46 results on '"Giacomo Vespasiani"'
Search Results
2. Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with hypertension: a systematic review and meta-analysis of randomised controlled trials
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George Siopis, George Moschonis, Evette Eweka, Jenny Jung, Dominika Kwasnicka, Bernard Yeboah-Asiamah Asare, Vimarsha Kodithuwakku, Ruben Willems, Nick Verhaeghe, Lieven Annemans, Rajesh Vedanthan, Brian Oldenburg, Yannis Manios, Enying Gong, Konstantinos Votis, Sofia Segkouli, Andreas Triantafyllidis, Odysseas Kyparissis, Ioannis Paliokas, Eleftheria Polychroniou, Dirk De Craemer, Kostas Anastasiou, Konstantinos Tserpes, Christina Mavrogianni, Eva Karaglani, Electra Kalogerakou, Maria Maragkoudaki, Agathi Ntzouvani, Katerina Kontochristopoulou, Sabine Dupont, Elizabeth Dupont, Leo Dauzon, Maartje Roskams, Niamh Lennox-Chhugani, Martin Perrin, Niamh Daly Day, Georgina Ferrer, Orla Snook, Edelweiss Aldasoro, Alejandro Gil-Salmerón, Pilar Gangas Peiró, Darren Curran, Fiona Lyne, Nereide A. Curreri, Nazzareno Pierantozzi, Claudia D'Antonio, Giacomo Vespasiani, Teresa Almonti, Helen Skouteris, Tracy Taylor, Melissa Savaglio, Konstantinos Makrilakis, George Stergiou, Stavros Liatis, George Karamanakos, Chrysi Koliaki, Anastasios Kollias, Eva Zikou, Haris Dimosthenopoulos, Keng-Yen Huang, Samrachana Adhikari, Kun Qian, Julia Dickhaus, Kimberly Carney, Farhan Sahito, Dusan Pavlovic, Djordje Djokic, Arzoo Sahito, Gisella Battalova, Chiara Seghieri, Sabina Nutti, Milena Vanieri, Nicola Belle, Gaia Bertarelli, Paola Cantarelli, Francesca Ferre, Anna Noci, Constanza Tortu, Nadia Bozzi, Dina Ferrari, Rachele Borelli, Violeta Iotova, Yoto Yotov, Natalia Usheva, Anna Kozhuharova, Vanya Russeva, Vanya Marinova, Sonya Koleva, Virginia Atanasova, Tanya Stefanova, Kaloyan Tsochev, Luis Moreno Aznar, Rosa Magallón Botaya, Gloria Bueno Lozano, Pilar De Miguel-Etayo, Esther Ma Gonzalez-Gil, María L. Miguel-Berges, Susana Pérez, Bárbara Oliván Blázquez, Natalia Giménez-Legarre, Florian Toti, Skerdi Prifti, Blerina Bombaj, Ditila Doracaj, Ornela Laze, Adriana Lapardhaja, and Luftime Bruka
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Adult ,hypertension ,Medicine (miscellaneous) ,Health Informatics ,Smart-phone applications ,Systolic and diastolic blood pressures ,Health Information Management ,Settore SECS-P/07 - Economia Aziendale ,Medicine and Health Sciences ,Humans ,Decision Sciences (miscellaneous) ,human ,Settore SECS-S/05 - Statistica Sociale ,Randomized Controlled Trials as Topic ,Risk assessment ,blood pressure ,feasibility study ,Websites ,Health interventions ,Grading ,Smartphones ,Meta-analysis ,Randomized controlled trial ,Systolic blood pressure ,Feasibility Studies ,Systematic Review ,Adult, Blood Pressure, Feasibility Studies, Humans ,Hypertension, Randomized Controlled Trials as Topic, Grading, Risk assessment, Smartphones, Websites, Health interventions, Meta-analysis, Randomized controlled trial, Smart-phone applications, Systematic Review, Systolic and diastolic blood pressures, Systolic blood pressure, adult ,blood pressure, feasibility study, human, hypertension - Abstract
Background Digital health interventions are effective for hypertension self-management, but a comparison of the effectiveness and implementation of the different modes of interventions is not currently available. This study aimed to compare the effectiveness of SMS, smartphone application, and website interventions on improving blood pressure in adults with hypertension, and to report on their reach, uptake, and feasibility. Methods In this systematic review and meta-analysis we searched CINAHL Complete, Cochrane Central Register of Controlled Trials, Ovid Embase, Ovid MEDLINE, and APA PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) published in English from Jan 1, 2009, that examined the effectiveness of digital health interventions on reducing blood pressure in adults with hypertension. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint was change in the mean of systolic blood pressure. Risk of bias was assessed with Cochrane Risk of Bias 2. Data on systolic and diastolic blood pressure reduction were synthesised in a meta-analysis, and data on reach, uptake and feasibility were summarised narratively. Grading of Recommendations, Assessment, Development, and Evaluation criteria were used to evaluate the level of evidence. The study was registered with PROSPERO CRD42021247845. Findings Of the 3235 records identified, 29 RCTs from 13 regions (n=7592 participants) were included in the systematic review, and 28 of these RCTs (n=7092 participants) were included in the meta-analysis. 11 studies used SMS as the primary mode of delivery of the digital health intervention, 13 used smartphone applications, and five used websites. Overall, digital health intervention group participants had a –3·62 mm Hg (95% CI –5·22 to –2·02) greater reduction in systolic blood pressure, and a –2·45 mm Hg (–3·83 to –1·07) greater reduction in diastolic blood pressure, compared with control group participants. No statistically significant differences between the three different modes of delivery were observed for both the systolic (p=0·73) and the diastolic blood pressure (p=0·80) outcomes. Smartphone application interventions had a statistically significant reduction in diastolic blood pressure (–2·45 mm Hg [–4·15 to –0·74]); however, there were no statistically significant reductions for SMS interventions (–1·80 mm Hg [–4·60 to 1·00]) or website interventions (–3·43 mm Hg [–7·24 to 0·38]). Due to the considerable heterogeneity between included studies and the high risk of bias in some, the level of evidence was assigned a low overall score. Interventions were more effective among people with greater severity of hypertension at baseline. SMS interventions reported higher reach and smartphone application studies reported higher uptake, but differences were not statistically significant. Interpretation SMS, smartphone application, and website interventions were associated with statistically and clinically significant systolic and diastolic blood pressure reductions, compared with usual care, regardless of the mode of delivery of the intervention. This conclusion is tempered by the considerable heterogeneity of included studies and the high risk of bias in most. Future studies need to describe in detail the mediators and moderators of the effectiveness and implementation of these interventions, to both further improve their effectiveness as well as increase their reach, uptake, and feasibility.
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- 2023
3. Role of telemedicine during COVID-19 pandemic in type 2 diabetes outpatients: The AMD annals initiative
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Giuseppina T. Russo, Francesco Andreozzi, Mariella Calabrese, Paolo Di Bartolo, Graziano Di Cianni, Carlo Bruno Giorda, Emanuela Lapice, Elisa Manicardi, Annalisa Giandalia, Giuseppe Lucisano, Antonio Nicolucci, Alberto Rocca, Maria Chiara Rossi, Emanuele Spreafico, Giacomo Vespasiani, and Valeria Manicardi
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Endocrinology ,Diabetes Mellitus, Type 2 ,Endocrinology, Diabetes and Metabolism ,Outpatients ,Internal Medicine ,Humans ,COVID-19 ,General Medicine ,Pandemics ,Telemedicine - Abstract
Telemedicine is advocated as a fundamental tool in modern clinical management. However, data on the effects of telemedicine vs face-to-face consultation on clinical outcomes in type 2 diabetes (T2DM) are still uncertain. This paper describes the use of telemedicine during the 2020 COVID-19 emergency and compares volume activity and quality indicators of diabetes care between face-to-face vs telemedicine counseling in the large cohort of T2DM patients from the AMD Annals Initiative.Demographic and clinical characteristics, including laboratory parameters, rate of the screening of long-term complications, current therapies and the Q-score, a validated score that measures the overall quality of care, were compared between 364,898 patients attending face-to-face consultation and 46,424 on telemedicine, during the COVID-19 pandemic.Patients on telemedicine showed lower HbA1c levels (7.1 ± 1.2 % vs 7.3 ± 1.3 %, p 0.0001), and they were less frequently treated with metformin, GLP1-RAs and SGLT2i and more frequently with DPP4i. The telemedicine group showed reduced monitoring of the various parameters considered as process indicators, especially, eye and foot examination. The proportion of patients with a good quality of care (Q score 25) was higher among those receiving face-to-face consultation. Moreover, in the telemedicine group, all major clinical outcomes remained stable when further compared to those collected in the year 2019, when the same patients underwent a regular face-to-face consultation, suggesting that the care provided through telemedicine did not negatively affect the most important parameters.During the COVID-19 pandemic, telemedicine provided an acceptable quality of diabetes care, comparable to that of patients attending face-to-face consultation, although a less frequent screening of complications seems to have occurred in subjects consulted by telemedicine.
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- 2022
4. Metrological characterization of instruments for body impedance analysis
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Valerio Marcotuli, Matteo Zago, Alex P. Moorhead, Marco Vespasiani, Giacomo Vespasiani, and Marco Tarabini
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Mechanical Engineering ,Electrical and Electronic Engineering ,Instrumentation - Abstract
Body impedance analysis (BIA) is used to evaluate the human body composition by measuring the resistance and reactance of human tissues with a high-frequency, low-intensity electric current. Nonetheless, the estimation of the body composition is influenced by many factors: body status, environmental conditions, instrumentation, and measurement procedure. This work studies the effect of the connection cables, conductive electrodes, adhesive gel, and BIA device characteristics on the measurement uncertainty. Tests were initially performed on electric circuits with passive elements and on a jelly phantom simulating the body characteristics. Results showed that the cables mainly contribute to increase the error on the resistance measurement, while the electrodes and the adhesive introduce a negligible disturbance on the measurement chain. This paper also proposes a calibration procedure based on a multivariate linear regression to compensate for the systematic error effect of BIA devices.
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- 2022
5. INtegration of care for reaching targetS In Diabetic patiEnts: Design of the INSIDE Study
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Gerardo Medea, Domenico Cucinotta, Marco Comaschi, Aldo P. Maggioni, Antonio Nicolucci, Giacomo Vespasiani, Federico Spandonaro, Andrea Di Lenarda, Michele Massimo Gulizia, Guerrino Zuin, and Alberto Aglialoro
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medicine.medical_specialty ,Settore SECS-P/06 ,Endocrinology, Diabetes and Metabolism ,Population ,030209 endocrinology & metabolism ,Type 2 diabetes ,Diabetes ,Cardiovascular diseases ,Integrated care ,030204 cardiovascular system & hematology ,Helsinki declaration ,Study Protocol ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Informed consent ,Internal Medicine ,medicine ,Risk factor ,education ,education.field_of_study ,business.industry ,medicine.disease ,chemistry ,Good clinical practice ,Emergency medicine ,Glycated hemoglobin ,business - Abstract
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
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- 2019
6. New Digital Health Technologies for Insulin Initiation and Optimization for People With Type 2 Diabetes
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David Kerr, Steven Edelman, Giacomo Vespasiani, and Kamlesh Khunti
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Blood Glucose ,Endocrinology ,Diabetes Mellitus, Type 2 ,Endocrinology, Diabetes and Metabolism ,Blood Glucose Self-Monitoring ,Insulin, Regular, Human ,Humans ,Hypoglycemic Agents ,Insulin - Abstract
The health and economic burden of type 2 diabetes is of global significance. Many people with type 2 diabetes eventually need insulin to help reduce their risk of serious associated complications. However, barriers to the initiation and/or optimization of insulin expose people with diabetes to sustained hyperglycemia. In this review, we investigated how new and future technologies may provide opportunities to help overcome these barriers to the initiation and/or optimization of insulin.A focused literature search of PubMed and key scientific congresses was conducted. Software tools and devices developed to support the initiation and/or optimization of insulin were identified by manually filtering300 publications and conference abstracts.Most software tools have been developed for smartphone platforms. At present, published data suggest that the use of these technologies is associated with equivalent or improved glycemic outcomes compared with standard care, with additional benefits such as reduced time burden and improved knowledge of diabetes among health care providers. However, there remains paucity of good-quality evidence. Most new devices to support insulin therapy help track the dose and timing of insulin.New digital health tools may help to reduce barriers to optimal insulin therapy. An integrated solution that connects glucose monitoring, dose recording, and titration advice as well as records comorbidities and lifestyle factors has the potential to reduce the complexity and burden of treatment and may improve adherence to titration and treatment, resulting in better outcomes for people with diabetes.
