CORESEARCH experts have pioneered the introduction of experimental research methodologies for the assessment of the impact of new technologies, telemedicine and telecare models, in the management of chronic diseases.Due to the increasing availability of these interventions, it is crucial to establish their clinical efficacy and to measure their acceptance, satisfaction and quality of life, by quantifying the impact on costs and resources utilization.These information, along with those on safety, are fundamentals for the adoption of technologies in clinical practice and can also provide consistent tools for decision-making on reimbursement criteria or resources allocation.
The assessment of new technologies requires a wide range of skills, including: methodological skills for the research planning, based on the regulatory framework regarding medical devices; IT skills; application of tools for the evaluation of satisfaction and quality of life, application of advanced statistical techniques and evaluation of the use of public health and economic resources.
- Di Bartolo P, Nicolucci A, Cherubini V, Iafusco D, Scardapane M, Rossi MC. Young patients with type 1 diabetes poorly controlled and poorly compliant with self-monitoring of blood glucose: can technology help? Results of the i-NewTrend randomized clinical trial. Acta Diabetol. 2017 Apr;54(4):393-402. doi: 10.1007/s00592-017-0963-4. Epub 2017 Jan 30.
- Wu Y, Yao X, Vespasiani G, Nicolucci A, Dong Y, Kwong J, Li L, Sun X, Tian H, Li S. 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: e35.
- Nicolucci A, Cercone S, Chiriatti A, Muscas F, Gensini G. A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes. Diabetes Technol Ther. 2015;17:563-70.
- Valentini M, Scardapane M, Bondanini F, Bossi A, Colatrella A, Girelli A, Ciucci A, Leotta S, Minotti E, Pasotti F, Pesenti A, Rocca L, Sciangula L, Vavassori E, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 33G × 4 mm. AGO 01 study. Curr Med Res Opin. 2015;31:487-92.
- Rossi MC, Vespasiani G. Diabetes Interactive Diary: A Mobile Phone-Based Telemedicine System for Carbohydrate Counting and Bolus Calculator. In: Bruttomesso D, Grassi G (eds): Technological Advances in the Treatment of Type 1 Diabetes. Front Diabetes. Basel, Karger, 2015, vol 24, pp 226–235.
- Rossi MC, Nicolucci A, Lucisano G, Pellegrini F, Di Bartolo P, Miselli V, Anichini R, Vespasiani G; Did Study Group. 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. Diabetes Technol Ther. 2013;15:670-9.
- Del Prato S, Nicolucci A, Lovagnini-Scher AC, Turco S, Leotta S, Vespasiani G; ELEONOR Study Group. Telecare Provides comparable efficacy to conventional self-monitored blood glucose in patients with type 2 diabetes titrating one injection of insulin glulisine-the ELEONOR study. Diabetes Technol Ther. 2012;14:175-82.
- Nicolucci A, Del Prato S, Vespasiani G; ELEONOR Study Group. Optimizing insulin glargine plus one injection of insulin glulisine in type 2 diabetes in the ELEONOR study: similar effects of telecare and conventional self-monitoring of blood glucose on patient functional health status and treatment satisfaction. Diabetes Care. 2011;34:2524-6.
- Rossi MC, Nicolucci A, Di Bartolo P, Bruttomesso D, Girelli A, Ampudia FJ, Kerr D, Ceriello A, Mayor Cde L, Pellegrini F, Horwitz D, Vespasiani G. 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. Diabetes Care. 2010;33:109-15.
- Rossi MC, Perozzi C, Consorti C, Almonti T, Foglini P, Giostra N, Nanni P, Talevi S, Bartolomei D, Vespasiani G. 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. Diabetes Technol Ther. 2010;12:641-7.
- Rossi MCE, Nicolucci A, Di Bartolo P, Horwltz D, Vespaslani G. The Diabetes Interactive Diary -A Useful Tool for Diabetes Management? European Endocrinology. 2010;6:39-42.
- Dalfrà MG, Nicolucci A, Lapolla A; TISG. The effect of telemedicine on outcome and quality of life in pregnant women with diabetes. J Telemed Telecare. 2009;15(5):238-42.
- Rossi MC, Nicolucci A, Pellegrini F, Bruttomesso D, Bartolo PD, Marelli G, Dal Pos M, Galetta M, Horwitz D, Vespasiani G. Interactive diary for diabetes: A useful and easy-to-use new telemedicine system to support the decision-making process in type 1 diabetes. Diabetes Technol Ther. 2009;11:19-24.
- EQuality1 Study Group–Evaluation of QUALITY of Life and Costs in Diabetes Type 1, Nicolucci A, Maione A, Franciosi M, Amoretti R, Busetto E, Capani F, Bruttomesso D, Di Bartolo P, Girelli A, Leonetti F, Morviducci L, Ponzi P, Vitacolonna E. Quality of life and treatment satisfaction in adults with Type 1 diabetes: a comparison between continuous subcutaneous insulin infusion and multiple daily injections. Diabet Med. 2008;25:213-20.