Treatment and Prevention of Diabetes in Italy

Overview of the Italian healthcare System

Italy has government-provided universal health insurance coverage. All citizens are registered with a general practitioner (GP). Patients with diabetes may be cared for by a GP or in a diabetes outpatient clinic (DOC). DOCs are multispecialty treatment centers, usually based in a hospital. DOCs have a full-time staff of diabetologists, endocrinologists, and/or internists, and a part-time staff of other specialists such as ophthalmologists and cardiologists.[1] Patients may choose either a GP or a DOC to be their primary care provider. Alternately, GPs may refer patients to DOCs. Within DOCs, patients may be followed by the same doctor, or may be seen by different doctors on different visits. Italy recognizes a specialty in diabetes and metabolic disorders separate from specialties in endocrinology and internal medicine; the term “diabetologist” is used to refer to specialists in diabetes and metabolic disorders.

Patients diagnosed with diabetes are issued a personal card from one of the 21 regional health systems.[2] The card provides an exemption from paying for any diabetes-related healthcare costs. The policy of the Italian healthcare system is to fully reimburse for all costs related to diagnosis, follow-up, treatment, and complication-related expenses. However, budgetary restrictions in some regions may prevent full reimbursement for these expenses.

Italian guidelines for diabetes treatment

Clinical guidelines for the treatment of diabetes have been defined by 3 Italian medical associations: Società Italiana di Diabetologia (SID),[3] Associazione Medici Diabetologi (AMD or AEMMEDI),[4] and Società Italiana di Endocrinologia e Diabetologia Pediatrica (SIEDP). The Agency for Regional Health Services (ASSR) oversees the clinical guidelines of the medical associations.[5] The AMD guidelines are based on the American Diabetes Association’s 2005 Standards of Medical Care in Diabetes.[4],[6] Additionally, the International Society for Pediatric and Adolescent Diabetes (ISPAD) offers an Italian translation of its guidelines for pediatric and adolescent patients with type 1 diabetes.[7] Antihyperglycemic medications approved for use in Italy are shown in Table 1.[8]

Table 1. Antihyperglycemic medications approved by the Italian Ministry of Health

Type 1 diabetes

Treatment of type 1 diabetes

Patients with type 1 diabetes require insulin therapy for survival. The ISPAD guidelines state that the optimal insulin regimen must be individualized to permit the lowest acheivable A1C without frequent or severe hypoglycemia. ISPAD notes that daily insulin dosage varies greatly between individuals, changes over time, and should be regularly re-evaluated. The ISPAD guidelines describe several different insulin regimens that may be used to attain optimal glycemic control, as shown in Table 2. The SID guidelines suggest a single, typical insulin regimen. The AMD guidelines do not specify any insulin regimens. Glycemic goals for type 1 diabetes are shown in Table 3. Both ISPAD and AMD guidelines note that attaining optimal glycemic control requires self-monitoring of blood glucose (SMBG) multiple times per day. No nationwide surveys of glycemic control in patients with type 1 diabetes have been published, but a report on 201 children and adolescents with type 1 diabetes published in 1999 found that mean A1C in this group was 7.8±1.4% (range 4.8-13.3%).[9]

Table 2. Recommended insulin regimens for patients with type 1 diabetes

Table 3. Recommended optimal glycemic goals in type 1 diabetes

*DCCT standardized

Prevention of type 1 diabetes

The Immunotherapy Diabetes (IMDIAB) Group has experimented with intensive insulin therapy with and without adjunctive treatment to preserve residual β-cell function and to reduce the risk of future vascular complications in patients with newly-diagnosed type 1 diabetes. Intensive insulin therapy (3-4 injections of regular insulin at mealtimes plus a bedtime dose of NPH) induced remission of type 1 diabetes in 11.6% of 189 consecutive patients in a multicenter trial.[10] The mean duration of remission was 9.6 months, with a range of 31 months. 10 A randomized, prospective trial of intensive insulin therapy (3 mealtime injections plus bedtime NPH) and adjunctive nicotinamide with or without vitamin E in 64 children with recent-onset type 1 diabetes showed that either treatment preserved baseline C-peptide secretion for up to 2 years.

Type 2 diabetes

Treatment of type 2 diabetes

Diet is essential in the treatment of patients with type 2 diabetes; about 5% of all patients with diabetes in Italy are treated with diet alone.[3] The SID[3] and AMD[4] guidelines both provide an overview of medical nutrition therapy (MNT) in diabetes. Italy’s native cuisine, like that of other Mediterranean countries, is rich in fish, nuts, and olive oil. The Mediterranean diet may have cardioprotective benefits compared with other Western European or North American diets.[11] A guideline for an Italian Mediterranean diet, with caloric values and macronutrient composition of typical foods, is available from the Istituto Nutrizione.[12]

Nearly all Italians with diabetes (95%) are treated with oral antihyperglycemic agents (46.9%), insulin (40.2%), or a combination of insulin and oral antihyperglycemic agents (7.9%).[3] Because type 2 diabetes is a progressive disease, most of these patients will eventually require insulin treatment. SID guidelines recommend a stepwise algorithm to treat type 2 diabetes, as shown in Table 4. The treatment algorithm and glycemic goals recommended as standard care by the International Diabetes Federation for type 2 diabetes have been included for comparison in Tables 4 and 5.[13] No treatment algorithm for type 2 diabetes is specified by the AMD guidelines. A recent survey of patients with type 2 diabetes revealed that about half of all patients are attaining A1C ≤7.0%.[1]