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- 2021
7. Prediction of complications of type 2 Diabetes: A Machine learning approach
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Antonio Nicolucci, Luca Romeo, Michele Bernardini, Marco Vespasiani, Maria Chiara Rossi, Massimiliano Petrelli, Antonio Ceriello, Paolo Di Bartolo, Emanuele Frontoni, and Giacomo Vespasiani
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Machine Learning ,Peripheral Vascular Diseases ,Endocrinology ,Diabetes Mellitus, Type 2 ,Endocrinology, Diabetes and Metabolism ,Internal Medicine ,Electronic Health Records ,Humans ,General Medicine - Abstract
To construct predictive models of diabetes complications (DCs) by big data machine learning, based on electronic medical records.Six groups of DCs were considered: eye complications, cardiovascular, cerebrovascular, and peripheral vascular disease, nephropathy, diabetic neuropathy. A supervised, tree-based learning approach (XGBoost) was used to predict the onset of each complication within 5 years (task 1). Furthermore, a separate prediction for early (within 2 years) and late (3-5 years) onset of complication (task 2) was performed. A dataset of 147.664 patients seen during 15 years by 23 centers was used. External validation was performed in five additional centers. Models were evaluated by considering accuracy, sensitivity, specificity, and area under the ROC curve (AUC).For all DCs considered, the predictive models in task 1 showed an accuracy 70 %, and AUC largely exceeded 0.80, reaching 0.97 for nephropathy. For task 2, all predictive models showed an accuracy 70 % and an AUC 0.85. Sensitivity in predicting the early occurrence of the complication ranged between 83.2 % (peripheral vascular disease) and 88.5 % (nephropathy).Machine learning approach offers the opportunity to identify patients at greater risk of complications. This can help overcoming clinical inertia and improving the quality of diabetes care.
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- 2022
8. A Novel Spatio-Temporal Multi-Task Approach for the Prediction of Diabetes-Related Complication: a Cardiopathy Case of Study
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Marco Vespasiani, Giacomo Vespasiani, Antonio Nicolucci, Luca Romeo, Giuseppe Armentano, and Emanuele Frontoni
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medicine.medical_specialty ,Physical medicine and rehabilitation ,Computer science ,Diabetes mellitus ,medicine ,Complication ,medicine.disease ,Task (project management) - Abstract
The prediction of the risk profile related to the cardiopathy complication is a core research task that could support clinical decision making. However, the design and implementation of a clinical decision support system based on Electronic Health Record (EHR) temporal data comprise of several challenges. Several single task learning approaches consider the prediction of the risk profile related to a specific diabetes complication (i.e., cardiopathy) independent from other complications. Accordingly, the state-of-the-art multi-task learning (MTL) model encapsulates only the temporal relatedness among the EHR data. However, this assumption might be restricted in the clinical scenario where both spatio-temporal constraints should be taken into account. The aim of this study is the proposal of two different MTL procedures, called spatio-temporal lasso (STL-MTL) and spatio-temporal group lasso (STGL-MTL), which encode the spatio-temporal relatedness using a regularization term and a graph-based approach (i.e., encoding the task relatedness using the structure matrix). Experimental results on a real-world EHR dataset demonstrate the robust performance and the interpretability of the proposed approach.
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- 2020
9. A Randomized Controlled, Treat-to-Target Study Evaluating the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) Administered Using Either Device-Supported or Routine Titration in People With Type 2 Diabetes
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Guillaume Charpentier, Christoph Hasslacher, Giacomo Vespasiani, Melanie J. Davies, Frank Flacke, Steve Bain, Harmonie Goyeau, Steven V. Edelman, and Michael Woloschak
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Adult ,Blood Glucose ,Male ,Endocrinology, Diabetes and Metabolism ,Biomedical Engineering ,Insulin Glargine ,Bioengineering ,Type 2 diabetes ,Pharmacology ,Hypoglycemia ,Internal Medicine ,medicine ,Humans ,Hypoglycemic Agents ,Aged ,Aged, 80 and over ,business.industry ,Insulin glargine ,Basal insulin ,Blood Glucose Self-Monitoring ,Treat to target ,Original Articles ,Middle Aged ,medicine.disease ,Diabetes Mellitus, Type 2 ,Titration ,Female ,business ,medicine.drug - Abstract
Background: The efficacy/safety of device-supported versus routine titration with Gla-300 in type 2 diabetes (T2DM) was evaluated. Method: AUTOMATIX was a 16-week, randomized, open-label, parallel-group, multicenter, noninferiority trial in insulin-treated or insulin-naïve people with T2DM. The fasting self-monitored plasma glucose (FSMPG) target was 90-130 mg/dL (5.0-7.2 mmol/L). Primary endpoint: proportion of participants achieving target FSMPG at week 16 without severe hypoglycemia. Secondary endpoints included: proportion reaching FSMPG target without confirmed (≤70 mg/dL [≤3.9 mmol/L]) or severe hypoglycemia; time to first achieve FSMPG target; mean FSMPG and HbA1c change (baseline to week 16). Safety endpoints included hypoglycemia and adverse events. Patient-reported outcomes (PROs) were also assessed. Results: Participants were randomized to device-supported (n = 75) or routine titration (n = 76); 17 participants in the device-supported group discontinued device use. Noninferiority was achieved for the primary endpoint (device-supported: 45.9%, routine: 36.8%; weighted difference: 9.04 [95% CI: −6.75, 24.83]), but not superiority ( P = .262). The proportion reaching FSMPG target range without confirmed (≤70 mg/dL [≤3.9 mmol/L]) or severe hypoglycemia was 34.3% vs 14.5%, respectively. The time at which 50% of the participants achieved the FSMPG target was less in the device-supported than routine titration arm (10 vs 13 weeks). Least squares mean HbA1c reduction, safety profiles, and PROs were similar in both arms. Mean “ease of use” score for the device, assessed by healthcare professionals and participants on a scale of 1-7, was ≥6. Conclusions: Device-supported self-titration had a good safety/efficacy profile, and was noninferior to routine titration and well accepted by diabetes specialists and patients.
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- 2019
10. Development and Validation of a Pattern-Recognition Engine for Visualization of Glycemic Patterns in Individuals Performing Low-Frequency SMBG
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Giorgio Grassi, Milena Saleh, Concetta Suraci, Jochen Sieber, Marianna Galetta, Giacomo Vespasiani, Antonio Nicolucci, and Giuseppe Prosperini
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business.industry ,Endocrinology, Diabetes and Metabolism ,030209 endocrinology & metabolism ,Pattern recognition ,Patient data ,medicine.disease ,Diabetes Therapy ,Visualization ,03 medical and health sciences ,Educational approach ,0302 clinical medicine ,Diabetes management ,Spouse ,Diabetes mellitus ,Internal Medicine ,medicine ,030212 general & internal medicine ,Artificial intelligence ,business ,Glycemic - Abstract
Background and Aims: Innovative technologies supporting healthcare professionals (HCPs) and patients in the review of self-monitoring blood glucose (SMBG) data may aid clinical and educational approach to diabetes management. MyStar Connect® (MSC) is a diabetes data management software that helps HCPs review patient data and adjust diabetes therapy. Filtering mechanisms are needed to visualize data efficiently. We developed a pattern recognition engine (PRE) for visualization of glycemic patterns of SMBG data in MSC. Method: 3-month of SMBG data from 184 insulin- and non-insulin treated patients, at low testing frequency (0.5-2 tests per day), were independently evaluated by three expert assessors. Daily and weekly hypo- and hyperglycemic patterns were identified, and compared to those identified by the PRE. Discrepancies were reconciled through discussion between the assessors. The rate of agreement between assessors and PRE was evaluated. The analyses were conducted separately for hypoglycemic and hyperglycemic patterns. Results: Daily patterns: 56 hypoglycemic and 247 hyperglycemic patterns were identified by the PRE. No disagreement was noted in the assessment of hypoglycemic patterns between the PRE and the assessors. In 23 cases of hyperglycemic patterns, a disagreement was noted, due to the PRE missing a pattern considered as present by the assessors. After further clarification, 18 cases were reconciled. Therefore, the rate of agreement between the PRE and the assessors was 100% for hypoglycemic patterns and 98% for hyperglycemic patterns. Weekly patterns: The assessors recognized that the PRE provided information not easily inferable by simple review of SMBG data. PRE was therefore considered reliable for all the patterns identified. Conclusion: The implementation of PRE can represent a useful tool to guide HCPs’ treatment decisions and educate patients performing SMBG at a low frequency. Disclosure G. Vespasiani: Consultant; Self; METEDA Srl. Other Relationship; Spouse/Partner; METEDA Srl. A. Nicolucci: None. M. Saleh: Employee; Self; Sanofi. J. Sieber: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. G. Prosperini: None. C. Suraci: None. M. Galetta: None. G. Grassi: None.
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- 2018
11. Trends over 8 years in quality of diabetes care: results of the AMD Annals continuous quality improvement initiative
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Antonino Cimino, Antonio Ceriello, Antonio Nicolucci, Riccardo Candido, Maria Chiara Rossi, Giacomo Vespasiani, Paolo Di Bartolo, Katherine Esposito, Fabio Pellegrini, Marco Scardapane, Giuseppe Lucisano, Illidio Meloncelli, Carlo Giorda, Marina Maggini, Edoardo Mannucci, Rossi, Maria Chiara, Candido, Riccardo, Ceriello, Antonio, Cimino, Antonino, Di Bartolo, Paolo, Giorda, Carlo, Esposito, Katherine, Lucisano, Giuseppe, Maggini, Marina, Mannucci, Edoardo, Meloncelli, Illidio, Nicolucci, Antonio, Pellegrini, Fabio, Scardapane, Marco, and Vespasiani, Giacomo
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Treatment intensity/appropriatene ,Male ,Gerontology ,Diabetes mellitu ,medicine.medical_specialty ,Quality management ,Electronic medical record ,Endocrinology, Diabetes and Metabolism ,media_common.quotation_subject ,Blood Pressure ,Type 2 diabetes ,Q Score ,Outcome measure ,Endocrinology ,Diabetes mellitus ,Internal Medicine ,medicine ,Humans ,Quality (business) ,Health policy ,Aged ,Quality of Health Care ,media_common ,Glycated Hemoglobin ,business.industry ,Medical record ,Quality of care ,Cholesterol, LDL ,General Medicine ,Middle Aged ,medicine.disease ,Quality Improvement ,Annals ,Diabetes Mellitus, Type 2 ,Italy ,Process measure ,Family medicine ,Female ,Patient Care ,business - Abstract
Quality of care monitoring is a key strategy for health policy. In Italy, the AMD Annals continuous monitoring and quality improvement initiative has been in place since 2006. Results after 8 years are now available.Quality of diabetes care indicators during the years 2004-2011 were extracted from electronic medical records of 300 diabetes clinics. From 200,000 to 500,000 patients with type 2 diabetes were analyzed per year. Six process indicators, eight intermediate outcome indicators, seven indicators of treatment intensity/appropriateness, and a quality of care summary score (Q score) were evaluated. Previous studies documented that the risk of developing a new cardiovascular event was 80 % higher in patients with a Q score15 and 20 % higher in those with a score between 15 and 25, as compared to those with a score25.The proportion of patients with HbA1c ≤7 %, LDL cholesterol100 mg/dl, and blood pressure ≥140/90 mmHg increased by 4.8, 21.9, and 10.0 %, respectively. Process and treatment intensity/appropriateness indicators consistently improved. The proportion of patients with a Q score15 decreased from 13.5 to 6.5 %, while those with a Q score25 increased from 22.9 to 38.5 %.AMD Annals document the progress in quality of diabetes care. Longitudinal improvements in Q score can translate into less cardiovascular events, with evident clinical and economic implications. AMD Annals represent a physician-led effort not requiring allocation of extra-economic resources, which is easy to implement and deeply rooted in routine clinical practice. They are a potential case model for other healthcare systems.
