Walsall Joint Diabetes Guidelines 2019

Walsall Joint Diabetes Guidelines 2018

Final Version

Review Due: April 2021

Final Version

Page 1 of 52

Contents

Contents

Page Introduction and Acknowledgements 2 Make the correct assessment 3 Make Diagnosis of Suspected Type 1 Diabetes (adult) 5 Diagnosis of Suspected Diabetes Mellitus in Children 6 Pathway for Diagnosing Suspected Type 1 Diabetes in Children 7 Diagnosis of Type 2 Diabetes 8 Management of Type 2 Diabetes (NICE NG 28 2015) 9 Oral Hypoglycaemic Drugs 11 Dose adjustments for DPP4 inhibitors 13 SGLT2 inhibitors: increased risk of lower extremity amputations 15 SGLT2 inhibitors: increased risk of diabetic ketoacidosis 16 SGLT2 inhibitors: reports of Fournier’s gangrene 17 Injectable Therapies – GLP-1 Analogues 18 Injectable Therapies – Initiating Insulin 19 Titrating Basal Insulin – Basal Insulin once/twice daily 20 Titrating BD Insulin – biphasic pre-mixed insulin 21 Biosimilars 22 Degludec 24 Toujeo 25 On-going review of Diabetes 26 Hypertension Management in Diabetes 27 Blood Glucose Monitoring 28 Blood Glucose Strips and Meters 29 Flash Glucose Monitoring – Freestyle Libre 30 Criteria for Freestyle Libre 31 Pathway for managing requests for Freestyle Libre 32 Urine and Ketone Testing 33 Diabetic Foot Referral – Podiatry Department 34 Management of Pregnancy in Diabetes 35 Gestational Diabetes and Post Natal Care 36 Education (for patients) 37 Education (continued) 39 Preferred Read Codes to support the Diabetes Pathway 45 Exception Reporting in Diabetes 46 Formulary Blood Glucose Meters 47 Formulary Pen Needles 50 Calculation Chart for Insulin Pens Prescribing 52

Page 2 of 52

Introduction and Acknowledgements

Introduction and Acknowledgements Introduction

These guidelines are intended to assist healthcare professionals manage patients with Diabetes in Walsall. They are intended to support the local implementation of the NICE Clinical Guideline on Diabetes. They were originally produced by the Diabetes STaR Group and have been ratified by the Walsall Joint Medicines Management Committee (JMMC) and formulary management group committee.

Background

These guidelines have been produced by a multidisciplinary team of professionals with an interest in diabetes to ensure that people with diabetes receive a quality service. These guidelines are based on the most up to date national guidance and have been through the trust’s ratification process. They will be used to monitor the quality of services and delivery of national best practice standard and recommendations. The guidelines will be reviewed and updated on a bi-annual basis by the diabetes team and in the event of significant changes resulting from new research findings and new best practice guidance. Guidelines are intended to guide and inform and should not be rigorously applied in all clinical circumstances. Good clinical practice always involves weighing the advantages against the disadvantages of a clinical intervention depending on individual circumstances. Guidelines do not replace an individual healthcare professionals’ duty of care and clinical judgement. It is a tool to aid the decision making process.

Acknowledgments Many thanks to all health care professionals and patient representatives who have inputted to and commented on these guidelines.

References NICE Guidance NICE Pathways

The information contained in the formulary is based on evidence available at the time of writing; it is issued for guidance and advice only. For information on the cautions, contra-indications, side effects and doses of individual drugs, please check the current SPC or BNF section for that drug. Prescribers remain responsible for their patients’ care and prescriptions signed.

Page 3 of 52

Make the correct assessment

Introduction and Acknowledgements

Make the correct diagnosis Symptoms (thirst, polyuria, weight loss, lack of energy) + abnormal glucose OR No symptoms but two abnormal fasting or random blood glucose results on different days HbA1c >48mmol/mol -if no symptoms to repeat test in two weeks Random plasma glucose 11.1mmol/L or above Fasting plasma glucose 7.0mmol/L or above Two-hour plasma glucose 11.1mmol/L or above during an oral glucose tolerance test

Initial assessment o Inform the patient of the result as appropriate. o Provide with ‘managing my diabetes’ the Walsall diabetes information pack o Discuss initial dietary adjustments and advice on physical activity to

o include alcohol and smoking cessation if required

o Discuss patients’ thoughts and fears about having been diagnosed

o with diabetes. o Refer to DESMOND education programme: o If non English speaking, refer to Asian education support worker o check Weight, BMI, BP, HbA₁ϲ, ACR, Lipids, U&E. waist circumference

o Discuss patient’s choice of care o Discuss possibilities of commencement of Metformin 500mg bd, slow titration of

dose

Organise follow-up appointment in four to six weeks

Second Appointment o Personalised HbA1c target for each patient o Check Metformin compliance/ side effects/titrate dose

o Check on dietary change and physical activity. Make further suggestions where appropriate

o Blood glucose

o Weight and BMI o Blood pressure o Smoking, alcohol and exercise levels o Discuss risks and complications of Feet, Eye, Cardiovascular system, Kidneys

o Discuss importance of correct self-management with support of surgery

Third Appointment o Check HbA₁ϲ, if not reducing, discuss escalation of treatment by oral therapy and the

implications – explain how control deteriorates with time i.e. progression of condition necessitating changes in treatment

o Discuss results from blood test along with cardiovascular risk factors o Additional therapy options/ optimise dose of medication o Agree targets and review target HbA1c.

Agree next appointment

4-6 weeks

4-6 weeks

Targets to be reviewed every 3 to 6 months

Targets to be achieved: HbA1c <48mmol/mol. Fasting Glucose 4 – 7 mmol/L Postprandial <8 mmol/L

If targets are achieved, continue:

o Diet o Regular

exercise

o Smoking advice

o Moderate alcohol

o Education

o Monitoring

Review regularly: Quality of life Understanding of

condition Complications Blood pressure Lipids Smoking habits

Lifestyle Link Support for smoking cessation and/or support with healthy eating and increasing exercise and activity: 01922 444044

Go to next page

Page 4 of 52

Make the correct assessment

Stage 1: Identify and manage risk of type 2 diabetes Encourage and promote people to have a risk assessment for type 2 diabetes using a validated tool, e.g. QD Score: http://www.qdscore.org; Diabetes UK (Leicester Diabetes Self Assessment) http://riskscore.diabetes.org.uk/2013:

o all eligible adults aged 40 and above (except pregnant women); o people aged 25–39 of South Asian, Chinese, African-Caribbean, black African and other

high-risk black and minority ethnic groups (except pregnant women) – consider offering blood test to this group;

o adults with conditions that increase the risk of type 2 diabetes. Keep up to date record of levels of risk and introduce a recall system.

Stage 2: provide evidence based, quality-assured, lifestyle change programme Low – intermediate risk

o Offer brief advice on: o risks of developing diabetes

o benefits of a healthy lifestyle

o modifying risk factors

o Reassess risk at least every 5 years. High risk score + HbA1c < 42mmol/mol = moderate risk (Lifestyle advice + repeat HbA1c in 3 years) + HbA1c 42-47mmol/mol = confirmed high risk (prediabetes – see advice below) + HbA1c > 48mmol/mol = possible type 2 diabetes (see further slides on management) PREDIABETES

o Offer blood test for HbA1c annually

o Offer group and individual-level interventions to prevent type 2 diabetes among people at risk

o Physical activity: explore what patients already know about physical exercise. Government recommends 150 minutes moderate-intensity, or 75 minutes vigorous-intensity exercise spread across the week – including activities to increase muscle strength on 2 days per week.

o Weight management advice to adults with BMI ≥25 (≥23 for patients of South Asian or Chinese descent). Patients can access weight management services through One You Walsall (01922 444044).

o Dietary advice: explore what patients already know about the types and amounts of food and drink that can help reduce the risk of type 2 diabetes. Provide information where necessary. Help people to assess their diet and identify where and how they could make it healthier, taking into account their individual needs, preferences and circumstances.

o Drug therapy: If patient unable to participate, or if intervention unsuccessful (HbA1c rising), offer metformin

o Reassess weight and BMI and offer blood test at least once per year

o If prediabetes confirmed, GP’s to refer the patients to National Diabetes Prevention Programme.

For further information, see NICE Guidance, NICE Pathways, NICE Quality Standards

Advice may include: • Weight control • Exercise

• Diet (whole grains instead of processed carbohydrates; water, tea, coffee instead of sugary drinks; polyunsaturated fats instead of trans-fats; poultry/fish instead of red meat or processed meat

Group and individual level interventions and advice is applicable to providers of intensive lifestyle change programmes, and primary healthcare teams

Page 5 of 52

Contact Telephone Numbers for advice Walsall Manor Hospital Diabetes Team Secretary 01922 656543 Secretary to Dr Senthi Kumar 01922 656030 Secretary to Dr Mian /Abdu 01922 656982 Paediatric Diabetes Team Office 01922 656750 Paediatric Assessment Unit (PAU) 01922 656888 Community Diabetes Team 1st Floor, Bentley Medical Centre Churchill Road Walsall

01922 604970

Make Diagnosis of Suspected Type 1 Diabetes (adult)

Typical symptoms (thirst, tiredness and increased urination) and a diagnostic blood glucose (random > 11.1mmol/L or fasting >7.0mmol/L), rapid weight loss.

