SheffieldDiabetesResourcePack

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Clinical Guidelines Audit Tool

Please give status of Guidelines: Revision

This resource pack was originally developed by the Sheffield DiabetesNetwork. The current version has been updated by a sub-group of theDiabetes Planning and Commissioning Group to take account of new drugsand new NICE guidance

1. Details of Guideline1.1 Title of Guideline: Diabetes: A Guide and Resource

Pack For Sheffield

1.2 Sponsor (Member of ET): Jeremy Wight

1.3 Author: Jenny Stephenson1.4 Lead Governance Sub Committee Diabetes Planning & Commissioning

Group1.5 Reason for Guideline: Update of previous version dated

Jan 2008. New NICE guidance1.5 Who does the Guideline affect? Patients with diabetes, staff caring

for patients with diabetes eg GPsand practice nurses

1.6 Are the National Guidelines/Codes ofPractices etc issued?

Yes

1.7 Has an Equality Impact Assessmentbeen carried out?

Yes

2. Information Collation2.1 Where was guidelines information

obtained from?NICE, supported by the specialistteam

3. Guideline Management3.1 Is there a requirement for a new or

revised management structure for theimplementation of the guidelines?

No

3.2 If YES attach a copy to this form.

3.3 If NO explain why. Quick update to bring in line withNICE

4.Consultation Process

4.1 Was there external/internalconsultation?

Internal through Diabetes P&CGPatients on Diabetes P&CGExternal with specialist teams

4.2 List groups/persons involved Diabetes P&CGGPs - Jenny Stephenson, CharlesHeatley, Jonathan RoddickSpecialist team: Nuala Creagh,Adrian Scott and others


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4.3 Have external/internal comments beenincluded?

Yes

4.4 If external/internal comments have notbeen included, state why

5. Implementation

5.1 How and to whom will the guidelines bedistributed?

NHS Sheffield intranet,Lunchtime training sessionsarranged for the diabetes LIS

5.2 If there are implementationrequirements such as training pleasedetail.

Will be undertaken as part of the LISDiabetes launch from September2009

5.3 What is the cost of implementation andhow will this be funded

None

6. Monitoring6.1 List the Key Performance Indicators % Patients with HbA1c controlled

Number of practices undertaking areview of their diabetes registerNumber of practices with an actionplan% patients transferred from hospitalcare stable 3 months after transfer

6.2 How will this be monitored QOF, National Diabetes AuditRecommending use of DiabetesEtool.

6.3 Frequency of Monitoring Annual

For use only where the Guidelines are for review:

7. Clinical Guideline Review7.1 Clinical Guideline Name Diabetes: A Guide and

Resource Pack ForSheffield

7.2 Revision No: ie, 1, 2 etc 3.07.3 Are any changes required of the Guidelines? New evidence

incorporated7.4 If YES, please state by whom, why and which sections

of the Guidelines have been revised.(If insufficient space, please continue on separatesheet and attach)

Review and quickupdate of all sectionsinformation that is nolonger up to date orcorrect was removedand replaced

7.5 Review of Clinical Guidelines undertaken by: Diabetes P&CG

7.6 Date of next review Sept 2011

7.7 Implementation/Monitoring Arrangements Diabetes P&CG


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Date Clinical Guideline was ratified by the Appropriate Sub-Committee:Ratified by Diabetes P&CG on 22 July 2009Signature of Sub-Committee Chair:M I AzizDate Clinical Guideline was adopted by the PCT at a PCT Board Meeting


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Diabetes: A Guide and Resource Pack forSheffield

Version: June 2009Date at ET/PEC:

Date ratified at Board:

Name and dept of originator/author: Dr Jenny Stephenson

Name of responsiblecommittee/individual and title:

Dr Muna I Abdel Aziz

Chair, Diabetes Planning &Commissioning Group

Date issued: September 2009

Review date: September 2011

Target audience: Health professionals providing carefor people with diabetes in primarycare

This policy/service has been reviewed in accordance with EqualitiesLegislation on race, disability, age, gender, sexual orientation and genderidentity, faith and belief.


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ChairmanTony Pedder Chief ExecutiveJan Sobieraj

NHS Sheffield is the Sheffield Primary Care Trust

Diabetes: A Guide and Resource Pack for Sheffield

Contents

Section PageIntroduction 1Chapter 1 Clinical protocols:Protocol 1: Diagnosis of Diabetes

4

Protocol 2: Early Detection of Diabetes in High Risk

Groups

8

Protocol 3: Impaired Glucose Tolerance 11Protocol 4: Guidelines for Referral to Specialist Services 13Protocol 5: Assessment of Newly Diagnosed Patientswith Type 2 Diabetes

16

Protocol 6: Performing a Routine Review 17Protocol 7: Performing an Annual Review 18Protocol 8: Gestational Diabetes 19Protocol 9: Home Blood Glucose Testing 20Chapter 2 Evidence based Guidelines:Guideline 1: Implementing a Diabetes Register

21

Guideline 2: Management of Blood Pressure 22Guideline 3: Glucose Control 25Guideline 4: Management of Lipids 39Guideline 5: Use of Aspirin 42Guideline 6: Foot Examinations 43Guideline 7: Eye Screening 47Guideline 8: Screening for Proteinuria 48Guideline 9: Macrovascular Disease 56Guideline 10: Starting Insulin in Primary Care 57Guideline 11: End of Life Care 60

Guideline 12: Ketoacidosis 65Guideline 13: Sick Day Rules for Staff 67Grading of Evidence 69Chapter 3 Education Nutrition and LifestylePatient Education

70

Nutrition in Type 2 Diabetes 74Weight Management / Waist Circumference 79Advice for Ethnic Minorities 84Physical Activity 89Smoking Cessation 90

Hypoglycemia 92Intercurrent Illness 94


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Pre-Pregnancy Counselling 96Achieving Lifestyle Change 97

Chapter 4 Psychological Aspects of Living withDiabetes

Depression Screening

100

102Chapter 5 Type 1 DiabetesGlucose ControlLipidsBlood Pressure

104

105Chapter 6 Directory of Specialist ServicesAdult Services

106

Diabetes Specialist Nursing Team 107Dietetic Service 109Community Diabetes Specialist Team CentralConsortium

110

Paediatric and Young Peoples Services 111Podiatry Service and Foot Clinics 113Renal Clinic 117Erectile Dysfunction Service 118Eye Screening Programme 119Diabetes UK (Sheffield) 123Research 124

Clinical Psychology Service for Diabetes 125AppendicesAppendix 1 Planning and Organisation 126

Appendix 2 The NSF 130Appendix 3 Resources: glucose meters and insulinpensHealthy Eating

132

138Appendix 4 Development of the Guidelines 141Appendix 5 Supplementary Psychological Guidance 143Appendix 6 References 150Appendix 7 New Units from June 09 157Appendix 8 Diet Sheets 162Appendix 9 Care Planning 181

Compliance StatementsMental Capacity ActEquality Impact Assessment

183

Appendix A Mental Capacity ComplianceStatement 184

Appendix B Equality Impact Assessment Tool 185Appendix C Clinical Policies and Guidelines

Appraisal Instrument187

Appendix D Version Control Sheet 189


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New drugsShort and long-acting insulin analogues have been developed in order to provide

more physiological insulin replacement, particularly in people with type 1 diabetes.

There are also two new agents :-1. Exenatide (Byetta) is a synthetic peptide (Exendin-4) for the treatment of type 2diabetes which has been developed from the saliva of the poisonous North Americanlizard, the Gila Monster. This Glucagon-Like Peptide (GLP-1) stimulates insulinresponse to a meal, slows gastric emptying and inhibits glucose production by theliver. In practice it also suppresses appetite and promotes weight loss. It has to begiven by sc injection twice a day and is expensive.

2. Sitagliptin (Januvia) is a selective once daily dipeptidyl peptidase-4 (DPP-4)inhibitor which enhances the regulation of glucose by stimulating insulin secretion

from beta-cells and modifying alpha-cell glucagon secretion. Like Byetta, it may alsopreserve beta cell function. There are no hypos with this agent, some weight loss,and it is given orally.

Diagnostic criteriaThe fasting plasma glucose threshold for diagnosing diabetes or pre-diabetic statesis > 6.0 mmol/l. See algorithm in chapter 1, section 1.3 (page 8).

Development of the guidelinesA sub-group of the Sheffield Diabetes Planning and Commissioning Group wasformed to review and revise the resource pack. This was completed in 2009,afterconsulting widely with staff working in the field locally.The guidelines have beenratified by the Diabetes Commissioning Group and have received final approvalthrough the clinical governance committee within Sheffield PCT.

The group had representation from all disciplines within the diabetes care pathway,including consultant physicians, GPs, specialist nurses, allied health professionalsand people with diabetes. A detailed description of the guideline developmentprocess and a full list of the groups membership can be found at appendix 4.

Guideline 4, on appropriate statin prescribing, has been agreed by a working party ofthe Diabetes Commissioning Group, the PCT Pharmacy advisers in accordance withNICE, and the Area Prescribing Committee. It is supported by Sheffield TeachingHospitals Medicines Management and Therapeutics Committee (MMTC).

EvidenceThe guidelines have been based upon evidence from systematic reviews andrandomised controlled trials. Evidence levels have been adapted from the USAgency for Health Care Policy and Research Classification. A full description of the

grading of evidence can be found at the end of chapter 2.