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- 2014
12. Correction: Mobile App-Based Interventions to Support Diabetes Self-Management: A Systematic Review of Randomized Controlled Trials to Identify Functions Associated with Glycemic Efficacy (Preprint)
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Yuan Wu, Xun Yao, Giacomo Vespasiani, Antonio Nicolucci, Yajie Dong, Joey Kwong, Ling Li, Xin Sun, Haoming Tian, and Sheyu Li
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UNSTRUCTURED In “Mobile App-Based Interventions to Support Diabetes Self-Management: A Systematic Review of Randomized Controlled Trials to Identify Functions Associated with Glycemic Efficacy” (JMIR Mhealth Uhealth 2017;5(3):e35), there was an error in Table 2. The “Mean (SD) HbA1c, %: baseline; end; change” for “Rossi 2013[1]” should read “I: 8.4 (NR); 7.9 (NR); –0.5 (NR); C: 8.5 (NR); 8.1 (NR); –0.5 (NR)” instead of “I: 8.4 (0.1); 7.9 (0.1); –0.5 (0.1); C: 8.5 (0.1); 8.1 (0.1); –0.5 (0.1)”. As a result, data were slightly changed as follows
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- 2017
13. Mobile App-Based Interventions to Support Diabetes Self-Management: A Systematic Review of Randomized Controlled Trials to Identify Functions Associated with Glycemic Efficacy
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Yuan Wu, Xun Yao, Giacomo Vespasiani, Antonio Nicolucci, Yajie Dong, Joey Kwong, Ling Li, Xin Sun, Haoming Tian, and Sheyu Li
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medicine.medical_specialty ,030209 endocrinology & metabolism ,Health Informatics ,Information technology ,Type 2 diabetes ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Diabetes mellitus ,Internal medicine ,medicine ,030212 general & internal medicine ,Adverse effect ,mobile health ,Glycemic efficacy ,mobile apps ,Type 1 diabetes ,Original Paper ,business.industry ,T58.5-58.64 ,medicine.disease ,Corrigenda and Addenda ,mobile applications ,mHealth ,classification ,Relative risk ,diabetes mellitus ,Public aspects of medicine ,RA1-1270 ,business ,Risk assessment - Abstract
BackgroundMobile health apps for diabetes self-management have different functions. However, the efficacy and safety of each function are not well studied, and no classification is available for these functions. ObjectiveThe aims of this study were to (1) develop and validate a taxonomy of apps for diabetes self-management, (2) investigate the glycemic efficacy of mobile app-based interventions among adults with diabetes in a systematic review of randomized controlled trials (RCTs), and (3) explore the contribution of different function to the effectiveness of entire app-based interventions using the taxonomy. MethodsWe developed a 3-axis taxonomy with columns of clinical modules, rows of functional modules and cells of functions with risk assessments. This taxonomy was validated by reviewing and classifying commercially available diabetes apps. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Chinese Biomedical Literature Database, and ClinicalTrials.gov from January 2007 to May 2016. We included RCTs of adult outpatients with diabetes that compared using mobile app-based interventions with usual care alone. The mean differences (MDs) in hemoglobin A1c (HbA1c) concentrations and risk ratios of adverse events were pooled using a random-effects meta-analysis. After taxonomic classification, we performed exploratory subgroup analyses of the presence or absence of each module across the included app-based interventions. ResultsAcross 12 included trials involving 974 participants, using app-based interventions was associated with a clinically significant reduction of HbA1c (MD 0.48%, 95% CI 0.19%-0.78%) without excess adverse events. Larger HbA1c reductions were noted among patients with type 2 diabetes than those with type 1 diabetes (MD 0.67%, 95% CI 0.30%-1.03% vs MD 0.37%, 95% CI –0.12%-0.86%). Having a complication prevention module in app-based interventions was associated with a greater HbA1c reduction (with complication prevention: MD 1.31%, 95% CI 0.66%-1.96% vs without: MD 0.38%, 95% CI 0.09%-0.67%; intersubgroup P=.01), as was having a structured display (with structured display: MD 0.69%, 95% CI 0.32%-1.06% vs without: MD 0.69%, 95% CI –0.18%-0.53%; intersubgroup P=.03). However, having a clinical decision-making function was not associated with a larger HbA1c reduction (with clinical decision making: MD 0.19%, 95% CI –0.24%-0.63% vs without: MD 0.61%, 95% CI 0.27%-0.95%; intersubgroup P=.14). ConclusionsThe use of mobile app-based interventions yields a clinically significant HbA1c reduction among adult outpatients with diabetes, especially among those with type 2 diabetes. Our study suggests that the clinical decision-making function needs further improvement and evaluation before being added to apps.
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- 2017
14. Improving quality of care in people with Type 2 diabetes through the Associazione Medici Diabetologi-annals initiative: a long-term cost-effectiveness analysis
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W. J. Valentine, Giacomo Vespasiani, C. K. Kristiansen, B. Hunt, Carlo Giorda, Antonio Nicolucci, and Fabio Pellegrini
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Male ,Gerontology ,Pediatrics ,medicine.medical_specialty ,Time Factors ,Cost-Benefit Analysis ,Endocrinology, Diabetes and Metabolism ,Type 2 diabetes ,Diabetes Complications ,Indirect costs ,Endocrinology ,Outcome Assessment, Health Care ,Internal Medicine ,medicine ,Humans ,Quality of care ,Treatment costs ,Aged ,Quality of Health Care ,business.industry ,Incidence ,Incidence (epidemiology) ,Disease Management ,Health Care Costs ,Cost-effectiveness analysis ,Middle Aged ,medicine.disease ,Diabetes Mellitus, Type 2 ,Italy ,Life expectancy ,Female ,Quality-Adjusted Life Years ,business - Abstract
Aims The Associazione Medici Diabetologi-annals initiative is a physician-led quality-of-care improvement scheme that has been shown to improve HbA1c concentration, blood pressure, lipid profiles and BMI in enrolled people with Type 2 diabetes. The present analysis investigated the long-term cost-effectiveness of enrolling people with Type 2 diabetes in the Associazione Medici Diabetologi-annals initiative compared with conventional management. Methods Long-term projections of clinical outcomes and direct costs (in 2010 Euros) were made using a published and validated model of Type 2 diabetes in people with Type 2 diabetes who were either enrolled in the Associazione Medici Diabetologi-annals initiative or who were receiving conventional management. Treatment effects were based on mean changes from baseline seen at 5 years after enrolment in the scheme. Costs and clinical outcomes were discounted at 3% per annum. Results The Associazione Medici Diabetologi-annals initiative was associated with improvements in mean discounted life expectancy and quality-adjusted life expectancy of 0.55 years (95% CI 0.54–0.57) years and 0.48 quality-adjusted life years (95% CI 0.46–0.49), respectively, compared with conventional management. Whilst treatment costs were higher in the Associazione Medici Diabetologi-annals arm, this was offset by savings as a result of the reduced incidence and treatment of diabetes-related complications. The Associazione Medici Diabetologi-annals initiative was found to be cost-saving over patient lifetimes compared with conventional management [€ 37,289 (95% CI 37,205–37,372) vs € 41,075 (95% CI 40,956–41,155)]. Conclusions Long-term projections indicate that the physician-led Associazione Medici Diabetologi-annals initiative represents a cost-saving method of improving long-term clinical outcomes compared with conventional management of people with Type 2 diabetes in Italy.
- Published
- 2013
15. Quality of Diabetes Care Predicts the Development of Cardiovascular Events: Results of the AMD-QUASAR Study
- Author
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Carlo Coscelli, Antonio Nicolucci, Maria Chiara Rossi, Giuseppe Lucisano, Domenico Cucinotta, Patrizia Di Blasi, Fabio Pellegrini, Marco Comaschi, Umberto Valentini, Giacomo Vespasiani, and Giovanni Bader
- Subjects
Research design ,Male ,medicine.medical_specialty ,National Health Programs ,Endocrinology, Diabetes and Metabolism ,Type 2 diabetes ,Predictive Value of Tests ,Internal medicine ,Diabetes mellitus ,Internal Medicine ,medicine ,Electronic Health Records ,Humans ,Longitudinal Studies ,Epidemiology/Health Services Research ,Original Research ,Aged ,Quality of Health Care ,Advanced and Specialized Nursing ,business.industry ,Incidence (epidemiology) ,Medical record ,Incidence ,Middle Aged ,medicine.disease ,Diabetes Mellitus, Type 2 ,Italy ,Cardiovascular Diseases ,Predictive value of tests ,Quality Score ,Physical therapy ,Microalbuminuria ,Female ,business - Abstract
OBJECTIVE The QUASAR (Quality Assessment Score and Cardiovascular Outcomes in Italian Diabetes Patients) study aimed to assess whether a quality-of-care summary score predicted the development of cardiovascular (CV) events in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS In 67 diabetes clinics, data on randomly selected patients were extracted from electronic medical records. The score was calculated using process and outcome indicators based on monitoring, targets, and treatment of A1C, blood pressure, LDL cholesterol, and microalbuminuria. The score ranged from 0 to 40. RESULTS Overall, 5,181 patients were analyzed; 477 (9.2%) patients developed a CV event after a median follow-up of 28 months. The incidence rate (per 1,000 person-years) of CV events was 62.4 in patients with a score of 25. Multilevel analysis, adjusted for clustering and case-mix, showed that the risk to develop a new CV event was 84% higher in patients with a score of 25. Mean quality score varied across centers from 16.5 ± 7.5 to 29.1 ± 6.3. When the score was tested as the dependent variable, it emerged that 18% of the variance in the score could be attributed to setting characteristics. CONCLUSIONS Our study documented a close relationship between quality of diabetes care and long-term outcomes. A simple score can be used to monitor quality of care and compare the performance of different centers/physicians.
