Italian guidelines for the treatment of type 2 diabetes

Abstract

Aim: This guideline is aimed at providing a reference for the pharmacological and non-pharmacological treatment of type 2 diabetes in adults. Methods : These recommendations apply to outpatients, either in primary care or at specialist referral. Prior cardiovascular events, heart failure, renal disease, hypoglycemic risk and other conditions affecting life expectancy have been considered as factors capable of modifying treatment strategies. The following areas have been assessed: therapeutic goals, nutritional therapy, physical exercise, educational programs, pharmacological treatment, glucose monitoring. This guideline has been developed following the methods described in the Manual of the National Guideline System ( http://www.snlg-iss.it ). For each question, the panel nominated by the Società Italiana di Diabetologia (SID) and Associazione Medici Diabetologi (AMD) identified potentially relevant outcomes, which were then rated for their impact on therapeutic choices. Only outcomes classified as “critical” were considered in the systematic review of evidence and in the formulation of recommendations. Results: The present guideline contains recommendations on the following clinical aspects of type 2 diabetes: 1) treatment targets; 2) nutritional therapy; 3) physical exercise; 4) educational therapy; 5) pharmacological treatment (for patients with and without previous cardiovascular disease); and 6) glycemic monitoring. Conclusions: The present guideline is directed to physicians, nurses, dietitians and educators working in Diabetes specialist clinics; general practitioners; nurses and dietitian working in territorial services or private offices; and patients with diabetes. LISTS OF ABBREVIATIONS AND ACRONYMS LG: Linea Guida AMD: Associazione Medici Ospedalieri SID: Società Italiana di Diabetologia PICOS: Population, Intervention, Comparison, Outcome, Study type MNT: Medical Nutrition Therapy NPH: Neutral Protamine Hagedorn AMSTAR MH-OR: Mantel–Haenszel Odds Ratio WMD: Weighted mean difference GRADE: Grades of Recommendation, Assessment, Development, and Evaluation EtD: Evidence to Decision GUIDELINE DEVELOPMENT TEAM Coordinator : Edoardo Mannucci, diabetologist. Panel members : Riccardo Candido, diabetologist; Lina delle Monache, diabetic patient; Marco Gallo 4 , diabetologist; Andrea Giaccari, diabetologist; Maria Luisa Masini, dietitian; Angela Mazzone, nurse; Gerardo Medea, general practitioner; Basilio Pintaudi, diabetologist Giovanni Targher, diabetologist; Marina Trento, pedagogist; Giuseppe Turchetti, economist. Evidence Review Team : Matteo Monami, Valentina Lorenzoni External reviewers : Giampaolo Fadini 1 , Antonio Nicolucci 2 , Gianluca Perseghin 3 1 Department of Medicine, University of Padova; 2 Coresearch, Pescara; 3 Metabolic Medicine, Policilinico di Monza, Bicocca University of Milan CONFLICTS OF INTEREST The assessment of interests of members of the Guideline development team is aimed at determining conflicts of interest for each question and the actions needed for their management in the process of elaboration of the Guideline. The assessment is based on the policy of the Istituto Superiore di Sanità for the management of conflicts of interest in the development of Guideline 1 . Each interest is assessed for its nature, type, relevance for the content of the Guideline, economic value, timing and duration. The assessment includes the following information which can be of help in determining the extent to which the competing interest could reasonably affect the expert’s position: type of interest; relevance for the content of the guideline; timing and duration; and position of the expert in the organization (in case of institutional interests). With respect to type of potentially competing interests, these include: With respect to type of potentially competing interests, these include: Economic interests, i.e., financial relationships with organizations directly producing goods or services relevant for the guideline topic. Economic interests include any monetary transaction or value related to payments for services, property shares, stock options, patents and royalties. Relevant interest can be personal, related to family members or institutional (i.e., related to the organization in which the expert works). Indirect interests, such as career advancement, social position and personal beliefs. Interests considered can be: Economic interests, i.e., financial relationships with organizations involved in products or services relevant for the subject of the guideline, including any direct payment for services, property shares, stock options, and patents or copyright royalties). Economic interests can be either: personal economic interest, i.e., related to a personal financial benefit; familial economic interest, i.e., related to the income of family members; institutional economic interests, i.e., related to benefits for the institution in which the subject works. Intellectual interests, i.e., benefits for career advancement and social status. Both economic and intellectual interests can be specific (i.e., directly related to the subject of the guideline) or aspecific (when they are not related to the content of the guideline). Any reported potentially conflicting interest is classified as: Level 1 (minimal or not relevant): no action needed Level 2 (potentially relevant): this can be managed either with full participation to the development of the guideline with public disclosure of the conflict of interest at the end of the recommendation related to the interest; exclusion of the subject with the competing interest form the discussion of those recommendations possibly influenced