New insulin delivery devices and glycemic outcomes in young patients with type 1 diabetes: a protocol for a systematic review and meta-analysis.

Background: Optimal type 1 diabetes mellitus (T1D) care requires lifelong appropriate insulin treatment, which can be provided either by multiple daily injections (MDI) of insulin or by continuous subcutaneous insulin infusion (CSII). An increasing number of trials and previous systematic reviews and meta-analyses (SRMA) have compared both CSII and MDI but have provided limited information on equity and fairness regarding access to, and the effect of, those insulin devices. This study protocol proposes a clear and transparent methodology for conducting a SRMA of the literature (1) to assess the effect of CSII versus MDI on glycemic and patient-reported outcomes (PROs) among young patients with T1D and (2) to identify health inequalities in the use of CSII.

Methods: This protocol was developed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P), the PRISMA-E (PRISMA-Equity 2012 Guidelines), and the Cochrane Collaboration Handbook. We will include randomized clinical trials and non-randomized studies published between January 2000 and June 2019 to assess the effectiveness of CSII versus MDI on glycemic and PROs in young patients with T1D. To assess health inequality among those who received CSII, we will use the PROGRESS framework. To gather relevant studies, a search will be conducted in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews, and the Health Technology Assessment (HTA) database. We will select studies that compared glycemic outcomes (the glycosylated hemoglobin values, severe hypoglycemia episodes, diabetic ketoacidosis events, and/or time spent in range or in hyper-hypoglycemia), and health-related quality of life, as a PRO, between therapies. Screening and selection of studies will be conducted independently by two researchers. Subgroup analyses will be performed according to age group, length of follow-up, and the use of adjunctive technological therapies that might influence glycemic outcomes.

Discussion: Studies of the average effects of CSII versus MDI may have not assessed their impact on health equity, as some intended populations have been excluded. Therefore, this study will address health equity issues when assessing effects of CSII. The results will be published in a peer-review journal. Ethics approval will not be needed.

Systematic Review Registration: PROSPERO CRD42018116474.