- Published
- 2011
16. Four-year impact of a continuous quality improvement effort implemented by a network of diabetes outpatient clinics: the AMD-Annals initiative
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Adolfo Arcangeli, Antonino Cimino, Umberto Valentini, Sandro Gentile, D. Fava, Antonio Nicolucci, Maria Chiara Rossi, Giacomo Vespasiani, Carlo Giorda, Fabio Pellegrini, G. De Bigontina, and Illidio Meloncelli
- Subjects
medicine.medical_specialty ,Pediatrics ,Quality management ,business.industry ,Endocrinology, Diabetes and Metabolism ,Public health ,Electronic medical record ,medicine.disease ,Endocrinology ,Blood pressure ,Diabetes mellitus ,Ambulatory ,Emergency medicine ,Internal Medicine ,medicine ,Outpatient clinic ,business ,Glycated haemoglobin - Abstract
Diabet. Med. 27, 1041–1048 (2010) Abstract Aims We evaluated the impact of a continuous quality improvement effort implemented by a network of Italian diabetes clinics operating in the national healthcare system. Methods This was a controlled before-and-after study involving 95 centres, of which 67 joined the initiative since 2004 (group A) and 18 were first involved in 2007 (group B, control). All centres used electronic medical record systems. Information on quality indicators was extracted for the period 2004–2007. Data were centrally analysed anonymously and results were published annually. Each centre’s performance was ranked against the ‘best performers’. We compared quality indicators between the two groups of centres over 4 years. Results Over 100 000 Type 2 diabetes mellitus patients were evaluated annually. The proportion of patients with glycated haemoglobin levels
- Published
- 2010
17. An Interactive Diary for Diet Management (DAI): A New Telemedicine System Able to Promote Body Weight Reduction, Nutritional Education, and Consumption of Fresh Local Produce
- Author
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Susanna Talevi, Paolo Foglini, Maria Chiara Rossi, Paola Nanni, Teresa Almonti, Dante Bartolomei, Carla Consorti, Nena Giostra, Giacomo Vespasiani, and Cinzia Perozzi
- Subjects
Adult ,Male ,medicine.medical_specialty ,Dieticians ,Waist ,Diet, Reducing ,Endocrinology, Diabetes and Metabolism ,Health Behavior ,Diet, Mediterranean ,Body Mass Index ,Endocrinology ,Patient satisfaction ,McNemar's test ,Patient Education as Topic ,Surveys and Questionnaires ,Weight Loss ,medicine ,Humans ,Longitudinal Studies ,medicine.diagnostic_test ,business.industry ,Patient Selection ,Body Weight ,Middle Aged ,Telemedicine ,Confidence interval ,Test (assessment) ,Medical Laboratory Technology ,Italy ,Patient Satisfaction ,Physical therapy ,Female ,Waist Circumference ,Lipid profile ,business ,Body mass index - Abstract
The aim of this multicenter, longitudinal, single-arm, pre-post comparison was to test a telemedicine system able to promote body weight reduction, nutritional education, and consumption of fresh local produce.DAI (MeTeDa srl, San Benedetto del Tronto, Italy) is a software for mobile phones to support patients following a specific dietetic program. It facilitates the communication between the patient and dietician via short text messages. Overall, three specialized dieticians enrolled 140 consecutive patients with body mass index (BMI)or=25 kg/m(2) who voluntered to follow a specific diet program to be managed with DAI. At baseline and after 20 weeks, data on body weight, waist circumference, BMI, fasting blood glucose, lipid profile, food habits, and physical activity were collected and compared by the Wilcoxon test or the McNemar test.Overall, 115 individuals (82.1%) completed the follow-up. The mean (95% confidence interval) reduction in body weight was -2.5 (-3.2; -1.8) kg, whereas the reduction in waist circumference was -3.7 (-4.6; -2.9) cm, and that in BMI was 1.0 (-0.7; -1.2) kg/m(2). The software was useful as an educational tool: participants achieving the Mediterranean diet targets increased from 14.4% to 69.8% after 20 weeks. On average, each patient recognized and chose fresh local vegetables eight times per week during the follow-up. Participants regularly communicated with dieticians through short text messages.This study allowed the documentation of the efficacy of a new telemedicine system in supporting people who need to lose body weight. The tool was also suitable for a more articulated initiative of "nutritional education" aiming to promote the healthy properties of the Mediterranean diet and the consumption of local produce.
- Published
- 2010
18. Obesity and changes in urine albumin/creatinine ratio in patients with type 2 diabetes: The DEMAND Study
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Fabio Pellegrini, Umberto Valentini, Antonio Ceriello, Antonio Nicolucci, Giacomo Vespasiani, Maria Chiara Rossi, S. De Cosmo, Carlo Giorda, B. Pomili, Domenico Cucinotta, and Marco Comaschi
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Endocrinology, Diabetes and Metabolism ,Serum albumin ,Medicine (miscellaneous) ,Type 2 diabetes ,Ambulatory Care Facilities ,Risk Assessment ,Body Mass Index ,chemistry.chemical_compound ,Risk Factors ,Internal medicine ,Diabetes mellitus ,Odds Ratio ,Albuminuria ,Humans ,Medicine ,Outpatient clinic ,Diabetic Nephropathies ,Longitudinal Studies ,Obesity ,Aged ,Creatinine ,Nutrition and Dietetics ,biology ,business.industry ,Odds ratio ,Middle Aged ,medicine.disease ,Cross-Sectional Studies ,Logistic Models ,Endocrinology ,Diabetes Mellitus, Type 2 ,Italy ,chemistry ,Disease Progression ,biology.protein ,Female ,Waist Circumference ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Body mass index ,Biomarkers - Abstract
Background and aims Obesity is a potential risk factor for renal disease in non-diabetic subjects. It remains unclear whether this also applies to diabetic patients. We investigated whether obesity predicted changes in albumin excretion rate in individuals with type 2 diabetes. Methods and results Fifty Italian diabetes outpatient clinics enrolled a random sample of 1289 patients. A morning spot urine sample was collected to determine urinary albumin/creatinine ratio (ACR) at baseline and after 1 year from the study initiation. Progression of albumin excretion was defined as a doubling in ACR, while regression was defined as a 50% reduction. Multivariate logistic regression analyses were used to evaluate correlates of these outcomes. Data are expressed as odds ratios (OR) with 95% confidence intervals (CI). The risk of progression increased by 7% (OR = 1.07; 95%CI 1.00–1.15) for every 5-cm increase in waist circumference measured at baseline, and by 17% (OR = 1.17; 95%CI 1.03–1.33) for every one-unit increase in BMI during follow-up. The likelihood of regression was not independently associated with any of the variables investigated. The effect of obesity on progression of ACR was independent of metabolic control, blood pressure, treatment, and baseline level of albumin excretion. Conclusions We found a tight link between obesity and changes in albumin excretion in diabetic subjects, suggesting potential benefits of interventions on body weight on end-organ renal damage.
- Published
- 2010
19. Correction: Mobile App-Based Interventions to Support Diabetes Self-Management: A Systematic Review of Randomized Controlled Trials to Identify Functions Associated with Glycemic Efficacy
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Xin Sun, Ling Li, Sheyu Li, Yajie Dong, Joey Kwong, Antonio Nicolucci, Giacomo Vespasiani, Yuan Wu, Xun Yao, and Haoming Tian
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Glycemic efficacy ,medicine.medical_specialty ,Type 1 diabetes ,business.industry ,030209 endocrinology & metabolism ,Health Informatics ,Information technology ,Type 2 diabetes ,T58.5-58.64 ,medicine.disease ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Relative risk ,Internal medicine ,Diabetes mellitus ,medicine ,030212 general & internal medicine ,Public aspects of medicine ,RA1-1270 ,business ,Adverse effect ,Risk assessment - Abstract
Background: Mobile health apps for diabetes self-management have different functions. However, the efficacy and safety of each function are not well studied, and no classification is available for these functions. Objective: The aims of this study were to (1) develop and validate a taxonomy of apps for diabetes self-management, (2) investigate the glycemic efficacy of mobile app-based interventions among adults with diabetes in a systematic review of randomized controlled trials (RCTs), and (3) explore the contribution of different function to the effectiveness of entire app-based interventions using the taxonomy. Methods: We developed a 3-axis taxonomy with columns of clinical modules, rows of functional modules and cells of functions with risk assessments. This taxonomy was validated by reviewing and classifying commercially available diabetes apps. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, the Chinese Biomedical Literature Database, and ClinicalTrials.gov from January 2007 to May 2016. We included RCTs of adult outpatients with diabetes that compared using mobile app-based interventions with usual care alone. The mean differences (MDs) in hemoglobin A1c (HbA1c) concentrations and risk ratios of adverse events were pooled using a random-effects meta-analysis. After taxonomic classification, we performed exploratory subgroup analyses of the presence or absence of each module across the included app-based interventions. Results: Across 12 included trials involving 974 participants, using app-based interventions was associated with a clinically significant reduction of HbA1c (MD 0.48%, 95% CI 0.19%-0.77%) without excess adverse events. Larger HbA1c reductions were noted among patients with type 2 diabetes than those with type 1 diabetes (MD 0.67%, 95% CI 0.30%-1.03% vs MD 0.36%, 95% CI 0.08%-0.81%). Having a complication prevention module in app-based interventions was associated with a greater HbA1c reduction (with complication prevention: MD 1.31%, 95% CI 0.66%-1.96% vs without: MD 0.38%, 95% CI 0.09%-0.67%; intersubgroup P=.01), as was having a structured display (with structured display: MD 0.69%, 95% CI 0.32%-1.06% vs without: MD 0.16%, 95% CI 0.16%-0.48%; intersubgroup P=.03). However, having a clinical decision-making function was not associated with a larger HbA1c reduction (with clinical decision making: MD 0.18%, 95% CI 0.21%-0.56% vs without: MD 0.61%, 95% CI 0.27%-0.95%; intersubgroup P=.10). Conclusions: The use of mobile app-based interventions yields a clinically significant HbA1c reduction among adult outpatients with diabetes, especially among those with type 2 diabetes. Our study suggests that the clinical decision-making function needs further improvement and evaluation before being added to apps. [JMIR Mhealth Uhealth 2017;5(3):e35]
- Published
- 2018
20. Diabetes Interactive Diary: A New Telemedicine System Enabling Flexible Diet and Insulin Therapy While Improving Quality of Life
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Daniela Bruttomesso, Antonio Nicolucci, Fabio Pellegrini, Antonio Ceriello, Angela Girelli, Paolo Di Bartolo, David Kerr, Carmen De La Questa Mayor, Giacomo Vespasiani, David Horwitz, Francisco J. Ampudia, and Maria Chiara Rossi
- Subjects
Advanced and Specialized Nursing ,Type 1 diabetes ,medicine.medical_specialty ,business.industry ,Diet therapy ,Endocrinology, Diabetes and Metabolism ,Blood sugar ,medicine.disease ,law.invention ,Surgery ,Carbohydrate counting ,Randomized controlled trial ,Quality of life ,law ,Diabetes mellitus ,Internal medicine ,Internal Medicine ,medicine ,medicine.symptom ,business ,Weight gain - Abstract
OBJECTIVE Widespread use of carbohydrate counting is limited by its complex education. In this study we compared a Diabetes Interactive Diary (DID) with standard carbohydrate counting in terms of metabolic and weight control, time required for education, quality of life, and treatment satisfaction. RESEARCH DESIGN AND METHODS Adults with type 1 diabetes were randomly assigned to DID (group A, n = 67) or standard education (group B, n = 63) and followed for 6 months. A subgroup also completed the SF-36 Health Survey (SF-36) and World Health Organization-Diabetes Treatment Satisfaction Questionnaire (WHO-DTSQ) at each visit. RESULTS Of 130 patients (aged 35.7 ± 9.4 years; diabetes duration 16.5 ± 10.5 years), 11 dropped out. Time for education was 6 h (range 2–15 h) in group A and 12 h (2.5–25 h) in group B (P = 0.07). A1C reduction was similar in both groups (group A from 8.2 ± 0.8 to 7.8 ± 0.8% and group B from 8.4 ± 0.7 to 7.9 ± 1.1%; P = 0.68). Nonsignificant differences in favor of group A were documented for fasting blood glucose and body weight. No severe hypoglycemic episode occurred. WHO-DTSQ scores increased significantly more in group A (from 26.7 ± 4.4 to 30.3 ± 4.5) than in group B (from 27.5 ± 4.8 to 28.6 ± 5.1) (P = 0.04). Role Physical, General Health, Vitality, and Role Emotional SF-36 scores improved significantly more in group A than in group B. CONCLUSIONS DID is at least as effective as traditional carbohydrate counting education, allowing dietary freedom for a larger proportion of type 1 diabetic patients. DID is safe, requires less time for education, and is associated with lower weight gain. DID significantly improved treatment satisfaction and several quality-of-life dimensions.
