TYPE 1 DIABETES IN ADULTS

Transcription

1 The National Collaborating Centre for Chronic Condition Funded to produce guideline for the NHS by NICE TYPE 1 DIABETES IN ADULTS National clinical guideline for diagnoi and management in primary and econdary care Publihed by ROYAL COLLEGE OF PHYSICIANS

2 Acknowledgement The National Collaborating Centre for Chronic Condition would like to thank Elizabeth Aung, Stora Djumaeva, Jane Ingham, Hilary Jackon, Mike Pearon and Sarah William of the National Collaborating Centre for Chronic Condition for their work and advice on thi project, Emma Cox and Bridget Turner of Diabete UK for their dicuion paper on upport group, and Jane Cowl and Victoria Thoma of the Patient Involvement Unit for NICE for their advice and aitance. Thank are alo due to Sue Blakeney, Kevin Shotliffe and Roemary Walker for attending a meeting a deputie to repreent the College of Optometrit, Diabete UK and the Royal College of Nuring repectively, and Derek Lowe for hi expert advice on interpreting tatitical apect of the evidence bae. We are alo grateful to the National Collaborating Centre for Primary Care for haring their work on the revied Type 2 diabete foot care guideline with u. ROYAL COLLEGE OF PHYSICIANS 11 St Andrew Place, London NW1 4LE Regitered charity No Copyright 2004 Royal College of Phyician of London ISBN Typeet by Dan-Set Graphic, Telford, Shrophire Printed in Great Britain by Sarum ColourView Group, Salibury, Wilthire

3 Memberhip of development group Conenu Reference Group (CRG) The name with an aterik (*) againt them were alo member of the Guideline Development Group (GDG). Dr John Atbury, repreenting the Faculty of Public Health Medicine Conultant in Health Protection, Health Protection Agency, Cumbria and Lancahire M Clare Bailey, repreenting the Royal College of Ophthalmologit Conultant Ophthalmologit, Britol Eye Hopital Mr Steven Barne* Health Service Reearch Fellow, National Collaborating Centre for Chronic Condition Mr Richard Broughton, repreenting the College of Optometrit Community Optometrit, Surrey Dr Vincent Connelly, repreenting the Royal College of Phyician of London* Conultant Phyician and Clinical Director, The Jame Cook Univerity Hopital, Middlebrough Dr Melanie Davie, repreenting Diabete UK Conultant Phyician in Diabete and Endocrinology, Univerity Hopital of Leiceter NHS Trut Mr Richard Edlin* Reearch Aociate in Health Economic, Sheffield Health Economic Group, Univerity of Sheffield, and Health Economit, National Collaborating Centre for Chronic Condition Dr Gary Frot, repreenting the Britih Dietetic Aociation* Head of Therapy Service and Nutrition & Dietetic Reearch Group, Imperial College and Hammermith Hopital NHS Trut Dr Roger Gadby, repreenting the Royal College of General Practitioner* GP in Nuneaton, Warwickhire, Senior Lecturer in Primary Care at the Univerity of Warwick and Medical Advier, Warwick Diabete Care Dr Marilyn Gallichan, repreenting the Royal College of Nuring Diabete Specialit Nure, Royal Cornwall Hopital Trut Mr Rob Grant* Project Manager, National Collaborating Centre for Chronic Condition M Irene Gummeron, Royal Pharmaceutical Society of Great Britain Pharmacit, Yorkhire M Debbie Hammond, patient and carer repreentative repreenting Diabete UK* Dr Simon Heller, Diabete UK* Reader in Medicine, Univerity of Sheffield and Honorary Conultant Phyician, Sheffield Teaching Hopital NHS Trut iii

4 Type 1 diabete in adult: national clinical guideline for diagnoi and management Profeor Philip Home* Profeor of Diabete Medicine, Univerity of Newcatle upon Tyne, and Clinical Advior, National Collaborating Centre for Chronic Condition Profeor De Johnton Profeor of Endocrinology and Metabolic Medicine, Imperial College and Hammermith Hopital NHS Trut, and CRG Chair, National Collaborating Centre for Chronic Condition Dr Colin Johnton, repreenting Diabete UK Conultant Phyician and Endocrinologit, Wet Hertfordhire Hopital NHS Trut Dr George Kaiano, repreenting the Royal College of General Practitioner General Practitioner, Berkhire Dr Eric Kilpatrick, Aociation of Clinical Biochemit Conultant in Chemical Pathology, Hull Royal Infirmary M Suzanne Luca, patient and carer repreentative, repreenting Diabete UK* M Emma Marcu, repreenting the Britih Dietetic Aociation Clinical Specialit Diabete Dietitian, Heart of Birmingham Teaching Primary Care Trut Dr Alatair Maon* GDG Lead, National Collaborating Centre for Chronic Condition Dr Greg McAnulty, repreenting the Royal College of Anaethetit Conultant in ITU and Anaetheia, St George Healthcare NHS Trut Dr Colin McIntoh, repreenting Diabete UK* Conultant Phyician in Diabete and Endocrinology, Chelea and Wetminter Hopital NHS Trut and Honorary Senior Lecturer, Imperial College London M Sarah O Brien, Royal College of Nuring* Nure Conultant, St Helen and Knowley Hopital NHS Trut Dr Vinod Patel, repreenting Diabete UK Conultant Diabetologit, George Eliot Hopital NHS Trut and Reader in Clinical Skill, Univerity of Warwick Medical School M Karen Reid* Information Scientit, National Collaborating Centre for Chronic Condition Profeor Ken Shaw, Royal College of General Practitioner Conultant Phyician and Director of Reearch & Development, Portmouth Hopital NHS Trut, and Aociation of Britih Clinical Diabetologit Mr David Turner, patient and carer repreentative, repreenting Diabete UK* M Barbara Wall, Society of Chiropodit and Podiatrit Senior Lecturer and Programme Leader for Podiatry, Univerity of Eat London The National Collaborating Centre for Women and Children Health convened a eparate guideline development group to develop the children and adolecent Type 1 diabete guideline. Dr Vincent Connelly wa a member of both group, helped co-ordinate the work of the two national collaborating centre throughout the proce, and chaired the joint meeting of the two GDG. iv