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3

Use of the Guide and Resource Pack for Sheffield

The guidelines are aimed at all health professionals providing care for people withdiabetes in primary care, although it will also be useful resource for non-diabetesspecialists in secondary care and students. It will assist in diagnosing and managing

diabetes and its associated complications, advise on when referral to specialistservices is needed, and provide a checklist for conducting routine reviews.

In addition, the pack contains a comprehensive directory of specialist services andlocal support groups.

The guidelines generally refer to all adults with type 1 or type 2 diabetes, unlessexceptions are given within the specific guideline. Children and young people withdiabetes will be treated at Sheffield Childrens NHS Trust (SCH) or at joint adolescentclinics with Sheffield Teaching Hospitals Foundation NHS Trust (STH). Most adultswith type 1 diabetes are currently treated at STH.


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4

Chapter 1. Clinical protocols

Protocol 1: Diagnosis of diabetes and other hyperglycaemicstates

1.1 BackgroundThe purpose of diagnosis is to identify those at risk of developing the complicationsof diabetes, both arterial (macrovascular) and microvascular, as well as to deal withany symptoms.

1.2 Management classificationDiabetes symptoms and risk of arterial and microvascular damage

Impaired glucose tolerance (IGT)and

Impaired fasting glycemia (IFG)

risk of arterial damage and of progression to diabetes

1.3 Diagnostic algorithmSee next page.

Important diagnostic cautions:If patient is asymptomatic, then two diagnostic glucose values required on 2separate days.Never base the diagnosis of diabetes solely on a stick reading of a finger prick

glucose - it must be confirmed on a venous plasma measurement in a laboratory.Fasting glucose estimations require a certainty of no calorie intake for 10-16hours.Diagnostic procedures should not be performed during acute illness or aftertrauma or surgery.

1.4 Actiondiabetes confirmed test urine for ketones:- Type 1 - if two of: short history (days or weeks), marked weight loss,

ketonuria, refer to specialist services (Chapter 5, Directory of Specialist

Services) within 48 hrs.- Type 2 - see Initial Assessment .

IGT/ IFG - target CHD risk factors/ screen annually for diabetes.

1.5 Date: May 2009. Review date:May 2012


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5

1.3 Diagnostic algorithm: Diagnosis of diabetes(June 04)

GLYCOSURIA Incidental Hyperglycaemia SYMPTOMS

Take a History

RANDOM PLASMA GLUCOSE

< 5.5 mmol/l 5.5 11 mmol/l >11 mmol/l

FASTING PLASMA GLUCOSE

5.5 - 6 mmol/lconsider annualcheck and CHD

risk factors

6.1 6.97.0

repeat, if confirmed

OGTT

2hr 11

NORMAL IMPAIRED

FASTINGGLUCOSE

IMPAIRED

GLUCOSETOLERANCE

DIABETES

Fasting 6.02hr


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1.6 Supplementary information 1: Suggested method forperforming a glucose tolerance test in the surgery

Lucozade is no longer recommended to be used in a GTT as from time to time itsconstituents change, as it is a foodstuff rather than a drug.Instead, Polycal Liquid should be used. This is available on a prescription, orPractices can purchase some from their local Pharmacy. The 200ml cartons can beeither orange or neutral flavoured.It does not need to be refrigerated before use.

NB The laboratories are unable to perform GTTs (except at hospital request).

The patient should arrive at the start of the day after fasting from 10pm the previous

evening. Drinks of water could be allowed beforehand.

The correct volume of Polycal is 113ml. It needs to be measured accurately. Asuggestion is to purchase a plastic tumbler and measure 113ml of water using a20ml syringe, marking the level clearly in two places on the side. The liquid can bediluted a little which may make it more palatable.

A fasting blood glucose sample is taken. The patient then drinks the Polycal over aminute or so.

The patient can be offered to sit in the Surgery for the requisite two hours, or allowedhome, but only if no exercise is taken (activity decreases blood glucose).

Exactly 2 hours after the glucose drink, a blood glucose sample is taken and againsent to the laboratory, in the same specimen bag as the first sample, andappropriately labelled. Arrangements of follow-up are made before the patient leaves.


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1.7 Supplementary information 2: Patient information on theperforming of a glucose tolerance test

You have been asked to make an appointment for a Glucose Tolerance Test. This isbecause you have recently had some blood tests that suggest you may havediabetes. This needs to be checked out, because diabetes is a common andimportant problem that can be controlled if it is caught early. Diabetes is a conditionwhere the body cannot cope with sugar, particularly after eating or drinking sweetthings, and this shows as a high level of sugar in the blood stream.

This test is done to see what effect a large sugary drink has on the system by takinga blood sample before and after this drink to see if the blood sugar level rises. It mayshow a definite rise in blood sugar, when it may indicate diabetes, or in-betweenlevels, which indicate that diabetes may come on later.

You will be asked to make an early morning appointment for the first blood test. Youshould have nothing to eat after 10pm, and only water to drink if needed.

The first blood sample is taken at the Surgery, and you are then asked to drink aglassful of a sugary drink called Polycal. The time is noted.

You will then be asked to wait for exactly two hours before the second blood sampleis taken, and resting in this time. You could read a book in the waiting room, or drivehome and rest there. It is important that you rest and dont be active, and haveNOTHING to eat or drink in between (water is OK).

Exactly two hours after drinking the Polycal, you will have the final blood test, andcan then go home and eat and drink normally. You should make an appointmentbefore leaving for the GP or Nurse in order to discuss the result.

Thank You.


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Protocol 2: Early detection of diabetes among high riskgroups

2.1 Background

Standard 2 of the NSF states that the NHS will develop, implement and monitorstrategies to identify people who do not know that they have diabetes. In Feb 2009NICE recommended that there should be population screening of all people aged 40to 75 for diabetes and also cardiovascular risk, now that diabetic and CVD risk hasrisen in the population due to increasing age and prevalence of diabetes.Screening groups of people (adults) who have one or more risk factors for diabetesshould continue as before.

2.2 Risk factors for diabetes

Risk Factors for Diabetes in Adults:Family history of type 2 diabetes in at least one first degree relative

Overweight BMI 30 or more, especially if over 40 years of ageRace Highest risk in South Asian, African, Afro-CaribbeanKnown impaired glucose tolerance

Previous gestational diabetesKnown cardiovascular disease and hypertension

Some antipsychotic drugs, mainly olanzapine and clozapine

Several risk factors for diabetes and cardiovascular disease are the same, so it maybe appropriate to offer a combined screening programme for both conditions.

Given the serious implications of a diagnosis of diabetes, patients should be givensufficient information as to why they are being offered screening, so that they cangive informed consent.

2.3 Symptoms and signs of diabetes

Many people with diabetes will be diagnosed only if professionals remain alert to the

possibility that they may have diabetes. The symptoms and signs are describedbelow.

Symptoms of Diabetes:

Increased thirstPassing a lot of urine, especially at night (may cause bedwetting in childrenand incontinence in older people)Extreme tiredness

Weight loss despite increased appetiteBlurred vision

Pruritus (itchy skin)

Tingling, pain or numbness in feet, legs or handsImpotence


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Signs of Diabetes:Persistent or recurrent infections, such as genital thrush, UTIs in women,dental or skin infectionsCataracts

Signs of microvascular complications such as diabetic retinopathy detectedby an optometrist during a routine check, foot ulcers, loss of sensation inlower limbs, proteinuria if infection is excluded


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2.4 Case finding among high risk groups

People in the high risk groups listed above should be offered a blood glucose test forscreening purposes, not a urine test. A random capillary sample (thumbprick) can be

used initially, but if over 6.0 mmol/l should be confirmed by a FASTING venousplasma sample sent to the laboratory. The result can then be dealt with inaccordance with the diagnosis algorithm in this section of the Guidelines.

Systematic testing for diabetes is recommended by the National ScreeningCommittee for the above high risk groups. Those with known cardiovascular diseaseinclude those with angina, MI, TIA, stroke and peripheral vascular disease at anyage. Type 2 diabetes is also up to six times more common in people of South Asiandescent and up to three times more common in those of African and Afro-Caribbeanand Middle Eastern descent, compared with the white population. It is also morecommon in people of Chinese origin and other non-white groups.

Note that in some ethnic groups, blood testing may not be acceptable, and also thatinformed consent needs to be obtained perhaps using an interpreter.

There is little evidence yet to advise a screening interval for glucose testing in peopleat higher risk, but an annual interval is mainly used in those with CVD andhypertension. Sugar is taken with the other bloods for lipids, liver function and ureaand electrolytes.

Even if an initial screening test is negative, advice should still be given that they areat increased risk of developing diabetes and given appropriate lifestyle advice toreduce this risk (see Impaired Glucose Tolerance guideline later).

.


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Protocol 3: Management of patients with impaired glucosetolerance

3.1 Definition

See 'Diagnosis of Diabetes' flowchart in protocol 1. Impaired glucose tolerance isshown in a glucose tolerance test by a 2-hour glucose level of 7.8 11mmol/l, and afasting glucose of less than 7.0. Impaired fasting glycemia is shown by a 2-hourglucose level of less than 7.8 but a fasting glucose of 6.1-6.9mmol/l.

3.2 RationaleImpaired Glucose Tolerance (IGT) indicates an increased risk of the development oftype 2 diabetes of approximately 5% per year, (higher in South Asian people). If bothIGT and IFG co-exist, then the individual is at greater diabetes risk, namely 15% riskover five years. IGT is often part of the Metabolic Syndrome, which comprisesobesity, dyslipidaemia (raised triglyceride and total cholesterol, lowered protectiveHDL cholesterol), hypertension, abnormal clotting, gout and cardiovascular disease.