Is the patient ill (vomiting or semiconscious)?

Yes ADMIT

Is there moderate/heavy ketonuria? (Blood ketone

>1.5mmol/L or > ++ urine test)

Immediate Indication for insulin. Telephone contact if assistant

needed not paper referral

Provide patient with a meter that tests ketones (GlucoMen Areo 2K). Patient

to start insulin the same week. To monitor blood glucose levels and GP to prescribe testing strips and ketone

strips (required less frequently).

No

No

Yes

Page 6 of 52

Diabetes Specialist Nurses: Debbie McCausland 07776 245354 Beckie Wood 07825 725133 Paediatric Diabetes Team Office 01922 656750 Paediatric Assessment Unit 01922 656888

Diagnosis of Suspected Diabetes Mellitus in Children

Introduction and Acknowledgements

There has been a year on year increase in the incidence of diabetes mellitus in children. Currently there are approximately 23500 children with diabetes in England and Wales. Though incidence of other forms of diabetes is rising, insulin dependent diabetes (Type 1 DM) still accounts for more than 90% of diabetes in children. Type 2 diabetes remains rare with incidence of 1-2.5% . Therefore, diabetes in children needs to be assumed to be type 1 DM unless proven otherwise. Approximately 25% of newly diagnosed diabetic children have subtle symptoms and signs therefore the diagnosis is not made until they present in Diabetic Ketoacidosis (DKA). This percentage rises to 35% in children under 5 years of age . DKA in children is associated with higher morbidity and mortality. Early recognition and prompt referral to paediatric unit for insulin initiation will reduce the risk of child developing DKA.

Early diagnosis of type 1 diabetes is essential. Signs and symptoms should not be ignored or overlooked.

Signs & Symptoms of Diabetes in Children include: (These can be very subtle)

o Increased thirst o Excessive drinking of fluids o Increased frequency and amount of urine passed. o Bed wetting in a previously dry child

o Excessive tiredness

o Weight loss despite increased appetite

o Less commonly constipation and oral/vulval thrush

Diabetes UK Campaign 2013: Type 1 diabetes awareness in children

Toilet Thirsty

Tired

Thinner

Presence of any of these signs/ symptoms should warrant urgent capillary blood glucose measurement and referral made to the paediatric diabetes team to be seen that day if Random CBG >11. It is not necessary to carry out fasting blood glucose tests as this will delay diagnosis and can potentially increase the risk of the child developing DKA. If in doubt, contact the diabetes team immediately for further advice. All children with diabetes mellitus need to be looked after by a specialist paediatric diabetes team.

1. National Paediatric Diabetes Audit 2010-11, RCPCH. 2. Diabetes Care May 2006 vol. 29 no. 5 1150-1159

3. Paediatric Diabetes Best Practice Tariff, Department of Health 2012

Page 7 of 52

Pathway for Diagnosing Suspected Type 1 Diabetes in Children4

Introduction and Acknowledgements

Symptoms/Signs suggestive of Diabetes

Check Capillary Blood Glucose immediately

(Do not send for blood tests in hospital or book for Fasting Blood tests)

Consider other causes of symptoms

Random Capillary Blood Glucose > 11mmol/l

Refer to Paediatric Assessment Unit on same day by phone

(01922 656888). You may be advised to call

ambulance if DKA suspected

No Yes

Type 2 diabetes in children

Remember that type 2 diabetes may be seen especially in overweight older children, who may be very insulin resistant. Symptoms include tiredness, thirst, polyuria. They may have acanthosis nigricans, central obesity and abnormal fat distribution. If suspecting type 2 diabetes in such a child who is not acutely unwell, a capillary glucose may be followed with fasting glucose and HbA1c. Any child with HbA1c >42mmol/mol should be referred to paediatrics as they will need further investigation and management.

4 Adapted from Diabetes UK 4Ts Campaign poster, 2013

Page 8 of 52

Diagnosis of Type 2 Diabetes

Introduction and Acknowledgements

People who should be screened for diabetes include:

o Caucasians aged over 40 years o Black, Asian and Minority ethnic groups

aged over 25

o with one or more of the following: o BMI >27, waist circumference females

>80cm (31.5inch) o South Asian males >89cm (35inch), other

males >94cm (37inch) o Ischaemic heart disease o Vascular disease o Hypertension

o Glycosuria on routine screening o First degree family history of diabetes

o History gestational diabetes or Polycystic Ovary Syndrome (PCOS)

(Then annually)

Screening for diabetes

Symptoms often absent but may be

o Polydipsia

o Polyuria

o Nocturia

o Lethargy

o Weight Loss

o Pruritis Vulvae

o Balanitis

o Blurred Vision

o Recurrent sepsis

Low risk High risk

Computerised risk score (QDiabetes. Diabetes risk score)

Lifestyle advice, repeat HbA1c in 5 years

42-48 mmol/mol >48 mmol/mol

Repeat HbA1c within 2 weeks if asymptomatic.

Otherwise code for diabetes and follow type 2 diabetes

pathway.

< 42 mmol/mol

High risk (Prediabetes) (read code 14o8)

Reinforce diet and lifestyle changes. Optimise

treatment for cardiovascular risk factors,

repeat HbA1c annually. Offer metformin if HbA1c

rising. Offer Diabetes Prevention Programme.

Moderate risk: Reinforce diet and lifestyle changes, repeat HbA1c in 3 years

Page 9 of 52

Management of Type 2 Diabetes (NICE NG 28 2015)

Introduction and Acknowledgements

If the person is symptomatically hyperglycaemic, consider insulin or an SU in combination with metformin from the start. Review treatment when blood glucose control has been achieved.

Reinforce advice on diet, lifestyle and adherence to drug treatment. Agree an individualised HbA1c target 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. Where appropriate, support the person to aim for the HbA1c levels in the algorithm. Measure HbA1c levels at 3/6 monthly intervals, as appropriate. If the person achieves an HbA1c target lower than target with no hypoglycaemia, encourage them to maintain it. Be aware that there are other possible reasons for a low HbA1c level. Base choice of drug treatment on: effectiveness, safety (see MHRA guidance), tolerability, the person’s individual clinical circumstances, preferences and needs, available licensed indications or combinations, and cost (if 2 drugs in the same class are appropriate, choose the option with the lowest acquisition cost). 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 while driving or operating machinery, is pregnant or planning to become pregnant or if there is evidence of hypoglycaemic episodes.

Page 10 of 52

Management of Type 2 Diabetes (NICE NG 28 2015)

Introduction and Acknowledgements

This chart is adapted from NICE care pathway for blood-glucose-lowering therapy. NICE NG 28 2015 Caution: Insulin therapy should only be initiated in practices where the necessary skills are experienced is in place to do so effectively and safely. The use of human basal insulin or analogue basal insulin should be determined by clinical need of the patient. Basal insulin should be given approximately the same time every day. Start daily fasting (pre-breakfast) glucose monitoring (additional glucose tests only if patient feels unwell)

Pioglitazone is associated with an increased risk of heart failure, bladder cancer and bone fracture. Known risk factors for these conditions, including increased age, should be carefully evaluated before treatment: see the manufacturers’ summaries of product characteristics for details. Medicines and Healthcare products Regulatory Agency (MHRA) guidance (2011) advises that ‘prescribers should review the safety and efficacy of pioglitazone in individuals after 3–6 months of treatment to ensure that only patients who are deriving benefit continue to be treated’. MHRA guidance (2011) notes that cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for the development of cardiac failure. It advises that if the combination is used, people should be observed for signs and symptoms of heart failure, weight gain, and oedema. Pioglitazone should be discontinued if any deterioration in cardiac status occurs.

Combinations of drugs including sodium–glucose cotransporter 2 inhibitors may be appropriate for some people at first and second intensification; see NICE technology appraisal guidance 288, 315 and 336 on dapagliflozin, canagliflozin and empagliflozin respectively. All three SGLT-2 inhibitors are recommended as options in dual therapy regimens with metformin under certain conditions. All three are also recommended as options in combination with insulin. At the time of publication, only canaglifozin and empagliflozin are recommended as options in triple therapy regimens. The role of dapagliflozin in triple therapy will be reassessed by NICE in a partial update of TA288. Serious and life-threatening cases of diabetic ketoacidosis have been reported in people taking SGLT-2 inhibitors (canagliflozin, dapagliflozin or empagliflozin) or shortly after stopping the SGLT-2 inhibitor. MHRA guidance (2015) advises testing for raised ketones in people with symptoms of diabetic ketoacidosis, even if plasma glucose levels are near normal.

Only continue GLP-1 mimetic therapy if the person has a beneficial metabolic response (a reduction of HbA1c by at least 11 mmol/mol [1.0%] and a weight loss of at least 3% of initial body weight in 6 months).