- Published
- 2009
21. Correlates of diabetes-related distress in type 2 diabetes: Findings from the benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study
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Basilio Pintaudi, Giacomo Vespasiani, Antonio Nicolucci, Giuseppe Lucisano, Maria Chiara Rossi, Soren E. Skovlund, Angela Bulotta, and Sandro Gentile
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Male ,medicine.medical_specialty ,Type 2 diabetes ,Social support ,Diabetes mellitus ,Internal medicine ,Patient-Centered Care ,Surveys and Questionnaires ,Diet, Diabetic ,medicine ,Humans ,Aged ,Glycated Hemoglobin ,business.industry ,Patient-centered outcomes ,Medical record ,Type 2 Diabetes Mellitus ,Social Support ,Middle Aged ,medicine.disease ,Health Surveys ,Self Care ,Psychiatry and Mental health ,Clinical Psychology ,Distress ,Benchmarking ,Treatment Outcome ,Diabetes Mellitus, Type 2 ,Italy ,Hyperglycemia ,Physical therapy ,Educational Status ,Female ,Power, Psychological ,business ,Psychosocial ,Stress, Psychological - Abstract
To evaluate correlates of high diabetes-related distress (HD) among individuals with type 2 diabetes mellitus (T2DM).The study involved a sample of patients with T2DM who filled in the Problem Areas in Diabetes questionnaire (PAID-5); a score ≥ 40 indicates HD. Additional instruments included: SF12 health survey (SF12), Well-Being Index (WHO-5), Diabetes Empowerment Scale-Short Form (DES-SF), Patient Assessment of Chronic Illness Care-Short Form (PACIC-SF), Health Care Climate-Short Form (HCC-SF), Global Satisfaction with Diabetes Treatment (GSDT), Summary of Diabetes Self-Care Activities (SDSCA-6); Barriers to Medications (BM), Perceived Social Support (PSS). Clinical data were extracted from computerized medical records. Multivariable logistic regression analyses were performed to identify correlates of HD.Of 2374 patients (mean age 65.0±10.2 years, diabetes duration 14.0±15.3 years, 59.9% males), 1429 (60.2%) had HD. Compared to patients with a PAID-5 score40 those with HD were more often female, living alone, had a lower level of education, higher HbA1c levels, a greater perceived impact of hyperglycemic and hypoglycemic symptoms, a greater number of diabetes-related complications, lower scores of WHO-5, DES-SF, PSS, GSDT, SF-12 PCS, SDSCA-healthy diet and physical activity subscales, higher scores of BM and SDSCA-SMBG component. Multivariable analyses confirmed the relationship between HD and symptoms of hyperglycemia, levels of empowerment, global satisfaction with treatment, perception of barriers to medication, and psychological well-being. Conclusion HD is extremely common among people with T2DM, affecting almost two-thirds of patients. High levels of distress are associated with worse clinical and psychosocial outcomes and should be considered as a key patient-centered indicator.
- Published
- 2015
22. Interplay among patient empowerment and clinical and person-centered outcomes in type 2 diabetes. The BENCH-D study
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Maria Chiara, Rossi, Giuseppe, Lucisano, Martha, Funnell, Basilio, Pintaudi, Angela, Bulotta, Sandro, Gentile, Marco, Scardapane, Soren Eik, Skovlund, Giacomo, Vespasiani, Antonio, Nicolucci, C, De Francesco, Rossi, Maria Chiara, Lucisano, Giuseppe, Funnell, Martha, Pintaudi, Basilio, Bulotta, Angela, Gentile, Sandro, Scardapane, Marco, Skovlund, Soren Eik, Vespasiani, Giacomo, and Nicolucci, Antonio
- Subjects
Blood Glucose ,Male ,medicine.medical_specialty ,Multivariate analysis ,media_common.quotation_subject ,Person-centered outcome ,Type 2 diabetes ,Type 2 diabete ,Diabetes mellitus ,Internal medicine ,Humans ,Medicine ,Empowerment ,Aged ,media_common ,Glycemic ,business.industry ,Blood Glucose Self-Monitoring ,Medicine (all) ,Quality of care ,General Medicine ,Middle Aged ,medicine.disease ,Self Care ,Distress ,Diabetes Mellitus, Type 2 ,Quartile ,Female ,Patient Participation ,Power, Psychological ,business ,Psychosocial ,Clinical psychology - Abstract
Objective: We evaluated empowerment in T2DM and identified its correlates. Methods: A sample of individuals self-administered the Diabetes Empowerment Scale-Short Form (DESSF) and other 9 validated instruments (person-centered outcomes). Correlates of DES-SF were identified through univariate and multivariate analyses. For person-centered outcomes, ORs express the likelihood of being in upper quartile of DES-SF (Q4) by 5 units of the scale. Results: Overall, 2390 individuals were involved. Individuals in Q4 were younger, more often males, had higher levels of school education, lower HbA1c levels and prevalence of complications as compared to individuals in the other quartiles. The likelihood of being in Q4 was directly associated with higher selfreported self-monitoring of blood glucose (SDSCA6–SMBG) (OR = 1.09; 95% CI: 1.03–1.15), higher satisfaction with diabetes treatment (GSDT) (OR = 1.15; 95% CI: 1.07–1.25), perceived quality of chronic illness care and patient support (PACIC-SF) (OR = 1.23; 95% CI: 1.16–1.31), and better person-centered communication (HCC-SF) (OR = 1.10; 95% CI: 1.01–1.19) and inversely associated with diabetes-related distress (PAID-5) (OR = 0.95; 95% CI: 0.92–0.98). Adjusted DES-SF mean scores ranged between centers from 69.8 to 93.6 (intra-class correlation = 0.10; p < 0.0001). Conclusions: Empowerment was associated with better glycemic control, psychosocial functioning and perceived access to person-centered chronic illness care. Practice of diabetes center plays a specific role. Practice implications: DES-SF represents a process and outcome indicator in the practice of diabetes centers.
- Published
- 2015
23. Diabetes Interactive Diary: A Mobile Phone-Based Telemedicine System for Carbohydrate Counting and Bolus Calculator
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Maria Chiara Rossi and Giacomo Vespasiani
- Subjects
medicine.medical_specialty ,Type 1 diabetes ,Telemedicine ,business.industry ,Insulin ,medicine.medical_treatment ,Hypoglycemia ,medicine.disease ,Carbohydrate counting ,Mobile phone ,Diabetes mellitus ,medicine ,Intensive care medicine ,business ,Simulation ,Glycemic - Abstract
A flexible therapy for type 1 diabetes based on carbohydrate counting and insulin dose adjustment can promote glycemic control and quality of life without worsening severe hypoglycemia or cardiovascular risk. The complexity of the standard education required by the flexible therapy can be managed with the ‘Diabetes Interactive Diary (DID)', a carbohydrate/bolus calculator for mobile phones. It also works as a telemedicine system based on communication between patient and physician via text messages (SMS). The efficacy and safety of the DID have been tested in 3 main studies. The DID was demonstrated to be effective in improving metabolic control as well as standard education while ensuring several additional benefits. First, it halved the time dedicated to education and simplified the calculation of carbohydrates content and insulin doses, allowing more individuals with type 1 diabetes to adopt the flexible regimen. Second, the use of the DID was also associated with an 86% decrease in risk of grade 2 hypoglycemia. Additionally, several quality of life scales were significantly improved, suggesting that the use of telemedicine can increase the acceptance of insulin treatment and help patients cope with the disease. Currently, the DID is available as a free app for smartphones.
- Published
- 2014
24. Benchmarking activities based on person centered measures: a diabetes case study from Italy
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Soren E. Skovlund, S Gentile, Maria Chiara Rossi, Antonio Nicolucci, Giacomo Vespasiani, Giuseppe Lucisano, Angela Bulotta, and B Pintaudi
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Distress ,Nursing ,business.industry ,Order (business) ,Diabetes mellitus ,Usual care ,Public Health, Environmental and Occupational Health ,Medicine ,Person centered ,Benchmarking ,business ,medicine.disease - Abstract
Issue/problem A wide consensus exists about the role of patient involvement in the management of diabetes (DM) in order to achieve the desired therapeutic goals. However, major problems in dealing with psycho-social problems have been documented in usual care. In particular, diabetes-related distress (DRD) is common amongst people with DM and hampers efforts to self-manage their condition. The BENCH-D AMD study, part of the DAWN 2 initiatives in Italy, aims to evaluate whether a benchmarking activity based on …
- Published
- 2014
25. Raccomandazioni e indicazioni per i nuovi strumenti per la salute del Cittadino: un nuovo FSE?
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Isabella Castiglioni, Maurizio Cipolla, Mario Costa, Antonio V. Gaddi, Daniela Luzi, Velio Macellari, Marco Manca, Michele Martoni, Gregorio Mercurio, Carmelo Militello, Franco Naccarella, Fabrizio Pecoraro, Chiara Rabbito, Fabrizio L. Ricci, Giulio Rigon, Giovanni Rinaldi, Angelo Rossi Mori, Giancarmine Russo, Oscar Tamburis, Rita Verbicaro, Giacomo Vespasiani, Luigi Zampetti, Castiglioni, Isabella, Cipolla, Maurizio, Costa, Mario, Gaddi, Antonio V., Luzi, Daniela, Macellari, Velio, Manca, Marco, Martoni, Michele, Mercurio, Gregorio, Militello, Carmelo, Naccarella, Franco, Pecoraro, Fabrizio, Rabbito, Chiara, Ricci, Fabrizio L., Rigon, Giulio, Rinaldi, Giovanni, Rossi Mori, Angelo, Russo, Giancarmine, Tamburis, Oscar, Verbicaro, Rita, Vespasiani, Giacomo, and Zampetti, Luigi
- Published
- 2014
26. The Relationship Between Physicians’ Self-Reported Target Fasting Blood Glucose Levels and Metabolic Control in Type 2 Diabetes
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Maurizio Belfiglio, Sherrie H. Kaplan, Antonio Nicolucci, D. Cavaliere, R Della Vedova, Miriam Valentini, Monica Franciosi, Fabio Capani, G. De Berardis, M. Massi Benedetti, Giacomo Vespasiani, Sheldon Greenfield, Fabio Pellegrini, outcomes in type diabetes, C. Taboga, G. Tognoni, A Corsi, B. Di Nardo, Massimo Tombesi, V. Caimi, and Michele Sacco
- Subjects
Advanced and Specialized Nursing ,Research design ,medicine.medical_specialty ,business.industry ,Endocrinology, Diabetes and Metabolism ,Type 2 diabetes ,medicine.disease ,Diabetes mellitus ,Internal medicine ,Metabolic control analysis ,Health care ,Internal Medicine ,medicine ,Population study ,Medical emergency ,Quality of care ,business ,Body mass index - Abstract
OBJECTIVE—To investigate the relationship between beliefs of physicians relative to intensive metabolic control in type 2 diabetes and levels of HbA1c obtained in a sample of their patients. RESEARCH DESIGN AND METHODS—Physicians’ beliefs were investigated through a questionnaire sent to a sample of self-selected clinicians participating in a nationwide initiative aimed at assessing the relationship between the quality of care delivered to patients with type 2 diabetes and their outcomes. At the same time, physicians were asked to collect clinical data on a random sample of their patients, stratified by age ( RESULTS—Of 456 physicians, 342 (75%) returned the questionnaire. Among the responders, 200 diabetologists and 99 general practitioners (GPs) recruited 3,297 patients; 2,003 of whom were always followed by the same physician and 1,294 of whom were seen by different physicians in the same structure on different occasions. Only 14% of the respondents used target FBG levels ≤6.1 mmol/l, whereas 38% pursued values >7.8 mmol/l, with no statistically significant difference between diabetologists and GPs. The analysis of the relationship between FBG targets and metabolic control, restricted to those patients always seen by the same physician, showed a strong linear association, with mean HbA1c values of 7.0 ± 1.6 for patients in the charge of physicians pursuing FBG levels ≤6.1 mmol/l and 7.8 ± 1.8 for those followed by physicians who used target values >7.8 mmol/l. After adjusting for patients’ and physicians’ characteristics, the risk of having HbA1c values >7.0% was highly correlated with physicians’ beliefs. Patients followed by different physicians in the same unit showed a risk of inadequate metabolic control similar to that of patients followed by physicians adopting a nonaggressive policy. CONCLUSIONS—Doctors adopt extremely heterogeneous target FBG levels in patients with type 2 diabetes, which in turn represent an important independent predictor of metabolic control. To improve patient outcomes, physicians-centered educational activities aimed at increasing the awareness of the potential benefits of a tight metabolic control in patients with type 2 diabetes are urgently needed.
