Authors' recommendations: International guidelines and HTA reports agree upon the lack of robust evidence supporting the use of CSII pumps, of CGM devices and of semi-integrated systems. They agree upon advising a limited use and restricted to most suitable patients, which should be identified through explicit and shared criteria. Results form the most recent and good quality systematic review of randomised controlled trials highlight that studies have small numbers of patients, a short duration (maximum 52 weeks), evaluate only short-term clinical outcomes (glycaemic control, hypoglycaemic episodes, body parameters, quality of life) and no clinical outcomes related to micro- or macrovascular complications. A literature search of primary studies (RCTs) published after the publication of the systematic review retrieved four additional studies, all evaluating rt-CGM in different population of patients. Concerning CSII pumps, the available evidence shows a slight difference in HbA1c levels - considered not significant from a clinical point of view - and in global quality of life for type 1 adults diabetic patients, while no difference both in glycaemic parameters and in QOL is shown in paediatric patients with type 1 diabetes and in adult patients with type 2 diabetes. Data on CGM devices, drawn from studies on mixed population of patients with type 1 diabetes, children/ adolescents and adults, with a short period of observation, show a statistically significant difference - that, however, was judged as clinically not significant - in glycaemic parameters (HbA1c, time in hyperglycaemia) in favour of CGM versus SMBG. Two studies investigated the use of rt-CGM in type 2 diabetic patients and in pregnant women with type 1 or 2 diabetes, respectively, without showing any statistically significant difference against SBGM. Finally, data from 4 studies show that, during a short observation time, there is a statistically - and clinically - significant difference of HbA1c and time spent in hyperglycaemia in favour of SAP in mixed populations of paediatric and adult patients with type 1 diabetes. Evidence on the use of SAP in type 2 diabetic patients is absent. Ongoing studies are numerous, some of them enrolling large numbers of patients. However the majority of ongoing studies are of a short duration (maximum length of one year) and consider only surrogate outcomes. Information on ongoing studies highlights that research is shifting towards the evaluation of fully integrated systems suggesting a decreased interest from manufacturers on providing robust and definitive data on CSII. Given this trend in the ongoing research, no further update on evidence related to CSII will be carried out. A research focus on rt-CGM is still present including patients with type 2 diabetes and literature will be monitored. The presumed clinical impact on long-term micro- and macrovascular outcomes of innovative devices for diabetes is not confirmed by presently available data. Moreover, no shared criteria to identify patients who could benefit most from these devices are available even if very specific subgroup populations that could benefit from the use of rt-CGM, CSII or SAP are identified by some guidance.

Project Status: Completed

Year Published: 2014

URL for published report: http://assr.regione.emilia-romagna.it/it/servizi/pubblicazioni/short-report/short-report-n-7-innovative-medical-devices-for-diabetes-management

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Italy

Organisation Name: Agenzia Sanitaria e Sociale Regionale (Regional Agency for Health and Social Care)

Contact Address: Viale Aldo Moro 21, 40127 Bologna, Italia tel. +39 051 5277177 fax +39 051 5277049

Contact Name: Ballini_Lu@regione.emilia-romagna.it

Contact Email: Ballini_Lu@regione.emilia-romagna.it

Copyright: Agenzia sanitaria e sociale regionale, Regione Emilia-Romagna