Metformin - Be aware that, if metformin is contraindicated or not tolerated, repaglinide is both clinically effective and cost effective in adults with type 2 diabetes. However, discuss with any person for whom repaglinide is being considered, that there is no licensed non-metformin-based combination containing repaglinide that can be offered at first intensification. Biosimilars - The recommendations in this guideline also apply to any current and future biosimilar product(s) of insulin glargine e.g Abasaglar that have an appropriate Marketing Authorisation that allows the use of the biosimilar(s) in the same indication. A biosimilar can be used as a first line choice IN NEW PATIENTS.

Insulin-based treatment · • When starting insulin, use a structured programme and continue metformin for people without contraindications or

intolerance. Review the continued need for other blood glucose lowering therapies. • Offer NPH insulin once or twice daily according to need. · • Consider starting both NPH and short-acting insulin either separately or as pre-mixed (biphasic) human insulin

(particularly if HbA1c is 75 mmol/mol (9.0%) or higher). • Consider, as an alternative to NPH insulin, using insulin glargine or detemir if the person: needs assistance to inject

insulin, lifestyle is restricted by recurrent symptomatic hypoglycaemic episodes or would otherwise need twice-daily NPH insulin in combination with oral blood glucose lowering drugs.

• Consider pre-mixed (biphasic) preparations that include short-acting insulin analogues, rather than pre-mixed (biphasic) preparations that include short-acting human insulin preparations, if: the person prefers injecting insulin immediately before a meal, hypoglycaemia is a problem or blood glucose levels rise markedly after meals.

• Long acting insulin such as long acting glargine (Toujeo – once daily) or Degludec (Tresiba) can be considered in patients where minimum administrations are required such as housebound patients where district nurses maybe visiting

• Only offer a GLP-1 mimetic in combination with insulin with specialist care advice and ongoing support from a consultant-led multidisciplinary team.

• Monitor people on insulin for the need to change the regimen. • An SGLT-2i in combination with insulin with or without

Page 11 of 52

Oral Hypoglycaemic Drugs

Introduction and Acknowledgements

Metformin

• Start with 500mg daily (standard release) for 1-2 weeks

• Titrate every 1-2 weeks to max dose of 1.5g BD

• GI disturbance may be prevented by gradually increasing the dose over time

• Take with or immediately after a meal • Modified release (MR) metformin (Sukkarto MR) should be considered in

patients who cannot tolerate standard release. Maximum dose of MR is 2g daily, available in 1g tablets

• Metformin available in powder form for those unable to swallow large tablets

• Not associated with weight gain

CONTRAINDICATED in patients with • eGFR < 45 – consider reduction in dose if <30 then discontinue

• severe heart failure/COPD • severe liver disease (ALT > 3 x normal level) • Metformin should be stopped 48 hours before and after any radiological

procedure needing intravenous contrast

Sulphonylureas

• Gliclazide 40-80 mg OD, titrate every 4-6 weeks until max 160mg BD or Glimepiride 1mg OD titrate every 4-6 weeks until max 6mg OD (caution with elderly, renal impairment)

• Tablets should be taken before meals

• Weight gain is a recognised side effect • Educate on management of hypoglycaemia, including driving

• Educate regarding need to inform DVLA and insurance as appropriate • AVOID glibenclamide in patients over 70 years and in those with poor renal

function • Not recommended in pregnant women

Thiazolidinedione (Pioglitazone)

Current NICE recommends combination with either metformin (preferably) or sulphonylurea, however are frequently used with both when glycaemic control is not satisfactory with one agent. The use of this class of drug should be carefully considered as there is an established risk of weight gain along with heart failure and oedema. There is also a risk of fractures occurring in women. Patients should be carefully assessed for cardiovascular risk prior to its use. Avoid in patients with a risk of bladder cancer. Assess bladder cancer risks and refer to BNF.

Page 12 of 52

DPP-4

inhibitors License-Only continue DPP-inhibitor if reduction in HbA1c of at least 0.5 % in six months

Dose-over 18 years of age

Alogliptin

Vipidia™

Alogliptin is licensed for use in type 2 diabetes as dual therapy in

combination with either metformin, pioglitazone, a sulfonylurea, or insulin

(when treatment with these drugs alone fails to achieve adequate

glycaemic control); it is also licensed for use as triple therapy in

combination with metformin and either pioglitazone or insulin.

25 mg once daily

Linagliptin

Trajenta™

Linagliptin is licensed for use in type 2 diabetes as monotherapy (if

metformin inappropriate), or in combination with metformin (when

treatment with metformin alone fails to achieve adequate glycaemic

control), or both metformin and a sulfonylurea (when dual therapy with

these drugs fails to achieve adequate glycaemic control). Linagliptin may

also be used in combination with insulin (with or without metformin) when

a stable dose of insulin has not provided adequate glycaemic control.

5 mg once daily

Saxagliptin

Onglyza™ See vildagliptin section. 5 mg once daily

Sitagliptin Januvia™

Sitagliptin is licensed for use in type 2 diabetes as monotherapy (if

metformin inappropriate), or in combination with metformin or a

sulfonylurea (if metformin inappropriate), or pioglitazone (when treatment

with either metformin or a sulfonylurea or pioglitazone fails to achieve

adequate glycaemic control), and also in combination with both metformin

and a sulfonylurea (when dual therapy with these drugs fails to achieve

adequate glycaemic control). Sitagliptin is also licensed for use in

combination with both metformin and pioglitazone when dual therapy with

these drugs fails to achieve adequate glycaemic control, and may also be

used in combination with insulin (with or without metformin) when a stable

dose of insulin has not provided adequate glycaemic control.

100 mg once daily

Vildagliptin Galvus™

Saxagliptin and vildagliptin are licensed for use in type 2 diabetes as

monotherapy (if metformin inappropriate), or in combination with

metformin or a sulfonylurea (if metformin inappropriate), or pioglitazone

(when treatment with either metformin or a sulfonylurea or pioglitazone

fails to achieve adequate glycaemic control), and also in combination with

both metformin and a sulfonylurea (when dual therapy with these drugs

fails to achieve adequate glycaemic control). The combination of either

saxagliptin or vildagliptin, and insulin (with or without metformin) is also

licensed for use when a stable dose of insulin has not provided adequate

glycaemic control.

Monotherapy, 50 mg twice daily

Dual therapy in combination with metformin or pioglitazone, 50 mg twice daily

Dual therapy in combination with a sulfonylurea, 50 mg daily in the morning Triple therapy in combination with metformin and a sulfonylurea, 50 mg twice daily

In combination with insulin (with or without metformin), 50 mg twice daily

Oral Hypoglycaemic Drugs

Introduction and Acknowledgements

Page 13 of 52

Usu

al

da

ily

do

se

s o

f D

PP

-4 i

nh

ibit

ors

as

pe

r S

um

ma

rie

s o

f P

rod

uct

Ch

ara

cte

ris

tic

s (

SP

C)

Renal Impairment

Mild renal impairment

(creatinine clearance [CrCl] ≥ 50 ml/min)

Moderate renal impairment (CrCl ≥ 30 to < 50 mL/min)

Severe renal impairment (CrCl < 30 mL/min)

Alogliptin 25mg

(VipidiaTM

) No dose adjustment

is required 12.5mg ONCE daily 6.25mg ONCE daily

Linagliptin 5mg

(TrajentaTM

) No dose adjustment is required

Saxagliptin 5mg

(OnglyzaTM

) No dose adjustment

is required 2.5mg ONCE daily 2.5mg ONCE daily

Sitagliptin 100mg

(JanuviaTM

) No dose adjustment

is required 50mg ONCE daily 25mg ONCE daily

Vildagliptin 100mg

(GalvusTM

) No dose adjustment

is required 50mg ONCE daily 50mg ONCE daily

Sitagliptin & Metformin 50/1000mg

TWICE daily (Janumet™)

No dose adjustment is required (for CrCl

≥ 60 ml/min)

Not be used in patients with moderate or severe renal impairment (creatinine clearance < 60

mL/min)

Vildagliptin & Metformin

50/850mg or 50/1000mg

TWICE daily (Eucreas™)

Not be used in patients with creatinine clearance < 60 ml/min

Dose adjustments for DPP4 inhibitors

Introduction and Acknowledgements

Page 14 of 52

Oral Hypoglycaemic Drugs

Introduction and Acknowledgements

SGLT2 inhibitor (sodium-glucose co-transporter-2) This is a new class of drug which increases glucose secretion from the kidney with the potential of improving glycaemic control and possible weight reduction. Consider a lower dose of insulin or sulphonylurea when used in combination. They can be used as monotherapy or in addition to other glucose lowering drugs including insulin Drugs include:

• Dapagliflozin (Forxiga™) 10mg once daily (starting dose of 5mg recommended in

patients with severe hepatic impairment)

• Canagliflozin (Invokana™) 100 mg once daily preferably before breakfast; if necessary and if tolerated, increase to 300 mg once daily. CANVAS and CANVAS-R trials showed weight loss, improvement in cardiovascular and renal outcomes.

