The assessment should include:

The person’s self-monitoring skills

The quality and appropriate frequency of testing

Checking that the person knows how to interpret the blood glucose results and what action to take

The impact on the person’s quality of life

The continued benefit to the person

The equipment used

Diabetes UK guidance on self-monitoring of blood glucose in adults with type 2 diabetes states;

Self-monitoring of blood glucose levels in people with type 2 diabetes on insulin should

be regarded as an integral part of treatment and should not be restricted.

All drivers with type 2 diabetes on medication that carries a risk of hypoglycaemia

should be informed of the DVLA requirements for each of the medicines they are

prescribed. The patient can then decide on whether they wish to carry out SMBG or

not.

For patients prescribed medication other than those with a risk of hypoglycaemia and

insulin, SMBG may be available based on an individual assessment of need. If a patient

is motivated to carry out SMBG and feels that its use will help maximise the effect of

lifestyle and medication, then access to SMBG should be discussed and agreed between

the patient and their clinician.

NOTE: This document has been developed based on the best available knowledge at the same time

of publishing, clinicians should remain alert to new developments and the possibility that guidance

may change.

References

Diabetes UK position statement on self-monitoring of blood glucose for adults with type 2 diabetes (2017) https://diabetes-resources-production.s3-eu-west-1.amazonaws.com/diabetes-storage/migration/pdf/SMBGType2%2520Final%2520April%25202017.pdf

NICE Clinical Guideline 28 Type 2 diabetes in adults: management (May 2017) https://www.nice.org.uk/guidance/ng28

NICE clinical Guideline 17 Type 1 diabetes in adults: diagnosis and management (July 2016) https://www.nice.org.uk/guidance/ng17

Acknowledgement to Bradford and Airedale tPCT PACE Diabetes Toolkit February 2009 and Brighton & Hove PCT

DVLA assessing fitness to drive – a guide for medical professionals (January 2018) https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/670819/assessing-fitness-to-drive-a-guide-for-medical-professionals.pdf

DVLA. Communication sent to patients when notifying DVLA of their condition. To display the poster in your surgery/clinic. [cid:hope_encode_maker@0002] <http://www.primary-diagnostic.co.uk/pd/clicks2.asp?PersonCode=691932&idm=335&ids=5>. For more information go to: www.direct.gov.uk/diabetesrules <http://www.primary-

diagnostic.co.uk/pd/clicks2.asp?PersonCode=691932&idm=335&ids=3>

58

Table for use with NHS West Kent Guidelines on Self-Monitoring of Blood Glucose (SMBG) in people with Diabetes

*Quantities have been rounded to multiples of 50 strips as 1 Box usually contains 50 strips. Exceptions include Accu-Check Compact Plus where 1 pack contains 3 drums of 17

strips (51) and Accu-Check Mobile where 1 pack comprises 100 strips presented as two cassettes each of 50 strips

Diabetes Type

Treatment Group

Monitoring Regime

A management plan should be developed and agreed with the individual

Usual Blood Glucose Strip Requirement*

Initiation Repeat prescription

Type 1 Diabetes

Most people with Type 1 diabetes

SMBG is an integral part of treating Type 1 Diabetes

Patients should be educated in SMBG and adjust treatment accordingly

The majority of patients with Type 1 Diabetes should be encouraged to monitor at least 4 or more times a day to prevent hypoglycaemia and control hyperglycaemia

100 strips

250 strips every 2 months [but may need more]

Intensive management or loss of hypoglycaemic Awareness

Frequent testing essential in: newly diagnosed children, under 5yrs; insulin pump therapy users; those unwell or carbohydrate counting

A management plan should be developed and agreed with the individual up to 8 or more tests daily For complete loss of awareness of hypoglycaemia, consider continuous glucose monitoring.