NOTE IGT is not associated with microvascular but with macrovascular disease.There is evidence that the progression towards Type 2 diabetes can be halted oreven reversed by weight loss. People with IGT should be encouraged to worktowards a 10% weight loss in total if obese (BMI 30 or more), and, if non obese, toaim for a BMI of under 25 (if Caucasian) and under 23 (if Asian).

Note that patients with IGT and/or IFG should not enter the Eye ScreeningProgramme, as it is not needed.

3.3 Clinical Care

The aim is to attend to cardiovascular risk factors and prevent progression to overtdiabetes.

1. Inform the person that they have an increased risk of developing diabetes andcardiovascular disease, but that they can work with their health adviser toreduce that risk. Inform them about what symptoms to watch for, such asinfections, polyuria, dry mouth and tiredness mainly.

2. Ideally using a Personal Care Plan, discuss possible targets which the personfeels are reasonable and attainable. See below.

3. BMI as described above.4. Smoking aim to stop. Offer smoking cessation support.5. Physical Activity work out an attainable programme, aiming for 30 minutes

of moderate exercise at least five times a week.Monitoring:

1. Measure fasting blood glucose annually2. BP treat if rises above 140/90.3.Measure lipid profile annually.

NBHBA1c is not used as a monitoring tool at the present time.

3.4 Weight lossThis often presents problems as, due to a number of individual reasons, weight lossmay be difficult to attain. Motivational aspects of the consultation are coveredelsewhere in the Guidelines, but drug treatments may be considered in Type 2diabetes.


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See Nutritional Management section, but for current advice on the use of drugtreatments for weight loss, consult the NICE guidance. The Sheffield Formulary alsois a source of relevant information.

See below there is now evidence for using metformin to promote weight loss andalso independently to reduce the risk of progression to diabetes from IGT. Metformincan be used in non-diabetic people as it does not cause hypoglycaemia. Also agentssuch as orlistat and sibutramine can be used to aid weight loss, alongside motivationand a healthy balanced diet.

3.5 EvidenceFinnish and American studies on intensive group management of weight show weightloss can prevent or slow the onset of overt diabetes.Feb 02, New England Journal of Medicine, reduction of progression to T2DM inpatients with IGT, using lifestyle intervention (which was also more effective thanmetformin alone). Also, increased physical activity alone (without weight loss)resulted in delay of onset of diabetes.

3.6 Date: May 09 Review date: May 2012


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Protocol 4: Guidelines for referral to specialist services

4.1 Emergency referralsSuspected diagnosis of diabetic ketoacidosis : protracted vomiting /dehydration / drowsiness, with ketonuria admitSuspected diagnosis of hyperosmolar non-ketotic coma : severe thirst,

lethargy, dehydration associated with meter glucose of 28 or more. AdmitDiabetic foot infections: spreading cellulitis, abscess, wet gangrene -admit/same day referralHypoglycemia severe hypoglycemic coma, not responding promptly to IVdextrose or IM Glucagon

- secondary to deliberate or suspected overdose and/or high alcoholconsumption

- secondary to sulphonylurea and / or poor social circumstancesGastroenteritis with repeated vomiting in type 1 diabetes

Intercurrent infection with severe hyperglycemiaUncontrolled vomiting due to known or suspected diabetic autonomic

neuropathyPregnant patients with intractable vomiting associated with dehydration /ketonuria

4.2 Urgent referrals (telephone or fax within 24 hours)

newly diagnosed child

same day referral to Children's Hospital (phone RMO via switchboard)

newly diagnosed patient if clearly unwell, or ketonuria ++ or more

telephone referral to Diabetes Centres at the RHH or NGH hospitalswithin 24 hours

weekend contact RMO

pregnant women

refer to antenatal clinic (Chapter 5, Directory of Specialist Services) to beseen within one working week

other newly diagnosed patients with type 1 diabetes refer to one of thediabetes centres within 48 hours

Diabetic foot problems

Diabetic foot ulcer/necrotic lesioncallus with local infectionsuspected Charcot arthropathynail pathology with ischaemia and infection

undiagnosed problem in at risk foot


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4.3 Routine referralsRefer to hospital consultant/specialist service as indicated in table below.

Condition Clinic

Blood pressure BP >150 systolic or >90 diastolic despite 3 ormore agents

Diabetes or

General Medicine

GlucoseHbA1C >8.0% on maximum oral agentswhere good glucose control is appropriatetarget

hyperglycaemic symptoms on maximum oralagents

hypoglycaemic unawareness

Consider startinginsulin in primary care

Diabetes or as above

Diabetes

Lipids cholesterol level above target or triglyceride>10mM despite maximum lipid loweringagents

Diabetes, or LipidClinics or write foradvice

Young people 16 65 years if cognitive impairment/significant

co-morbidities

Dr Hendra RHH

Memory clinic

Diabetic foot high risk feet for special footwear

reordering of special footwear

Diabetic Foot

Orthotist

Neuropathies refractorypainful neuropathy

suspected amyotrophy, diabeticmononeuropathy

Diabetes, ProfessorTesfaye

Diabetes

Peripheralvascular disease

severe claudication, ischaemic rest pain Vascular surgeons

Erectile

dysfunction

if sildenafil unsuccessful

for second opinion re diagnosis or suitabilityor another treatment

for psychosexual or relationship therapy

Erectile Dysfunction

Clinic (Urology)ONLY

Porterbrook Clinic

Renal proteinuria >0.5g/24hrs

microalbuminuria in Type 1

creatinine > 200M

Diabetes

Diabetes

Diabetes/Renal

Eyes sudden visual loss

gradual visual loss

Eye Casualty

Optometrist

Ischaemic heartdisease

see local NSF Guidelines Fast Track or GeneralCardiology

Cerebrovasculardisease

new TIAs/CVA Single point ofaccess:

Tel: 226 1223

Psychologicaldifficulties

Adjustment difficulties eg following thediagnosis of diabetes or diabetes-relatedcomplications, during adolescence,pregnancy and other times of transition

Psychological difficulties related to orinfluencing ongoing diabetes self-care egdepression, anxiety, eating disorders, needlephobia

Longer-term and/or complex needs egpeople with multiple health and/or mental

Diabetes


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Condition Clinichealth problems

Pre-pregnancycounselling

Antenatal Diabetes

*see Chapter 5, Directory of Specialist Services for contact details and how to refer.


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Protocol 5: Assessment of newly diagnosed patients withtype 2 diabetes

5.1 Assessment

Enter patient details on practice system by coding appropriatelyDiscuss general aspects of diabetes and history of illness

Establish patient's knowledge of illness and educational needs

Measure height and weight; calculate body mass indexWaist circumference aim for under 94cm if male (under 90cm if Asianmale); under 80cm if female. WC is a determinant of metabolic riskMeasure blood pressure

Test urine for ketones and protein; arrange MSU if protein present. If allnegative then test a fresh urine for microalbuminuria

Take blood for glucose, HbA1c, U+E, baseline LFTs, triglycerides +cholesterol: HDL ratio for primary prevention (preferably a fasting

sample)total cholesterol for secondary prevention

Examine feet for diabetic complications

Load all information onto appropriate diabetes template on system

5.2 Action

Consider initial psychological, educational & lifestyle issues (see Chapter3),diet being the mainstayConsider home blood glucose measurements in certain circumstances (see

Protocol 1)Refer for local podiatry or chiropody if peripheral vascular disease,neuropathy or other foot risk factor. (See Guideline 6)Register with Sheffield Diabetes Eye Screening ProgrammeIntroduce Diabetes UKArrange next appointment - regular and early reviews will be necessary untilthe patient has a good understanding of diabetes, and metabolic control andcontrol of blood pressure are achieved


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Protocol 6: Performing a routine review

6.1 BackgroundEnsure that patients with established diabetes are coded up correctly on the practice

system, and are booked for regular appointments (see Appendix 1). Establish apolicy for the frequency of follow-up of people with diabetes three to six monthlydepending on need. Those with borderline control or complications, for example, willneed closer follow up.

6.2 Assessment

Weigh patient / BMI / waist circumference

Measure blood pressure

Test urine for protein; check MSU if proteinuria, microalbuminuria annually(See Guideline 8)

Take blood for HbA1c, and for lipids if previous levels above target, and otherblood tests depending on the individual and medication

6.3 Action

Discuss the patient's general well-being and progress:

patient concerns

blood sugars if home testingsymptoms of hypoglycaemia if on sulphonylurea / insulin

lifestyle issues - smoking, diet, physical activity

Evaluate

knowledge

self managementmental state ?depression

Negotiate targets for

blood sugarslifestyle issues

Modify treatment forglucose

blood pressurelipids

Record all details in the practices diabetes template, and in diabetes co-operation/ BP monitoring cards/patient held records if used

Arrange next appointment


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Protocol 7: Performing an annual review

7.1 Assessment

Weigh patient, calculate BMI (kg/m2);waist circumferenceMeasure blood pressure

Test urine for protein; check MSU if proteinuria, microalbuminuria annually(see Guideline 8)

Enquire about symptoms of complications:angina, shortness of breath, intermittent claudication, TIAs

neuropathic symptoms, erectile dysfunction, any visual changes

Examine feet for diabetic complications: peripheral pulses and sensation,callus, deformity - clawed toes, bony prominence, hallux valgus, hammertoes, Charcot foot

Examine insulin injection sites for lumpiness/fat hypertrophy

Take blood for:

HbA1c, glucose,U+Es, eGFR

Cholesterol and triglycerides, and liver function tests,

FBC if on a glitazone

Ensure eye screening has occurred in the past 12 months

7.2 Action

Discuss the patient's general well-being and progress:

patient concernsblood sugarssymptoms of hypoglycaemia if on sulphonylurea/insulinlifestyle issues - smoking, diet and meal pattern, physical activity

Evaluate

knowledgeself management

mental state ?depression

Negotiate targets for

blood sugarslifestyle issues

Modify treatment for

glucoseblood pressure

lipids

Record all details in the diabetes template and in diabetes co-operation/ BPmonitoring cards/patient held records if used

Arrange next appointment


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Protocol 8: Management of gestational diabetes

8.1 BackgroundGestational diabetes (GDM) is diabetes first diagnosed in pregnancy that resolvesafter delivery. The lifetime risk of developing type 2 diabetes is 30%, and there is also

an increased risk of CVD in the future.