- Published
- 2001
27. Baseline Quality-of-Care Data From a Quality-Improvement Program Implemented by a Network of Diabetes Outpatient Clinics
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Gualtiero De Bigontina, Antonio Nicolucci, Carlo Giorda, Illidio Meloncelli, Giacomo Vespasiani, Fabio Pellegrini, Maria Chiara Rossi, Adolfo Arcangeli, Antonino Cimino, and Umberto Valentini
- Subjects
Research design ,Male ,medicine.medical_specialty ,Quality management ,Quality Assurance, Health Care ,Endocrinology, Diabetes and Metabolism ,Blood Pressure ,Type 2 diabetes ,Ambulatory Care Facilities ,Diabetes mellitus ,Internal Medicine ,medicine ,Diabetes Mellitus ,Outpatient clinic ,Albuminuria ,Humans ,Epidemiology/Health Services Research ,Aged ,Quality Indicators, Health Care ,Advanced and Specialized Nursing ,Glycated Hemoglobin ,business.industry ,Medical record ,Benchmarking ,Middle Aged ,medicine.disease ,Lipids ,Surgery ,Treatment Outcome ,Emergency medicine ,Female ,business ,Quality assurance - Abstract
OBJECTIVE—To describe patterns of diabetes care and implement benchmarking activities at the national level. RESEARCH DESIGN AND METHODS—A total of 86 clinics participated, all using electronic medical records. Quality indicators were identified, and software was developed, enabling the extraction of the information needed for quality-of-care profiling. RESULTS—Overall, 114,249 patients with type 2 diabetes were seen during 2004. A1C was measured at least once in 88.0% of the patients, lipid profile in 64.6%, blood pressure in 77.2%, and microalbuminuria in 48.1%. Overall, 43.1% of individuals had A1C ≤7.0%, 36.6% had blood pressure ≤130/85 mmHg, and 29.8% had LDL cholesterol CONCLUSIONS—This study is the first step of a nationwide quality-improvement effort and documents the possibility of obtaining standardized information to be used for diabetes care profiling and benchmarking activities.
- Published
- 2008
28. Impact of the 'Diabetes Interactive Diary' telemedicine system on metabolic control, risk of hypoglycemia, and quality of life: a randomized clinical trial in type 1 diabetes
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Maria Chiara, Rossi, Antonio, Nicolucci, Giuseppe, Lucisano, Fabio, Pellegrini, Paolo, Di Bartolo, Valerio, Miselli, Roberto, Anichini, Giacomo, Vespasiani, and S Maria, Imbaro
- Subjects
Insulin glulisine ,Adult ,Male ,Risk ,medicine.medical_specialty ,Pediatrics ,Patient Dropouts ,Endocrinology, Diabetes and Metabolism ,Hypoglycemia ,law.invention ,Endocrinology ,Randomized controlled trial ,law ,Diabetes mellitus ,Internal medicine ,medicine ,Humans ,Hypoglycemic Agents ,Glycated Hemoglobin ,Type 1 diabetes ,Intention-to-treat analysis ,Insulin glargine ,business.industry ,Repeated measures design ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Diet Records ,Telemedicine ,Intention to Treat Analysis ,Medical Laboratory Technology ,Diabetes Mellitus, Type 1 ,Italy ,Patient Satisfaction ,Hyperglycemia ,Quality of Life ,Drug Therapy, Combination ,Female ,business ,medicine.drug - Abstract
Telemedicine systems based on mobile phones represent new promising educational tools. The "Diabetes Interactive Diary" (DID) is a carbohydrate/bolus calculator promoting the patient-physician communication via short message service. This study aimed to compare the efficacy of the DID versus usual care on metabolic control, hypoglycemia, and quality of life.Patients with type 1 diabetes on a basal:bolus regimen with insulin glargine and insulin glulisine, not previously educated on carbohydrate (CHO) counting, were randomized to DID (Group A; n=63) or traditional education (Group B; n=64). Generalized hierarchical linear regression models for repeated measures were applied to compare changes between groups. Incidence of hypoglycemia was compared using Poisson regression models.Of 127 patients (age, 36.9±10.5 years; diabetes duration, 16.3±9.3 years), 15 (11.8%) dropped out. After 6 months, hemoglobin A1c (HbA1c) levels decreased by -0.49±0.11 in Group A and -0.48±0.11 in Group B (P=0.73). Group A showed a 86% lower risk of grade 2 hypoglycemia than Group B. Compared with usual care, DID improved the "perceived frequency of hyperglycemic episodes" scale of the Diabetes Treatment Satisfaction Questionnaire and the "social relations" and the "fear of hypoglycemia" dimensions of the Diabetes Specific Quality of Life Scale. Results obtained with DID markedly differ among patients and centers.DID is no more effective than traditional CHO counting education in reducing HbA1c levels. DID reduces the risk of moderate/severe hypoglycemia and improves quality of life. A better understanding of patients' and healthcare professionals' attitudes associated with an effective care supported by technology is essential to avoid waste of resources.
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- 2013
29. Prospective, randomized trial on intensive SMBG management added value in non-insulin-treated T2DM patients (PRISMA): a study to determine the effect of a structured SMBG intervention
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Francesco Giorgino, Massimo Porta, Antonio Ceriello, Marina Scavini, Christopher Parkin, Erminio Bonizzoni, Raffaele Marino, Davide Bottalico, Antonio Tiengo, Giacomo Vespasiani, Domenico Cucinotta, Emanuele Bosi, Scavini, M, Bosi, Emanuele, Ceriello, A, Giorgino, F, Porta, M, Tiengo, A, Vespasiani, G, Bottalico, D, Marino, R, Parkin, C, Bonizzoni, E, and Cucinotta, D.
- Subjects
Adult ,Blood Glucose ,medicine.medical_specialty ,endocrine system diseases ,Office Visits ,Endocrinology, Diabetes and Metabolism ,Type 2 diabetes ,Hypoglycemia ,law.invention ,Endocrinology ,Randomized controlled trial ,Patient Education as Topic ,Diabetes management ,law ,Diabetes mellitus ,Type 2 diabetes mellitus ,Diabetes medication algorithm ,medicine ,Internal Medicine ,Humans ,Hypoglycemic Agents ,Patient empowerment ,Glycemic ,Aged ,Glycated Hemoglobin ,business.industry ,Blood Glucose Self-Monitoring ,nutritional and metabolic diseases ,General Medicine ,Middle Aged ,medicine.disease ,Regimen ,Diabetes Mellitus, Type 2 ,Italy ,Self-monitoring of blood glucose ,Physical therapy ,Original Article ,Randomized clinical trial ,business ,Algorithms ,Patient education - Abstract
Self-monitoring of blood glucose (SMBG) is a core component of diabetes management. However, the International Diabetes Federation recommends that SMBG be performed in a structured manner and that the data are accurately interpreted and used to take appropriate therapeutic actions. We designed a study to evaluate the impact of structured SMBG on glycemic control in non-insulin-treated type 2 diabetes (T2DM) patients. The Prospective, Randomized Trial on Intensive SMBG Management Added Value in Non-insulin-Treated T2DM Patients (PRISMA) is a 12-month, prospective, multicenter, open, parallel group, randomized, and controlled trial to evaluate the added value of an intensive, structured SMBG regimen in T2DM patients treated with oral agents and/or diet. One thousand patients (500 per arm) will be enrolled at 39 clinical sites in Italy. Eligible patients will be randomized to the intensive structured monitoring (ISM) group or the active control (AC) group, with a glycosylated hemoglobin (HbA1c) target of
- Published
- 2013
30. Vibration Perception Threshold in the Screening of Sensorimotor Distal Symmetric Polyneuropathy
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Maria Chiara Rossi, Patricia Roldan, Giacomo Vespasiani, Massimiliano Copetti, Valeria Premrou, Laura Maffei, and Fabio Pellegrini
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Adult ,medicine.medical_specialty ,Endocrinology, Diabetes and Metabolism ,media_common.quotation_subject ,Population ,Biomedical Engineering ,Bioengineering ,Audiology ,Mechanotransduction, Cellular ,Vibration ,Young Adult ,Vibration perception ,Age Distribution ,Diabetic Neuropathies ,Predictive Value of Tests ,Reference Values ,Sensory threshold ,Statistics ,Internal Medicine ,Humans ,Medicine ,p-value ,Young adult ,Letters to the Editor ,education ,Normality ,Aged ,media_common ,Neurologic Examination ,education.field_of_study ,business.industry ,Age Factors ,Middle Aged ,Confidence interval ,Touch Perception ,Sensory Thresholds ,Predictive value of tests ,business - Abstract
Use of the vibration perception threshold (VPT) is a simple way of detecting large-fiber dysfunction, thus identifying individuals with diabetes at risk of ulceration.1-2 Nevertheless, poor standardization of measurement limits its use in clinical practice;3-5 furthermore, the unique normality threshold of 25 V is criticized due to the physiologic increase in VPT with age.6 The development of devices reducing the intra- and interoperator variability in the test execution could help research and clinical practice in the identification of new relevant reference thresholds. In this context the UltraBiotesiometer Meteda contains specific features that reduce the variability of the measurements, that is, the vibration activated only under controlled pressure, five indicator lights allowing the monitoring of the pressure, and the elasticity of vibration electrically controlled in both directions. We adopted this new technologically advanced biothesiometer to assess VPT trends in subjects without sensorimotor distal symmetric polyneuropathy and identify age-specific normality thresholds. A random sample of 150 consecutive individuals have been identified among those routinely referred to one endocrinology center in Argentina. Patients were considered eligible for the study if diabetes, neuropathy, and slipped disc were excluded. Recruitment was stratified according to three age classes: 60 years. VPT was measured using UltraBiotesiometer Meteda. Normal ranges for VPT were computed using the normal approximation. The upper limit of this range was reported along with its 95% confidence intervals. Subjects with values larger than the estimated upper limit should be considered as “nonnormal.” Subgroup analyses for each age class were performed. VPT values were log-transformed before analyses because their skewed distribution. A P value < .05 was considered significant. All analyses were performed using R software. Our results document that normality threshold in the overall population is lower (20 V) than that currently suggested by guidelines (25 V) and relevant differences in VPT upper limits exist according to age classes (Table 1). The normality thresholds identified cannot provide direct indications for changing clinical practice, but the clear trend and the marked differences among the upper limits in the three age classes cannot be ignored. Further longitudinal studies adopting technologically advanced devices are needed to assess the association between age-specific normality thresholds and incidence of lower limb complications. Table 1. Upper Limits of Normal Range Above Which the Subject Should Be Considered as “Nonnormal” Overall and According to Age Classes.
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- 2014
31. Diabetes Interactive Diary: a new telemedicine system enabling flexible diet and insulin therapy while improving quality of life: an open-label, international, multicenter, randomized study
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Maria C E, Rossi, Antonio, Nicolucci, Paolo, Di Bartolo, Daniela, Bruttomesso, Angela, Girelli, Francisco J, Ampudia, David, Kerr, Antonio, Ceriello, Carmen De La Questa, Mayor, Fabio, Pellegrini, David, Horwitz, and Giacomo, Vespasiani
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Adult ,Male ,Diabetes Mellitus, Type 1 ,Treatment Outcome ,Emerging Treatments and Technologies ,Quality of Life ,Humans ,Hypoglycemic Agents ,Insulin ,Female ,Middle Aged ,Original Research - Abstract
OBJECTIVE Widespread use of carbohydrate counting is limited by its complex education. In this study we compared a Diabetes Interactive Diary (DID) with standard carbohydrate counting in terms of metabolic and weight control, time required for education, quality of life, and treatment satisfaction. RESEARCH DESIGN AND METHODS Adults with type 1 diabetes were randomly assigned to DID (group A, n = 67) or standard education (group B, n = 63) and followed for 6 months. A subgroup also completed the SF-36 Health Survey (SF-36) and World Health Organization-Diabetes Treatment Satisfaction Questionnaire (WHO-DTSQ) at each visit. RESULTS Of 130 patients (aged 35.7 ± 9.4 years; diabetes duration 16.5 ± 10.5 years), 11 dropped out. Time for education was 6 h (range 2–15 h) in group A and 12 h (2.5–25 h) in group B (P = 0.07). A1C reduction was similar in both groups (group A from 8.2 ± 0.8 to 7.8 ± 0.8% and group B from 8.4 ± 0.7 to 7.9 ± 1.1%; P = 0.68). Nonsignificant differences in favor of group A were documented for fasting blood glucose and body weight. No severe hypoglycemic episode occurred. WHO-DTSQ scores increased significantly more in group A (from 26.7 ± 4.4 to 30.3 ± 4.5) than in group B (from 27.5 ± 4.8 to 28.6 ± 5.1) (P = 0.04). Role Physical, General Health, Vitality, and Role Emotional SF-36 scores improved significantly more in group A than in group B. CONCLUSIONS DID is at least as effective as traditional carbohydrate counting education, allowing dietary freedom for a larger proportion of type 1 diabetic patients. DID is safe, requires less time for education, and is associated with lower weight gain. DID significantly improved treatment satisfaction and several quality-of-life dimensions.
