Certification and prescription in the diabetology field: occupational and medico-legal aspects.

Abstract: Diabetes mellitus is an ever-increasing disease and is defined as a "social disease" due to the significant economic damage it causes to the affected individuals and the community involved in its care. This paper presents the process of certification of diabetic disease and the application for invalidity in order to obtain welfare and economic benefits provided by law; it, also, describes the prescription process and the appropriateness of therapeutic prescription for the diabetic patient in terms of clinical-prescriptive appropriateness and economic-prescriptive appropriateness. Finally, it reports on the side effects of the most common antidi-abetics, the off-label use of metformin and the physician's responsibili-ties in the light of the Gelli-Bianco law.

OSAS and metabolic diseases: Round Table, 99(th) SIO National Congress, Bari 2012.

This draft of the Official Round Table held during the 99th SIO National Congress is an updated review on the diagnostic tools, the importance of polysomnographic recording and a critical analysis of the surgical techniques in obstructive sleep apnoea syndrome (OSAS). The review and analysis of available publications is the premise along with a specific analysis of the relationship between OSAS and metabolic and vascular disorders. In addition, the most recent investigations on sleep disorders and altered glucose metabolism are summarised and discussed together with the results of a study by the authors involving a fairly large number of patients with OSAS and diabetes.

A prospective randomised-controlled pilot study for evaluating the teaching utility of interactive educational diabetes simulators.

AIDA is an interactive educational diabetes simulator that is useful for recreating clinically realistic diabetes situations. It is available without charge from http://www.2aida.org on the Web. This paper describes a prospective, clinical randomised-controlled trial (RCT) run at the Ospedale di Marino (Italy) for evaluating the educational utility of AIDA in small group teaching sessions. Twenty-four volunteers (12 male and 12 female) with Type 1 diabetes of more than 6-year duration, aged 19-48 years, who gave written informed consent, were randomly assigned to one of two study groups, each receiving different teaching interventions. Group A was exposed to the AIDA diabetes simulator, while Group B (the control group) received conventional lessons with slides and transparencies. Six lessons were held for each group (one per week). At the end of the conventional lessons, after a 'washout' period of 4 weeks, Group B entered a partial cross-over phase with the simulator during a further 6-week block of lessons. Before and after the 6 weeks of lessons, twice for Group A and 3 times for Group B, all subjects had their HbA1c measured. The subjects also carefully documented the incidence of any symptomatic hypoglycaemic episodes ('hypos'), whether mild (sweating, dizziness), moderate (nausea, vomiting), or severe (requiring assistance). All data were analysed using non-parametric statistics (Wilcoxon signed rank tests). HbA1c levels in Group A dropped significantly from 7.2% to 6.4% after lessons with the diabetes simulator (p = 0.01). No significant changes in HbA1c were observed in Group B between baseline (7.1%) and the end of the control lessons (7.0%), or the end of the cross-over phase lessons (6.8%). The number of 'hypos' decreased significantly from 31 to 14 in Group A (p = 0.03) after AIDA lessons, but did not change significantly in Group B from baseline (n = 20) to after the control lessons (n = 22). However, the number of 'hypos' did decrease significantly (to n = 10) in Group B after exposure to the simulator during the cross-over phase (p = 0.03 vs 6-week data). Larger trials involving more patients in more centres are clearly needed, but this proof-of-concept (pilot) study does demonstrate the feasibility of using a prospective RCT approach for the evaluation of educational diabetes simulation software such as AIDA.

Questionnaires for a randomized controlled trial methodology to evaluate the teaching utility of diabetes simulation programs.