• Empagliflozin (Jardiance™) 10mg once daily, if necessary and if tolerated, increase to a max. of 25mg once daily (initiation not recommended over 85 years). EMPA-REG study shows weight loss and improved CV outcomes.

• Ertugliflozin (Steglatro ™) 5mg once daily, if necessary and if tolerated, increase to a max. of 15mg once daily

Approved for use with exclusion criteria as follows:

• Known renal impairment eGFR <60ml/min • This drug is not license for type 1 DM or non-diabetic but obese patient • Patient with frequent recurrent UTI • Patient on concurrent diuretics (caution) • Patient with known recurrent episodes of dehydration • Recurrent genital candida infection

UTI Prophylaxis Advice: keep private parts dry to minimise the chances of infection.

Discontinue if patient has not achieved a 0.5% (5.5mmol/mol) reduction in HbA1c at six months.

The CREDENCE randomised controlled trial was undertaken to investigate the impact of the (SGLT2) inhibitor canagliflozin on renal outcomes in patients with type 2 diabetes and chronic kidney disease. There has been a growing interest in the renal effects of this drug class, and in this study the risk of kidney failure was lower in the canagliflozin group than the placebo group. NICE has recently published guidance for the SGLT2 inhibitor ertugliflozin in combination with metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor (n.b. previous NICE guidance on ertugliflozin covered its use as monotherapy and dual therapy with metformin).

See SGLT2 inhibitors safety issues Pg. 15-16

Page 15 of 52

SGLT2 inhibitors: increased risk of lower extremity amputations

Introduction and Acknowledgements

Advice for healthcare professionals (taken from MHRA guidance and Summary of Product Characteristics (SPCs)):

• Carefully monitor patients receiving any SGLT-2 inhibitors who have risk factors for amputation (e.g. poor control of diabetes and problems with the heart and blood vessels)

• Consider stopping any SGLT-2 inhibitors if a patient develops foot complications such as infection, skin ulcers, osteomyelitis or gangrene

• Monitor all patients for signs and symptoms of water or salt loss; ensure patients stay sufficiently hydrated to prevent volume depletion and euglycaemic diabetic ketoacidosis in line with recommendations in the product information. Note that diuretics can exacerbate dehydration.

• Advise patients to 1) stay well hydrated 2) carry out routine preventive foot care 3) seek medical advice promptly if they develop skin ulceration, discolouration, or new pain or tenderness

• Start treatment for foot problems (e.g., ulceration, infection, or new pain or tenderness) as early as possible

• Continue to follow standard treatment guidelines for routine preventive foot care for people with diabetes

• Canagliflozin (two-fold increase) and ertugliflozin (1.2-1.6-fold increase) may increase risk of lower-limb amputation in type 2 diabetes patients. Evidence does not currently show an increased risk for dapagliflozin and empagliflozin (due to limited data) but the risk may be a class effect. Preventive foot care is important for all patients with diabetes.

• Report any suspected side effects with SGLT2 inhibitors or any other medicine via Yellow Card scheme

Page 16 of 52

SGLT2 inhibitors: increased risk of diabetic ketoacidosis

Advice for healthcare professionals:

When treating patients who are taking a sodium-glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, empagliflozin or ertugliflozin):

• inform them of the signs and symptoms of diabetic ketoacidosis (DKA) – see below – and advise them to seek immediate medical advice if they develop any of these

• discuss the risk factors for DKA with patients (see below)

• discontinue treatment with the SGLT2 inhibitor immediately if DKAis suspected or diagnosed

• do not restart treatment with any SGLT2 inhibitor in patients who experienced DKA during use, unless another cause for DKA was identified and resolved

• interrupt treatment with the SGLT2 inhibitor in patients who are hospitalised for major surgery or acute serious illnesses; treatment may be restarted once the patient’s condition has stabilised

• report suspected side effects to SGLT2 inhibitors or any other medicines on a Yellow Card scheme

Page 17 of 52

SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis

of the genitalia or perineum)

Advice for healthcare professionals:

There have been reports of Fournier’s gangrene in patients taking sodium-glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, empagliflozin or ertugliflozin).

• Post-marketing cases of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) have been associated with the use of sodium-glucose co-transporter 2 (SGLT2) inhibitors (canagliflozin, dapagliflozin, or empagliflozin)

• Fournier’s gangrene is a rare but serious and potentially life-threatening infection

• If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and

urgently start treatment (including antibiotics and surgical debridement as required)

• Urogenital infection or perineal abscess may precede necrotising

fasciitis

• Advise patients to seek urgent medical attention if they experience severe pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise

• Report suspected adverse drug reactions to a SGLT2 inhibitor to the

Yellow Card Scheme without delay

Page 18 of 52

Injectable Therapies – GLP-1 Analogues

GLP-1 Analogues These drugs mimic the action of incretin hormones and are resistant to the effects of DPP-4. They are given by sub-cutaneous injection once daily in the case of Liraglutide and lixisenatide and twice daily in the case of Exenatide. Exenatide prolonged release, dulaglutide and semaglutide are given as a once weekly injection. The primary action of these drugs is the reduction of HbA1c, however they have also been shown to help with weight reduction. They may cause GI side effects with nausea commonplace, this however usually improves within two weeks. Therapy should only continue if there is 11mmol/mol HbA1c reduction and body weight reduction of 3% is achieved. If there is inadequate response other GLP-1 analogues may be considered. If GLP-1 therapy with different agents are sequentially without a break is used, the HbA1c and weight taken prior to the initiation of first agent should be used as the baseline for audit purpose. Drugs include: Dulaglutide (Trulicity) - once weekly Liraglutide (Victoza) – once daily Semaglutide (Ozempic) - once weekly To be continued for existing patients only, not for initiation in new patients from March 2019: Exenatide (Byetta) – twice daily Modified release exenatide (Bydureon) - once weekly Lixisenatide (Lyxumia) – once daily Discontinue if patient has not achieved a 11mmol/mol reduction in HbA1c and 3% reduction in weight at six months.

Page 19 of 52

Injectable Therapies – Initiating Insulin

Caution: Insulin therapy should only be initiated in practices where the necessary skills

and experience is in place to do so effectively and safely.

Oral structured information on initiation

If indicated begin Human NPH insulin once or twice daily (see below)

Oral treatment options and GLP1 tried as per NICE CG87 HbA1c >7.5% (59mmol/mol)

If HbA1c >7.5% (59mmol/mol) Review the profile of random blood glucose

results

Liraglutide is licensed for use with basal insulin ONLY

• If the person needs help with injecting and LA analogues would reduce injecting to one daily or

• The person’s lifestyle is restricted by recurrent symptomatic restricted by recurrent symptomatic hypoglycaemia episodes or

• The person would otherwise need twice daily basal insulin injections plus oral glucose lowering drugs or

• The person cannot use the devises to inject NPH

If immediate injection before a meal is preferred or

• Hypoglycaemic episodes or • Blood glucose levels rise markedly

after meals

If HbA1c >9.0% (75mmol/mol)

Consider twice daily biphasic human insulin (pre mixed) particularly once daily regimen

may be an option (See below

Consider pre mixed preparations of insulin analogues (including short acting) rather than pre mixed human insulin preparations

• If a person does not reach HbA1c target because of hypoglycaemia, or

• The person has significant hypoglycaemia with NPH insulin irrespective of HbA1c, or

• The person cannot use the delivery device for NPH but could use LA insulin analogue or

• The person needs help to inject insulin and could reduce the number of injections with LA insulin analogue.

Consider switching from NPH to a long acting insulin analogue (detemir or glargine such as

Semglee) (see below)

Review use of sulphonylurea if hypoglycaemia

occurs with insulin plus sulphonylurea

Monitor those using basal insulin regimens (NPH or LA insulin analogue) for the need for

short acting insulin before meals for pre mixed insulin.

Monitor those using pre mixed insulin once or twice daily for the need for further injections of short acting insulin before meals or change of

mealtime plus basal regimen.

Offer a once daily long acting insulin analogue (detemir or glargine such as

Semglee)

Oral treatment options and GLP1 tried as per NICE CG87 HbA1c >7.5% (59mmol/mol)

Page 20 of 52

Algorithm for Insulin Dose Titration After consideration of changes in diet/activity

Fasting Blood Glucose (mmol/L) Insulin Dose Change (units)

Less than 4 Reduce insulin to previous dose

4 -6 No change

Greater than 6 Increase dose by 2 units

Titrating Basal Insulin – Basal Insulin once/twice daily

Caution: Insulin therapy should only be initiated in practices where the necessary skills and experience is in place to do

so effectively and safely. The use of human basal insulin or analogue basal insulin should be determined by clinical need of the patient.

Start daily fasting (pre-breakfast) glucose monitoring (additional glucose tests only

if patient feels unwell)

Target: Fasting glucose <6mmol/L HbA1c <58mmol/mol

Check HbA1c 3 months after stable insulin dose and 6 monthly thereafter

Note: Basal insulin should be given approximately the same time each day.

