Pietro Passera

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.

The locus of control in patients with Type 1 and Type 2 diabetes managed by individual and group care

Aims  The locus of control theory distinguishes people (internals) who attribute events in life to their own control, and those (externals) who attribute events to external circumstances. It is used to assess self‐management behaviour in chronic illnesses. Group care is a model of systemic group education that improves lifestyle behaviour and quality of life in patients with Type 1 and Type 2 diabetes. This study investigated the locus of control in Type 1 and Type 2 diabetes and the possible differences between patients managed by group care and control subjects followed by traditional one‐to‐one care.

Diabetic retinopathy as a cause of blindness in the province of Turin, north-west Italy, in 1967-1991.

Diabetes is known to be a major contributor to blindness in industrialized countries but few data are available on the situation in Italy. As an introductory step to the implementation of permanent screening for diabetic retinopathy, a search was carried out on the causes of visual loss in the provincial territory surrounding Turin, the main city of North‐West Italy. The case notes of all 4549 residents in the province who were certified blind between 1967 and 1991 were examined with regard to cause, age at onset, and year of onset of visual acuity 1/20. Diabetic retinopathy was the second commonest cause of bilateral blindness (13.1 % of cases), preceded by cataract (26.7%) and followed by myopia (11.1%), optic atrophy (8.9%), glaucoma (8.9%), retinitis pigmentosa (7.2%), and senile macular degeneration (4.1%). Diabetic retinopathy was the commonest eye disease among those who became blind between the ages of 50 and 70 and remained the leading cause of visual loss when the age groups 20 to 70 were pooled together. The incidence of diabetic retinopathy‐related blindness did not show any trend to decrease over the 25 years investigated. It is concluded that, in spite of widespread availability of facilities for its assessment and treatment, diabetic retinopathy remains a leading cause of blindness in North‐West Italy. This fully justifies the implementation of screening programmes and efficient referral chains for the early detection and prompt treatment of this complication of diabetes.

Estimating the Delay Between Onset and Diagnosis of Type 2 Diabetes From the Time Course of Retinopathy Prevalence

OBJECTIVE By correlating known diabetes duration with the prevalence of retinopathy, more than 10 years have been estimated to lapse between the onset and diagnosis of type 2 diabetes. Such calculations, however, assumed a linear model, included stages of retinopathy not specific to diabetes, and allowed 5 years for retinopathy to occur after the onset of diabetes. We calculated the duration of undiagnosed type 2 diabetes in outpatients screened for retinopathy in a hospital-based diabetes clinic after correcting these assumptions. RESEARCH DESIGN AND METHODS Diabetic patients (n = 12,074; 35,545 fundus examinations) were stratified into younger onset (YO; age at onset <30 years) or older onset (OO; age at onset ≥30 years), insulin treated (IT) or not IT (NIT), and with mild/more severe diabetic retinopathy (AnyDR) or moderate/more severe diabetic retinopathy (ModDR). The best-fitting equation correlating known duration among the OO-NIT group with the prevalence of ModDR was used to extrapolate time from appearance of retinopathy to diagnosis of type 2 diabetes. Time for retinopathy to develop after diabetes was calculated from the equation correlating the duration among the YO-IT group with appearance of ModDR. RESULTS There were 1,719 patients in the OO-NIT group with AnyDR and 685 with ModDR and 756 in the YO-IT group with AnyDR and 385 with ModDR. A linear model showed ModDR appeared 2.66 years before diagnosis among those in the OO-NIT group. A quadratic model suggested that ModDR appeared 3.29 years after diagnosis among those in the YO-IT group. The resulting estimate was 6.05 years (2.66 + 3.29) between the onset and diagnosis of diabetes, compared with 13.36 years using standard criteria. CONCLUSIONS Using best-fitting models and stratifying by glucose-lowering treatment and severity of retinopathy substantially lowers the estimated duration of undiagnosed type 2 diabetes.

Quality of Life, Coping Ability, and Metabolic Control in Patients With Type 1 Diabetes Managed By Group Care and a Carbohydrate Counting Program

Group care is a clinical-pedagogic model in which traditional routine visits are substituted by sessions of group education. This approach improves quality of life and metabolic control in patients with type 2 diabetes (1) but only quality of life in those with type 1 diabetes (2). The latter must match multiple daily insulin administrations with blood glucose monitoring, dietary intake, and energy expenditure (3). We hypothesized that to improve their coping strategies, patients with type 1 diabetes need more specific training in the technical aspects of day-to-day management of insulin therapy. To verify this, we studied the effects of embedding a carbohydrate counting program within group care on quality of life, knowledge …

The role of endothelium in the pathogenesis of diabetic microangiopathy.