AIDA is an interactive educational diabetes simulator which has been made available without charge on the Internet. Since its launch on the World Wide Web in 1996 over 87,000 people have visited the AIDA Website--http://www.2aida.org--and over 22,000 copies of the program have been downloaded from there free-of-charge. The AIDA software is believed to be of use in recreating clinically realistic diabetes situations for interactive simulation. However, despite its widespread application, its actual utility for supporting the education of patients with type 1 diabetes mellitus remains to be objectively demonstrated in a clinical randomised controlled trial (RCT) setting. The current "Diabetes Information Technology & WebWatch" column overviews a prospective RCT methodology for formally evaluating the educational utility of an interactive diabetes simulator, like AIDA. The protocol makes use of two study arms--each receiving different educational interventions. During lessons, arm A of the study will be exposed to the AIDA simulator (the active intervention), while arm B (the control group) will benefit from conventional educational methods using standard presentations with slides and transparencies. Six lessons will be held for each study arm (one per week). At the beginning and end of the study self-monitoring blood glucose (SMBG) data will be collected, details of any hypoglycemic episodes recorded, and assessments made of glycosylated hemoglobin (HbA1c) levels. Participants will also be required to complete a detailed questionnaire to assess their self-confidence, quality of life and metabolic control, attitudes towards SMBG, and knowledge about insulin dosage calculation. Comparisons will be made between arm A and arm B using unpaired statistical analyses. A partial cross-over study design is also proposed whereby subsequently the control group will be exposed to the AIDA simulator during a further 6-week course of lessons. This will ensure that the maximum number of subjects will eventually receive the active intervention, and will also allow further within group paired analyses to be applied (with greater statistical power). This current "Diabetes Information Technology & WebWatch" column documents two of the questionnaires which are intended to be used for this RCT approach.

Utility of the AIDA diabetes simulator as an interactive educational teaching tool for general practitioners (primary care physicians).

In previous "Diabetes Information Technology & WebWatch" columns, various user experience with an interactive educational "virtual diabetes patient" simulator called AIDA have been documented. The simulator is available free of charge from http://www.2aida.org on the Web, and user comments that have been received to date about the program have highlighted some of the many and varied ways in which a range of people have been applying the diabetes simulations in their own particular situations and practices. Inevitably, up to now, a great deal of attention has focused on use by individuals with diabetes and their relatives, as well as by health-care professionals such as diabetologists/endocrinologists and diabetes educators. However, an important group of health-carers involved in the provision of day-to-day care for many people with diabetes are primary care physicians (general practitioners). The current "Diabetes Information Technology & WebWatch" column addresses this area, overviewing a workshop which was held in September 2000 in Italy to gain experience with application of the AIDA diabetes simulation approach as a teaching tool for general practitioners (GPs). Feedback obtained from participants attending the workshop was very positive, with GPs reporting the simulation approach to be both of interest and use. Further workshops involving other healthcare professionals--in particular, nurses--are planned.

A randomised-controlled clinical trial methodology for evaluating the teaching utility of interactive educational diabetes simulators.

AIDA is an interactive educational diabetes simulator which has been made available without charge on the Internet. Since its launch on the World Wide Web in 1996 over 58,000 people have visited the AIDA Web site (http://www.2aida.org) and over 17,500 copies of the program have been downloaded from there free-of-charge. The AIDA software is believed to be of use in recreating clinical (diabetes) situations for interactive simulation. However, despite its widespread usage, its actual utility for supporting the education of patients with Type 1 diabetes mellitus remains to be objectively demonstrated in a randomised-controlled clinical trial setting. This paper describes a prospective, randomised-controlled trial (RCT) methodology for formally evaluating the educational utility of an interactive diabetes simulator, like AIDA. The protocol makes use of two study arms, each receiving different educational interventions. During lessons, Arm A of the study will be exposed to the AIDA simulator (the active intervention), while Arm B (the control group) will benefit from conventional educational methods using standard presentations with slides and transparencies. Six lessons will be held for each study arm (one per week). At the beginning and end of the study self-monitoring blood glucose (SMBG) data will be collected, details of any hypoglycaemic episodes recorded, and assessments made of HbA1c. Participants will also be required to complete a detailed questionnaire to assess their self-confidence, quality of life and metabolic control, attitudes towards SMBG, and knowledge about insulin dosage calculation. Comparisons will be made between Arm A and Arm B using unpaired statistical analyses. A partial cross-over study design is also proposed whereby subsequently the control group will be exposed to the AIDA simulator during a further 6-week course of lessons. This will ensure that the maximum number of subjects will eventually receive the active intervention, and will also allow further within group paired analyses to be applied (with greater statistical power). An initial evaluation study using this RCT approach has just recently commenced in the Ospedale di Marino in Marino (Rome), Italy.

Use of the AIDA diabetes simulation software--www.2aida.org--as an interactive educational tool for teaching student nurses.