5 Content Preface Gloary vii ix THE DEVELOPMENT OF THE GUIDELINE 1 Introduction Definition Health and reource burden Scope Other relevant work 5 2 Methodology Aim and principle The developer Searching for the evidence Syntheiing the evidence Health economic evidence Drafting recommendation Agreeing recommendation Writing the guideline Structure of the guideline 13 3 Key meage of the guideline Key recommendation An outline Type 1 diabete care algorithm Audit criteria 18 THE GUIDELINE 4 Diagnoi Rationale Evidence Comment Conideration 25 5 Care proce and upport Scope of thi chapter Optimal healthcare procee Support group Quality audit and monitoring 33 6 Education programme and elf-care Education programme for adult with Type 1 diabete Self-monitoring of blood glucoe Dietary management Phyical activity Cultural and individual lifetyle 49 v

6 Type 1 diabete in adult: national clinical guideline for diagnoi and management 7 Blood glucoe control and inulin therapy Clinical monitoring of blood glucoe Glucoe control aement level Inulin regimen Inulin delivery Hypoglycaemia: prevention of hypoglycaemia, problem related to 69 hypoglycaemia and management of ymptomatic hypoglycaemia 8 Arterial rik control Identification of arterial rik Intervention to reduce rik and to manage arterial dieae Blood preure 83 9 Management of late complication: diabetic eye dieae Retinopathy urveillance programme Screening tet for retinopathy Referral Non-urgical treatment of diabetic retinopathy Management of late complication: diabetic kidney dieae Kidney damage Management of late complication: diabete foot problem Screening and urveillance of diabetic foot problem Management of foot ulceration and aociated rik factor Management of late complication: diabete nerve damage Diagnoi and management of erectile dyfunction Diagnoi and management of autonomic neuropathy Optimum management of painful neuropathy Management of pecial ituation Adult who are newly diagnoed Diabetic ketoacidoi Inpatient management Aociated illne Pychological problem Eating diorder Area for future reearch 135 APPENDICES A: Clinical quetion and earch trategie 139 B: Unlicened medicine 145 C: The cope of the guideline 146 D: Evidence table 151 REFERENCES 153 vi

7 Preface It i a pleaure to introduce thi national guideline on Type 1 diabete in adult, commiioned by the National Intitute for Clinical Excellence (NICE) to identify bet practice for the NHS in the management of Type 1 diabete. It i the fourth uch guideline to be prepared by the National Collaborating Centre for Chronic Condition (NCC-CC) baed at the Royal College of Phyician of London. Type 1 diabete can, if poorly controlled, produce devatating problem in both the hort and the long term. Good control of blood glucoe level reduce the rik of thee problem ariing, but can be very difficult for patient and carer to achieve. Thi guideline emphaie that the NHS hould provide all patient with the mean and the neceary undertanding to control their diabete, and that it hould help patient integrate the dieae management with their other activitie and goal. It argue that every peron with diabete hould be able to develop their own care plan and utilie effective treatment in a way agreeable to them. The input of variou health profeional may be needed to achieve thi, and hould be readily available. A ytem of regular monitoring, o that any complication which do develop are picked up at an early tage and treated appropriately, hould alo be provided. In common with all NICE guideline recommendation, thoe for Type 1 diabete have been developed uing a rigorou, evidence-baed methodology. An extenive earch identified the relevant medical literature, and paper were carefully aeed to enure that recommendation were baed on treatment and practice of proven benefit. Thi proce wa carried out by a guideline development group (GDG), a mall team from the NCC-CC working together with patient and health profeional with wide expertie in Type 1 diabete. They have ued the available evidence to produce guidance that i clinically relevant a well a methodologically ound. The availability of clinical expertie alo allowed recommendation to be made in area for which there i inadequate evidence, but which are important to patient and carer. At the ame time the need for further reearch in thee area wa indentified. It goe without aying that the member of the GDG deerve enormou thank for their effort. The technical team at the NCC-CC, the GDG Lead, the Clinical Advior and the ret of the group have all worked incredibly hard over the pat two year, and have been mot generou with their time. Thank are alo due to all thoe who commented on the guideline at variou tage of development. Since I have aumed the directorhip of the NCC-CC only at the very end of thi proce, I can ay without any elf-aggrandiement that they have done a magnificent job. Thi full guideline i both an excellent clinical reference work and a practical working document which will improve the care of thoe with Type 1 diabete. Bernard Higgin MD FRCP Director, National Collaborating Centre for Chronic Condition vii