by the competing interest. Level 3 (relevant): this can be managed with the exclusion of the subject with the competing interest from the discussion of possibly affected recommendation, or with the total exclusion of the subject with competing interest from the elaboration of the guideline. DECLARATION OF POTENTIAL CONFLICTS OF INTEREST All members of the panel and of the evidence review team compiled annually a declaration of potential conflicts of interest, which were collectively discussed to determine their relevance. In all cases, the reported conflicts were considered minimal or irrelevant (Level 1); therefore, all components of the panel and of the evidence review team participated to the elaboration of all recommendations. Panel members: Edoardo Mannucci received fees for training activities from Mundipharma and speaking fees from Abbott, Eli Lilly e Novo Nordisk; Riccardo Candido received consulting fees from Boehringer Ingelheim, Eli Lilly, Merck, Menarini and Roche, and speaking fees from Abbott, Eli Lilly, Mundipharma, Novo Nordisk and Sanofi; Andrea Giaccari received consulting fees from Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck, Mundipharma, Novo Nordisk e Sanofi, and his Institution received research grants from Amgen and AstraZeneca; Gerardo Medea received consulting fees from AstraZeneca and Grunenthal; Basilio Pintaudi received consulting and/or speaking fees from Eli Lilly e Novo Nordisk; and Giovanni Targher received consulting fees from Novartis; Giuseppe Turchetti received speaking fees from Eli Lilly, and his Institution received research grants from Merck. Lina Delle Monache, Marco Gallo, Maria Luisa Masini, Angela Mazzone and Marina Trento have no interest to declare. Evidence review team members: Matteo Monami receives speaking fees from Sanofi; Valentina Lorenzoni has no interest to declare. External reviewers: Gian Paolo Fadini received research grants from Mundipharma, consulting fees from Abbott, Boehringer, Novo Nordisk and Lilly, and speaking fees from Abbott, Novo Nordisk, Sanofi, Boehringer e AstraZeneca; Gianluca Perseghin received consulting fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck, Novo Nordisk, PicDare; and Antonio Nicolucci received research grants from Sanofi and Novo Nordisk. FINANCIAL SUPPORT No external financial support was collected for the development of this guideline. Travel for panel were for by Società Italiana di of panel and evidence review team not any payment for their in the guideline. OF GUIDELINE 2 diabetes is the form of its is with a relevant impact on public with type 2 diabetes 3 in of and with a In the care of patients with type 2 diabetes is by a of specialist and general which a of areas to be of patients not therapeutic and the management of pharmacological is This is by the development of therapeutic and clinical the of those in the of clinical recommendations and their is The in on the management of diabetes in without participation of other involved in the care of diabetes. In other in are by This guideline is aimed at providing a reference for pharmacological and non-pharmacological treatment of type 2 diabetes in of or are as for in of diabetes treatment, based on clinical of with diabetes and the organization of These recommendations apply to outpatients, either in primary care or at specialist referral. Prior cardiovascular events, heart failure, renal disease, hypoglycemic risk and other conditions affecting life expectancy be considered as factors capable of modifying treatment strategies. The following areas be assessed: therapeutic goals, nutritional therapy, physical exercise, educational programs, pharmacological treatment, glucose monitoring. All the considered are with for glucose and nutritional be on the of of The guideline is directed to physicians, nurses, dietitians and educators working in Diabetes specialist clinics; general nurses and dietitian working in territorial services or private offices; patients with diabetes. the development of the guideline, be the of each recommendation on the organization of care and and The of the guideline be their 1) their and and specific activities of 2) GUIDELINE DEVELOPMENT The guideline was developed following the methods described in the Manual of the National Guideline System ( http://www.snlg-iss.it ). Each recommendation a clinical question, by the panel the of outcomes For each question, the panel identified potentially relevant outcomes, which were then rated for their impact on therapeutic a : outcomes of relevance : not outcomes Only outcomes classified as “critical” were considered in the systematic review of and in the formulation of recommendations. of outcomes with their for each recommendation, is reported in Evidence review and assessment of of evidence systematic review for outcomes for each question was on the following of of For was the for glucose were for each as in each of for were to the no were for all the other Only in were of were for The systematic review was the following of potentially with the on the of and for as full of relevant on the of a and exclusion assessment of the risk of (i.e., AMSTAR 2 for systematic and the for of the of considered outcomes, in for each for outcomes and for with The was with were considered for of 2 and of The and of evidence for outcomes by the panel were rated the of the Guideline ( with the , which of systematic for and of of and of economic and of were with ( and ( for and For relevant were on the of and for full to the and of no was methods and were in including type of to which were and of recommendations The guideline panel and for each clinical question, of evidence and of of were on the of of and of were External review The panel identified