G. Grassi

Rethink Organization to iMprove Education and Outcomes (ROMEO): A multicenter randomized trial of lifestyle intervention by group care to manage type 2 diabetes

OBJECTIVE A trial was performed to establish whether our group care model for lifestyle intervention in type 2 diabetes can be exported to other clinics. RESEARCH DESIGN AND METHODS This study was a 4-year, two-armed, multicenter controlled trial in 13 hospital-based diabetes clinics in Italy (current controlled trials no. ISRCTN19509463). A total of 815 non–insulin-treated patients aged <80 years with ≥1 year known diabetes duration were randomized to either group or individual care. RESULTS After 4 years, patients in group care had lower A1C, total cholesterol, LDL cholesterol, triglycerides, systolic and diastolic blood pressure, BMI, and serum creatinine and higher HDL cholesterol (P < 0.001, for all) than control subjects receiving individual care, despite similar pharmacological prescriptions. Health behaviors, quality of life, and knowledge of diabetes had become better in group care patients than in control subjects (P < 0.001, for all). CONCLUSIONS The favorable clinical, cognitive, and psychological outcomes of group care can be reproduced in different clinical settings.

Cancer mortality reduction and metformin: a retrospective cohort study in type 2 diabetic patients.

Aims: Few studies suggest that metformin decreases cancer mortality in type‐2 diabetic patients (T2DP). We explored the association between the type and duration of antidiabetic therapies and cancer and other‐than‐cancer mortality in a T2DP cohort, taking into account the competing risks between different causes of death and multiple potential confounding effects. The mortality rates were compared with the general population from the same area.

Renal damage in patients with Type 2 diabetes: a strong predictor of mortality.

Aims  (i) To compare mortality rates in a cohort of Type 2 diabetic patients with those of the general population; (ii) to assess the prognostic role of pre‐existing chronic conditions; (iii) to evaluate the impact of different severity of renal damage on mortality.

Simple lifestyle recommendations and the outcomes of gestational diabetes. A 2×2 factorial randomized trial

The benefits of exercise and behavioural recommendations in gestational diabetes mellitus (GDM) are controversial. In a randomized trial with a 2×2 factorial design, we examined the effect of exercise and behavioural recommendations on metabolic variables, and maternal/neonatal outcomes in 200 GDM patients. All women were given the same diet: group D received dietary recommendations only; group E was advised to briskly walk 20‐min/day; group B received behavioural dietary recommendations; group BE was prescribed the same as B + E. Dietary habits improved in all groups. In a multivariable regression model, fasting glucose did not change. Exercise, but not behavioural recommendations, was associated with the reduction of postprandial glucose (p < 0001), glycated haemoglobin (HbA1c; p < 0.001), triglycerides (p = 0.02) and C‐reactive protein (CRP; p < 0.001) and reduced any maternal/neonatal complications (OR = 0.50; 95%CI=0.28–0.89;p = 0.02). In GDM patients a simple exercise programme reduced maternal postprandial glucose, HbA1c, CRP, triglycerides and any maternal/neonatal complications, but not fasting glucose values.

Carbohydrate counting improves coping ability and metabolic control in patients with Type 1 diabetes managed by Group Care.

Background and aims: To assess, in patients with Type 1 diabetes (T1 DM), the effects of adding a carbohydrate counting programme (CCP) to continuing education by Group Care on coping ability, quality of life (QoL), knowledge of diabetes, and metabolic control. Materials and methods: Out of 56 patients with T1 DM followed by Group Care, 27 were randomized to receive an 8-session CCP and 29 controls continued Group Care without a CCP. QoL, knowledge, and coping ability were assessed at baseline and after 30 months. Glycated hemoglobin (HbA1c), body weight, blood glucose, hypoglycemic episodes, and insulin dosages were checked every 3 months. Results: QoL improved (p<0.0001) in both CCP (88.7±9.2 vs78.0±9.9) and control patients (88.7±12.5 vs 80.4±11.7). At the end of study, patients on CCP had better scores in knowledge [difference 0.72 (95% CI 0.44; 0.99), p<0.0001] and the 3 coping areas [problem solving: 1.75 (1.2; 2.3), p<0.0001; social support seeking: −1.4 (−2.3; −0.48) p<0.005; avoidance: −1.59 (−2.6; −0.56), p<0.005] than controls. All variables showed a greater, although not statistically significant, improvement in patients with poor schooling. At 30 months, HbA1c was lower in the CCP patients than controls (7.2±0.9 vs 7.9±1.4), p<0.05. There were no changes in insulin dosage, hypoglycemic episodes or blood lipids. Conclusions: This study confirms that Group Care improves QoL in people with T1 DM, but suggests that specific educational and psychological supports are needed to modify adaptation to the disease. The CCP we developed appears effective in promoting change, also in patients with poor schooling.