8.2 Risk FactorsObesity BMI 30 or more

Family history of diabetesPrevious gestational diabetes

Previous unexplained stillbirth, or baby weighing 4.5Kg or moreGlycosuria on two or more occasions during the current pregnancy

8.3 DiagnosisThe diagnosis of GDM is confirmed on a glucose tolerance test (GTT), when the 2-

hour level is over 7.8 mmol/l. Such GTTs are performed at RHH

8.4 ManagementIt is managed in the combined antenatal/diabetes service. Targets are tight controlwhere possible; 20-30% need insulin.

8.5 General advicePatients must be informed of the condition, its management and also of the risk ofdeveloping type 2 diabetes and cardiovascular disease. This should becomplemented by advice and support to reduce this risk, and information to helpthem recognise the symptoms of diabetes thirst, passing more urine, nocturia,recurrent infections including thrush, and tiredness.

To reduce the diabetes risk:Aim for a BMI 25 or less

Lower general vascular risk by:Being physically active (at least 30 minutes of moderate intensityactivity 5 times per week)Not smoking

Having a diet that comprises 5 fruit and vegetables daily, low insaturated fat, moderate poly- and monounsaturated fats, low salt, andhigh in low Glycemic Index foods (unrefined carbohydrates)

This can all be discussed at the postnatal check, and periodically at other healthchecks such as smears.

8.6 Practice follow upPractice register of patients who have had GDM, using appropriate code L1809Using this code to run a report annually and invite patients for blood sugar test(preferably fasting, but not always practical). The result of this is managed as the flowchart in protocol 1 (section 1.3) of these Guidelines.

8.7 Date: May 2009 Review Date: May 2012


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Protocol 9: Home blood glucose monitoring

Background

NHS expenditure on blood glucose monitoring electrodes and equipment

available on prescription exceeds the expenditure on oral hypoglycemicdrugs. There is evidence that home blood glucose monitoring (HBGM) is insome cases unnecessary, ie does not contribute to the patients management,or results are incorrect, and that therefore some of this expenditure is wasted.

Therefore, we recommend HBGM to patients only if testing is informing insulindosing, or if there is a danger of hypos (on insulin or gliclazide), and if in theindividual case the result will be acted upon. NICE recommends 3-6 monthlyHBA1c for monitoring control in stable Type 2 diabetes rather than HBGM.

Situations where HBGM is essential

These situations are where there is a danger of sudden blood glucosechanges, or where results are used to adjust treatment:

People with Type 1 diabetes

Type 2 diabetes if treated with insulin, especially in the titration phasewhen bedtime insulin in first started

Patients with loss of hypoglycemia warning

Diabetes in pregnancy, whether treated with insulin or not

Situations where HBGM may be used : Type 2 diabetes

When insulin is being considered and sugar profiles are used todetermine degree of control or the insulin regime

Possibility of hypoglycemia eg illness/vomiting when taking gliclazide

History of hypos when on gliclazide, and the person drives, or wouldsuffer very badly if in a hypo, eg frail living alone

Initially on diagnosis, where for interest and support in selfmanagement, the patient could be offered testing to see the effect ofdifferent foods, drinks or physical activity on the blood sugar

Situations where HBGM is not recommended

Stable well controlled Type 2 diabetes on diet alone, or on oralhypoglycemic drugs, where treatment is titrated using HBA1c ratherthan sugar measurements

Patient declines (preference or on religious grounds)

Where the patient physically cannot perform it, eg due to arthritis of thehands, and there is no carer.


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1. Guideline for implementing and maintaining a diabetesregister

1.1 Recommendation: Identify all people with diabetes and place on adiabetes register (ie. coded correctly and retrievable from the Practice system).

1.2 Evidence:Grade AII

1.3 Rationale: A register is needed to facilitate recall for review and audit

1.4 To whom does this guideline apply? All people with diabetes (type1and type 2)

1.5 Guidance:

1.6 Exceptions: there are no exceptions for this guideline


Case Finding

Test for diabetes if:(see Chapter 1 Clinical Protocols, for diagnosis of diabetes,and Early Detection of Diabetes.)suspicious symptoms

thirst, polyuria or weight lossnocturia or incontinence

recurrent infections, especially candidiasis or boilsneuropathic symptoms such as pain, numbness and paraesthesiae

vague or unexplained symptoms, lassitude

hypertensionarterial disease (coronary heart, peripheral vascular or cerebrovascular;

hypertension)

Screen annually for diabetes if high risk of developing diabetes:

obesity (BMI >30)

Asian, African or African Caribbean originfamily historyhistory of gestational diabetes or a large baby (>4kg)

ActionAt confirmation of diagnosis or on joining the practice, patients with a diagnosis ofdiabetes should be included in a computerised register (see Appendix 1).Maintain register. Use for recall and follow-up. Use approved codes for each

category. Load information whenever possible by using the diabetes template.Maintain RegisterEnsure a robust system in the practice to code patients appropriately wheneverthe information reaches the practice, eg new diagnoses, in hospital letters etc.This keeps the register up to date, which is essential for good diabetes care.


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2. Guideline for the management of blood pressure

2.1 Recommendation: Monitor BP at least 6 monthly. Treat if hypertensive.

2.2 Evidence: Level 1+ (NICE CG87)

2.3 Rationale: Control of BP reduces cardiovascular complications, renal diseaseand retinopathy.

2.4 To whom does this guideline apply? All people with diabetes (type 1 andtype 2). See also Chapter 5: Type 1 diabetes

2.5 Guidance:

AssessmentMeasure BP* and other risk factors

systolic BP > 150mmHgand/or

diastolic BP > 90mmHg

Systolic BP >140mmHgand/or

diastolic BP > 80 mmHg

systolic BP >130 and ordiastolic >80 mmHg

and there is kidney, eye orcerebrovascular damage:

Offer lifestyle advice. Repeatblood pressure

measurements within 1month


measurements within 2months


measurements within 2months

NB1. Add medications if lifestyle advice does not reduce blood pressure to below 140/80 mmHg

(below 130/80 mmHg if there is kidney, eye or cerebrovascular damage).

2. Target BP after treatment is < 140mmHg systolic and < 80mmHg diastolic, (below 130/80mmHg if there is kidney, eye or cerebrovascular disease).

3. Systolic and diastolic BP thresholds and treatment targets are equally important

*BP should be measured:

in the sitting position, after the patient has rested for 5 minsmeasure blood pressure on both of the patients arms with the higher value identifying thereference arm for future measurementusing a conventional sphygmomanometer, or approved automatic one, with large cuff if armcircumference >33cm. The machine should be calibrated at least once a yearthe reading of the diastolic BP should be read as the disappearance of the second soundand BP should be read to the nearest 2mm Hgat least 2 measurements should be made at each visit

standing BP should also be measured at initial assessment because of potential problem ofpostural hypotension. If there is no postural hypotension treatment decisions may be madeon sitting BP. If there is postural hypotension, standing BP should be measured at each visit

and treatment decisions based on standing BP.


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Investigation of hypertension

all patients: Urine for protein and ECG (latter to assess cardiac enlargement)

consider secondary causes, especially if severe/difficult to control/under 40 yearsremember and check concordance with medication and other causes such as high alcoholintake (above 3u/day for men and 2u/day for women), drugs such as steroids etc.

Treatment1. Lifestyle advice

Advise regarding: smoking, weight, physical activity, alcohol, saturated fat and dietary salt (seeChapter 3 Education Nutrition & Lifestyle)

2. Antihypertensive Drugsa. stepped care:

single drug controls 70%, or to >200uM, stop ACE inhibiter

If serum potassium > 5.5mmol/l stop ACE inhibitor or other appropriate medicatione.g. potassium sparing diuretics including spironolactone

NB Angiotensin receptor Blockers (eg losartan) can be use instead of ACE ifpersistent cough or other side effects develop

4. Follow up:

when target attained check BP 3 monthly

patients attending hospital should carry BP record cards

Hospital referral

consider if BP remains above target despite 3 or more agents


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References

NICE CG87: The management of type 2 diabetes. May 2009. Available at:http://www.nice.org.uk/nicemedia/pdf/CG87NICEGuideline.pdf

NICE CG CG34: Management of hypertension in adults in primary care.Available athttp://www.nice.org.uk/nicemedia/pdf/CG034NICEguideline.pdf

UKPDS Group: Tight blood pressure control and the risk of macrovascular andmicrovascular complications in type 2 diabetes. UKPDS 38. BMJ 1998. 317. 703-13.

HOT Study Group: Effects of intensive blood pressure lowering and low dose aspirinin patients with hypertension: principal results of the Hypertension Optimal Treatmentrandomised trial. Lancet 1998. 351. 1755-62.