Table 4. Recommended treatment algorithm for most adults with type 2 diabetes

Abbreviations: TZD = thiazolidinedione (“glitazone”)

Table 5. Recommended optimal glycemic goals for most adults with type 2 diabetes

*DCCT standardized

Prevention of type 2 diabetes

Obesity is the leading risk factor for the development of type 2 diabetes. The Quality of Life in Obesity: Evaluation and Disease Surveillance (QUOVADIS) study is a prospective, observational study of patients seeking obesity treatment at accredited Italian medical centers. Most Italian patients are aware of the benefits of weight loss for present and future health, but like their US counterparts, unrealistically expect to lose at least twice as much weight (23% weight loss) as is usually attainable through pharmacotherapy or behavior modification (~10% weight loss).[14] Italian research has shown a protective effect against type 2 diabetes in obese patients who exercise regularly.[15] Prevention or remission of type 2 diabetes has been observed in a 4-year case-control study of morbidly obese individuals treated with laparoscopic gastric banding.[16] Improvements in hypertension outcomes were also observed.[17]

References

1. De Berardis G, Pellegrini F, Franciosi M, et al; QuED Study Group. Quality of care and outcomes in type 2 diabetic patients. A comparison between general practice and diabetes clinics. Diabetes Care. 2004;27:398-406.
2. Associazione Medici Diabetologi. Rapporto Sociale Diabete 2003. Available at: http://www.infodiabetes.it/documenti_amd/rapporto_sociale_diabete/Rapporto_Sociale_Diabete_2003.pdf. Accessed May 2006.
3. Comaschi M, et al. Linee guida per la prevenzione cardiovascolare nel paziente diabetico. Available at: http://www.siditalia.it/Pubblicazioni/Linee%20Guida.pdf. Accessed June 2005.
4. Associazione Medici Diabetologi. Gli standard ADA delle cure mediche per i pazienti con diabete mellito. Monge L, De Micheli A, trans-eds. Available at: http://www.aemmedi.it/uploads/pdf/LINEEGUIDAADA2005.pdf. Accessed May 2006.
5. International Diabetes Federation. Diabetes: the policy puzzle: towards benchmarking in the EU 25. Available at: http://www.idf.org/webdata/docs/idf-europe/DiabetesReport2005.pdf. Accessed May 2006.
6. American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2005;28(suppl 1):S4-S36.
7. International Society for Pediatric and Adolescent Diabetes. Consensus Guidelines 2000. Linee Guida dell’ISPAD per la Gestione del Diabete mellito nei Bambini e negli Adolescenti. Chiarelli F, ed. Pisa, Italy: Pacini Editore SpA; 2001:1-152. Available at: http://www.d4pro.com/diabetesguidelines/ispad/Downloads/ISPAD_Italy.pdf. Accessed May 2006.
8. Ministero della Salute. Medicinali e vigilanza. Banca dati. [Database. Available at: http://www.ministerosalute.it/medicinali/bancadati/SceltaPA.jsp. Accessed June 2005.
9. Vanelli M, Chiarelli F, Chiari G, et al. Metabolic control in children and adolescents with diabetes: experience of two Italian regional centers. J Pediatr Endocrinol Metab. 1999;12:403-409.
10. Pozzilli P, Manfrini S, Buzzetti R, et al; IMDIAB Group. Glucose evaluation trial for remission (GETREM) in type 1 diabetes: a European multicentre study. Diabetes Res Clin Pract. 2005;68:258-264.
11. Ciccarone E, Di Castelnuovo A, Salcuni M, et al; Gendiabe Investigators. A high-score Mediterranean dietary pattern is associated with a reduced risk of peripheral arterial disease in Italian patients with type 2 diabetes. J Thromb Haemost. 2003;1:1744-1752.
12. Istituto Nazionale di Ricerca per gli Alimenti e la Nutrizione. Linee guida per una sana alimentazione Italiana. 2003:1-84. Available at: http://www.aemmedi.it/uploads/pdf/alimentazione/istitutonutrizione.pdf. Accessed May 2006.
13. International Diabetes Federation Clinical Guidelines Task Force. Global guideline for type 2 diabetes. Brussels, Belgium: International Diabetes Federation; 2005:1-79. Available at: http://www.idf.org/webdata/docs/IDF%20GGT2D.pdf. Accessed September 2005.
14. Dalle Grave R, Calugi S, Magri F, et al; QUOVADIS Study Group. Weight loss expectations in obese patients seeking treatment at medical centers. Obes Res. 2004;12:2005-2012.
15. Marchesini G, Pontiroli A, Salvioli G, et al; QUOVADIS Study Group. Snoring, hypertension and type 2 diabetes in obesity. Protection by physical activity. J Endocrinol Invest. 2004;27:150-157.
16. Pontiroli AE, Folli F, Paganelli M, et al. Laparoscopic gastric banding prevents type 2 diabetes and arterial hypertension and induces their remission in morbid obesity: a 4-year case-controlled study. Diabetes Care. 2005;28:2703-2709.