Start basal insulin 10 units daily

HbA1c above target, hypoglycaemic or other management problems

Increase dose every 4 days if indicated as per chart below

Reduce to previous dose immediately if glucose <4mmol/L on any day

Refer to specialist services

Page 21 of 52

Pre-lunch glucose

Pre-tea glucose

Dose change Pre-bed glucose

Pre-breakfast glucose

Dose change

Less than 4 Less than 4 Reduce to previous

Less than 6 Less than 4 Reduce to previous

Between 4-7 Between 4-7 No change Between 6-10 Between 4-7 No change Between 4-

7 Between 7-10

Increase by 2 units

Between 6-10 Greater than 7 Increase by 2 units

Greater than 10

Greater than 10

Greater than 10

Greater than 7

Titrating BD Insulin – biphasic pre-mixed insulin

Caution: The use of human biphasic insulin or analogue biphasic insulin should be determined by clinical need of the patient.

Check HbA1c 3 months after stable insulin dose, and 6 monthly thereafter (reduce frequency of home glucose monitoring when on stable insulin doses)

Check random blood glucose twice a day alternating between pre-breakfast/pre-evening meal and pre-lunch/pre-bedtime

Target: Pre-meal Glucose: 4-7mmol/L Bedtime glucose: 6-10mmol/L

HbA1c <58mmol/mol

Refer to specialist services

HbA1c above target, hypoglycaemic or other management problems

Adjust Insulin dose every 4 days as indicted in the table below

Start insulin 12 units before breakfast and 8 units before evening meal

Difficulty in dose titration, hypoglycaemia

HbA1c > target/other management

problems

Note: Dose Timing: Analogue Biphasic immediately or no longer than 10-15 minutes prior to food. Human Biphasic insulin 20-30 minutes prior to food. Morning Insulin affects pre-lunch and pre-tea levels

Evening Insulin affects bedtime and fasting glucose levels

Reduce Insulin to previous dose immediately if glucose less than 4 mmol/L on any day. Dose titration schedules are a guide and can be modified as necessary.

Page 22 of 52

Biosimilars

A biosimilar medicine is a biological medicine which is highly similar to another biological medicine already licensed for use. It is a biological medicine which has been shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety and efficacy. A biosimilar is made or derived from a biological source and as such are complex, with inherent variability in their structure. Biosimilar medicines are not considered generic equivalents to their originator biological medicine because the two products are similar but not identical. However, they will have met regulatory requirements in terms of comparative Abasaglar and Semglee are biosimilars that contains insulin glargine, an insulin analogue and has a prolonged duration of action. Abasaglar and Semglee should be administered once daily at any time but at the same time each day. The Abasaglar and Semglee dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, it can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to insulin glargine and are not the same as IU or the units used to express the potency of other insulin analogues. However this is a Biosimilar which means although it has the same licensed indication as for Lantus, as a biosimilar it has been agreed by the local formulary committee and the Walsall Joint Medicines Management Committee that Semglee should be initiated in new patients only or as part of medication review and optimisation in poorly controlled patients on Lantus or Levemir. Patients who are already stabilised on Lantus or Abasaglar should remain on that brand. This should be prescribed as the specific brand name and not as Insulin Glargine.

Page 23 of 52

Biosimilars

Insulin Lispro Sanofi is a biosimilar that contains insulin lispro, an insulin analogue, it has a faster onset of action (15 minutes) and shorter duration of action (2 to 5 hours). The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, it can also be given together with longer acting insulin or oral sulphonylurea medicinal products on the advice of a physician as per SPC. The potency of this medicinal product is stated in units. It is a prefilled pen available in two strengths (100 units/ml and 200 units/ml) For both, the needed dose is dialed in units. The number of units is shown in the dose window of the pen regardless of strength and no dose conversion should be done when transferring a patient to a new strength or to another insulin lispro pre-filled pen with a different dose step as per SPC. This is a Biosimilar which means although it has the same licensed indication as for Humalog, as a biosimilar it has been agreed by the local formulary committee and the Walsall Joint Medicines Management Committee that Insulin Lispro Sanofi should be initiated in new patients only or as part of medication review and optimisation in poorly controlled patients on Humalog. Patients who are already stabilised on Humalog should remain on that brand. This should be prescribed as brand insulin lispro sanofi and not as insulin lispro.

Page 24 of 52

Degludec

Insulin degludec is ultra-long acting basal insulin with a half-life of 25 hours. It is administered once daily but the long duration of action gives some flexibility in administering the insulin at different times of the day provided there is minimum interval of 8 hours and a maximum of 40 hours between injections. It is available in two strengths (100 IU/mL and 200 IU/mL) in pre-filled pens. Patients with the below mentioned clinical indications may be considered for insulin degludec in Walsall. Initiation is currently restricted to secondary care diabetes team.

• Pre-insulin pump patients

• Type 1 diabetes patients with unpredictable fluctuations in blood sugar/ severe recurrent hypoglycaemia despite receiving appropriate education in self-management (DAFNE or other courses) on a basal bolus regime with other analogue long acting insulins

• Recurrent DKA admissions on other insulin regime

• Patients on long acting analogue insulin with nocturnal hypoglycaemic episodes (type 1 or type 2 patients)

• Patients unable to achieve personalised glycaemic target due to varying work pattern and consequent non concordance with long acting insulin

• Insulin degludec/liraglutide (Xultophy) IDegLira is a combination treatment GLP-1 and long acting insulin that maybe suitable for certain patients and should be closely monitored

Page 25 of 52

Toujeo

Toujeo is a form of insulin glargine available at a 300 units per ml strength pre-filled pen. It is a basal insulin administered once daily at any time of the day (preferably the same time every day) with a half-life of 18-19 hours. When needed, patients can administer Toujeo up to 3 hours before or after their usual time of administration. Patients with the below mentioned clinical indications may be considered for Toujeo in Walsall. Initiation is currently restricted to secondary care diabetes team.

• Pre-insulin pump patients

• Type 1 diabetes patients with unpredictable fluctuations in blood sugar/ severe recurrent hypoglycaemia despite receiving appropriate education in self-management (DAFNE or other courses) on a basal bolus regime with other analogue long acting insulins.

• Recurrent DKA admissions on other insulin regime

• Patients on long acting analogue insulin with nocturnal hypoglycaemic episodes (type 1 or type 2 patients)

• Patients unable to achieve personalised glycaemic target due to varying work pattern and consequent non concordance with long acting insulin

Page 26 of 52

On-going review of Diabetes

On-going review is an essentially part of the planned management of people with diabetes. The following should be covered during the annual review

• Weight/BMI, BP

• Patients monitoring records

• Symptoms of hyperglycaemia • Episodes of hypoglycaemia • Problems with medication • Injection sites for lipohypertrophy • Problems with eyesight,

paraesthesia, erectile dysfunction

• Macro-vascular disease – angina, TIA, claudication

• Bloods for: • HbA1c • Creatinine • Lipids (see page 5) • (Target total cholesterol

<4mmol/L, LDL <2.0mmol/L. For more details see NICE guideline CG181

• Urine for: Albumin Creatinine ratio

Renal (Creatinine, eGFR) Blood pressure Microalbuminuria

Vascular • Discuss smoking

cessation

• Diet review • Advise on exercise • Lipids • BP • ED

Retinopathy

Retinal screening programme using digital photography Screening not required if attending hospital Ophthalmology services

Foot care • Deformity/callus

• Check dorsalis pedis and posterior tibial foot pulses

• Vibration perception 10g monofilament (if available)

• Active foot ulcers (refer)

Plans should be made in conjunction with the patient, and recorded in the patients notes for: Hyperglycaemia, hypertension, hyperlipidaemia

Consider NICE guidelines for further information: NICE Guideline CG181, NICE Guideline CG182, NICE

Guideline NG28.

Page 27 of 52

Hypertension Management in Diabetes

Lowering of BP in Type 2 diabetes is associated not just with a reduction in the risk of CVD but also eye and

kidney microvascular complications. A BP-lowering strategy is thus particularly effective and cost effective in those with diabetes kidney, eye, or cerebrovascular damage, with interventional thresholds and targets of 130/80mm/Hg in those people and 140/80mm/Hg in all others. Strategy should include lifestyle advice, medications if lifestyle advice does not achieve targets, and monitoring every one to two months with intensification of medication of not to target.

BP > 130/80 (for diagnosis refer to NICE Guideline CG127)

ACEI (A2RB if genuine intolerance to ACEI) or CCB (as per formulary)

Uncontrolled (BP>130/80, sustained over at least 3 readings) ACE (A2RB) plus CCB

(as per formulary)

Uncontrolled (BP>130/80, sustained over at least 3 readings) Check compliance

Add indapamide 2.5mg daily

Uncontrolled (BP>130/80, sustained over at least 3 readings) ACE (A2RB) plus CCB

(as per formulary)

(if signs and symptoms of CKD, refer to NICE Guideline CG182)

Page 28 of 52

Blood Glucose Monitoring

Who should test?

The following is general guidance on the frequency of blood glucose testing in diabetics. This should be discussed with the patient and the frequency of testing agreed with the patient, taking into account his/her circumstances at the time and guidance from the DVLA.