British Hypertension Society Guidelines for hypertension management 2004 (BHSIV) : Summary. BMJ 2004. 328. 634-40.

ALLHAT Collaborative Research Group. Major outcomes in high risk hypertensivepatients randomised to ACE inhibitor or calcium channel blocker vs diuretic. JAMA2002. 288. 2981-2997.
http://www.nice.org.uk/nicemedia/pdf/CG87NICEGuideline.pdfhttp://www.nice.org.uk/nicemedia/pdf/CG87NICEGuideline.pdfhttp://www.nice.org.uk/nicemedia/pdf/CG034NICEguideline.pdfhttp://www.nice.org.uk/nicemedia/pdf/CG034NICEguideline.pdfhttp://www.nice.org.uk/nicemedia/pdf/CG034NICEguideline.pdfhttp://www.nice.org.uk/nicemedia/pdf/CG034NICEguideline.pdfhttp://www.nice.org.uk/nicemedia/pdf/CG87NICEGuideline.pdf


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3. Guideline for glucose control

3.1 Recommendation: HbA1c should be as close to 6.5% as possible, while avoiding

hypoglycaemia. Higher target levels may be appropriate as agreed with individual patients.

3.2 Evidence: Level 2++

3.3 Rationale: UKPDS 35 (Type II diabetes) shows that higher HbA1Cs are associatedwith a greater number of complications in diabetes. A meta-analysis (Kelly et al 2009) oftrials looking at tight blood glucose control in type II diabetes concluded Intensive glucosecontrol reduced the risk for some cardiovascular disease (such as nonfatal myocardialinfarction), did not reduce the risk for cardiovascular death or all-cause mortality, andincreased the risk for severe hypoglycaemia.

For more details, see the blog from the national prescribing centre

http://www.npci.org.uk/blog/?p=435

For type 1 diabetes the evidence shows a clear benefit of more intensive treatment; forexample the Diabetes Control and Complications Trial/Epidemiology of DiabetesInterventions and Complications (DCCT/EDIC) Research Group demonstrated that thefrequencies of serious complications in patients with T1DM, especially when treatedintensively, are lower than that reported historically.

For more details, see the blog from the national prescribing centrehttp://www.npci.org.uk/blog/?p=540

3.4 To whom does this guideline apply? All people with diabetes (type 1 and type

2). See also Chapter 5: Type 1 diabetes
http://www.npci.org.uk/blog/?p=435http://www.npci.org.uk/blog/?p=435http://www.npci.org.uk/blog/?p=540http://www.npci.org.uk/blog/?p=540http://www.npci.org.uk/blog/?p=540http://www.npci.org.uk/blog/?p=435


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3.5 Guidance:

AssessmentAfter diagnosis HbA1C should be measured at least 3-4 monthly for 12 months. Thereafter HbA1Cshould be measured 3-6 monthly, depending on clinical need.

normal good glucose control* acceptable suboptimalHbA1C < 6.5% 6.5% to< 7.0% < 7.5% >7.5%

Treatment targets

Tailor treatment goals to the individual. Usual target is 6.5 for patients on two or fewermedications for blood sugar control, and 7.5 on 3 or more medications (NICE CG87). Aim forgood glucose control* in most cases (see Home Blood Glucose Monitoring Protocol, Chapter3.)

Inappropriate to aim for HbA1C < 7.5% if:

Life expectancy limited because of severe complications e.g. severe CVD, or otherdisease e.g. disseminated malignancyIn those for whom the dangers of hypoglycemia outweigh the benefit of tighter control,eg frail elderly patients: in these groups avoidance of hypos and osmotic symptoms aresuitable targets except in diet controlled patients (see Management of Hyperglycemia inelderly people, 3.11)Hypoglycaemia unawareness or recurrent major hypos: specialist advice / referral isrequired in this group (STH has special expertise in management of this problem andwelcomes specific referrals).

Action

If HbA1C elevated strongly recommend one or more of the following:

Oral agents: check appropriate times, correct doses and patient concordance. Increaseif necessary, (see Algorithm for Glucose Management in Type 2 Diabetes). Considerthe impact of treatment on body weightReview diet and activity. Discuss scope for, and benefit of, change. Consider referral toCommunity Dietitian for assessment and use of anti-obesity drugs where appropriate.Consider exercise referral schemeConsider insulin if on maximum dose of oral agents and HbA1C > 7.5% (NICE CG87) orosmotic symptoms, or patient choice

Consider exenatide (sc injection) or sitagliptin (oral) instead of insulin if the criteria inNICE CG87 are met

If HbA1C


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Algorithm for Glucose Management of Type 2 Diabetes(Taken from NICE CG87 2009)

Lifestyle measures(unless patient is unwell, with many symptoms or perhaps type 1 diabetes is suspected.)

Consider use of anti-obesity drugs in motivated patients.

If HBA1C remains 6.5% or over

Review every 3-6months if control

achieved

Add SulphonylureaWith active dose titration

Monitor for expected deterioration

Exenatide may beconsidered here whenoverweight. Prescribe

within current

guidelines

Add Pioglitazone or InsulinWith active dose titration

HBA1c7.5% orabove

Insulin + metformin + sulfonylurea

With active dose titration and monitoring.Increase insulin dose and intensity over time.

HBA1C 7.5%or above

A rapid-acting insulinsecretagogue may beconsidered in pt withnon-routine dailypattern. Only consider

pioglitazone ifhypoglycemia onsulfonylurea is apotential problem

MetforminWith active dose titration

(consider sulfonylurea if glucoselevels high/not overweight)

HBA1C 6.5% or over


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3.1 Supplementary information 2: Glucose management in type 2diabetes (See Algorithm above)

From the outset it must be explained to patients that diabetes is a progressivecondition and it is normal to need increased therapy, i.e.: addition of newagents or insulin with time.

Table Summary of glucose lowering interventions in type 2 Diabetes

Intervention Advantages Disadvantages

Step 1: initialLifestyle advice todecrease weightAnd increase activity

Metformin

Low cost, many healthbenefits

Weight neutral, reducedmacrovascularcomplications, inexpensive

Fails for most in first year

GI side effects, Rare lacticacidosis; cannot start if creatinine150+ or eGFR below 30

Step 2: additionaltherapySulphonylureas

Inexpensive Weight gain (less than insulin orglitazones), hypoglycaemia

Step 3Insulin

Triple therapy (metformin,sulphonylurea, glitazone)

Consider newer agents(see below)

No dose limit.Improved lipids

avoids insulin

Injections, monitoring, weight gain,hypoglycaemia, training

Weight gain, heart failure,expensive, less effective thaninsulin; pioglitazone first line ashas better CVD risk profile than

rosiglitazoneIncreased fracture risk in womenwith the glitazones

Step 1 Lifestyle advice

Dietary and physical activity advice, with emphasis on benefits of weight loss in theoverweight and of exercise (see Chapter 3: Education, Nutrition and Lifestyle)In motivated patients consider use of anti-obesity drugs (best results in people who

lose >2kg before starting drugs). Note that orlistat is first choice because sibutraminecan increase blood pressure in susceptible individuals.

Step 2 Additional therapy

Metformin could be added within 2-3 months of diagnosis if lifestyle interventions failto achieve or maintain metabolic goals. However, if the patient is symptomatic atdiagnosis with high HBA1c, then metformin should be offered at time of diagnosis

A sulphonylurea should be added 3-6 months after metformin, or at any time whenthe HbA1C goal is not achieved

Step 3 Triple oral therapy or add insulin

Triple oral therapy is relatively expensive and less effective than insulin, but can beconsidered if HbA1C not severely raised (


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Usually insulin is instituted as a single basal dose of intermediate or long-actinginsulin at bedtime, added to daytime oral agents

Glitazones should usually be discontinued when insulin is started (they areoccasionally prescribed under specialist supervision)

Consider referral for Very Low Calorie Diet Clinic for intensive weight management inpeople wishing to defer/avoid insulin

Step 4 Intensification of insulin treatmentUsually consists of additional injections that might include a short acting insulinbefore selected meals: indicated when fasting blood glucose at target but HbA1C stillhighOtherwise, conversion to a biphasic isophane insulin e.g. Humulin M3 or Mixtard 30twice daily could be the next stepWhen pre-meal insulin is started sulphonylureas should be discontinued

Blood glucose monitoring and carbohydrate counting essential in this group for bestresults

Additional Notes about Oral Hypoglycaemic agents.

a. Metformin

Cautions

Avoid if eGFR falls below 30ml/min/1.73m2, or creatinine 150mmol/l or above

Side effects

Lactic acidosis (rare, except in patients with dehydration & stage 4/5 renaldisease)

Diarrhoea, nausea, abdominal discomfort common; less likely if low startingdose and gradual titration. Side effects commonly settle within a fortnight.

Dose

500mg once daily with food

Increase at 1-2 weekly intervals by 500mg to a maximum of 1g twice daily.Advise patient not to increase dose till side effects settle

Notes

Try MR preparation if side effects do not settle (given once or twice daily,never tds)

b. Sulphonlyureas.

Side effects

Hypoglycaemia: educate re symptoms and treatment of hypos

Dose Start low dose eg gliclazide 40mg bd to avoid hypoglycaemia. Titrate at 4 8week intervals, more quickly if osmotic symptoms persist

Notes

Gliclazide is the formulary choiceSheffield formulary does not recommend Gliclazide MR

Glibenclamide: Avoid in the elderly or impaired renal function increased riskof hypoglycaemia.