8 Gloary ACE inhibitor ADA AER Albuminuria Alpha-glucoidae inhibitor AMIDA Autoimmune dieae Baal-bolu inulin regimen BGAT BMI CDA CGMS CMAP Cochrane review Concordance COPD Cot-effectivene C-peptide CRG CSII DAFNE DCCT Deep ubcutaneou fat Diabete centre Angiotenin-converting enzyme inhibitor. American Diabete Aociation. Albumin excretion rate; a meaure of kidney damage due to diabete (and other condition) and a rik factor for arterial dieae. The preence of albumin and other protein in urine. Group of drug which inhibit the digetion of complex carbohydrate in the gut, and thu flatten the pot-meal blood glucoe excurion. Active meal-time inulin doe adjutment (ee DAFNE). Condition in which a peron own tiue become the target of attack by their immune ytem. A meal-time + baal inulin regimen, in which hort- or rapid-acting inulin i given before meal, and an extended-acting inulin to cover requirement at night and ometime between meal. Blood glucoe awarene training. Body ma index; an index of body weight corrected for height. Canadian Diabete Aociation. Continuou glucoe monitoring ytem. Compound mucle action potential. The Cochrane Library conit of a regularly updated collection of evidence-baed medicine databae including the Cochrane Databae of Sytematic Review (review of randomied controlled trial prepared by the Cochrane Collaboration). Concordance i a concept reflecting the extent to which a coure of action agreed between clinician and a peron with diabete i actually carried out; often but not olely ued in the ene of therapeutic intervention or behavioural change. Chronic obtructive pulmonary dieae. Comparative analyi of the cot and health benefit of the treatment or care. In cot effectivene analyi, the outcome of different intervention are converted into health gain for which a cot can be aociated, for example, cot per diabetic complication prevented. Biologically inactive part of proinulin molecule, ecreted in equal molar quantitie with inulin. C-peptide level give information on endogenou inulin ecretion. Conenu Reference Group. Continuou ubcutaneou inulin infuion; inulin therapy delivered by a pump rather than injection. Doe adjutment for normal eating; a recent adaptation of a ytem of elf-adjutment of meal-time inulin doe requirement baed on aement of intended food intake. Diabete Control and Complication Trial; a landmark tudy of the effect of intenification of diabete care on development of microvacular complication. Layer of ubcutaneou fat into which inulin ha to be injected for optimal effect. A generic term for a ource of a unified multidiciplinary diabete ervice. ix

9 Type 1 diabete in adult: national clinical guideline for diagnoi and management Diabete mellitu Diabete regiter Diabete UK DKA DSME ECG Education ELISA EmAb FBG Framingham equation Fuzzy logic Chronic condition characteried by elevated blood glucoe level. Diabete i of divere aetiology and pathogenei, and hould not be regarded a a ingle dieae. Predominant type are Type 1 diabete and Type 2 diabete, diabete econdary to other pancreatic dieae or other endocrine dieae, and diabete of onet in pregnancy. A databae, at practice, clinic or regional level, including all people diagnoed with diabete, and containing information on outcome, complication recall and urveillance, and treatment. Self-help charity for people with diabete in the UK, and a profeional organiation for diabete care. Diabetic ketoacidoi. Diabete elf-management education. Electrocardiogram. In the context of thi guideline, patient education in elf-management of everyday diabete iue like inulin therapy, dietary change, elf-monitoring of glucoe level, phyical exercie, foot care, coping with concurrent illne, how to avoid hypoglycaemia, complication, arterial rik control, job and travel. Enzyme-linked immunoorbent aay. Anti-endomyial antibodie. Fating blood glucoe level or concentration. A widely known and ued calculation of arterial rik, derived from a long-term tudy in Framingham, Maachuett. Not valid in people with Type 1 or Type 2 diabete. A logical computing technique, here a ued to control inulin infuion on the bai of degree of certainty of meaurement. GA Anti-gliadin antibodie; ued in the detection of coeliac dieae. GDG Guideline Development Group. GFR Glomerular filtration rate; a meaure of kidney function. GHb Glycated haemoglobin, ee HbA 1c. Glucoe excurion Change in blood glucoe level epecially after meal. Grade (of A code (eg A, B, C) linked to a guideline recommendation, indicating the trength recommendation) of the evidence upporting that recommendation. The grading doe not indicate the importance of the recommendation, nor the certainty of it being true. HbA 1c The predominant form of glycated haemoglobin, preent in red blood cell, and formed when the normal haemoglobin A react non-enzymatically with glucoe. A the reaction i low and only concentration dependent, the amount of HbA 1c formed i proportional only to the concentration of HbA and glucoe. A HbA remain in the circulation for around three month, the amount of HbA 1c preent, expreed a a percentage of HbA, i proportional to the glucoe concentration over that time. HPLC High performance liquid chromatography; one method ued in the meaurement of HbA 1c. HTA Health technology aement; funded by the NHS Reearch and Development Directorate. ICA Ilet cell antibodie (ee ilet B cell). IDF International Diabete Federation; a global federation of diabete aociation. IgA Immunoglobulin A. IGT Impaired glucoe tolerance; a condition of hyperglycaemia le marked by diabete but aociation with a high rik of arterial damage. x