Diet controlled Type 2 Diabetes, controlled with diet alone if patient is stable, probably does not need to monitor blood glucose at home. Recommend 3-4 monthly HbA1c.

Oral medication

Type 2 Diabetes, on diet plus oral hypoglycaemic treatment. If the patient is stable, there is little evidence to support routine home blood glucose testing in patients who are not on insulin treatment. It is acknowledged, however, that home blood glucose monitoring may be appropriate for patients on diet/oral hypoglycaemics in certain clinical circumstances, for example:

• To aid education in newly diagnosed patients or patients with poor glycaemic control • In patients suspected of experiencing hypoglycaemic episodes on

sulphonylurea/metformin • In patients already established on a regime of home blood glucose monitoring which is

significantly contributing to glycaemic control • During ante-natal assessment.

In these circumstances the aims of home blood glucose testing should be discussed with the patient. Frequency of testing will be determined by clinical circumstances.

Insulin

Blood glucose monitoring is important in patients treated with insulin to ensure that the dose of insulin is appropriate. One or two multipoint profiles per week are the minimum accepted frequency, for example, before breakfast, 1-2 hours after breakfast, before evening meal and after evening meal. Where patients adjust the dose of insulin according to their blood glucose level then this should be taken prior to insulin injection. The exact frequency of monitoring for these patients should be appropriate to the lifestyle of the patient. Blood glucose testing may need to increase where there are significant changes in lifestyle or the patient is unwell. Other situations where more frequent blood glucose testing may be appropriate include:

• Suspected hypoglycaemic episodes, to assist patients to achieve better control, • until good control is achieved • HbA1c high: symptoms of hyperglycaemia, until good control is achieved • Short-term need to monitor blood glucose more frequently. e.g. during inter-current

illness; diabetes in pregnancy. • Recent change in treatment, until patient is stabilised

Page 29 of 52

Blood Glucose Strips and Meters

A wide choice of meters is available on the Walsall local formulary. Patients should be guided to choose a meter that they are able to use. They should then use the testing strips appropriate to that machine. It is useful for practices to keep a note of the blood glucose meter that patients use and ensure that patients keep this information updated. It is essential that patients are taught clearly how to take their blood glucose level using the meter and test strip that they have chosen. 50% of self-monitored blood glucose measurements are inaccurate, usually due to operator error, for example forgetting to wash hands. Patients should be advised on how to perform quality control tests. Patients should understand clearly why they are testing their blood glucose. It should not be considered a stand-alone activity. Patients with diabetes should be recommended to record their blood glucose results (with date and time) along with any symptoms of diabetic problems to provide a cumulative record. Along with HbA1c

this can then form the basis of treatment modifications at diabetic reviews. Patients receiving meters should be encouraged to see the practice nurse for guidance on blood testing. Local community pharmacists should also be advised to signpost such patients to their practice nurse.

Advice on repeat prescriptions of blood glucose monitoring strips

There is significant wastage of blood glucose monitoring strips through over prescribing, over-ordering by patients and unnecessary blood glucose testing. There are a number of ways to reduce unnecessary prescriptions:

• Only prescribe blood glucose testing strips on acute prescriptions thereby making it easier to monitor and control the supply of blood testing strips in line with patient needs

• Ask your patient to bring the meter so you can check the results and use of the meter/strips. Include the normal directions for use on the prescription, enabling better compliance checks to be made by practice staff

• Review use of lancets and aligning the quantity prescribed with that of testing strips

Note: It may also be useful including in any diabetic review the question “how often do you test?”

Page 30 of 52

Flash Glucose Monitoring

Freestyle Libre (initiated by secondary care)

Following formulary application and ratification from the Joint Medicines Management Committee (JMMC) in April 2019 flash glucose monitoring – Freestyle Libre will be available for certain patients who meet the attached NHSE criteria. Please note any patients who are initiated on the Freestyle Libre device should be done so by the diabetes specialist nurse or consultant. Further on-going prescriptions will be continued in primary care following specialist initiation. Any patient who requests this in primary care should be directed to the specialist in the first instance. If suitable for initiation by the specialist, the specialist will be responsible for:

• training the patient how to use the device • completion of an online Blueteq form which allows the CCG to monitor the

number of initiations per month and appropriate continuations • reviewing the patient at 3 months and 6 months to ensure this continues

to be suitable for the patient • providing the first sensor at the training (which lasts for 2 weeks) • following initiation and training, communication via a letter to the GP

practice to instruct that the patient meets the NHSE criteria and that the GP practice can continue to prescribe the Freestyle Libre sensors

The patient will be required to ensure they use the device appropriately and attend the reviews as set out by the diabetes specialist nurse or consultant This is not a device that is suitable for all patients with diabetes and if you have any queries contact the local diabetes specialist team or the medicines management team.

See the criteria and flowchart for further information.

Page 31 of 52

1. People with Type 1 diabetes OR with any form of diabetes on haemodialysis and on insulin treatment

who, in either of the above, are clinically indicated as requiring intensive monitoring >8 times daily, as demonstrated on a meter download/review over the past 3 months OR with diabetes associated with cystic fibrosis on insulin treatment

2. Pregnant women with Type 1 Diabetes - 12 months in total inclusive of post-delivery period. 3. People with Type 1 diabetes unable to routinely self-monitor blood glucose due to disability who require carers to support glucose monitoring and insulin management. 4. People with Type 1 diabetes for whom the specialist diabetes MDT determines have occupational (e.g. working in insufficiently hygienic conditions to safely facilitate fingerprick testing) or psychosocial circumstances that warrant a 6-month trial of Libre with appropriate adjunct support.

5. Previous self-funders of Flash Glucose Monitors with Type 1 diabetes where those with clinical responsibility for their diabetes care are satisfied that their clinical history suggests that they would have satisfied one or more of these criteria prior to them commencing use of Flash Glucose Monitoring had these criteria been in place prior to April 2019 AND has shown improvement in HbA1c since self-funding.

6. For those with Type 1 diabetes and recurrent severe hypoglycemia or impaired awareness of hypoglycemia, NICE suggests that Continuous Glucose Monitoring with an alarm is the standard. Other evidence-based alternatives with NICE guidance or NICE TA support are pump therapy, psychological support, structured education, islet transplantation and whole pancreas transplantation. However, if the person with diabetes and their clinician consider that a Flash Glucose Monitoring system would be more appropriate for the individual’s specific situation, then this can be considered.

Other requirements: 1. Education on Flash Glucose Monitoring has been provided (online or in person) 2. Agree to scan glucose levels no less than 8 times per day and use the sensor >70% of the time. 3. Agree to regular reviews with the local clinical team. 4. Previous attendance, or due consideration given to future attendance, at a Type 1 diabetes structured education programme (DAFNE or equivalent if available locally)

Note: Continuing prescription for long-term use of Flash Glucose Monitoring-post initial 6 months- would be contingent upon evidence of agreeing with the above conditions and that on-going use of the Flash Glucose Monitoring is demonstrably improving an individual’s diabetes self-management - for example improvement of HbA1c or Time In Range; improvement in symptoms such as DKA or hypoglycaemia; or improvement in psycho-social wellbeing.

Criteria for Freestyle Libre

Page 32 of 52

Managing Requests for Freestyle Libre

Page 33 of 52

Urine and Ketone Testing

Urine testing Urine testing for glucose is not recommended for routine monitoring of glycaemic control.

Ketones testing

Blood or urine testing for ketones is useful in detecting early onset Diabetic Ketoacidosis in Type 1 diabetes. We recommend all patients with Type 1 diabetes have the facility to test for ketones (either blood or urine test) during times of illness or when a rise in ketone levels is suspected. Walsall Healthcare NHS Trust recommends the use of GlucoMen Areo 2K for all healthcare personnel. A record of quality control results should be maintained, including time, date and results for Q/C test on meter in use in accordance with blood glucose monitoring (insulin administration and usage policy). The record should be available for audit.

Page 34 of 52

Diabetic Foot Referral – Podiatry Department

Chronic

Acute

Following annual foot check: Absent pulse, Neuropathy or general foot problem

FOOT ULCER Non-healing ulcer: i.e. shown no Sign of major improvements within 4 weeks

Red or swollen area on foot, any new ulcer or impending ulceration’

Charcot Joint Alert Hot swollen, neuropathic, diabetic foot – no signs of infections – Suspect Charcot Arthropathy

To be referred to the Multidisciplinary Foot Clinic

01922 721172

Ext: 6543

E-mail: diabetesfeet.walsall@nhs.net (your email will be triaged to the relevant service within 24 hours)

Accident and Emergency

E-mail: diabetesfeet.walsall@nhs.net (your email will be triaged to the relevant service within 24 hours) MAU Diabetic Foot DVT team ensure vascular assessment within 24 hours and refer to vascular team, Manor Hospital if appropriate. Telephone: 721172 ext 7763

All Patients Designated as High Risk: On-going review by advanced diabetes podiatry service Follow up by diabetes team centre if appropriate, including long-term risk factors, e.g. smoking, lipids

Information given about future foot care, how to access services in an emergency, and how to contact DNS

Once healed refer to orthotics for footwear

Severe Infection In non-healing ulcer, spreading cellulitis

Acute/Critical Ischaemia

Features include the following: Discolouration of toes; pale, dusky, black, Signs of necrosis: Pain at rest, often at night Cold, Diminished/absent pulses. If in doubt, refer for admission, assessment or urgent vascular appointment.