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c. Thiazolidinediones, pioglitazone is the formulary choice

Side effects

Mild anaemia due to fluid retention, peripheral oedema, new or worsenedheart failure, weight gain.DO NOT USE glitazone if macular or retinal oedema

Pioglitazone has a more favourable CVD risk profile than rosiglitazone, and isnow the glitazone of choice for new patients, and any others who have CVDor who wish to change.

Dose

Pioglitazone start at 30mg, max dose 45mg. Less expensive and morefavourable effect on lipids than rosiglitazone.

Notes

Liver function tests should be checked 2 monthly for 12 months then annually- but mild abnormalities common in T2DM (fatty liver) are not acontraindication.

Combination therapy with metformin is likely to help concordance.

d. Other agents

Exenatide (Byetta)

given subcutaneouslyrelatively expensivemay help to lose weight

some risk of hypoglycemiamaximum benefit usually a drop in HBA1c of around 1%

risk of pancreatitis

Sitagliptin (Januvia)

given once daily orallyrelatively expensivesome risk of hypoglycemiain place of glitazonemay help lose weight

maximum benefit usually a drop in HBA1c of around 1%

Repaglinide

enhances insulin response to meals; should only be taken before meals

rapid onset and short duration of action. Not generally recommended

BELOW IS THE SHEFFIELD CONSENSUS SUMMARY OF NICE GUIDANCE ONGLUCOSE CONTROL IN DIABETES, DATED NOVEMBER 08. IT IS ADDED HERE FORREFERENCE.


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3.2 Supplementary Information: Management of Type 2 Diabetes -Sheffield Summary of updated NICE guideline CG87 May 2009

The original guidelines from NICE were published in 2002. Since then, there hasbeen substantial change in the way that diabetes care is being delivered, not leastthe new GMS contract in 2003. In addition, in the intervening years, there has been

substantial new evidence of various aspects of management and the emergence ofvarious new therapies. This is a summary of the revised NICE guideline CG87, May2009.

Education & Lifestyle ManagementThis aspect is one of the most important challenges of the updated NICE guidance,with implications both for patients and healthcare staff education.

Every person and/or their carer should be offered structured education aroundthe time of diagnosis with annual reinforcement. A structured educationprogramme requires an evidence based approach, should be tailored toindividual needs, with a formal curriculum, and delivered by trained educators.

Group settings are preferred.In addition, regular nutritional advice, that is sensitive to cultural needs, shouldbe delivered by health professionals with specific expertise and competenciesin nutrition. A dietician plays a key role, but all team members need to deliverconsistent dietary and lifestyle advice. A normal healthy diet based on highfibre and low glycaemic index carbohydrates is recommended.

There is now strong evidence that structured education provides people with theskills to successfully self-manage their diabetes and enable them to take control oftheir condition. The Healthcare Commission survey in 2007 showed that only 11% ofpeople with type 2 diabetes have been offered structured education. In Sheffield

these programmes are DESMOND for people with newly diagnosed type 2 diabetesand DAFNE for people with Type 1. The challenge is to offer ongoing structurededucation and dietary advice for all patients with established diabetes.

Monitoring of Glycaemic ControlThe guideline notes that the setting of a single target figure is unhelpful andacknowledges the difficulties of setting and achieving targets in the real world. Itreflects the controversy of setting very low targets, particularly in view of the recentresults from the ACCORD and ADVANCE studies.

Involve the person with diabetes in the setting of an individualised target,

which may be higher than the generally recommended HbA1c level of 6.5%.Patients should be encouraged to maintain their individual target unless theresulting side effects (including hypoglycaemia) or their efforts to achieve thisimpair their quality of life.

Extremely tight glycaemic control (HbA1C


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Self-monitoring is particularly indicated in,o Those on insulin treatmento Those on oral therapies to provide information on hypoglycaemia and

to assess changes in glycaemic control as a result of changes inlifestyle or medication.

o Monitoring changes during inter-current illnesso Ensuring safety during activities, including driving

Individuals who do self monitor should be assessed at least annually and in astructured way including:

o Self-monitoring skillso The quality and appropriate frequency of testingo The use made of the results obtainedo The impact on quality of lifeo The continued benefito The equipment used.

If self-monitoring is appropriate but blood glucose monitoring is unacceptableto the individual, discuss the use of urine glucose monitoring.

Glucose Lowering TherapiesThere are important changes to the previous guidelines, particularly in relation tothiazolidinediones (pioglitazone first line in Sheffield). The mainstay of oral therapiesremains metformin and sulphonylureas.

Metformin remains the first line treatment for those in whom lifestyleintervention has not been successful, unless contra-indicated by renalimpairment (eGFR < 30 ml/minute/1.73m2 or serum creatinine greater than150micromol/l)) or low cardiac output.Sulphonylureas should remain the mainstay of second line therapy.

If glycaemic targets (6.5% if the persons job or otherissues make the risk of hypoglycaemia with sulphonylureas particularlysignificant or they are taking a sulphonylurea and are not able to toleratemetformin (or it is contraindicated).

Exenatide should be considered as an alternative to insulin orthiazolidinediones in people with a BMI > 35kg/m2 (adjust lower in patientsfrom ethnic minorities), or a BMI < 35.0 kg/m2, and therapy with insulin wouldhave significant occupational implications or weight loss would benefit othersignificant obesity-related comorbidities. Only continue if there are benefitsseen in terms of HbA1c improvement of 1% at 6 months and weight reductionof 3% at 12 months.Consider a DPP-4 inhibiter (sitagliptin is the Sheffield formulary choice)second line in patients with HbA1c level >6.5% who are unable to toleratemetformin or a glitazone or in whom either metformin or a sulphonylurea iscontraindicated. Or 3rd line for patients on both metformin and a sulphonylureaif HbA1c level >7.5% and insulin is unacceptable or inappropriate Onlycontinue if there are benefits seen in terms of HbA1c improvement of 0.5% at

6 months.


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Oral therapies (both metformin and sulphonylureas) should be continued ifstarting a basal insulin, but sulphonylureas should be reviewed if starting pre-mixed insulin therapy. Pioglitazone, in combination with insulin may be helpfulin certain circumstances, but currently it is recommended to stop glitazonewhen commencing insulin.

The type of insulin regimen chosen needs to be made on an individual basis.No overall advantage of one approach over another was identified.

Human NPH (isophane) insulin should be the default basal insulin of choicefor most people. Insulin glargine, which is significantly more expensive, isindicated particularly in those with disabling (especially nocturnal)hypoglycaemia and in those who require help from others to administerinsulin. There is no clear evidence that glargine is superior to NPH insulin forthe majority of people with type 2 diabetes. According to some evidence,glargine may be associated with a higher incidence of cancer, but recentlyevidence is emerging that this has been over stated. The current Sheffieldstance is that patients should be made aware of this but that the risksbalanced with benefits, and if the patient has a current or past history of

cancer, then a trial change to another background insulin could be tried.

The guideline emphasises the importance of individualising insulin regimens. Itemphasises the importance of structured education and active dose titration as ameans to achieve better glycaemic control. The principal benefit of the long actinginsulin analogue, glargine, is reduced hypoglycaemia. Other benefits of glargine aremarginal at best. NPH insulin, eg Insulatard, which is substantially cheaper, shouldremain the first choice basal insulin for most people. Although not reviewed in thisguideline, it is unlikely that the advice on insulin detemir will be any different.

Reference:

NICE CG87: Type 2 diabetes. Available athttp://guidance.nice.org.uk/CG87
http://guidance.nice.org.uk/CG87http://guidance.nice.org.uk/CG87http://guidance.nice.org.uk/CG87http://guidance.nice.org.uk/CG87


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1. Insulin regimens in type 2 diabetes

See Guideline 10, Chapter 2.

Insulin initiation for patients with type 2 diabetes in primary care

a) Indications for insulin therapy

Poor glycaemic control on maximum tolerated doses of oral agents

Severe symptoms, particularly tiredness and weight loss

Severe intercurrent illnessPregnancy

It is essential that before embarking on initiating insulin therapy that the decision andprocess is discussed with the patient and the Diabetes Specialist team (Consultant andDiabetes Specialist Nurse). Ideally all patients should also be referred for a pre-insulin

assessment by a dietician, in order to optimise the chances of achieving lifestyle change andto reduce the risks of weight gain on insulin: in some patients the need for insulin can bedelayed or avoided. In addition to this there should be arranged mentorship for the primarycare staff involved.

b) Initiating insulin therapy education models

Groups adhering to a structured curriculum. Insulin initiation and education forself-management takes place for 6-8 people over a period of 6 weeks. Advantages ofthis model are that it gives the opportunity for group support and is also efficient on stafftime.

Enhanced One to one for patients who are not suitable for a group start.

Both approaches focus on the patient TAKING RESPONSIBILITY following acomprehensive self-management programme.

c) Indicative content of programmeBackground to needing insulin, targets of control, self-monitoring, gadgets, insulin dose andadjustment, lifestyle management and change, foot care advice, sick day rules, etc.

d) Personnel requiredThere should be a GP and practice nurse with a specialist interest and demonstrated furthertraining in diabetes supported by a diabetes specialist nurse, consultant and ideally adietician. Also essential is the support of the rest of the primary health care team as well as

adequate staffing and resources. The patients should have a recognised support networkand a contact point.

e) Treatment optionsRegimens to consider are:-

Night-time Isophane (eg Humulin I or Insulatard) with daytime MetforminNight-time long acting analogue (eg glargine) if sub optimal fasting sugars with night-timehypoglycaemia, on night-time isophane and metformin

BD mixture (eg Mixtard)Intensive insulin regimen with carbohydrate counting (Basal Bolus)

Regimens should be decided in conjunction with the DSN and patient, taking lifestyle issuesinto account.