250 strips 250 strips every month [but may need less]

Pre-pregnancy, Pregnancy in Type 1 & Type 2 & Gestational Diabetes

All pregnant women with diabetes planning a pregnancy, pregnant women with diabetes and gestational diabetes

All should SMBG at least 4 times a day (in some cases up to 8 times a day), to include both fasting, post prandial and bedtime blood glucose measurements.

150 strips for the first month

150-250 strips every month

Type 2 Diabetes

Insulin therapy +/- hypoglycaemic agents

Consider SMBG 2 to 4 times a day. This may be reduced to once daily or less if glycaemic control is considered to be stable in agreement with the patient. Patients should be made aware of the DVLA requirements for blood glucose testing and make an informed decision about testing.

Increase testing during periods of illness, instability or use of oral steroids

Assess patients understanding and use of results to adjust diet, lifestyle and treatment. Provide extra training

100 strips

50-150 strips every month depending on number of tests per day

SU alone or in conjunction with other therapies

Patients on sulfonylureas should not need to routinely self-monitor blood glucose, but SMBG can be considered if there is symptomatic hypoglycaemia, suspected asymptomatic hypoglycaemia, use of oral steroids, risk of hypoglycaemia due to renal impairment or high alcohol intake, plus in those with certain occupations (i.e. HGV, PSV or train drivers) or under DVLA requirements.

Pattern of monitoring should be agreed as part of a management plan

50 strips to facilitate monitoring agreed

Review frequency and quantity of strips to be dispensed when initial prescription used up.

Diet & Physical Activity alone +/- MET or glitazones or DPP-4i or SGLT-2i or GLP-1 RA (once stabilized)

SMBG not routinely recommended as part of routine care – discuss with clinician

Issued as required with agreement & education of the patient

Review frequency and quantity of strips to be dispensed when initial prescription used up.

Key Practice Points

SMBG should form part of a wider programme of management where the results are used to inform diet, lifestyle or treatment changes

Patients who self monitor must be given adequate training in self-monitoring techniques, including regular quality control of their meters

Patients and health care professionals (HCP) should be clear about what they hope to achieve by SMBG

Patients may need extra strips to comply with DVLA guidelines (see Appendix A and the link https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/670819/assessing-fitness-to-drive-a-guide-for-medical-professionals.pdf for the most up to date information).

Community Pharmacists are strongly advised not to sell blood glucose monitoring meters to patients without prior discussion with the patient’s diabetes key worker / HCP, if the intention is to obtain test strips from FP10 NHS prescriptions

Frequency of SMBG should be reviewed regularly and excess use addressed

60

Appendices

Provide advice about the legislation in place to ensure medical standards regarding fitness to drive with diabetes according to the Driver and Vehicle Licensing Agency (DVLA) as at Nov 2011.

Most up to date information can be obtained via http://www.dft.gov.uk/dvla/medical.aspx

Appendix A: ‘At a glance’ guide to the current medical standards (diabetes) of fitness to drive

The table below has been provided by the DVLA (Medical Advisor). Any information in the table and rest of the document in Appendix A that refers the reader to another section must refer to the DVLA website for further information.

# confirmed by Medical Advisor at DVLA (Dr G B Rees) that these drivers must monitor their blood glucose at least twice daily and at times relevant to driving. The Honorary Medical Advisory Panel has clarified the advice given to a driver with insulin-treated diabetes regarding the frequency of blood glucose monitoring in relation to driving. If driving multiple short journeys, such as a delivery driver, it would be appropriate to measure blood glucose before the first journey and then every two hours. It is not necessary to test before each individual journey.

## confirmed by Medical Advisor at DVLA (Dr G B Rees) that those with insulin-treated diabetes applying for Group 2 driving entitlement require an annual examination with an independent Consultant Diabetologist. This examination cannot be carried out by a General Practitioner.

Appendix B: Information for drivers with Diabetes treated by non-insulin medication, diet or both (INF188/2).

Appendix C: A Guide to Insulin Treated Diabetes and Driving (DIABINF).

