INtegration of care for reaching targetS In Diabetic patiEnts: Design of the INSIDE Study.

Introduction: Three Italian scientific associations of different specialties (AMD, Associazione Medici Diabetologi-for diabetologists; ANMCO,Associazione Nazionale Medici Cardiologi Ospedalieri-for cardiologists; SIMG, Società Italiana di Medicina Generale-for General Practitioners) designed this study to assess whether an integrated care organization comprising three different specialists can improve adherence and can achieve the guidelines targets in a population of individuals with type 2 diabetes, without established cardiovascular disease but at high risk (≥ 20% at 10 years according to the CUORE.ISS risk cards) compared with the current standards of care provided by the Italian National Health Service.

Methods: Thirty primary care centers (general practitioners, GPs), 30 cardiology centers and 30 diabetes centers have been selected by the scientific associations, disseminated in the national territory, on the basis of proven previous cooperation in other studies. Each primary care center will enroll 100 type 2 diabetic subjects, > 45 years old, with no established cardiovascular disease, but with a high risk due to the presence of at least one other risk factor besides diabetes over the cutoff [hypertension > 135/80 mmHg, LDL cholesterol > 70 mg/dl, tobacco smoke, first-degree familiarity for CHD (coronary heart disease), central obesity according the WHO criteria]. Fifteen of 30 selected primary care centers, chosen randomly, will continue the treatment of the 100 identified patients according to their "usual care," driven by Good Clinical Practice and by current guidelines (control group or "UC"-usual care), collecting all available clinical and instrumental data and transferring them to the electronic CRF. The remaining 15, after informed consent, will submit their 100 patients each in a specific integrated pathway, which entails the mandatory operational integration and exchange of information with the diabetes specialists and cardiologists pertaining to the same previously identified area. The integrated care path for the patients in the proband group (IC, integrated care) is based on application of the recommendations of the Italian Guidelines aimed at achieving the proposed targets for the main risk factors [LDL < 70 mg/dl; SBP < 130 mmHg; HbA1c (glycated hemoglobin) ≤ 7% (52 mmol/mol]. All the clinical data will be recorded on a shared electronic CRF. The trial will last 3 years: 6 months for the enrollment and randomization of the centers, 6 months for the enrollment of the probands and control subjects, and 2 years of follow-up. The study will be conducted according the Helsinki Declaration on human experimentation ethics.

Planned Outcomes: The primary planned outcome is represented by the increase in the percentage of people that achieve the target values of at least two out of three of the considered risk factors [HbA1c, SBP (systolic blood pressure), LDL cholesterol] compared with the percentage actually achieved in the control group. The secondary outcomes are: (1) a MACE (major adverse cardiac event) composite: non-fatal myocardial infarction, non-fatal stroke, mortality from any cause and hospitalization for cardiovascular disease; (2) the number of early diagnoses of new onset complications; (3) evaluation of adverse events and safety of the probands and control patients; (4) comparative cost analysis and cost-effectiveness analysis.