10 Gloary Inulin analogue Inulin regimen ISDN Ilet B-cell; ometime β-cell Iophane inulin ISPAD Lente inulin MCV MDI Metabolic yndrome Methodological limitation Microalbuminuria MNCV MODY Multidiciplinary team NCC-CC NHS NICE NPH inulin NPT NSC NSF OGTT PDE5 inhibitor PPAR-γ agonit A derivative of human inulin in which change of the amino-acid equence alter duration of action after injection. A therapeutic combination of different inulin preparation, including time of injection and frequency during a day. Ioorbide dinitrate. Located in the ilet of Langerhan of the pancrea, the cell which produce inulin. A ynonym for NPH (neutral protamine Hagedorn) inulin. International Society for Paediatric and Adolecent Diabete. A baal inulin, made by combining inulin with large amount of zinc; firt available in Motor conduction velocity. Multiple daily injection (ee baal-bolu inulin regimen). Overweight (abdominal adipoity), inulin inenitivity, higher blood preure, abnormal blood fat profile. Feature of the deign or reporting of a clinical tudy which are known to be aociated with rik of bia or lack of validity. Where a tudy i reported in thi guideline a having ignificant methodological limitation, a recommendation ha not been directly derived from it. A low but clinically ignificant level of albumin and other protein in the urine. Motor nerve conduction velocity. Maturity onet diabete in the young, a dominant gene diorder, not to be confued with Type 1 diabete, and not inulin dependent. Team of people of differing expertie; for diabete care with expertie in patient education, prevention, therapy, management of complication, foot care, diet, counelling and the like. The National Collaborating Centre for Chronic Condition, et up in 2000 to undertake commiion from NICE to develop clinical guideline for the NHS. National Health Service. Thi guideline i written for the NHS in England and Wale. National Intitute for Clinical Excellence; a pecial health authority et up within the NHS to develop appropriate and conitent advice on health care technologie, and to commiion evidence-baed guideline. Neutral protamine Hagedorn inulin, a baal inulin, named after the Danih reearcher Han Chritian Hagedorn, and developed in the Synonymou with iophane inulin. Near patient teting. National Screening Committee (UK). National Service Framework; a nationwide initiative deigned to improve delivery of care for a related group of condition. Oral glucoe tolerance tet; a diagnotic tet ometime ued in people with equivocal diabete. Phophodieterae type 5 inhibitor, a cla of drug developed in recent year to treat erectile dyfunction. A group of drug which improve inulin enitivity in people with reduced enitivity to their own or injected inulin; preently the licened drug are both of the chemical group known a thiazolidinedione (trivially glitazone ). xi

11 Type 1 diabete in adult: national clinical guideline for diagnoi and management PROCAM Proteinuria QALY RCT RDW Rigican SIGN SNAP SWM Technology appraial Type 1 diabete Type 2 diabete UKDIABS UKPDS VO 2 max VPT WHO Propective Cardiovacular Münter Heart Study an epidemiological tudy performed in Germany. The preence of protein in the urine. Quality-adjuted life year; a meaure of a peron quality of life, ued here in the ene of lo of quality through dieae, and gain in quality through health care intervention. Randomied clinical trial; a trial in which people are randomly aigned to two (or more) group: one (the experimental group) receiving the treatment that i being teted, and the other (the comparion or control group) receiving an alternative treatment, a placebo (dummy treatment) or no treatment. The two group are followed up to compare difference in outcome to ee how effective the experimental treatment wa. Such trial deign help minimie experimental bia. Red cell ditribution width. An intrument ued in reearch to meaure penile tumecence and rigidity. Scottih Intercollegiate Guideline Network. Senory nerve action potential. Semme-Weintein monofilament. Formal acertainment and review of the evidence urrounding a health technology, retricted in the current document to appraial undertaken by NICE. Inulin-deficiency dieae, developing predominantly in childhood, characterized by hyperglycaemia if untreated, and with a conequent high rik of vacular damage uing developing over a period of decade. Diabete generally of low onet mainly found in adult and in aociation with feature of the metabolic yndrome. Carrie a very high rik of vacular dieae. While not inulin-dependent, many people with the condition eventually require inulin therapy for optimal blood glucoe control. A large tudy/initiative of the collection of outcome and proce data from diabete care ervice throughout the UK. United Kingdom Propective Diabete Study a landmark tudy of the effect of different diabete therapie on vacular complication in people with Type 2 diabete. The oxygen conumption of a peron exerciing maximally. Vibratory perception threhold. World Health Organization. xii

12 THE DEVELOPMENT OF THE GUIDELINE

13 1 Introduction The word diabete refer to a group of diorder with a number of common feature, of which raied blood glucoe i the mot evident. In England and Wale the three mot common type of diabete are: Type 1 diabete Type 2 diabete getational diabete (diabete of pregnancy). Thi guideline i concerned only with Type 1 diabete. The underlying diorder i that of a pure hormone deficiency dieae: lack of inulin. Becaue hormone replacement with inulin therapy i uboptimal, and depite the implementation of lifetyle and dieae management meaure, acute and long-term complication are endemic. In people whoe diabete i untreated, glucoe metabolim may be ufficiently diturbed to caue ymptom, typically of polyuria, thirt, weight lo and fatigue. With further worening, diabetic coma (ketoacidoi) may occur due to diturbed fat metabolim. Becaue inulin therapy, problematically, can give rie to high and low blood glucoe level, people with diabete have to engage in a high level of elf-care to contain the rik of acute and late complication. The main complication of diabete in the longer term are: eye, kidney, and nerve damage arterial dieae affecting the heart, brain and feet. In many people with Type 1 diabete, abnormalitie of blood preure and blood lipid alo develop, particularly in aociation with diabetic kidney damage. In uch people there i a very high rik of premature arterial dieae. 1.1 Definition The Guideline Development Group (GDG, ee 2.2) worked to the World Health Organization (WHO) definition of Type 1 diabete, a condition of deficiency of inulin ecretion from the pancrea, uually due to auto-immune damage of the inulin producing cell. However the clinical condition i generally recognied on the bai of diabete (high blood glucoe level) occurring in mainly younger and thinner people in the abence of other precipitating caue. 8 The GDG were, however, conciou that ome people with evident Type 1 diabete and thu abolute inulin deficiency, alo have inulin inenitivity in the context of the metabolic yndrome (overweight, inulin inenitivity, higher blood preure, abnormal blood fat profile). It wa noted that Type 2 diabete in the young, and the condition known a maturity onet diabete in the young (MODY), hould not be confued with Type 1 diabete. Thi i mainly an iue of definition of Type 2 diabete or MODY rather than Type 1 diabete. Some condition of pancreatic damage have a imilar phenotype to Type 1 diabete, but thee are uually obviou and of little conequence to the management of the diabete, o are not conidered further. 3