A randomised controlled clinical trial of nurse-, dietitian- and pedagogistled Group Care for the management of Type 2 diabetes

Aim: To verify if Group Care, a model to manage Type 2 diabetes (T2DM) by systemic continuing group education, can be administered by nurses and dieticians under pedagogic guidance, and improve metabolic control, quality of life, Locus of Control, and insulin resistance. Material and subjects: Twenty-five patients with non-insulin-treated T2DM were randomized to Group Care and 24 to continued habitual individual care and education delivered by a diabetes specialist and pedagogist, respectively. Six nurses and 1 dietician received training by an accredited programme, a detailed operating manual and pedagogical supervision throughout the study. Follow-up was for 2 yr and included measurements of fasting blood glucose, glycated hemoglobin (HbA1c), body mass index, waist circumference, lipids, creatinine, blood pressure, serum insulin, homeostasis model assessment (HOMA) index of insulin resistance, health behaviors, quality of life, state and trait anxiety, and Locus of Control. Results: One patient on Group Care and 3 controls dropped out. At the end of study, the patients on Group Care had lower HbA1c (7.6± 0.8 vs 8.4± 1.3, p<0.05), insulin (18.0± 9.6 vs 24.3± 13.7, p<0.001), HOMA index (6.9± 5.4 vs 9.2± 6.6, p<0.05), and fatalistic attitude (17.2± 5.9 vs 24.9± 4.2, p<0.001) and better quality of life (65.0± 11.0 vs 78.4± 19.6, p<0.001) than controls. Conclusions: Group Care delivered by trained nurses and dietitan is associated with better outcomes than those obtained by a medically and pedagogically qualified team. It may offer a model for health operators to re-organize clinical practice and for patients to improve lifestyle and strengthen the therapeutic alliance with their carers.

A Generalized Allergic Reaction due to Zinc in Insulin Preparation

picillin-related rash usually appears 4-10 days after therapy and may often resolve even if therapy is continued. Our patients rash developed 24 h after self-medication with ampicillin. To our knowledge, there are no reports in the literature describing jaundice or a hepatic picture with doxycyline. The tetracycline class may produce clinical manifestations of jaundice within 4-10 days after beginning therapy, but it is usually associated with large intravenous doses, pregnancy, and renal disease. The patient had a positive serology for hepatitis B core antibody and hepatitis B surface antibody indicating that the patient had hepatitis B in the past but was not manifesting active disease. We want to alert the practitioner to the possibility of a drug hypersensitivity with hepatotoxicity associated with chlorpropamide. Discontinuance of the drug at the first manifestation of any allergic response such as rash may prevent cholestatic jaundice.

Cochlear, auditory brainstem responses in Type 1 diabetes: relationship with metabolic variables and diabetic complications

Few studies have analysed the presence of hearing abnormalities in diabetes. We assessed the presence of subclinical auditory alterations and their possible association with early vascular and neurological dysfunction in young adults with Type 1 diabetes of long duration.

Treatment of Allergy to Heterologous Monocomponent Insulin With Human Semisynthetic Insulin: Long-Term Study

Eight type II (non-insulin-dependent) diabetic subjects (7 women, 1 man, aged 42–61 yr), initially treated with oral hypoglycemic agents and intermittently treated with conventional insulins, were identified as developing allergic reactions to porcine and mixed-species monocomponent insulin. Allergy was systemic (urticaria and nonthrombocytopenic purpura) and local delayed in two subjects and local immediate or biphasic in six subjects. Lipoatrophy was present in two subjects. After treatment with human semisynthetic insulin (Monotard HM and Actrapid HM), systemic allergy disappeared. Local allergy disappeared in five subjects and was reduced in three subjects. No lipoatrophy occurred in new injection areas. The clinical results were accompanied by a significant decrease in serum insulinspecific IgE after 6, 12, 18, 24, 30, and 36 mo. Insulinspecific IgG showed an evident decrease in five of eight patients, but the difference in mean values was not significant after 6, 18, 24, 30, and 36 mo. With one exception, intradermal skin tests were positive to human, bovine, and porcine insulin before and after human insulin treatment.