In previous "Diabetes Information Technology & WebWatch" columns, various user experiences with an interactive educational virtual diabetes patient simulator, called AIDA, have been documented. The simulator is available free of charge from www.2aida.org on the Web. In the 5+ years since the program was first made available on the Internet, over 125,000 people have visited the AIDA Website and over 27,000 copies of the program have been downloaded, gratis. User comments that have been received about the program have highlighted some of the many and varied ways in which a range of people have been applying the diabetes simulations in their own particular situations and practices. Inevitably, up to now, a great deal of attention has focused on use of the program by individuals with diabetes and their relatives, as well as by health-care professionals such as diabetologists/endocrinologists, diabetes educators, and primary care physicians (general practitioners [GPs]). However, an important group of health-carers involved in the provision of day-to-day care for many people with diabetes are nurses. The current "Diabetes Information Technology & WebWatch" column overviews a workshop held in June 2001 in Italy to gain experience with application of the AIDA diabetes simulation approach as a teaching tool for student nurses. Feedback obtained from participants attending the workshop was generally very positive, with the student nurses reporting the simulation approach to be both of interest and of use. Further workshops involving other health-care students and professionals-in particular, medical students and qualified nurses-are planned.

Leptin levels in diabetic and nondiabetic subjects.

The role of leptin in human pathophysiology elicits considerable interest in view of its potential role as a treatment tool for obesity and other insulin resistant states, like type 2 diabetes mellitus (T2DM). Leptin has been extensively studied in obese humans, and much less so in other pathologic conditions. Leptin level has been reported to correlate with percent body fat mass (%FM), fasting serum insulin (FPI), insulin sensitivity and blood pressure. The aim of this study was to compare the leptin concentration, and its relationship with some anthropometric and biochemical parameters related to insulin resistance in 140 moderately obese type 2 diabetics (T2DM) and 160 age and weight matched non-diabetic controls in order to get a better insight into the possible role of leptin in the metabolic abnormalities of diabetes. The leptin levels were lower in the diabetic population only when both sexes were combined (p < 0.05) and were higher in the females of both groups. Among the nondiabetics, the leptin levels appeared to be related to BMI, %FM, HDL and FPI, while this was not the case in the diabetics. After correction for BMI, leptin appeared to be correlated with the FPI levels only in the non-diabetic females. When plasma leptin was included in a multiple linear regression model with plasma leptin as a dependent variable, BMI, W:Hr and FPI levels were significantly related to leptin in the non diabetic population, while no relationship reached the level of statistical significance among the diabetics, with the exception of the borderline value for the FPI (p = .052). In conclusion, leptin levels were independent of any of the parameters examined in our diabetic population, possibly due to the progressive loss of the normal mechanisms of leptin regulation with advancing disease. Conclusive data can only be obtained from the longitudinal study of a cohort of newly diagnosed diabetic subjects.

Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM.

OBJECTIVE: ACE inhibitors and calcium antagonists may favorably affect serum lipids and glucose metabolism. The primary aim of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) was to compare the effects of fosinopril and amlodipine on serum lipids and diabetes control in NIDDM patients with hypertension. Prospectively defined cardiovascular events were assessed as secondary outcomes. RESEARCH DESIGN AND METHODS: Inclusion criteria included a diagnosis of NIDDM and hypertension (systolic blood pressure of > 140 mmHg or diastolic blood pressure of > 90 mmHg). Exclusion criteria included a history of coronary heart disease or stroke, serum creatinine > 1.5 mg/dl, albuminuria > 40 micrograms/min, and use of lipid-lowering drugs, aspirin, or antihypertensive agents other than beta-blockers or diuretics. A total of 380 hypertensive diabetics were randomly assigned to open-label fosinopril (20 mg/day) or amlodipine (10 mg/day) and followed for up to 3.5 years. If blood pressure was not controlled, the other study drug was added. RESULTS: Both treatments were effective in lowering blood pressure. At the end of follow-up, between the two groups there was no significant difference in total serum cholesterol, HDL cholesterol, HbA1c, fasting serum glucose, or plasma insulin. The patients receiving fosinopril had a significantly lower risk of the combined outcome of acute myocardial infarction, stroke, or hospitalized angina than those receiving amlodipine (14/189 vs. 27/191; hazards ratio = 0.49, 95% CI = 0.26-0.95). CONCLUSIONS: Fosinopril and amlodipine had similar effects on biochemical measures, but the patients randomized to fosinopril had a significantly lower risk of major vascular events, compared with the patients randomized to amlodipine.