14 Type 1 diabete in adult: national clinical guideline for diagnoi and management 1.2 Health and reource burden Type 1 diabete can reult in a wide range of complication, and thee affect both the individual patient and the National Health Service. The economic impact of the dieae include: direct cot to the NHS indirect cot to the economy, including the effect of early mortality peronal impact of diabete and ubequent complication on patient and their familie. The direct cot of Type 1 diabete to the NHS wa etimated to be 96m in 1992 price, 1 which correpond to approximately 167m at 2001 price and population level. The GDG adjuted thi figure, uing more recent data and expert judgement, to correct for the underetimate of ome component 2,3 and to reflect change in tandard treatment, and arrived at a figure of 212m in 2001 price. The figure include: renal replacement therapy cot of 38m outpatient upport cot of 50m hopitaliation cot of 65m. Whilt the indirect cot of diabete are difficult to quantify, in 1992 the cot in term of lot productivity were etimated to be lightly higher than the direct cot of Type 1 diabete Scope The recommendation in the guideline are ubject to a number of limitation. The ponoring authority, NICE, i primarily concerned with health ervice in England and Wale, o the guideline only indirectly refer to: ocial ervice the voluntary ector employer ervice upplied by econdary and tertiary pecialtie for the late complication of diabete (for example renal, cardiological, urological and opthalmological ervice) the education ector (including chool and univeritie) other concerned with an individual health, rather than healthcare. Nonethele, the importance of other agencie mut not be ignored, and in each locality the aim hould be to integrate care for people with Type 1 diabete acro all relevant ector. A pre-agreed cope (ee Appendix C) defined the remit of the guideline and pecified which apect of Type 1 diabete would be included and excluded. The cope had been through takeholder conultation in accordance with procee etablihed by NICE 4 before the development of the guideline began, and covered both a children guideline and thi guideline for adult. It pecified that the group to be covered were to include babie, children, adolecent, adult, and older people with Type 1 diabete. Becaue NICE i conidering developing a eparate guideline on diabete in pregnancy, the cope did not cover: the management of women with diabete who wih to conceive or who are pregnant the management of women who develop diabete during pregnancy. 4

15 1 Introduction The guideline cope covered the following health etting: care received from primary and econdary healthcare profeional who have direct contact with and advie on the care of people with Type 1 diabete the interface between community and pecialit care, including the circumtance in which people hould be referred or admitted to pecialit care both within diabete care and to other pecialtie the interface between children and adult ervice upport/advice that the NHS hould offer to crèche, nurerie, chool and other intitution. The cope alo detail the apect of clinical management to be addreed (ee Appendix C). 1.4 Other relevant work Thi guideline ha been developed with the knowledge that other national work on diabete ha been completed or i in progre. Work on diabete not commiioned by NICE include: the National Service Framework for diabete, developed by the Department of Health ( an information trategy, developed by the NHS Information Authority ( guidance on health outcome indicator, developed by the National Centre for Health Outcome Development 5 a ytem of national clinical audit, et up by the Commiion for Health Improvement ( a report for HM Treaury which aim to provide an evidence-baed aement of longterm reource requirement for the NHS, and include information on diabete (Chapter 6). Securing our future health: taking a long-term view, alo known a the Firt Wanle Report, i available from ( conultation_and_legilation/wanle/conult_wanle_final.cfm) NICE ha commiioned thee other guideline on diabete: Type 2 diabete (completed): guideline E, retinopathy guideline F, renal dieae prevention and early management guideline G, blood glucoe management and patient education guideline H, blood preure and blood lipid management guideline 10, foot care (updated). NICE ha commiioned the following technical appraial relevant to diabete: Type 1 and Type 2 diabete (completed): appraial 53, long-acting inulin analogue appraial 57, inulin pump therapy appraial 60, patient education model 5

16 Type 1 diabete in adult: national clinical guideline for diagnoi and management Type 2 diabete (completed): appraial 9, roiglitazone appraial 21, proglitazone appraial 63, glitazone Type 1 and Type 2 diabete (completed): appraial 71, coronary artery tent appraial 73, myocardial perfuion cintigraphy Type 1 and Type 2 diabete (in development): coronary event: tatin. 6