Damage caused to the vessel wall by diverse mechanisms may lead to diabetic microangiopathy. Consequently, research work is more and more focusing on the pathophysiology of vascular cells, with particular emphasis on endothelium. This paper reviews the present knowledge on the alterations of small vessel endothelium in diabetes. The most important risk factors for diabetic microangiopathy are the duration of disease and the degree of metabolic control maintained throughout the years. However, genetic factors may also contribute. These are examined first, followed by the presumed roles played by increased protein glycation and the production of Advanced Glycosylation End Products, the “polyol pathway” and free radical generation. Endothelium is a widespread, extremely active organ which regulates complex physiologic functions and its structure and function are discussed in the second section of this review. The third part deals with how diabetes can affect endothelium and describes observations on endothelial metabolism in vitro as well as morphologic and functional alterations in the patients. Unfortunately, the mechanisms leading to progressive degeneration of the microcirculation and organ damage in diabetic patients remain largely unaccounted for.

Perceptions of diabetic retinopathy and screening procedures among diabetic people

Aims To assess how diabetic patients perceive retinopathy, screening for sight‐threatening lesions and their own role in preventing blindness.

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.

Association of Autoimmunity to Autonomic Nervous Structures With Nerve Function in Patients With Type 1 Diabetes: A 16-Year Prospective Study

OBJECTIVE We prospectively evaluated the association between autoimmunity to autonomic nervous structures and autonomic neuropathy in type 1 diabetes in relation to clinical variables. RESEARCH DESIGN AND METHODS A cohort of 112 patients with type 1 diabetes was prospectively followed from adolescence (T0) to approximately 4 (T4) and 16 (T16) years later. Standard cardiovascular (CV) tests and neurological examination were performed and related to the presence of circulating antibodies (Ab) to autonomic nervous structures detected at T0 and T4. Quality of life was assessed by a diabetes-specific questionnaire. RESULTS Sixty-six patients (59% of the cohort) were reexamined at T16 (age 31.4 ± 2 years; disease duration 23.4 ± 3.7 years). Nineteen had circulating Ab to autonomic structures. Prevalence of abnormal tests and autonomic symptoms were higher in Ab-positive (68 and 26%, respectively) than Ab-negative (32 and 4%) patients (P < 0.05). Among Ab-positive patients, the relative risk (RR) of having at least one altered CV test was 5.77 (95% CI 1.56–21.33), and an altered deep breathing (DB) test (<15 bpm) was 14.65 (2.48–86.46). Previous glycemic control was the only other predictor (RR 1.06 [1.002–1.13]/mmol/mol HbA1c increase). Presence of Ab carried over a 68% probability of developing an altered CV test; absence of Ab carried a 91% probability of not having an altered DB test and an 89% probability of not having an altered Valsalva ratio. Autonomic neuropathy was independently associated with worse quality of life. CONCLUSIONS Circulating Ab to autonomic structures are associated with the development of autonomic dysfunction in young diabetic patients independent of glycemic control.

Cognitive Function May be a Predictor of Retinopathy Progression in Patients with Type 2 Diabetes

Purpose Microvascular and macrovascular complications of diabetes, such as retinopathy and nephropathy, progress over time and may be associated with cognitive decline. In this article, we aim to gain further insight into the association between cognitive function and retinopathy in type 2 diabetes. Methods and Results In this observational 8-year prospective study of 498 outpatients, demographic and clinical variables were monitored, along with retinopathy, depression, anxiety, and cognitive function. Baseline fundus photographs were available in 477 patients, 240 with no retinopathy, 110 with mild retinopathy, and 127 with moderate/more severe retinopathy. Of the first 2 groups, 279 patients were reevaluated after 8 years, of whom 181 still had no/mild retinopathy and 98 had progressed to more severe stages. On multivariate analysis, retinopathy progression was associated with being insulin-treated (p = 0.036), and worse cognitive function (p = 0.025) at baseline. Conclusions Cognitive function may be an independent predictor of retinopathy progression.