APPENDIX A: ‘At a glance’ guide to the current medical standards (diabetes) of fitness to drive

The table below has been developed using https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/670819/assessing-fitness-to-drive-a-guide-for-medical-professionals.pdf. Please refer to this link for

more detailed information.

The applicant or licence holder must notify DVLA unless stated otherwise in the text

DIABETES MELLITUS

DIABETES MELLITUS GROUP 1 ENTITLEMENT

ODL - CAR, M/CYCLE

GROUP 2 ENTITLEMENT VOC – LGV/PCV

INSULIN-TREATED

Drivers are sent a detailed letter of explanation about their licence and driving by DVLA.

See Appendix C to this Chapter for a sample of this letter (DIABINF)

All the following criteria must be met for the DVLA to license the person with insulin-treated diabetes for 1, 2 or 3 years:

adequate awareness of hypoglycaemia

no more than 1 episode of severe hypoglycaemia while awake in the preceding 12 months or the most recent episode occurred more than 3 months ago.

practises appropriate blood glucose monitoring

not regarded as a likely risk to the public while driving

meets the visual standards for acuity and visual field

under regular review

All the following criteria must be met for the DVLA to license the person with insulin-treated diabetes for 1 year (with annual review as indicated last below): ■ full awareness of hypoglycaemia ■ no episode of severe hypoglycaemia in the preceding 12 months ■ practises regular blood glucose monitoring as defined by the DVLA ■ must use a glucose meter with sufficient memory to store 3 months of readings ■ demonstrates an understanding of the risks of hypoglycaemia ■ no disqualifying complications of diabetes that would mean a licence being refused or revoked, such as visual field defect.

TEMPORARY INSULIN TREATMENT

e.g. gestational diabetes, post-myocardial infarction, participants in oral/inhaled insulin trials.

May drive and need not notify the DVLA, provided: ■ under medical supervision ■ not advised by clinician as at risk of disabling hypoglycaemia. May continue to drive but must notify the DVLA if: ■ disabling hypoglycaemia occurs ■ treatment continues for more than 3 months – or in gestational diabetes, continues for 3 months after delivery.

Must notify the DVLA and meet the above standards.

MANAGED BY TABLETS WHICH CARRY A RISK OF INDUCING HYPOGLYCAEMIA. THIS INCLUDES SULPHONYLUREAS AND GLINIDES

See Appendix B to this Chapter for INF188/2

May drive and need not notify the DVLA, provided: ■ no more than 1 episode of severe hypoglycaemia while awake in the last 12 months or the most recent episode occurred more than 3 months ago ■ if needed, detection of hypoglycaemia is by appropriate blood glucose monitoring at times relevant to driving and clinical factors, including frequency of driving ■ under regular review. It is appropriate to offer self monitoring of blood glucose at times relevant to driving to enable the detection of hypoglycaemia. If the above requirements Are met, the DVLA need not be informed. The DVLA must be notified if clinical information indicates the agency may need to undertake medical enquiries.

May drive but must notify the DVLA. All the following criteria must be met for the DVLA to issue a licence for 1, 2 or 3 years: ■ no episode of severe hypoglycaemia in the last 12 months ■ full awareness of hypoglycaemia ■ regular self-monitoring of blood glucose – at least twice daily and at times relevant to driving i.e. no more than 2 hours before the start of the first journey and every 2 hours while driving ■ demonstrates an understanding of the risks of hypoglycaemia ■ has no disqualifying complications of diabetes that mean a licence will be refused or revoked, such as visual field defect

DIABETES MELLITUS

GROUP 1 ENTITLEMENT

ODL - CAR, M/CYCLE

GROUP 2 ENTITLEMENT VOC – LGV/PCV

MANAGED BY TABLETS OTHER THAN THOSE ON THE PREVIOUS PAGE OR BY NON-INSULIN INJECTABLE MEDICATION

See Appendix B to this Chapter for INF188/2

If all the requirements set out in the attached information on INF188/2 are met, and they are under regular medical review, DVLA does not require notification. This information leaflet can be printed and retained for future reference.