17 2 Methodology 2.1 Aim and principle Thi chapter decribe the reource and technique ued to reach the clinical recommendation in thi guideline. Clinical guideline have been formally defined a ytematically developed tatement to ait both practitioner and patient deciion in pecific circumtance. 6 Thi guideline aim to offer the bet practice advice on the care of adult (defined a thoe aged 18 year or older) with Type 1 diabete. It give guidance on the management, monitoring and upport of people with Type 1 diabete. The context of the intended guidance i the primacy of the need of the individual with diabete, reflecting the difficultie of reconciling the problem of inulin replacement therapy with peronal lifetyle. The current guideline i aimed at helping all healthcare profeional provide optimal ervice for people with Type 1 diabete by: providing healthcare profeional with a et of explicit tatement on the bet known way to ait people with diabete with their mot common clinical problem, while maximiing the effectivene of the ervice in upporting the population with Type 1 diabete giving commiioning organiation and provider ervice pecific guidance on the bet way to provide complex ervice in a way that maximie efficiency and equity (ervice organiation i, however, outide the cope of thi clinical guideline) informing people with diabete of the optimal method for helping them elf-manage their diabete. Other, including the general public, may find the guideline of ue in undertanding the global and clinical approach to Type 1 diabete. Separate hort-form document for the public and for healthcare profeional are available; they ummarie the recommendation without giving full detail of the upporting evidence. The main principle behind the development of thi guideline are that it hould: conider all the mot important iue in the management of people with Type 1 diabete uing publihed evidence wherever thi i available be ueful to and uable by all profeional take full account of the perpective of the peron with Type 1 diabete and their carer indicate area of uncertainty or controvery needing further reearch. 2.2 The developer The National Collaborating Centre for Chronic Condition The National Collaborating Centre for Chronic Condition (NCC-CC) i houed by the Royal College of Phyician (RCP) but governed by a multiprofeional partner board, which include patient group and NHS management. It wa et up in 2000 to undertake commiion from the National Intitute for Clinical Excellence (NICE) to develop clinical guideline for the NHS in England and Wale. 7

18 Type 1 diabete in adult: national clinical guideline for diagnoi and management The technical team The technical team conited of: an information cientit a health ervice reearch fellow a clinical advior a health economit the chair of the Guideline Development Group (GDG) a project manager and wa upported by adminitrative peronnel. It took part in the GDG meeting, and alo met eparately each month. The Guideline Development Group The GDG met monthly for 10 month to review the evidence identified by the technical team, to comment on it completene and to develop and refine clinical recommendation baed on that evidence and other conideration. Editorial reponibility for thi guideline ret olely with the GDG. Nomination for group member were invited from variou takeholder organiation, which were elected to enure an appropriate mix of clinical profeion and patient group. Thee made up the Conenu Reference Group (CRG, ee below) and from their member the GDG wa elected to repreent the group involved in the day-to-day management of Type 1 diabete. It included two repreentative of people with Type 1 diabete. Each nominee wa expected to erve a an individual expert in their own right and not a a mandated repreentative, although they were encouraged to keep their parent organiation informed of the proce. Group memberhip detail can be found at the front of thi document. All group member made a formal declaration of interet at the tart of the guideline development and provided update throughout. The NCC-CC and the GDG Chair monitored thee. The Conenu Reference Group The larger Conenu Reference Group (CRG) met twice during the proce, once early in the development to enure the aim and clinical quetion (ee Appendix A) were appropriate, and again at the end of the proce to review the validity of the recommendation drafted by the GDG. The formal conenu technique ued for thi purpoe wa developed by the NCC-CC and i a modification of the RAND Nominal Group Technique. Involvement of people with Type 1 diabete The NCC-CC believe that the view of people with diabete and their carer are an integral part of the development proce of a guideline on Type 1 diabete. Patient organiation repreentation (Diabete UK) wa ecured on the Guideline Development Group and included a non-healthcare profeional with Type 1 diabete. People with diabete were alo preent a part of the GDG and CRG and were involved at every tage of the guideline development proce. 8

19 2 Methodology 2.3 Searching for the evidence There were four tage to evidence identification and retrieval: 1 The technical team et out a erie of pecific clinical quetion (ee Appendix A) that covered the iue identified in the project cope. The CRG met to dicu, refine and approve thee quetion a uitable for identifying appropriate evidence from within the publihed literature. 2 A total of 74 quetion were identified. The technical team and project executive agreed that a full literature earch and critical appraial proce could not be undertaken for all of thee area due to the time limitation of the guideline development proce. The technical team identified quetion where it wa felt that a full literature earch and critical appraial were eential. Reaon for thi included an awarene of new or unclear evidence, or a particular clinical need for evidence-baed guidance in the area. 3 The information cientit, with the aitance of the clinical advior, developed a earch trategy for each quetion to identify the available evidence. Identified title and abtract were reviewed for relevance to the agreed clinical quetion and full paper obtained a appropriate. Thee were aeed for incluion according to predefined criteria a developed by the Scottih Intercollegiate Guideline Network (SIGN). 4 The full paper were critically appraied by the health ervice reearch fellow and the pertinent data entered into evidence table. Thee were then reviewed and analyed by the GDG a the bai upon which recommendation were formulated. Due to the large amount of literature potentially relevant to Type 1 diabete, the incluion criteria aimed to limit the included tudie to thoe of a higher level (ee 2.6) conducted primarily in people with Type 1 diabete. Where thee were not available, lower-level tudie, well-conducted tudie outide Type 1 diabete (in Type 2 diabete or in the non-diabetic population), or more methodologically-limited tudie in people with Type 1 diabete, were included. Limited detail of the databae and contraint ued in the earche can be found in Appendix A. No formal contact wa made with the author of identified tudie. Additional contemporary article identified by the GDG on an ad hoc bai, and further publihed evidence identified by national takeholder organiation, were incorporated where appropriate after having been aeed for incluion by the ame criteria a evidence provided by the electronic earche. Searche were rerun at the end of the guideline development proce, thu including evidence publihed and included in the literature databae up to 27 May Studie recommended by takeholder or GDG member that were publihed after thi date were not conidered for incluion. The date hould be the tarting point for earching for new evidence for future update to thi guideline. 2.4 Syntheiing the evidence Abtract of article identified by the earche were creened for relevance, and hard copie were ordered of paper that appeared to provide ueful evidence relevant to each clinical quetion. Uing a validated appraial tool, each paper wa aeed for it methodological quality againt pre-defined criteria. Paper that met the incluion criteria were then aigned a level according 9