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- 2009
32. Interactive diary for diabetes: A useful and easy-to-use new telemedicine system to support the decision-making process in type 1 diabetes
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Paolo Di Bartolo, Antonio Nicolucci, Marianna Galetta, Giacomo Vespasiani, Michela Dal Pos, David Horwitz, Fabio Pellegrini, Giuseppe Marelli, Maria Chiara Rossi, and Daniela Bruttomesso
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Adult ,Male ,Telemedicine ,Short Message Service ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,MEDLINE ,Monitoring, Ambulatory ,computer.software_genre ,Text message ,Young Adult ,Endocrinology ,Patient Education as Topic ,Diabetes mellitus ,Surveys and Questionnaires ,medicine ,Dietary Carbohydrates ,Humans ,Insulin ,Decision-making ,Type 1 diabetes ,Multimedia ,business.industry ,medicine.disease ,Self Care ,Medical Laboratory Technology ,Diabetes Mellitus, Type 1 ,Female ,Medical emergency ,business ,computer - Abstract
Widespread use of carbohydrate (CHO) counting is limited by its complex educational needs, but a telemedicine system could simplify the patients' training.The Diabetes Interactive Diary (DID) was set up on patients' mobile phones and allowed to record the blood glucose values and quantify the total CHO intake during a meal, by choosing the specific food and the amount ingested from a list of pictures. It also suggested the most appropriate insulin bolus in relation to the patient's CHO/insulin ratio. Data were sent to the physician by Short Message Service (also known as text message). Two pilot studies were carried out to investigate the feasibility and acceptability of the system and its effectiveness in improving metabolic control.In the first study, 50 patients were involved in a survey with questionnaires administered before and 12 weeks after the start of the DID. The system was considered by almost all the patients as easy to use and very helpful. CHO counting and insulin bolus calculation were ranked as the most useful functions. In the second study, 41 consecutive patients using DID under routine clinical practice conditions were evaluated after a median of 9 months of follow-up. DID was associated with a nonstatistically significant reduction in fasting blood glucose (FBG), postprandial glucose (PPG), and hemoglobin A1c levels. FBG and PPG coefficient of variation (CV) values were significantly reduced: FBG-CV decreased by 6.7% (95% confidence interval -11.9, -1.6; P = 0.02), while PPG-CV decreased by 11.5% (95% confidence interval -19.3, -3.7; P = 0.01). No patients reported serious hypoglycemic episodes requiring medical intervention.DID can represent a useful, safe, and easy-to-use tool to help the patient with type 1 diabetes promote dietary freedom. Adjustment of insulin doses according to CHO intake allowed the reduction of glucose variability, increasingly recognized as an important, independent risk factor for cardiovascular events.
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- 2009
33. Identifying patients with type 2 diabetes at high risk of microalbuminuria: results of the DEMAND (Developing Education on Microalbuminuria for Awareness of reNal and cardiovascular risk in Diabetes) Study
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Giacomo Vespasiani, Domenico Cucinotta, Marco Comaschi, Antonio Ceriello, Fabio Pellegrini, Antonio Nicolucci, Salvatore De Cosmo, Carlo Giorda, Maria Chiara Rossi, and Umberto Valentini
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,Type 2 diabetes ,Risk Assessment ,Severity of Illness Index ,Patient Education as Topic ,Risk Factors ,Internal medicine ,Diabetes mellitus ,Odds Ratio ,Prevalence ,medicine ,Albuminuria ,Humans ,Outpatient clinic ,Risk factor ,Abdominal obesity ,Aged ,Aged, 80 and over ,Glycated Hemoglobin ,Transplantation ,business.industry ,Cholesterol, HDL ,Odds ratio ,Awareness ,Middle Aged ,medicine.disease ,Endocrinology ,Diabetes Mellitus, Type 2 ,Italy ,Cardiovascular Diseases ,Nephrology ,Creatinine ,Regression Analysis ,Female ,Microalbuminuria ,Metabolic syndrome ,medicine.symptom ,business - Abstract
We evaluated to what extent the presence of risk factors and their interactions increased the likelihood of microalbuminuria (MAU) among individuals with type 2 diabetes.Fifty-five Italian diabetes outpatient clinics enrolled a sample of patients with type 2 diabetes, without urinary infections and overt diabetic nephropathy. A morning spot urine sample was collected to centrally determine the urinary albumin/creatinine ratio (ACR). A tree-based regression technique (RECPAM) and multivariate analyses were performed to investigate interaction between correlates of MAU.Of the 1841 patients recruited, 228 (12.4%) were excluded due to the presence of urinary infections and 56 (3.5%) for the presence of macroalbuminuria. Overall, the prevalence of MAU (ACR = 30-299 mg/g) was of 19.1%. The RECPAM algorithm led to the identification of seven classes showing a marked difference in the likelihood of MAU. Non-smoker patients with HbA1c7% and waist circumference/=102 cm showed the lowest prevalence of MAU (7.5%), and represented the reference class. Patients with retinopathy, waist circumference98 cm and HbA1c8% showed the highest likelihood of MAU (odds ratio = 13.7; 95% confidence intervals 6.8-27.6). In the other classes identified, the risk of MAU ranged between 3 and 5. Age, systolic blood pressure, HDL cholesterol levels and diabetes treatment represented additional, global correlates of MAU.The likelihood of MAU is strongly related to the interaction between diabetes severity, smoking habits and several components of the metabolic syndrome. In particular, abdominal obesity, elevated blood pressure levels and low HDL cholesterol levels substantially increase the risk of MAU. It is of primary importance to monitor MAU in high-risk individuals and aggressively intervene on modifiable risk factors.
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- 2008
34. Partial gastrectomy and mineral metabolism: effects on gastrin-calcitonin release
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Carla Mannarelli, Giacomo Vespasiani, Anna Maria Scarponi, S. Cristallini, Andrea Blass, Paolo Filipponi, and F Gregorio
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Calcitonin ,Male ,Peptic Ulcer ,medicine.medical_specialty ,Adolescent ,Bone density ,medicine.medical_treatment ,Parathyroid hormone ,Biochemistry ,Endocrinology ,Calcitriol ,Bone Density ,Gastrectomy ,Internal medicine ,Gastrins ,medicine ,Humans ,Child ,Calcium metabolism ,Bone mineral ,business.industry ,medicine.disease ,Pentagastrin ,Osteopenia ,Bone Diseases, Metabolic ,Parathyroid Hormone ,Surgery ,business ,hormones, hormone substitutes, and hormone antagonists ,medicine.drug - Abstract
Bone mineral metabolism was studied in 20 male patients, between 8 and 18 years, after surgical treatment for peptic ulcer (ten Billroth 1 and ten Billroth 2 gastrectomies) and in 16 sex- and aged-matched healthy controls. The bone mineral content was statistically reduced only in the Billroth 2 group. Serum 25(OH)D was lower in all patients, but fractional calcium absorption was similar to the control value. This may be due to increases in 1,25(OH)2D and parathyroid activity (particularly in Billroth 2). Serum osteocalcin levels and hydroxyproline excretion were higher than in the controls. A positive linear correlation emerged not only between serum 1,25(OH)2D and PTH levels but also between each of these and serum osteocalcin and urine hydroxyproline. Both PTH and calcitriol were inversely correlated with the bone mineral mass in Billroth 2, confirming a trend observed in Billroth 1. Although calcitonin values were normal, basal gastrin levels were severely impaired in all patients. In response to a mixed meal, increases in gastrin and calcitonin were significantly lower than in the controls. The calcitonin response to intravenous calcium and pentagastrin infusion was not significantly different to the controls. The percentage increase in gastrin and calcitonin responses to oral calcium correlated positively with the reduction in bone mineral content only in the Billroth 2 group, suggesting a reduction in calcitonin release may contribute to gastric surgery osteopenia in these patients.
- Published
- 1990
35. Clinical characteristics and patterns of care of newly diagnosed type 2 diabetic patients
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Carlo Giorda, Claudio Noacco, Giacomo Vespasiani, Sergio Di Pietro, Domenico Cucinotta, Marco Comaschi, Antonio Nicolucci, and Carlo Coscelli
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Patterns of care ,Male ,Pediatrics ,medicine.medical_specialty ,Nutrition and Dietetics ,business.industry ,Endocrinology, Diabetes and Metabolism ,Medicine (miscellaneous) ,Newly diagnosed ,Health Promotion ,Middle Aged ,Diabetes Complications ,Cost of Illness ,Diabetes Mellitus, Type 2 ,Italy ,Patient Education as Topic ,medicine ,Ambulatory Care ,Humans ,Hypoglycemic Agents ,Female ,Cardiology and Cardiovascular Medicine ,business - Published
- 2007
36. Insulin storage in Europe: a comment to Grajower et al., Eli Lilly, and Novo Nordisk
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Marco, Gallo, Marco, Comoglio, Alberto, De Micheli, Luca, Monge, and Giacomo, Vespasiani
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Europe ,Drug Stability ,Diabetes Mellitus ,Humans ,Hypoglycemic Agents ,Insulin ,Drug Packaging - Published
- 2004
37. Evaluation of a bar-code system for nutrient analysis in dietary surveys
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Marilyn Martin, Michael E. J. Lean, Josephine Cooney, Tom Kk Ha, Mauro Bruni, Giacomo Vespasiani, Annie S. Anderson, Linda Maher, and Susan Eley
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Gerontology ,Adult ,Male ,Electronic Data Processing ,Nutrition and Dietetics ,Adolescent ,Public Health, Environmental and Occupational Health ,Medicine (miscellaneous) ,Data entry ,Portion size ,Middle Aged ,Key features ,Micronutrient ,Diet Surveys ,Nutrient ,Cross-Sectional Studies ,Scotland ,Food ,Environmental health ,Analysis software ,Humans ,Nutrient database ,Female ,Mathematics ,Aged - Abstract
Objective:A novel system for nutrient analysis has been developed and tested over 5 years. Its key features are a nutrient database of 600 commonly eaten foods (95% of foods eaten in 7-day surveys); a booklet identifying each food with a bar code, bar codes for gram weight and for portion sizes (small, medium, large) and a bar-code reader with dietary analysis software for PCs. In the present study the bar-code system has been evaluated by comparison with a commonly used manual entry nutrient analysis software for dietitians' use.Design:Cross-sectional.Setting:Glasgow city district.Subjects:One hundred and sixty adults aged 18–65 years old.Results:Comparing mean intakes for macro- and micronutrients, using the Bland and Altman method1, the bias between the two methods was small, ranging from 0.93 to 1.03. The bar-code system took significantly less professional time in data entry and nutrient analysis than the widely used manual system (29 min per 7-day diary vs. 47 min per 7-day diary, P < 0.001).Conclusions:It is suggested that the bar-code system offers greater speed with a saving of professional time needed for nutrient analysis of dietary surveys. This system is commended for maintaining accuracy while promoting economy.
