Comparative Efficacy of iBGStarÂ™ Glucose Meter vs. A Traditional Glucose Meter in Type 1 DiabetesAntonio Nicolucci1, Maria Chiara Rossi1*, Valentino Cherubini2, Diario Iafusco3, Fabio Pellegrini1 and Paolo Di Bartolo4
- *Corresponding Author:
- Maria Chiara Rossi
Laboratory of Clinical Epidemiology of Diabetes and Chronic Diseases
Mario Negri Sud Foundation, Via Nazionale
66030 S. Maria Imbaro (CH), Italy
Tel: +39 0872 570266
Fax: +39 0872 570263
E-mail: [email protected]
Received date: April 29, 2014; Accepted date: May 29, 2014; Published date: June 04, 2014
Citation: Nicolucci A, Rossi MC, Cherubini V, Iafusco V, Pellegrini F, et al. (2014) Comparative Efficacy of iBGStar™ Glucose Meter vs. A Traditional Glucose Meter in Type 1 Diabetes. J Diabetes Metab 5:382. doi: 10.4172/2155-6156.1000382
Copyright: © 2014 Nicolucci A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricteduse, distribution, and reproduction in any medium, provided the original author and source are credited.
Background: Optimal metabolic control and compliance to self-monitoring of blood glucose (SMBG) are poor in adolescents and young adults with type 1 diabetes mellitus (T1DM), and may require innovative management strategies. These may include the use of telemedicine and smartphone-linked blood glucose self-monitoring systems. To this purpose, a specific glucose meter (iBGStar™) and a dedicated Diabetes Manager Application (DMApp) have been developed. Aim of the study is to demonstrate the superiority of a smartphone-linked versus a traditional self-monitoring system in reducing HbA1c levels and improving compliance to SMBG. Methods/Design: The “i-NewTrend” study is an open-label, randomized (1:1) trial involving 21 diabetes outpatient clinics in Italy. Overall, 178 subjects aged 14–24 years with type 1 diabetes, with any diabetes duration, HbA1c ≥8%, treated with basal-bolus insulin regimen, and with poor compliance with SMBG will be randomized to two different SMBG strategies: Group A will use iBGStar™+ DMApp and Group B (control group) will use a traditional meter for SMBG during a 6-month follow-up (experimental phase). Between-group differences on metabolic control, compliance to SMBG, insulin doses, quality of life, risk of hypoglicaemic episodes and number and type of contacts with diabetes clinics will be evaluated. During a 6 month post-trial observational phase, all randomized patients in group A and B will use iBGStar™ + DMApp to evaluate the impact of the system on all the outcomes when the system is used under routine clinical practice conditions. Discussion: Results of the trial iNew Trend will assess whether and to what extent this new strategy of SMBG based on the use of iBGStar™ + DMApp will improve the management of type 1 diabetes in adolescents and young adults poorly controlled and poorly compliant, both in experimental and usual care settings.