20 Type 1 diabete in adult: national clinical guideline for diagnoi and management to the evidence hierarchy given under 2.6. Owing to practical limitation, election, critical appraial and data extraction were undertaken by one reviewer only. Evidence wa, however, conidered carefully by the GDG for accuracy and completene. Each clinical quetion dictated the tudy deign that wa prioritied in the earch trategy. In addition, certain topic within any one clinical quetion at time required different evidence type to be conidered. Randomied control trial (RCT) were the mot appropriate tudy deign for ome clinical quetion a they lend themelve particularly well to reearch into medicine. They were not, however, appropriate for all clinical quetion, for example the evaluation of diagnotic tet. RCT are difficult to perform in area uch a rehabilitation and lifetyle, where intervention are often tailored to the need of the individual. A a conequence, pharmaceutical intervention tend to be placed higher in the evidence hierarchy than other, equally important, intervention. Thi hould not be interpreted a a preference for a particular type of intervention or a a reflection of the quality of the evidence, particularly for thoe clinical area where non-rct evidence i valid and mot appropriate. Where available, evidence from well-conducted ytematic review wa appraied and preented. Trial included within thee review are lited in the evidence table but were not critically appraied. Studie identified in addition to thoe included in the ytematic review were included in the appraial proce. At time, evidence wa not available from tudie that included a Type 1 diabete population. Where a Type 2 or mixed diabete population, or non-diabete population, i conidered, it i indicated in the relevant evidence tatement. On occaion the group identified a clinical quetion that could not be appropriately anwered through undertaking a rigorou literature review (becaue the evidence wa carce, or conflicting). Thee quetion were addreed by group conenu, and the group conidered a ummary of the area in an expert-drafted dicuion paper. In thee intance there wa no formal aement of the tudie cited. Finally, national and international evidence-baed guideline were referred to during the development proce. Thee were not formally appraied becaue of the conitency of proce and of evidence bae can be difficult to acertain acro uch document. The evidence tatement hould be read with the following caveat in mind: all comparion dicued are tatitically ignificant unle otherwie tated where evidence i available from a good quality ytematic review or meta-analyi, then individual tudie are not reviewed and referenced. Any additional RCT evidence preented relate to tudie publihed ince the completion of ytematic review() included or thoe conidered relevant to thi guideline, but which may not have been uitable for incluion in the ytematic review() unle explicitly tated, all tudie relate to diabete population. The incluion of tudie of Type 1, Type 2 or mixed Type 1 and Type 2 diabete population varie between quetion (ee Appendix A) decription of tudie of poor methodological quality in evidence tatement include detail on all relevant intervention in a pecified quetion. However, no poitive recommendation have been baed olely on uch tudie 10

21 2 Methodology evidence tatement in thi guideline derived from one ytematic review may be graded with different hierarchy of evidence in different place, due to ome topic within the review being baed on a ynthei of the outcome of well-conducted randomied controlled trial and other being baed on a ynthei of non-randomied tudie, prevalance tudie and diagnotic tudie, or on conenu when other guideline are reviewed, ome of their recommendation are preented here a evidence tatement. Thee may not necearily reflect the recommendation made in thi guideline and are clearly labelled where individual trial are referred to in the evidence tatement a mall, medium, or large, thi equate to the following number of participant (at baeline): mall, le than 50; medium, from 50 to 200; large, greater than 200. Exact number for each trial can be found in the online evidence table. 2.5 Health economic evidence While evidence on cot-effectivene wa extracted from the clinical literature earche wherever it exited, thi wa rare. A uch, a eparate earch wa conducted to iolate the health economic evidence that attempted to identify the cot of, and the benefit accruing from, each trategy or intervention. An a priori tudy deign criterion wa not impoed, o information may come from ource other than RCT and formal economic evaluation. A the management of diabete i complex, many of the area covered by thi guideline have little economic evidence; within clinical trial it i not alway clear which of a range of intervention and trategie actually improve health. The GDG therefore expected the ueful coteffectivene evidence to fall within a limited range of area. Where earching produced either no evidence or inufficient evidence for a ubtantive health economic evidence tatement, thi fact i indicated. The health economit preented the economic evidence to the GDG alongide the clinical evidence. There i no tandard meaure to ae the quality of the economic evidence, and reported cot and benefit experienced in other healthcare ytem may not apply in the UK. The GDG had to ae not only the reult but alo their applicability. Health economic analyi can provide a framework for combining information from a variety of ource to form a tandard comparion of cot and benefit. However, the tak of producing thee etimate i complex and labour intenive, and require a level of clinical evidence that i not alway readily available. Evidence on the cot and benefit of a broad range of intervention wa preented to the GDG, but the iue of cultured human dermi for foot ulceration wa identified a a particularly important area for further economic analyi. The choice wa made on the ground that: thi treatment doe not have good quality economic evidence attached it ha a potentially large health benefit if made available, the treatment could have a large effect on NHS reource given the prevalence of diabetic foot ulcer there are uncertaintie urrounding both the benefit and reource, and an abence of cot-utility tudie. 11

