Evaluating optimal utilisation of technology in type 1 diabetes mellitus from a clinical and health economic perspective: Protocol for a systematic review

Abstract

Background: Technology has been implemented since the 1970s with the hope of improving glycaemic control and reducing the burden of complications for those living with type 1 diabetes. A clinical and cost-effectiveness comparison of all available technologies including continuous subcutaneous insulin infusion (CSII), continuous glucose monitors (CGMs), sensor-augmented pump therapy (including either low-glucose suspend or predictive low-glucose suspend), hybrid closed-loop systems, closed-loop (single-hormone or dual-hormone) systems, flash glucose monitoring (FGM), insulin bolus calculators, and 'smart-device' applications is currently lacking. This systematic review, network meta-analysis, and narrative synthesis aims to summarise available evidence regarding the clinical and cost-effectiveness of available technologies in the management of patients with type 1 diabetes. Methods: Relevant studies will be searched using a comprehensive strategy through MEDLINE, MEDLINE in-process and other non-indexed citations, EMBASE, PubMed, all evidenced-based medicine reviews, EconLit, Cost-effectiveness Analysis Registry, Research Papers in Economics, Web of Science, PsycInfo, CINAHL, and PROSPERO for randomised controlled trials and economic evaluations. The search strategy will assess if there are combinations of currently available technologies that are superior to each other or to insulin injections and capillary blood glucose testing with regard to glycaemic control, morbidity/mortality, quality of life, and cost-effectiveness. Two reviewers will screen all articles for eligibility and then independently evaluate risk of bias, complete quality assessment, and extract data for included studies. Network meta-analyses will be performed where there is sufficient homogenous clinical data. Narrative synthesis will be performed for heterogeneous clinical data that cannot be pooled for network meta-analysis with critical appraisal of economic evaluations. Discussion: This systematic review protocol utilises rigorous methodology and pre-determined eligibility criteria to provide a uniquely comprehensive search for a broad spectrum of clinical and economic outcomes in comparing multiple currently available technologies for managing type 1 diabetes. Evidence on which technologies may be most appropriate for particular patient groups will be examined as well as the economic justification for funding of different technologies. Systematic review registration: PROSPERO ( CRD42017077221 )