Acceptability and feasibility of continuous glucose monitoring in people with diabetes:protocol for a mixed-methods systematic review of quantitative and qualitative evidence

BACKGROUND: Good glycaemic control is a crucial part of diabetes management. Traditional assessment methods, including HbA1c checks and self-monitoring of blood glucose, can be unreliable and inaccurate. Continuous glucose monitoring (CGM) offers a non-invasive and more detailed alternative. Availability of this technology is increasing worldwide. However, there is no current comprehensive evidence on the acceptability and feasibility of these devices. This is a protocol for a mixed-methods systematic review of qualitative and quantitative evidence about acceptability and feasibility of CGM in people with diabetes. METHODS: We will search MEDLINE, Embase, CINAHL, and CENTRAL for qualitative and quantitative evidence about the feasibility and acceptability of CGM in all populations with diabetes (any type) using search terms for "continuous glucose monitoring" and "diabetes". We will not apply any study-type filters. Searches will be restricted to studies conducted in humans and those published from 2011 onwards. We will not restrict the search by language. Study selection and data extraction will be carried out by two reviewers independently using Rayyan and Eppi-Reviewer, respectively, with disagreements resolved by discussion. Data extraction will include key information about each study, as well as qualitative evidence in the form of participant quotes from primary studies and themes and subthemes based on the authors' analysis. Quantitative data relating to acceptability and feasibility including data loss, adherence, and quantitative ratings of acceptability will be extracted as means and standard deviations or n/N as appropriate. Qualitative evidence will be analysed using framework analysis informed by the Theoretical Framework of Acceptability. Where possible, quantitative evidence will be combined using random-effects meta-analysis; otherwise, a narrative synthesis will be performed. The most appropriate method for integrating qualitative and quantitative findings will be selected based on the data available. DISCUSSION: Ongoing assessment of the acceptability of interventions has been identified as crucially important to scale-up and implementation. This review will provide new knowledge with the potential to inform a programme theory of CGM as well as future roll-out to potentially vulnerable populations, including those with severe mental illness. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021255141.