alexa Comparative Efficacy of iBGStar™ Glucose Meter vs. A Traditional Glucose Meter in Type 1 Diabetes | OMICS International | Abstract
ISSN: 2155-6156

Journal of Diabetes & Metabolism
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Research Article

Comparative Efficacy of iBGStar™ Glucose Meter vs. A Traditional Glucose Meter in Type 1 Diabetes

Antonio Nicolucci1, Maria Chiara Rossi1*, Valentino Cherubini2, Diario Iafusco3, Fabio Pellegrini1 and Paolo Di Bartolo4

1Laboratory of Clinical Epidemiology of Diabetes and Chronic Diseases, Mario Negri Sud Foundation, Italy

2Department of Pediatrics, Polytechnic University of Marche, Italy

3Department of Pediatrics, Second University of Naples, Italy

4Diabetes Unit, Ravenna Local Health Unit,Italy

*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.

Abstract

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.

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