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f) Ongoing supportTimescale for reviewing control etc should be negotiated with the individual and the group asa whole and recorded in the personal care plan. When the insulin initiation programme iscomplete and glucose optimised, the patient should then re-enter the primary care systemfor ongoing review and monitoring.

Date: May 09 Review Date: May 2012.


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3.3 Supplementary Information - HBA1c Standardisation NEWUNITS

From June 2009 the units used to express HBA1c are changed from % glycatedhaemoglobin to mmol/mol of haemoglobin without glucose attached.

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has

prepared a new standard specific for HBA1c so all manufacturers of HBA1c calibrators willwork to the same reference range, so that results can be compared internationally, as canresearch findings..

Targets in New Units

The equivalent of DCCT HBA1c targets of 6.5% and 7.5% are 48 mmol/mol and 59mmol/mol respectively. The non-diabetic reference range of 4.0% - 6.0% is now 20mmol/mol 42 mmol/mol.

New Values Comparison

DCCT- HBA1c (%) IFCC- HBA1c (mmol/mol)

6.0 426.5 487.0 537.5 598.0 649.0 75

However, the new standards, like the old standards, do not account for other conditionswhich could affect the HBA1c result, such as anaemia and haemoglobinopathies. In thesecases, HBA1c can only be used as a guide as to trends in glucose control, and anotherassay such as fructosamine (consult Haematology Lab before ordering) could elucidate truevalues in the case of haemoglobinopathies.


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3.4 Supplementary information : Safe Disposal of Sharps

Appropriate and safe disposal of discarded sharps is very important for the safety ofpatients, their families and contractors involved in waste disposal. This guideline describesthe correct way to do this.

a) Disposal of sharps

Sharps including needles, needles and syringes, lancets, empty insulin cartridges orvials must be disposed of in a sharps bin

All people using sharps should have a sharps bin prescribed using FP10 - small 1lsharps bin called a Sharpsguard

Safe clips may be used but the clips must be disposed of in the sharps bin

b) Disposal of sharps bins

These should be delivered to GP surgeries for disposal

The city wide contract for waste disposal covers this

GP surgeries require a special exemption to deal with these sharps bins most practicealready have this

Drop bins will be available for practice so patients can put their full bins directly into thiswithout practice staff having to handle them at all

Housebound patients can arrange for the local authority to collect the full bins but theremay be a charge for this

Pharmacies will not be able to collect sharps bins

Date: May 09 Review date: May 2012


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3.4 Supplementary information: Guidance for the management ofhyperglycaemia (type 2 diabetes) in older people

The approach to management of diabetes in the older people may need to be adapted in

light of their physical and cognitive function, concomitant drugs and social factors.

As with younger adults, the goals of treatment should take into account the wishes of theperson with diabetes and their carers, as well as the risks associated with hypoglycaemia.Specifically, some older people with diabetes may be socially isolated or have limitedcognitive/physical function such that they may have difficulty recognising and dealing withhypoglycaemia.

Alternatively, many older people with diabetes have relatively little in the way of co-morbidityand have a good quality of life such that the aims of their diabetes management should bethe same as for younger adults - while recognising that these may change with increasingfrailty or the development of impairments and disabilities.

Guidance:

Fit and well-preserved older people with diabetes should be managed in the samefashion and with the same glycaemic, cholesterol and blood pressure targets as foryounger adults

Socially isolated, frail or cognitively impaired older people with diabetes, who requiresuphonylureas or insulin, should receive regular monitoring of their HbA1c such that thisremains above 7.5%, the primary aim being symptom control.

Age per se is not a contraindication for insulin - which may be started in community for fitand otherwise healthy older people.

If insulin therapy is considered for people aged over 75 yr, or if the patient is cognitivelyor physically impaired, then referral to the Sheffield specialist diabetes team could beconsidered.

Metformin and glitazones should be used with caution in older people. Metformin cancause renal failure, and glitazones are associated with cardiac failure, increased fracturerisk in women, weight gain and hepatic impairment.

Most Physicians in Elderly Medicine would feel that these patients with diabetes fall intoa group whose 10 year risk is greater than 20% and that they therefore should beconsidered for treatment with statins



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4. Guideline for the management of lipids in diabetes.

4.1 Recommendation: Lipids should be monitored in diabetes at least annually. Acardiovascular risk assessment may not need to be carried out before treating with astatin (see below).

4.2 Evidence: There is good evidence for statin use in both primary and secondaryprevention. Evidence level 1++

4.3 Rationale: Patients with both Type 1 and Type 2 diabetes have a high risk ofdeveloping cardiovascular disease.

4.4 To whom does this guideline apply? All people with diabetes as identified below.

4.5 Guidance:For patients with both type I and type II, treat as below.

Assessment of hyperlipidaemiaExclude secondary causes of hyperlipidaemia: hypothyroidism, renal disease(especially with heavy proteinuria), alcohol abuseSevere hypertriglyceridaemia usually indicates poor glucose control, alcoholexcess or a familial hyperlipidaemiaModerate or severe hypercholesterolaemia, when associated with severehypertriglyceridaemia may also be due to poor glucose control

Non lipid-lowering therapy

Improving glucose control may result in dramatic falls in triglyceride andcholesterol levels in severe mixed hyperlipidaemia

Lifestyle measures, e.g. diet, weight loss and physical activity, have moremodest effect (except where diet results in marked improvement of glucosecontrol). However, the effect is additional to that of drug treatment. Any dietarychanges will also have additional health benefitsReduction of alcohol intake may also result in marked fall in triglycerides

PRIMARY PREVENTIONCriteria

Treat patients over 40 with at least one other CVD risk factor or diabeticcomplication e.g. nephropathy or retinopathy; strong family history of CVD in firstdegree relatives or features of metabolic syndrome (dyslipidaemia, centralobesity, hypertension)

Patients 40 and over, with no complications, risk factors above or known CVD,perform an annual cardiovascular risk assessment using the UKPDS riskcalculator:-www.dtu.ox.ac.uk/index.php?maindoc=/riskengine/ and treat withstatin if CVD 10-year risk reaches or exceeds 20%.

Treatment

Initially prescribe simvastatin 40mg at night, giving concurrent information onlifestyle modification (may be titrated from 20mg to reduce side effects)Consider titrating up to simvastatin 80mg after one month if a cholesterol of lessthan 4mmol/l and a LDL cholesterol of less than 2mmol/l is not reached withsimvastatin 40mg. However, incidence of side effects is increased

No further titration to more potent statins is recommended as other agents arenot cost effective for this indication


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b) SECONDARY PREVENTION

Existing or newly diagnosed cardiovascular disease, or an increased albuminexcretion rate

Consider intensifying therapy with atorvastatin 80mg or addition of ezetimibeto achieve a target of less than 4mmol/l cholesterol or 2mmol/l of LDL if not

reached with simvastatin 80mg.

Diabetes with acute coronary syndrome (ST or non ST elevation MI, orunstable angina)

Patients will be seen in secondary care.

These patients may be treated with more potent statins.

The agent with the best evidence base in this condition is atorvastatin 80mg.

NOTES1. Hypertriglyceridaemia is an independent risk factor for CHD, but not as strong a

predictor as cholesterol. HDL cholesterol is protective. 2. For cholesterol profile assay, the sample may be random or fasting; if triglycerides

are high (>5mmol/L) then a fasting sample is preferable.3. Treat patients regardless of chronological age. However, patients with limited life

expectancy due either to other diseases or old age may gain little from this or otherpreventative treatments and indeed are more likely to suffer side effects. Thesefactors should be taken into account before treating with statins.

Fibrates:

are an alternative if statins are not toleratedare the treatment of choice in:

o moderate isolated hypertriglyceridaemiao severe (>10mmol/L) hypertriglyceridaemia - reduce risk of pancreatitis.

Monitor frequently, e.g. 1 - 2 weekly if Tg > 10mmol/L. Consider referral

Combination therapy with statin and fibrate ideally to be prescribed byspecialistso justified for mixed hyperlipidaemia which persists on a single drugo carries increased risk of myositis. Ask about muscle aches and discontinue

drugs if CPK 10 x normal

Refer to hospital lipid clinic

if persistent hypercholesterolaemia, or severe hypertriglyceridaemia (ie>10mmol/l) despite oral agents

Monitoring:Check LFTs before starting, after 1-3 months, and then 6 monthly for 1 yearCheck CPK before starting, and thereafter only if the patient has severemuscle pains

Side effects

Trial evidence shows most common statin side effects occur equally in the activetreatment and placebo arms. If a patient experiences side effects consider a lower doseof simvastatin or pravastatin.