Severe Infection abscess or pus

The Main Podiatry department is based at: Bentley Medical Centre, Churchill Road, Walsall WS2 0BA Email: diabetesfeet.walsall@nhs.net (your email will be triaged to the relevant service within 24 hours) Contact number: 01922 423525 Diabetes Department: 01922 656543 Diabetes Podiatry Mobile: 07990 798512

Diabetic foot infections are complicated, symptoms may be masked and require specialist input as soon as possible. Please prescribe as below and refer on immediately. Please swab for later follow up. Recommended antibiotics

1st

line

Flucloxacillin 500mg QDS or Clarithromycin 500mg BD (If penicillin allergy) Add

Metronidazole (presence of anaerobes) 400mg TDS or Co-amoxiclav 625mg TDS (caution regarding C.Difficile) is good for mixed infection or osteomyelitis

For treatment of painful diabetic neuropathy see NICE clinical guideline 96 (neuropathic pain in March 2010)

Page 35 of 52

Management of Pregnancy in Diabetes

Pre-pregnancy

All women (of child bearing age) should receive pregnancy advice at each visit (this should be documented in case notes) highlighting:

1. The benefits of pre conception glycaemic control 2. The importance of planning pregnancy and avoiding unplanned conception

3. Contraceptive advice

If planning a pregnancy: Ensure good glycaemic control (HbA₁ϲ <6.5% (48mmol/mol), ideally HbA₁ϲ <43mmol/mol (if it is safe) before stopping contraception. If HbA₁ϲ is >10 (86mmol/L) advise to avoid pregnancy.

a) Advice regarding hypoglycaemia and hypoglycaemia awareness

b) Encourage diet and exercise and weight management (to BMI <27kg) c) Start Folic Acid 5mg od d) Review on-going medications (stop ACE, ARBs, consider alternative for

blood pressure,e.g. Labetalol, Methyldopa, Nifedipine, stop statins, patient to be switched to insulin and metformin based treatment only well before conception)

e) Make sure screening for complications is up to date: - • Retinal photos (do not offer rapid optimisation of glycaemic

control until after retinal assessment and treatments are completed).

• Urine ACR, U&E (refer if ACR is positive or serum creatinine is >120 or GFR <45)

f) Refer to specialist diabetes service if required g) Refer to combined diabetes antenatal clinic immediately after pregnancy

is confirmed

Safety of Medications before and During Pregnancy • Stop ALL oral diabetic agents before conception, except Metformin and start

insulin to bring HbA1c down to 48 mmol/mol. Longer acting drugs like Bydureon need to be stopped 3 months prior to conception.

• Stop ACE and ARBs IMMEDIATELY and consider alternative anti-hypertensive e.g. Methyldopa or Labetalol

• Stop STATINS

• Refer to combined diabetes antenatal clinic

Page 36 of 52

Gestational Diabetes and Post Natal Care

Gestational Diabetes (In liaison with Community Midwifes) 1. Risk factor for gestational diabetes:

• BMI >30 • Previous macrosomic baby 4.5kgs or more

• Previous gestational diabetes • Family origin with high prevalence of diabetes – South Asians, Black Caribbean,

Middle Eastern 2. If any of the above risk factors (except c – see point 3 below) perform oral glucose

tolerance test (OGTT) at 24 - 28 weeks’ gestation. This will be done by maternity services.

3. If previous gestational diabetes: Either:

a) Early BG monitoring starting at 16-18 weeks (refer to combined antenatal clinic) or

b) Organised glucose tolerance test at 16-18 weeks, if OGTT negative repeat at 24-28 weeks

c) Information and advice before screening. Advise that: • There is a small risk of birth complications if gestational diabetes is

not controlled

• Gestational diabetes will respond to diet and exercise in most women • Oral hypoglycaemic agents or insulin injections may be needed if diet

and exercise do not control blood glucose levels • Extra monitoring and care may be needed during pregnancy and

labour 4. Refer to combined antenatal diabetic clinic if screening positive

Post Natal Care

1. Women with diabetes who are breast feeding to continue to avoid drugs that were discontinued for safety reasons during or pre-pregnancy

2. Risk of hypoglycaemia, especially while breast feeding (to have food available before and during breast feeding)

3. Metformin and Glibenclamide can be taken during breast feeding BUT NOT any other oral hypoglycaemic agent (see NICE Guidelines)

4. Women with gestational diabetes:

a) Advise on risk gestational diabetes (35-50% risk of developing Type 2 Diabetes) b) Increased risk of gestational diabetes in further pregnancy

c) Importance of weight control, diet, exercise and healthy life d) Annual HbA₁ϲ for follow up in the long term

Page 37 of 52

Education (for patients)

Diabetes & Me (accredited by the University of Wolverhampton) – locally run diabetes education programme for Type 2 Diabetes patients. All patients newly diagnosed with Type 2 diabetes within one year of diagnosis should be offered the opportunity to attend the education programme.

A referral form should be fully completed and sent to diabetes.andme@nhs.net (this inbox is monitored daily, normally referrals processed in 1-2 days). Patients are sent invitations based on which venue is more suitable (distance) and has availability. The session runs for 5 hours from 10:00-15:00. This must be completed in one full day session. For more information contact Community Diabetes team on 01922 604970.

Members of staff can communicate in South Asian languages (including Punjabi, Hindi and Urdu) and can offer education sessions in these languages to patients. These sessions run on a Wednesday morning (alternating between male/female weeks) from the Aaina Community Hub in Caldmore.

DAFNE (Dose Adjustment For Normal Eating) Type 1 Diabetes patients should receive more information and education on management during their regular diabetes review appointments, however if need be they can also be referred to specialists for further advice and support. DAFNE (Dose Adjustment For Normal Eating) is a nationally accredited formal education programme for people with Type1 Diabetes. This is a five day course run by specially trained diabetes nurses, dieticians and Consultants. The patient will need to be referred to a DAFNE centre to gain access to the course, currently in the West Midlands this is:

Birmingham Community Healthcare NHS Trust Finch Road Primary Care Centre

City Hospital Fernbank Medical Centre

PAK Surgery

Sandwell and West Birmingham NHS Trust Sandwell General Hospital

University Hospital Birmingham NHS Foundation Trust Queen Elizabeth Hospital Worcestershire NHS: Worcestershire Royal Hospital Diabetes Centre, Smallwood House, Redditch *please check the DAFNE website for current list of centres before referring

Page 38 of 52

Education (for patients)

Living Well Taking Control – (National Diabetes Prevention Programme) Living Well Taking Control has been commissioned to deliver the Healthier You: NHS Diabetes Prevention Programme in Walsall.

If you are over 18 years old and have had a blood test within the last 12 months which indicates you are at a high risk of developing Type 2 diabetes (the most recent blood test will be used) then your GP may refer you to the programme.

GPs can refer by using the Healthier You Diabetes Prevention Programme template found on their GP system. This is a branded template for Living Well Taking Control which gets sent to the secure nhs.net inbox for the programme (scwcsu.lwtc@nhs.net).

The patients will be invited to an individual meeting with a Facilitator where they will take a few measurements and assess whether they’re eligible to join the programme. There are 13 x 1 hour or 1½ hour sessions made up of over 12 months. All sessions are group-based in an informal setting and are led by a trained Facilitator. Between sessions patients will be able to put into practice what they learn and also stay in contact with members of the group if they wish.

In the first 7 weeks, variety of topics discussed including healthy eating, physical activity and positive mental health and information to help set personal goals to make simple, but important, changes to their lifestyle. The following 6 sessions they will receive more support and you can learn more and review progress. These sessions last for about an hour.

GP practices are currently working to identify eligible patients through the NHS Health Checks programme or through reviewing patients on the register.

If you have any queries about the NHS Diabetes Prevention Programme delivered by Living Well Taking Control you can call the team on 0330 2233 706.

Page 39 of 52

Education (continued)

Discussion on the following topics should include:

What is Diabetes?

How blood glucose is controlled before diabetes. What happens to blood glucose control in diabetes, types of diabetes, contributing factors, causes and signs of diabetes/ hyperglycaemia, outline of treatment of diabetes, and progressive nature of diabetes. Lifestyle Issues Significance & implications of a diagnosis of diabetes re: travel, sex, smoking, driving. Diet Diet principles/healthy eating and drinking

Assess current diet including cultural/religious needs e.g. fasting

Changes in diet, meal planning and cooking needed to follow healthy eating principles

Effect of alcohol Effects of diet on weight and weight on blood glucose control Benefits of strategies for weight management if required

Activity and Exercise

Effect of physical activity on blood glucose levels, blood pressure and weight Importance of physical activity

Need to consider pre-existing health problems before embarking on increased activity

Risk of hypoglycaemia/preventing/treating hypoglycaemia Inform of support available/contact numbers for One You Walsall, for all activity services Education for South Asian patients Education sessions are available to non-English speaking patients in Hindi and Urdu They are carried out by the Diabetes Educator and include ‘What is Diabetes, Diet, and Activity and Lifestyle’. They are held weekly and referrals can be made to the Diabetes Educator, Community Diabetes Team, Bentley Medical Centre, Churchill Road, Walsall. Fax number: 01922 604975.