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- 2000
38. Evaluation of New Computerized Method for Recording 7-Day Food Intake in IDDM Patients
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Angela A Rivellese, Mariarosa M Ventura, Giacomo Vespasiani, Mauro Bruni, Vincenza Moriconi, Vincenza Pacioni, Maria T Sulpini, Renato Borrelli, Angela Giacco, Claudio Cangemi, Luigi Perna, Paolo Brunetti, and Gabriele Riccardi
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Adult ,Male ,Food intake ,medicine.medical_specialty ,Time Factors ,Endocrinology, Diabetes and Metabolism ,Time saving ,law.invention ,Eating ,Randomized controlled trial ,Computer Systems ,law ,Internal Medicine ,medicine ,Humans ,Advanced and Specialized Nursing ,Analysis of Variance ,business.industry ,Middle Aged ,Crossover study ,Surgery ,Food record ,Diabetes Mellitus, Type 1 ,Food ,Insulin dependent diabetes ,Anesthesia ,Female ,Analysis of variance ,Patient Participation ,business - Abstract
Objective To evaluate a new computerized method for recording 7-day food intake. Research Design and Methods Randomized crossover trial was conducted with patients recording the amount and type of every food and drink consumed during a week by either a computerized device (Food-meter) or recording the data in a diary. Each method was applied twice. Twenty-one insulin-dependent diabetic patients (mean ± SD age 25 ± 9 yr) were studied. Results The two methods showed very good agreement in the evaluation of the patients' diets (1792 ± 408 vs. 1764 ± 436 kcal∕day, 84 ± 19 vs. 82 ± 21 g∕day protein, 68 ± 22 vs. 67 ± 23 g∕day fat, 210 ± 60 vs. 207 ± 58 g∕day carbohydrate with the conventional and computerized methods, respectively). The variability between the methods and the variability within each method were of similar magnitude. Conclusions The Food-meter represents a useful tool for computerizing the 7-day food record. The method is easy, reliable, and time saving. Moreover, it minimizes the risk of transcriptional errors.
- Published
- 1991
39. Validation of a computerised measurement system for guided routine evaluation of cardiovascular autonomic neuropathy
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Antonio Nicolucci, Lina Clementi, M. Massi Benedetti, Giacomo Vespasiani, Illidio Meloncelli, Stanislao Lostia, Salvatore Branca, Salvatore Verga, F. Romagnoli, Mauro Bruni, Rita Amoretti, and Fabrizio Carinci
- Subjects
Adult ,medicine.medical_specialty ,Health Informatics ,Likelihood ratios in diagnostic testing ,Cardiovascular System ,Sensitivity and Specificity ,Electrocardiography ,Diabetic Neuropathies ,Predictive Value of Tests ,Internal medicine ,Diabetes mellitus ,Heart rate ,medicine ,Humans ,Mass Screening ,Sensitivity (control systems) ,Diagnosis, Computer-Assisted ,Aged ,Likelihood Functions ,Routine screening ,business.industry ,Middle Aged ,medicine.disease ,Predictive value ,Computer Science Applications ,Surgery ,Blood pressure ,Autonomic Nervous System Diseases ,Evaluation Studies as Topic ,Data Interpretation, Statistical ,Cardiology ,business ,Autonomic neuropathy ,Software - Abstract
A study for evaluating the use of the Cardionomic system was conducted in six Italian Centres for Diabetes. Cardionomic is a portable computerised system that is used for a guided step-by-step performance of several cardiovascular tests for autonomic neuropathy (heart rate and blood pressure). It has been compared to the traditional method using an electrocardiograph. In this study, which involved 74 diabetic patients, 392 cardiovascular tests were conducted with the electrocardiograph and 392 were done using the portable system. The results were compared to the results obtained with the ECG assuming the latter as the standard ones. All the indices of validity that were investigated (sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio) indicate that the proposed system is reliable. Because it saves a considerable amount of time and is also easy to use, it represents a valid alternative for the routine screening of autonomic neuropathy.
- Published
- 1996
40. The Diabetes Interactive Diary – A Useful Tool for Diabetes Management?
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Giacomo Vespasiani, David Horwitz, Maria Ce Rossi, Antonio Nicolucci, and Paolo Di Bartolo
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medicine.medical_specialty ,Endocrinology ,Endocrine and Autonomic Systems ,Diabetes management ,business.industry ,Endocrinology, Diabetes and Metabolism ,Diabetes mellitus ,medicine ,Intensive care medicine ,medicine.disease ,business - Abstract
Adoption of a flexible diet and insulin therapy for people with type 1 diabetes reduces the daily burden of the disease. In particular, carbohydrate counting and insulin dose adjustment at each meal promote dietary freedom, quality of life and glycaemic control, without worsening severe hypoglycaemia or cardiovascular risk. To overcome the complex education required to adopt this method, the Diabetes Interactive Diary (DID) represents an automatic carbohydrate/insulin bolus calculator in a mobile phone. It also works as a telemedicine system based on communication between patient and physician via text messages. To avoid methodological flaws found in previous studies on similar devices, DID is undergoing a process of evaluation similar to that usually adopted for pharmacological products: first, its feasibility, acceptability and safety were documented in a phase I study; second, its effectiveness on metabolic control, weight loss and quality of life were preliminarily highlighted in a phase II randomised study; and third, a confirmatory phase III randomised trial is currently under way to investigate the DID’s impact on glycaemic variability. If the DID’s effectiveness is confirmed, it will increase the proportion of patients who may benefit from flexible diabetes management.
- Published
- 2010
41. An Interactive Diary for Diet Management (DAI): A New Telemedicine System Able to Promote Body Weight Reduction, Nutritional Education, and Consumption of Fresh Local Produce.
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Maria Chiara Rossi, Cinzia Perozzi, Carla Consorti, Teresa Almonti, Paolo Foglini, Nena Giostra, Paola Nanni, Susanna Talevi, Dante Bartolomei, and Giacomo Vespasiani
- Published
- 2010
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42. Interactive Diary for Diabetes: A Useful and Easy-to-Use New Telemedicine System to Support the Decision-Making Process in Type 1 Diabetes.
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Maria C.E. Rossi, Antonio Nicolucci, Fabio Pellegrini, Daniela Bruttomesso, Paolo Di Bartolo, Giuseppe Marelli, Michela Dal Pos, Marianna Galetta, David Horwitz, and Giacomo Vespasiani
- Published
- 2009
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43. Realization of a paper slide-rule to evaluate glycide exchanges, the calorie content in foods, and the calories burnt up by physical exercise
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Giacomo Vespasiani, M. Galetta, L. Clementi, M. Bruni, and I. Meloncelli
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medicine.medical_specialty ,Calorie ,Slide rule ,Multimedia ,Computer science ,Physical exercise ,General Medicine ,computer.software_genre ,law.invention ,law ,Physical therapy ,medicine ,Realization (systems) ,computer - Published
- 1994
44. Proposal for an educational system of numeric elaboration of glycemia values shown on an ordinary television set (One Touch II Video-LifeScan S.p.A)
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M. Bruni, D. Santoro, Giacomo Vespasiani, I. Meloncelli, L. Clementi, and M. Galetta
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Multimedia ,Computer science ,law ,General Medicine ,computer.software_genre ,computer ,Television set ,Elaboration ,law.invention ,Educational systems - Published
- 1994
45. Benchmarking network for clinical and humanistic outcomes in diabetes (BENCH-D) study: protocol, tools, and population
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Basilio Pintaudi, G. Marra, Antonio Nicolucci, Giuseppe Lucisano, Maria Chiara Rossi, Sandro Gentile, Soren E. Skovlund, Fabio Pellegrini, Giacomo Vespasiani, Nicolucci, Antonio, Rossi, Maria C., Pellegrini, Fabio, Lucisano, Giuseppe, Pintaudi, Basilio, Gentile, Sandro, Marra, Giampiero, Skovlund, Soren E., and Vespasiani, Giacomo
- Subjects
education.field_of_study ,medicine.medical_specialty ,Multidisciplinary ,Quality management ,Patient-centered outcomes ,business.industry ,Population ,Quality of care ,Type 2 diabetes ,Context (language use) ,Benchmarking ,Type 2 diabete ,Study Protocol ,Family medicine ,Scale (social sciences) ,Patient-centered outcome ,Health care ,Medicine ,business ,education ,Psychosocial - Abstract
Background: In the context of the DAWN-2 initiatives, the BENCH-D Study aims to test a model of regional benchmarking to improve not only the quality of diabetes care, but also patient-centred outcomes. Methods/Design: As part of the AMD-Annals quality improvement program, 32 diabetes clinics in 4 Italian regions extracted clinical data from electronic databases for measuring process and outcome quality indicators. A random sample of patients with type 2 diabetes filled in a questionnaire including validated instruments to assess patientcentred indicators: SF-12 Health Survey, WHO-5 Well-Being Index, Diabetes Empowerment Scale, Problem Areas in Diabetes, Health Care Climate Questionnaire, Patients Assessment of Chronic Illness Care, Barriers to Medications, Patient Support, Diabetes Self-care Activities, and Global Satisfaction for Diabetes Treatment. Data were discussed with participants in regional meetings. Main problems, obstacles and solutions were identified through a standardized process, and a regional mandate was produced to drive the priority actions. Overall, clinical indicators on 78,854 patients have been measured; additionally, 2,390 patients filled-in the questionnaire. The regional mandates were officially launched in March 2012. Clinical and patient-centred indicators will be evaluated again after 18 months. A final assessment of clinical indicators will take place after 30 months. Discussion: In the context of the BENCH-D study, a set of instruments has been validated to measure patient wellbeing and satisfaction with the care. In the four regional meetings, different priorities were identified, reflecting different organizational resources of the different areas. In all the regions, a major challenge was represented by the need of skills and instruments to address psychosocial issues of people with diabetes. The BENCH-D study allows a field testing of benchmarking activities focused on clinical and patient-centred indicators.
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46. Identifying patients with type 2 diabetes at high risk of microalbuminuria: results of the DEMAND (Developing Education on Microalbuminuria for Awareness of reNal and cardiovascular risk in Diabetes) Study.
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Maria C.E. Rossi, Antonio Nicolucci, Fabio Pellegrini, Marco Comaschi, Antonio Ceriello, Domenico Cucinotta, Carlo Giorda, Umberto Valentini, Giacomo Vespasiani, and Salvatore De Cosmo
- Subjects
ENDOCRINE diseases ,TYPE 2 diabetes ,BLOOD pressure ,CHOLESTEROL - Abstract
Background. We evaluated to what extent the presence of risk factors and their interactions increased the likelihood of microalbuminuria (MAU) among individuals with type 2 diabetes. Methods. Fifty-five Italian diabetes outpatient clinics enrolled a sample of patients with type 2 diabetes, without urinary infections and overt diabetic nephropathy. A morning spot urine sample was collected to centrally determine the urinary albumin/creatinine ratio (ACR). A tree-based regression technique (RECPAM) and multivariate analyses were performed to investigate interaction between correlates of MAU. Results. Of the 1841 patients recruited, 228 (12.4%) were excluded due to the presence of urinary infections and 56 (3.5%) for the presence of macroalbuminuria. Overall, the prevalence of MAU (ACR = 30â299 mg/g) was of 19.1%. The RECPAM algorithm led to the identification of seven classes showing a marked difference in the likelihood of MAU. Non-smoker patients with HbA1c 98 cm and HbA1c >8% showed the highest likelihood of MAU (odds ratio = 13.7; 95% confidence intervals 6.8â27.6). In the other classes identified, the risk of MAU ranged between 3 and 5. Age, systolic blood pressure, HDL cholesterol levels and diabetes treatment represented additional, global correlates of MAU. Conclusions. The likelihood of MAU is strongly related to the interaction between diabetes severity, smoking habits and several components of the metabolic syndrome. In particular, abdominal obesity, elevated blood pressure levels and low HDL cholesterol levels substantially increase the risk of MAU. It is of primary importance to monitor MAU in high-risk individuals and aggressively intervene on modifiable risk factors. [ABSTRACT FROM AUTHOR]
- Published
- 2008
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