Muscle aching: Rare, but advise to stop immediately and consult if persistent

unexplained muscle pain. Then check CK for evidence of myositis / rhabdomyolysis.CK > 10 times upper limit of normal confirms


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Contraindications: Statins are contra-indicated in active liver disease (orpersistently abnormal liver function tests) and in pregnancy (adequate contraceptionrequired during treatment and for one month afterwards) and breastfeeding

Cautions: Statins should be used with caution in those with a history of liver diseaseor with a high alcohol intake (use should be avoided in active liver disease).Hypothyroidism should be managed adequately before starting treatment with astatin

Drug Interactions: Please refer to the BNF for a full list of drug interactions. Thereare potentially important interactions between simvastatin / atorvastatin andcyclosporin, fibrates, macrolides (eg erythromycin) and azole antifungals (egketoconazole). Simvastatin potentiates warfarin slightly on average and INR shouldbe measured more frequently until it is stable. Atorvastatin causes a slight decreasein INR

4.6 Exceptions: there are no exceptions to this guideline



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5 Guideline for use of aspirin

5.1 Recommendations:o Offer aspirin 75mg daily for all diabetics for secondary prevention of

cardiovascular disease (if no contraindications exist).

o Offer aspirin 75mg daily for primary prevention in at risk individuals, but takeinto account the individuals risk/benefit.

5.2 Evidence: Secondary prevention 1+, Primary prevention less clear

A more detailed appraisal of the evidence can be found on the nationalprescribing centre website http://www.npci.org.uk/blog/?p=359

5.3 Rationale: This guideline follows NICE CG87 and local guidelines with regard toprescribing aspirin for primary prevention of cardiovascular events in diabetes.

5.4 Towhom does this guideline apply? All people with diabetes identified asdetailed below

5.5 Guidance:

Sheffield clopidogrel guidelines suggest clopidogrel may be used in place ofaspirin For patients with ischaemic heart disease, ischaemic stroke, transientischaemic attack or peripheral artery disease who are unable to take aspirindue to contra-indication or known allergy


Offer Aspirin 75mg daily for secondary prevention

Offer aspirin 75mg daily for primary prevention:

If over 50 years, and CVD risk > 20% over 10 years and BP is


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6 Guideline on foot examinations

6.1 Recommendation:Feet should be examined regularly to identify at risk feetand active problems. Education should be given about foot care.

6.2Evidence: Grade AI6.3 Rationale: Reduction in both ulceration and amputation for those with at riskfeet in specialised intensive education and foot care programmes.

6.4 Towhom does this guideline apply? All people with diabetes (type 1 andtype 2)

6.5 Guidance:

Assessment

ask about previous foot problems and current symptomsnote risk factors for ulceration

previous foot ulcercallusdeformity (clawed toes, bony prominence, Charcot foot, hallux varus or valgus,hammer toes)sensory loss monofilament test preferred

inability to feel monofilament pressed against plantar surface of great toe

or first, third or fifth metatarsal head. Apply perpendicularly until filamentbuckles to give 10g force. Abnormality at one or more site on each foot isconsistent with neuropathy.reduced pinprick sensation

reduced vibration sense at great toe compared to ankle

peripheral arterial disease

absent foot pulses

thin shiny skin, absent hair, loss of subcutaneous tissuedusky red or cyanosed skin

old age, poor vision, social deprivation or isolation, smoking

Actionlow current risk foot (normal sensation, palpable pulses)

basic foot care advice

refer to podiatry for group foot care education sessions (these are ideally carriedout within 6 months of diagnosis)

at risk foot (neuropathy or absent pulses or other risk factor)

enhance foot care education

inspect feet 3-6 monthlyrefer for podiatry

advise on appropriate footwearhigh risk foot (neuropathy or absent pulses plus deformity, or previous

ulcer/amputation)as for at risk foot and

refer for special footwearperipheral arterial disease

address metabolic diabetes control and other risk factors


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6.6 Exceptions: There are no exceptions to this guideline

6.7 Date: May 09 Reviewdate: May 2012

painful neuropathy:

optimise glucose control, try simple analgesics

add 1) Amitriptyline or Imipramine; 2) Gabapentin and Pregabalin or; 3) Duloxetine(similarly effective for neuropathic symptoms and are first line drugs):

a) Amitriptyline or Imipramine these are cheaper but less well tolerated due to side effects:dry mouth, sedation, urinary retention, confusion in elderly. Higher doses are contraindicatedin those with ischaemic heart disease. Start at 25mg nocte, increase by 25mg to max150mg, depending on tolerance of side effectsb) Gabapentin start 300mg once daily for 2-3 days, bd for 2-3 days, then tds. Titrate as

necessary; doses exceeding 1800mg daily may be needed. Pregabalin start at 75 mg bdfor 2 days and then 150 mg bd with maximum dose being 300 mg bd. Drowsiness anddizziness are the commonest side effects. They are contraindicated in patients withperipheral oedema.c) Duloxetine (selective serotonin noradrenalin reuptake inhibitor SNRI) Start at 30 mg odfor 2 days and then 60 mg od. Maximum dose is 60 mg bd. Side effects include nausea anddizziness. It is contraindicated in those with liver disease.d) Tramadol 50-100mg sometimes helpful for severe neuropathic pain. Do not give it incombination with tricyclic antidepressants or duloxetine (an SNRI).e) Oxycodone 10-60 mg/ day is also indicated for severe refractory painful neuropathy. Sideeffects are those of opiates.

Charcot arthropathy:suspect if patient with neuropathy presents with warm swollen foot and/or leg. Maybe pain and erythemaTypically mimics cellulitis or DVT or gout

Previously rare, therefore often missedAdvise to avoid weight-bearingPhone or Fax same day referral to the Diabetes Centre

Hospital referral if

refractory painful neuropathy or atypical painful neuropathy (e.g. assymetrical painfulneuropathy). Refer to general Diabetes Clinic

foot deformity and neuropathy or peripheral arterial disease refer to Foot Clinic forspecial footwear

symptomatic peripheral arterial disease (severe, intermittent claudication, ischaemic restpain) consider referral to vascular surgeon for admission or early clinic referral

spreading cellulitis, abscess or wet gangrene admit as emergency/same day referral toDiabetes Centre

Refer to next Diabetic Foot Clinic if:

new diabetic foot ulcer (break in skin below the level of the malleoli) or necrotic lesioncallus with local infectionnail pathology with ischaemia and infectionsuspected Charcot arthropathy (or same day referral to Diabetes Centre)undiagnosed foot problem in At Risk foot


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6.8 Supplementary information 1: Referral protocol for the preventionand management of foot problems in people with Diabetes

Yes

No

Yes No

Yes

No

No

Yes No Yes

Is person at low current risk offoot ulcer?(normal sensation, palpable pulses,foot and footwear ok)

Are you competent in assessing the diabeticfoot, using the Foot Assessment Tool?

examine patient's feet and lower legs to detectrisk factors following the Foot AssessmentTool include:

- testing of foot sensation(using 10 g monofilament or vibration)

- palpation of foot pulses- inspection for any foot deformity or lesions-

inspection of footwear

Refer patient toPodiatry Service,or to Diabetic Foot clinicif ulceration present

Request training indiabetic foot

assessment

Does the individual have a foot ulcer?

Refer to DiabeticFoot Clinic

Refer patient to PodiatryService for clinical

appointment (within 4 weeks)

Are any other risk factorspresent? Poor vision, over70 years of age?

Refer to podiatryService indicating thatpatient has beenassessed as low risk.Patient will be invited toa Foot Care educationtalk (Within 6 months)

Is the patient alreadyattending the NHS Podiatry

service?

followprotocolindicating that theindividual is a currentpatient on any referralor Contact the Podiatristdirectly to arrange care


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6.9 Supplementary information 2: Foot care advice for people withdiabetes

Basic foot care advice - for people with no neuropathy, peripheral arterial disease,callus, deformity etc.

ask your diabetic clinic to check the blood supply and sensation of your feeteach year

look at your feet daily (or get someone to do this for you)

contact your doctor or podiatrist if there seems to be a problem even it if doesnot hurt

keep your feet clean and well moisturised

wear well fitting shoes

try to keep your diabetes well controlled

dont smoke

Foot care advice for people with at risk/high risk feet

see your clinic or podiatrist regularly for foot checks

look at your feet daily (or get someone to do this for you)

contact your doctor or podiatrist urgently if there are any sores, blisters,changes in skin colour or septic areas

wear well fitting shoes. If you are given special shoes, your must wear them

as they are designed to protect your feetwear in new shoes gradually - wear for 1-2 hours/day

check shoes for rough edges and bits inside like grit, every time you wearthem. Socks should be the correct fit and worn inside out to prevent injurycaused by the seams

avoid contact with heat. You may not feel it if your feet burn

never go barefoot

keep your feet clean and well moisturised

never attempt self treatment or use corn cures. Ask to see a HCP Registered

Podiatrist for nail care

Dont Smoke

try to keep your diabetes well controlled

ask that someone teach you to look after your feet


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7 Guideline on eye screening

7.1 Recommendation: Screen eyes annually from diagnosis for all people withdiabetes aged 12 or over.

7.2 Evidence: Grade AI7.3 Rationale: Fundi should be examined regularlyto reduce risk of visualimpairment with photocoagulation.

7.4 To whom does this guideline apply? All adults with diabetes and childrenwith diabetes aged 12 and over.

7.5 Guidance:

7.6 Exceptions: Children aged 11 or under are not required to register for theDiabetes Eye Screening Programme.


7.8 Supplementary information: Sheffield Eye Screening Programme

It is a requirement of the National Service Framework for Diabetes that all peoplewith diabetes are offered annual retinopathy screening by digital photography. Theexisting scheme in Sheffield has, therefore, had to be redesigned to meet the newstandards.

All people aged 12 or over are now on the central eye screening register, includingthose who receive their diabetes care from the hospital. Those who are underdiabetic ophthalmic care at STH will have their retinal examination undertaken at thehospital rather than in the community until discharge. Further information on the eyescreening programme can be found in cha

Documents

SheffieldDiabetesResourcePack