Alternatively, if the information indicates that medical enquiries will need to be undertaken, DVLA should be notified.

May drive but must notify the DVLA. The DVLA may issue a licence if certain requirements are met and the driver is under regular medical review. A licence is refused or revoked if relevant disqualifying complications have developed, such as diabetic retinopathy affecting visual acuity or visual fields.

A short-term licence may be issued if diabetes complications have developed but the required medical standards have been met.

Drivers are advised to monitor their blood glucose regularly and at times relevant to driving. They must be under regular medical review.

MANAGED BY DIET ALONE Need not notify DVLA unless develop relevant disabilities e.g. Diabetic eye problems affecting visual acuity or visual field or if insulin required.

Need not notify DVLA unless develop relevant disabilities e.g. Diabetic eye problems affecting visual acuity or visual field or if insulin required.

Impaired awareness of Hypoglycaemia If confirmed, driving must stop. Driving may resume provided reports show awareness of hypoglycaemia has been regained, confirmed by consultant/GP report.

See previous page for insulin treated. Refusal or revocation.

Eyesight complications (affecting visual acuity or fields)

See Section in DVLA: Visual Disorders Must not drive and must notify the DVLA.

The licence will be refused or revoked.

Refer to DVLA document insulin-treated diabetes (page 69) and Chapter 6, visual disorders

Renal Disorders See Section in DVLA: Renal Disorders See Section in DVLA: Renal Disorders

Limb Disability e.g. peripheral neuropathy

See Section in DVLA: disabilities and vehicle adaptations at Appendix F

As Group I

Continuous glucose monitoring systems: Because these systems measure interstitial glucose, drivers must also monitor blood glucose levels as outlines above.

FURTHER INFORMATION

• Police, Ambulance and Health Service Vehicle Driver Licensing* The Secretary of State’s Honorary Medical Advisory Panel on Diabetes and Driving has recommended that drivers with insulin treated diabetes should not drive emergency vehicles. This takes account of the difficulties for an individual, regardless of whether they may appear to have exemplary glycaemic control, in adhering to the monitoring processes required when responding to an emergency situation.

*Caveat: The advice of the Panels on the interpretation of EC and UK legislation, and its appropriate application, is made within the context of driver licensing and the DVLA process. It is for others to decide whether or how those recommendations should be interpreted for their own areas of interest, in the knowledge of their specific circumstances. A Guide for Drivers with Insulin Treated Diabetes who wish to apply for Group 2 (LGV/PCV) Entitlement Qualifying Conditions which must be met

No episode of hypoglycaemia requiring the assistance of another person has occurred in the preceding 12 months.

Must have full hypoglycaemic awareness.

Must demonstrate an understanding of the risks of hypoglycaemia.

Will not be able to apply until their condition has been stable for a period of at least one month.

Must regularly monitor their condition by checking their blood glucose levels at least twice daily and at times relevant to driving. A glucose meter with a memory function to measure and record blood glucose levels must be used.

DVLA will arrange an examination by an independent hospital consultant who specialises in the treatment of diabetes every 12 months. At the examination, the consultant will require sight of their blood glucose records for the previous 3 months.

Must have no other condition which would render them a danger when driving Group 2 vehicles.

They will be required to sign an undertaking to comply with the directions of doctors(s) treating the diabetes and to report immediately to DVLA any significant change in their condition.

APPENDIX B: Information for drivers with Diabetes treated by non-insulin medication, diet or both (INF188/2)

Drivers do not need to tell DVLA if their diabetes is treaded by tablets, diet or both and they are free of the complications listed below.

Some people with diabetes develop associated problems that may affect their driving.