external with a specific of clinical research in with at on and a of at of the guideline panel and evidence review and members of the of or were External reviewers received a of the guideline and their to the The panel collectively discussed the by the external the to the guideline and the to Guideline be the from the of of the guideline. The evidence review team and the guideline panel the or the of to the extent of modifying the formulation of a recommendation, of its or of the of the guideline panel the to or clinical and the of modifying the outcomes of interest and their relevance. In case of in clinical and/or outcomes, the process of evidence review and development of recommendation be OF of evidence is the in is the in are research is needed for a assessment of and of the are not and of be considered with of recommendations recommendation for the of patients the for all patients the recommendation and a for policy the recommendation can be for the of recommendation for the include a of and for the of patients the recommendation, a for policy a discussion be OF of the of and is for patients with type 2 diabetes with capable of of the of is for patients with type 2 diabetes with which are not capable of of the of of or is for patients with type 2 diabetes with which are not capable of of the of Medical Nutrition Therapy is for the treatment of type 2 diabetes. of the of a a for the treatment of type 2 diabetes. of the of physical for the treatment of type 2 diabetes. of the of is no evidence to a of for training in the treatment of type 2 diabetes. of the of and training for the treatment of type 2 diabetes. educational for the treatment of type 2 diabetes. of the of educational programs, for the treatment of type 2 diabetes. of the of treatment the of as treatment in patients with type 2 without previous cardiovascular or are as and be considered as 1 ). of the of the of or as treatment in patients with type 2 diabetes with previous cardiovascular and without heart and be considered as 1 ). of the of the of as treatment in patients with type 2 diabetes with previous heart and be considered as and be considered as 1 ). of the of the of of for all patients with type 2 diabetes treatment with of the of the of for patients with type 2 diabetes treatment with of the of The of in patients with type 2 diabetes is not of the of to a of glucose in the treatment of type 2 diabetes. of the of not a glucose or on glucose in patients with type 2 diabetes on of the of in patients with is the in patients with type 2 diabetes are not with capable of with type 2 diabetes with glucose glucose Relevant outcomes of diabetes 2 No and is for patients with type 2 diabetes with capable of of the of the of glucose of the to and (i.e., or the risk of not of cardiovascular or a glycemic the risk of with For this the for patients with capable of is and can be considered for patients or with life expectancy of are no from on the and of of glucose in patients in benefits of glucose are 2 of This could in patients or with life expectancy of for be to the of of the benefits of glycemic and the with in patients with and monitoring. to this guideline can be assessed by the of patients at in the a evidence The of in type 2 diabetes is with a risk of and and , . is a of with in or not with hypoglycemic risk are the evidence of on outcomes : of on outcomes : No on and and cardiovascular of of treatment, of treatment : (i.e., and not : No on and of of treatment with of glucose No on No evidence of in No patients The benefits are at 2 of treatment are the evidence of on outcomes : of glucose of on outcomes : of of treatment, of treatment (i.e., and not : of of treatment with of glucose was the external for For based on reported a of of evidence is the of the evidence of evidence for all outcomes considered or in value the evidence No or No evidence of or and and are considered outcomes of the treatment of type 2 diabetes by 4 of the and the or the evidence the The of of is for the of and The of of is the risk of the of are the evidence for of with direct for and on and considered of evidence of is the of the evidence of evidence this the of the the or the evidence the The of is of of determining a of for the management of diabetic of to be at to in the be the impact on evidence evidence to or diabetes treatment 4 , , , on their and The of for outcomes of the organization of care and to the to evidence No specific evidence is on this the to evidence of patients with type 2 diabetes in the 4 , , in patients not with is the in patients with type 2 diabetes are not with capable of with type 2 diabetes not with glucose glucose Relevant outcomes 2 No of diabetes 2 No is for patients with type 2 diabetes not with capable of of the of . the of glucose of the to and In glycemic to the risk of cardiovascular disease, with a . are no from on the and of of glucose in patients in benefits of glucose are 2 of This could in patients or with life expectancy of . for be to the of of the benefits of glycemic and . to this guideline can be assessed by the of patients at in 1 , 2 . of or is for patients with type 2 diabetes with are not capable of of the of . 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The of a of the of physical needed for a therapeutic in type 2 diabetes is relevant are the evidence No in and are the evidence No relevant risk with physical was in of evidence is the of the evidence of evidence for all outcomes or in value the evidence No or No evidence of or and are considered outcomes of the treatment of type 2 diabetes by 4 of the and the or the evidence not either the or the No for any of the outcomes were considered are the evidence

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