22 Type 1 diabete in adult: national clinical guideline for diagnoi and management 2.6 Drafting recommendation Evidence for each topic wa extracted into table and ummaried in evidence tatement. The GDG reviewed the evidence table and tatement at each meeting and reached a group opinion. Recommendation were explicitly linked to the evidence upporting them and graded according to the level of the evidence upon which they were baed, uing the grading ytem in the table below. It hould be noted that it i the level of evidence that determine the grade aigned to each recommendation. The grade doe not necearily reflect the clinical importance attached to the recommendation. Hierarchy of evidence Typical grading of recommendation Ia Evidence from meta-analyi of randomied controlled trial. A Baed on category I evidence. Ib Evidence from at leat one randomied controlled trial. IIa Evidence from at leat one controlled tudy without randomiation. B Baed on category II evidence or extrapolated from category I. IIb Evidence from at leat one other type of quai-experimental tudy. III Evidence from non-experimental decriptive tudie, uch a comparative tudie, correlation tudie and cae control tudie. C Baed on category III evidence or extrapolated from category I or II. IV Evidence from expert committee report or opinion and/or clinical experience of repected authoritie. D Directly baed on category IV evidence or extrapolated from category I, II or III. DS Evidence from diagnotic tudie. DS Evidence from diagnotic tudie. NICE Evidence from NICE guideline or health technology appraial programme. NICE Evidence from NICE guideline or health technology appraial programme. 2.7 Agreeing recommendation Once the evidence review had been completed and an early draft of the guideline produced, a one-day meeting of the CRG wa held to finalie the recommendation. Thi included a premeeting vote on the recommendation and a further vote at the CRG meeting, where the group wa aked to conider the draft guideline in two tage: 1 Are the evidence-baed tatement acceptable and i the evidence cited ufficient to jutify the grading attached? 2 Are the recommendation derived from the evidence jutified and are they ufficiently practical o that thoe at the clinical front line can implement them? Three type of recommendation were conidered: a) A recommendation from the GDG baed on trong evidence, uually noncontroverial unle there wa important evidence that had been mied or miinterpreted 12

23 2 Methodology b) A recommendation that wa baed on good evidence but where it wa neceary to extrapolate the finding to make it ueful in the NHS. The extrapolation wa approved by conenu c) Recommendation for which no evidence exited but which addre important apect of care, and for which a conenu on bet practice could be reached. Thi formal conenu method ha been etablihed within the NCC-CC, drawing on the knowledge et out in a health technology appraial, 7 the work of the Royal College of Nuring Intitute 1 and practical experience. It approximate to a modification of the RAND Nominal Group Technique and will be fully decribed in future publication. 2.8 Writing the guideline The draft verion of the guideline wa drawn up by the technical team in accordance with the deciion of the guideline group. Prior to publication, it wa circulated to takeholder according to the formal NICE takeholder conultation and validation phae. Modification were made to thi document in repone to comment received. Change were approved by the Guideline Development Group, who retain the final editorial authority for the content. 2.9 Structure of the guideline The part of thi document which contain recommendation (chapter 4 onward) i divided into ection, each of which cover a et of related topic. For each topic the layout i the ame: the rationale for including the topic i provided in one or two paragraph that imply et the recommendation in the context of their clinical importance the evidence tatement, both clinical and health economic, are then given, ummariing the evidence (more detail can be found in the evidence table, available on the web at Specific health economic evidence tatement alo follow the clinical evidence when available. The evidence tatement and table aim to contextualie and explain each recommendation the evidence tatement are followed by a conideration that reflect the thinking of the GDG in making the recommendation. Thi i intended to explain how the evidence wa ued to formulate the recommendation the recommendation follow. Thee are graded to indicate the level of the evidence behind the recommendation, rather than how valid the GDG believe them to be. In ome ection of the guideline, additional text providing more detailed guidance i contained within the recommendation. 13

24 3 Key meage of the guideline 3.1 Key recommendation 1 Patient-centred care The view and preference of individual with Type 1 diabete hould be integrated into their healthcare. Diabete ervice hould be organied, and taff trained, to allow and encourage thi. 2 Multidiciplinary team approach The range of profeional kill needed for delivery of optimal advice to adult with diabete hould be provided by a multidiciplinary team. Such a team hould include member having pecific training and interet to cover the following area of care: education/information giving nutrition therapeutic identification and management of complication foot care counelling pychological care. 3 Patient education Culturally appropriate education hould be offered after diagnoi to all adult with Type 1 diabete (and to thoe with ignificant input into the diabete care of other). It hould be repeated a requeted and according to annual review of need. Thi hould encompa the neceary undertanding, motivation and kill to manage appropriately: blood glucoe control (inulin, elf-monitoring, nutrition) arterial rik factor (blood lipid, blood preure, moking) late complication (feet, kidney, eye, heart). 4 Blood glucoe control Blood glucoe control hould be optimied toward attaining DCCT-harmonied HbA 1c target for prevention of microvacular dieae (7.5% or lower) and, in thoe at increaed rik, arterial dieae (6.5% or lower) a appropriate, while taking into account: the experience and preference of the inulin uer, in order to avoid hypoglycaemia the neceity to eek advice from profeional knowledgeable of the range of available mealtime and baal inulin and of optimal combination thereof, and their optimal ue. 15