What you need to tell the DVLA about

By law, you must tell us if any of the following applies:

you need treatment with insulin.

you need laser treatment or Anti-VEGF treatment to both eyes or in the remaining eye if you have sight in one eye only.

you have problems with vision in both eyes or in the remaining eye if you have sight in one eye only. By law, you must be able to read, with glasses or contact lenses if necessary, a car number plate in good daylight at 20.5 metres (67 feet) or 20 metres (65 feet) where narrower characters 50mm wide are displayed.

you develop any problems with the circulation or sensation in your legs or feet which make it necessary for you to drive certain types of vehicles only, for example automatic vehicles or vehicles with a hand-operated accelerator or brake. This must be noted on your driving licence.

you suffer more than one episode of hypoglycaemia (low blood sugar) requiring the assistance of another person within 12 months, or if you or your carer feels you are at high risk of developing disabling hypoglycaemia. For Group 2 drivers (bus/lorry), one episode of hypoglycaemia requiring the assistance of another person must be reported immediately.

you develop impaired awareness of hypoglycaemia (difficulty in recognising the warning symptoms of low blood sugar).

you suffer disabling hypoglycaemia while driving.

an existing medical condition gets worse or you develop any other condition that may affect your driving safely.

Advice about Hypoglycaemia

The risk of hypoglycaemia (low blood sugar) is the main hazard to safe driving and can occur with diabetes treated with insulin or tablets or both. This may endanger your own life as well as that of other road users. Many of the accidents caused by hypoglycaemia are because drivers continue to drive even though they are experiencing warning symptoms of hypoglycaemia. If you experience warning symptoms of hypoglycaemia while driving, you must always stop as soon as safely possible do not ignore the warning symptoms. In the interests of road safety, you must be sure that you can safely control a motor vehicle at all times.

How to tell the DVLA

If your doctor, specialist or optician tells you to report your condition to us, you need to fill in a DIAB1 medical questionnaire about diabetes. You can download this from https://www.gov.uk/diabetes-driving

Write to: Driver’s Medical Group, DVLA Swansea SA99 1TU

DVLA drivers’ medical enquiries Telephone: 0300 790 6806

E-mail: Email can be sent by using the following link https://www.gov.uk/contact-the-dvla/y/driving-and-medical-issues

APPENDIX C: A Guide to Insulin Treated Diabetes and Driving (DIABINF)

Drivers who have any form of diabetes treated with any insulin preparation must inform DVLA (Caveat: See Temporary Insulin Treatment)

HYPOGLYCAEMIA (LOW BLOOD SUGAR)

The risk of hypoglycaemia is the main hazard to safe driving. This may endanger your own life as well as that of other road users. Many of the accidents caused by hypoglycaemia are because drivers continue to drive even though they are experiencing warning symptoms of hypoglycaemia. If you experience warning symptoms of hypoglycaemia whilst driving, you must always stop as soon as safely possible – do not ignore the warning symptoms. Group 1 car and motorcycle drivers with insulin-treated diabetes are advised to take the following precautions:

Carry your glucose meter and blood glucose strips with you and ensure blood glucose testing no more than 2 hours before the start of the first journey and every 2 hours while driving

Applicants will be asked to sign an undertaking to comply with the directions of the healthcare professionals treating their diabetes and to report any significant change in their condition to the DVLA immediately.

Group 2 bus and lorry drivers with insulin-treated diabetes are advised to take the following precautions:

Regular blood glucose testing – at least twice daily including on days when not driving and no more than 2 hours before the start of the first journey and every 2 hours while driving.

More frequent self-monitoring may be required with any greater risk of hypoglycaemia (physical activity, altered meal routine), in which case a bus or lorry driver may be licensed if they use one or more glucose meters with memory functions to ensure 3 months of readings that will be available for assessment.

