Authors' objectives: This HTA report aims to understand if new devices do improve the management of diabetes type I in people aged 0-18 and are economically sustainable for the public system, according to the available evidence. We focused on the most innovative which showed to be the Sensor Augmented Pump. This device is the result of the joint use of continuous subcutaneous insulin infusion (CSII) and continuous blood monitoring systems devices (CGMS). We retrieved and analysed the evidence on its effectiveness, safety, acceptability, and on direct and indirect costs and information on its marketing status at international, national and regional level. Context specific epidemiological data were also collected in some of the participating regions on prevalence and incidence of the disease and on short and long term complications of type I diabetes mellitus (T1DM).

Authors' recommendations: Our final recommendation highlights that there is the need to generate new good quality evidence (in design and number of diabetics patients divided for classes of ages) to answer the study question. Clearer guidelines for the appropriate use of SAP should be produced and the evidence base on the use of these expensive and potentially important devices should be developed.

Project Status: Completed

Year Published: 2012

URL for published report: http://www.salute.gov.it/imgs/C_17_pagineAree_1202_listaFile_itemName_23_file.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Italy

Organisation Name: The Italian National Agency for Regional Health Services (Agenas)

Contact Address: Agenzia nazionale per i servizi sanitari regionali, Via Puglie 23, 00187 Rome, Italy

Contact Name: hta@agenas.it

Contact Email: hta@agenas.it

Copyright: Italian Ministry of Health and Agenas