Authors' objectives: HTW undertook an evidence review to address the question: What is the clinical effectiveness, cost-effectiveness and safety of closed loop systems and the artificial pancreas in the management of type 1 diabetes mellitus (T1DM)?

Authors' results and conclusions: HTW adapted evidence from the Scottish Health Technologies Group’s (SHTG) appraisal entitled ‘Closed loop systems and the artificial pancreas for the management of type 1 diabetes’ published in January 2022. We identified one additional systematic review and meta-analyses and five randomised control trials (RCTs) published after the latest search in the SHTG report. Five systematic reviews found that closed loop systems significantly increased percentage time in target glucose range compared to controls. Two systematic reviews found statistically significant differences in percentage change in HbA1c that favoured closed loop. Hypoglycaemic events were reported in three systematic reviews, two of these reported no significant differences and one reported a statistically significant reduction in the closed loop group. One systematic review found no statistically significant difference between closed loop and controls for severe hyperglycaemic events and diabetic ketosis events. Additionally, 15 RCTs were identified comparing closed loop systems with a relevant comparator that were not included in the secondary literature. The trials reported similar results to the secondary evidence: statistically significant improvements in mean percentage time in range favouring closed loop systems over the comparator. Quality of life data were available from five RCTs; findings were mixed with three reporting generally more favourable outcomes for closed loop groups and two reporting no significant difference between closed loop and controls. No new health economic studies published since the SHTG evaluation were identified. HTW adapted the SHTG cost-utility analysis. Closed loop systems were not estimated to be cost-effective against comparators with incremental cost-effectiveness ratios (ICER) between £24,446 and £79,463 per quality-adjusted life year (QALY) gained. In fully incremental analysis, multiple daily injections with flash glucose monitoring was estimated to be optimal among the strategies considered at a willingness to pay threshold of £20,000 per QALY gained. The HTW analysis shares the limitations of the SHTG analysis; most notably the reliance on assumptions around hypoglycaemic effects and a published algorithm to map percentage time in range to HbA1c reductions. Sensitivity analysis showed estimates to be highly sensitive to uncertainty in these areas. Scenario analysis also suggested closed loop systems may be cost-effective compared to continuous glucose monitoring with pump therapy for people with higher HbA1c levels at baseline, who more closely resemble those in clinical practice.

Authors' methods: HTW adapted evidence from the SHTG appraisal and reviewed evidence published after the latest SHTG search date. The Evidence Appraisal Report is based on a literature search (strategy available on request) for published clinical and economic evidence on the health technology of interest. It is not a full systematic review but aims to identify the best available evidence on the health technology of interest. Researchers critically evaluate and synthesise this evidence. We include the following clinical evidence in order of priority: systematic reviews; randomised trials; non-randomised trials. We only include evidence for “lower priority” evidence where outcomes are not reported by a “higher priority” source. We also search for economic evaluations or original research that can form the basis of an assessment of costs/cost comparison. We carry out various levels of economic evaluation, according to the evidence that is available to inform this.

Project Status: Completed

Year Published: 2022

URL for published report: https://healthtechnology.wales/reports-guidance/closed-loop-systems/

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Wales, United Kingdom

Organisation Name: Health Technology Wales

Contact Address: c/o Digital Health Care Wales, 21 Cowbridge Road East Cardiff CF11 9AD

Contact Name: Susan Myles, PhD

Contact Email: healthtechnology@wales.nhs.uk

Copyright: Health Technology Wales