How the DVLA checks diabetes management requirements for insulin-treated Group 2 bus and lorry licensing

The DVLA takes the following measures to ensure the requirements are met for licensing of insulin-treated Group 2 bus and lorry drivers: Requires the applicant’s usual doctor who provides diabetes care to undertake an annual

examination including review of the previous 3 months of glucose meter readings Arranges an examination to be undertaken every 12 months by an independent consultant

specialist in diabetes if the examination by their usual doctor is satisfactory At the examination, the consultant will require sight of blood glucose self-monitoring

records for the previous 3 months stored on the memory of a blood glucose meter The license application process cannot start until an applicant’s condition has been stable for

at least 1 month Applicants will be asked to sign an undertaking to comply with the directions of the

healthcare professionals treating their diabetes and to report any significant change in their condition to the DVLA immediately.

General advice

More frequent self-monitoring may be required with any greater risk of hypoglycaemia (physical activity, altered meal routine).

In each case if your blood glucose is 5.0mmol/l or less, take a snack before driving. If it is less than 5.0mmo1/1 or you feel hypoglycaemic, do not drive.

If hypoglycaemia develops while driving, stop the vehicle as soon as possible in a safe location, switch off the engine, remove the keys from the ignition and move from the driver’s seat.

Do not resume driving until 45 minutes after blood glucose has returned to normal. It takes up to 45 minutes for the brain to recover fully.

Always keep an emergency supply of fast-acting carbohydrate such as glucose tablets or sweets within easy reach in the vehicle.

Carry personal identification indicating that you have diabetes in case of injury in a road traffic accident.

Particular care should be taken during changes of insulin regimens, changes of lifestyle, exercise, travel and pregnancy.

Take regular meals, snacks and rest periods on long journeys. Always avoid alcohol. EYESIGHT

The law requires that all licensed drivers meet the following eyesight requirements (including drivers aided by prescribed glasses or contact lenses): ■ in good daylight, able to read the registration mark fixed to a vehicle registered under current standards at a distance of 20 metres with letters and numbers 79mm high by 50mm wide on a car registered since 1 September 2001 or at a distance of 20.5 metres with letters and numbers 79mm high by 57mm wide on a car registered before 1 September 2001 and ■ the visual acuity must be at least Snellen 6/12 with both eyes open or in the only eye if monocular. Group 2 bus and lorry drivers require a higher standard of visual acuity in addition: ■ a visual acuity (using corrective contact lenses where needed) of at least: ■ Snellen 6/7.5 (Snellen decimal 0.8) in the better eye and Snellen 6/60 (Snellen decimal 0.1) in the poorer eye ■ if glasses are worn to meet the minimum standards, they should have a corrective power not exceeding +8 dioptres in any meridian of either lens. LIMB PROBLEMS

Limb problems/amputations are unlikely to prevent driving. They may be overcome by either restricting driving to certain types of vehicles e.g. those with automatic transmission, or by adaptations such as hand-operated accelerator/brake.

PATIENTS MUST INFORM DVLA IF:

They suffer more than one episode of hypoglycaemia (low blood sugar) requiring the assistance of another person within the last 12 months, or if they are at high risk of developing disabling hypoglycaemia. For Group 2 drivers (bus/lorry), one episode of hypoglycaemia requiring the assistance of another person must be reported immediately.

They develop impaired awareness of hypoglycaemia. (difficulty in recognising the warning symptoms of low blood sugar)

They suffer disabling hypoglycaemia while driving.

An existing medical condition gets worse or they develop any other condition that may affect driving safely.

If they are unable to meet the number plate requirement.

They have any problem that affects your field of vision.

They have any condition that affects both eyes or the remaining eye if you have sight in one eye only

They have had laser treatment or Anti-VEGF treatment to both eyes for retinopathy, or to the remaining eye if monocular.

They develop problems with either the nerves or the circulation in their legs which prevent safe use of the foot pedals.

CONTACT THE DVLA

Web site: https://www.gov.uk/health-conditions-and-driving

Write to: Driver’s Medical Group, DVLA Swansea SA99 1TU

DVLA drivers’ medical enquiries Telephone: 0300 790 6806

E-mail: Email can be sent by using the following link https://www.gov.uk/contact-the-dvla/y/driving-and-medical-issues