Page 40 of 52

Education (continued)

Driving DVLA Insurance If on insulin treatment, need to inform the DVLA and insurance company. Discuss the importance of avoiding hypoglycaemia whilst driving, implications of diabetes regarding vocational licenses and the requirements concerning blood glucose monitoring in relation to driving. For full guidance on driving and diabetes see DVLA guide at www.dvla.org.uk

Smoking

• Effects of smoking • Benefits of stopping • Advise on support available at “One You Walsall ” on 01922 444044

• Record patients interest in stop smoking Pregnancy/Gestational Diabetes Remember to refer to the Diabetes Nurse Specialist when considering pregnancy, discuss:

• Use of contraception until glycaemic control targets achieved (HbA1c 48mmol/mol) • Preconception advice: the importance of good control at the time of conception as

well as during pregnancy

• Pregnancy: support and examinations to expect, dietary and treatment modifications

• Relationship between blood glucose and pregnancy outcomes • Risk of maternal and foetal complications • For gestational diabetes: diet advice, discuss insulin treatment if applicable, and

reducing the risk of developing diabetes after pregnancy

Insulin and injection technique • Discuss insulin regimens and types of insulin • Injection sites and technique • Duration of action of prescribed insulin, and timing of injections • Storage of insulin • Disposal of sharps • Insulin dose adjustment • Relationship between diet, exercise and insulin • How to manage changes from usual routine

Medicines Name, dose, timing, side effects of prescribed medicine

How the prescribed medication works Relationship between diet, activity and medication How to manage changes in usual routine e.g. fasting

Page 41 of 52

Low blood glucose (Hypoglycaemia)

• Causes, signs and symptoms (how I will feel, how will I appear to others) • Treatment • Prevention

• Reducing the risk, planning for extra activity, including sex

• Implications for driving, working at heights

• When to seek advice

• Indications for changing treatment • Need to carry identification/insulin passport and source of glucose

High blood glucose (Hyperglycaemia)

• Causes • Signs and symptoms (what you may notice) • Action to take • Indications for changing treatment • When to seek advice

Illness

• Effect of illness on diabetes • Continuing medication

• Increasing monitoring – indications for increasing treatment • Increasing fluids

• Food replacement • Signs, symptoms and action to take re: Hyperglycaemia Hyperosmolar state (HHS)

and ketones

• When to seek advice • Immunisations, (flu, pneumonia), to reduce risk of illness

Education (continued)

Page 42 of 52

Education (continued)

Foot care • Factors that increase the risk of foot problems in diabetes • Importance of daily foot examinations to detect problems promptly • Importance of daily foot care routine to promote the integrity of the skin • Signs/symptoms indicting the need for prompt medical assessment • Importance of foot assessment as part of annual review • Ensure only consult health professional council registered podiatrists • Inform when/how to access podiatry

Eye checks

• Outline reasons for eye screening • What retinal screening includes • Inform how to access retinal screening programme

• Inform that annual eye test is free of charge

Diabetes UK Inform the patient of this charity for people with diabetes

Prescription Exemption Certificate Ensure aware of entitlement to free prescriptions for prescribed oral diabetes

medication and insulin Inform how to obtain exemption certificate

Monitoring glucose level Significance of glucose control Targets for glucose control How/when to monitor (home testing and clinic tests) Technique for home monitoring method selected Significance of the results When action on results is required Annual Review Outline chronic complications macrovascular, microvascular and neuropathic

Explain the place of on-going review to screen for/detect complications and monitor the effect of: - current treatment - risk factors associated with chronic complications e.g. hypertension, hyperglycaemia, smoking, inactivity, BMI 26 and above

- importance of regular review and what this should include - targets for glucose, lipid and blood pressure control

Page 43 of 52

Education (continued)

Pump Therapy

Insulin pumps are available to a small select group of patients with Type 1 diabetes in Walsall who should meet the following criteria:

• All adults should fulfil the criteria in the NICE guidelines

• They are using a MDI with an analogue basal insulin

• They continue to have poor control despite the above

• They are motivated, as demonstrated by regular contact with the diabetes team. • Diligent hospital attendance

• They are doing a minimum of four blood glucose tests per day

• They can demonstrate good dietary knowledge, e.g. carbohydrate value

• They have a good understanding of the physiology of diabetes

• The adult wishes to improve their control not just their carers

• They and their carer’s are prepared to undertake and complete the training programme

• They agree to comply with instruction and direction after pump therapy has started. Pump therapy is not suitable for all people and the decision to initiate pump therapy remains the prerogative of the diabetes team.

• The pump remains the property of Walsall Healthcare NHS Trust • They agree to ensure the pump is insured as part of their household contents

and provide evidence of this to the diabetes team. • They keep the pump safe and use it appropriately

• They are responsible for the safe keeping of the pump, and if it is lost, stolen, or broken they are responsible for its replacement or reimbursement to Walsall Healthcare NHS Trust

• Walsall Healthcare NHS Trust will not provide a second pump

• If the pump is not being used or control and/or quality of life does not improve the pump will be returned to Walsall Healthcare NHS Trust

Contraindications 1. Those patients who are not motivated 2. Those who do not perform a minimum of four times daily blood glucose tests

3. Those who cannot achieve the competencies required

Caution Those who have proliferative or pre-proliferative retinopathy rapid improvement in control with pump therapy may make this worse Relative contraindications Severe or end stage diabetes Blindness Lack of support from friends and or family

Page 44 of 52

Units for HbA1c

Conversion chart for HbA1c from Diabetes Control and Complications Trial (DCCT) to international Federation of clinical chemistry (IFCC)

Or you can use the following equation: IFCC-HbA1c (mmol/L) = [DCCT-HbA₁ϲ (%) -2.15] x 10.929

Page 45 of 52

Preferred READ codes to support the diabetes pathway

Please note this is not an exhaustive list, but highlights some of the relevant preferred codes to support the diabetes pathway. At risk of diabetes

At risk of diabetes 14o8

(Impaired glucose tolerance) C11y2

(Impaired fasting glycaemia) C11y3

Personal history of gestational diabetes ZV13F

Pre-conception advice 67IJ Pre-conception advice declined 67IJ2

Diagnostic codes

Type 1 diabetes mellitus C10E

Type 2 diabetes mellitus C10F

Gestational diabetes L1809

Review codes

Diabetic annual review 66AS

Gestational diabetes annual review 66Ay

Micro albuminuria/proteinuria

Type 1 diabetes with persistent micro albuminuria C10EL

Type 1 diabetes with persistent proteinuria C10EK

Type 2 diabetes with persistent micro albuminuria C10FM

Type 2 diabetes with persistent proteinuria C10FL

Investigation codes

Urinary micro albumin (ACR) 46TC

HbA1c (IFCC aligned) 42W5

Education programme codes

Patient offered diabetes structured education 679R

Referral to structured education programme for diabetes 8Hj0

Attended structured education programme for diabetes 9OLB

Preferred Read Codes to support the Diabetes Pathway

Page 46 of 52

Exception reporting in diabetes

Exception reporting codes are usually best found through the EMIS web diabetes templates or clinical prompts. Exception reporting criteria Patients may be excepted if they meet the following criteria for exception reporting: A. Patients who have been recorded as refusing to attend review who have been invited on at least three occasions during the financial year to which the achievement payments relate (except in the case of indicator CS002, where the patient should have been invited on at least three occasions during the period of time specified in the indicator during which achievement is to be measured (e.g. the preceding five years ending on 31 March in the financial year to which achievement payments relate). B. Patients for whom it is not appropriate to review the chronic disease parameters due to particular circumstances, for example, a patient who has a terminal illness or is extremely frail. C. Patients newly diagnosed or who have recently registered with the contractor who should have measurements made within three months and delivery of clinical standards within nine months e.g. blood pressure or cholesterol measurements within target levels.

D. Patients who are on maximum tolerated doses of medication whose levels remain sub-optimal.

E. Patients for whom prescribing a medication is not clinically appropriate e.g. those who have an allergy, contra-indication or have experienced an adverse reaction.

F. Where a patient has not tolerated medication.

G. Where a patient does not agree to investigation or treatment (informed dissent) and this has been recorded in their patient record following a discussion with the patient.

H. Where the patient has a supervening condition which makes treatment of their condition inappropriate e.g. cholesterol reduction where the patient has liver disease.

I. Where an investigative service or secondary care service is unavailable

Exception Reporting in Diabetes

Page 47 of 52

Blood Glucose Meters - Formulary

Blood Glucose Meters - Formulary

Page 48 of 52

Page 49 of 52

Page 50 of 52

Pen Needles - Formulary

Page 51 of 52

Page 52 of 52

Calculation Chart for Insulin Pens Prescribing