Authors' objectives: Hybrid closed-loop systems are a new class of technology to manage type 1 diabetes mellitus. The system includes a combination of real-time continuous glucose monitoring from a continuous glucose monitoring device and a control algorithm to direct insulin delivery through an insulin pump. Evidence suggests that such technologies have the potential to improve the lives of people with type 1 diabetes mellitus and their families. Type 1 diabetes mellitus (T1DM) was formerly known as insulin-dependent diabetes. It is the result of an autoimmune process that leads to the destruction of the insulin-producing beta cells in the pancreas. Treatment with insulin is aimed at replicating the function of the pancreas to manage hyperglycaemia and avoid hypoglycaemia. The NICE glucose control target for type 1 diabetes is 48 mmol/mol (formerly 6.5%) but few people with type 1 diabetes achieve that. Interventions to manage diabetes include education, continuous glucose monitoring (including a sensor, transmitter and display device) and insulin therapy [multiple daily injections or continuous subcutaneous insulin infusion (CSII)]. CSII is an external pump that delivers insulin continuously from a refillable storage reservoir by means of a subcutaneously placed cannula. Sensor-augmented pump therapy systems combine continuous glucose monitor (CGM) with CSII. The systems are designed to measure interstitial glucose levels (every few minutes) and allow immediate real‑time adjustment of insulin therapy. The systems may produce alerts if the glucose levels become too high or too low. Sensor-augmented pumps can operate in standard (manual) and advanced (automatic) modes. In the manual open loop mode, the CGM and glucose pump do not communicate with each other, and insulin doses are programmed by the user, who makes manual adjustments. Hybrid closed-loop (HCL) systems are a new class of technology that use a combination of real-time glucose monitoring from a CGM device and a control algorithm to direct insulin delivery through an insulin pump. Evidence suggests that such technologies have the potential to improve the lives of people with type 1 diabetes and their families. The aim of this work was to evaluate the clinical effectiveness and cost-effectiveness of HCL systems in managing type 1 diabetes. The overall objectives of this project are to examine the clinical effectiveness and cost-effectiveness of HCL systems for managing glucose levels in people who have type 1 diabetes. What is the clinical effectiveness of HCL systems in managing glucose in people who have type 1 diabetes and are having difficulty managing their condition despite prior use of at least one of the following technologies: CSII, real-time continuous glucose monitoring (rtCGM), flash glucose monitoring [intermittently scanned continuous glucose monitoring (isCGM)]? What is the cost-effectiveness of HCL for managing glucose in people who have type 1 diabetes and are having difficulty managing their condition despite prior use of at least one of the following technologies: CSII, rt-CGM, isCGM?

Authors' results and conclusions: The clinical evidence identified 12 randomised controlled trials that compared hybrid closed loop with continuous subcutaneous insulin infusion + continuous glucose monitoring. Hybrid closed-loop arm of randomised controlled trials achieved improvement in glycated haemoglobin per cent [hybrid closed loop decreased glycated haemoglobin per cent by 0.28 (95% confidence interval −0.34 to −0.21), increased per cent of time in range (between 3.9 and 10.0 mmol/l) with a MD of 8.6 (95% confidence interval 7.03 to 10.22), and significantly decreased time in range (per cent above 10.0 mmol/l) with a MD of −7.2 (95% confidence interval −8.89 to −5.51), but did not significantly affect per cent of  time below range (

Authors' methods: A systematic review of clinical effectiveness and cost-effectiveness evidence following predefined inclusion criteria informed by the aim of this review. An independent economic assessment using iQVIA CDM to model cost-effectiveness. Systematic review methods followed the principles outlined in the Cochrane Handbook. A comprehensive search was developed iteratively and undertaken in a range of relevant bibliographic databases and other source. Date limits were used to identify records added to the databases since the searches for Diagnostic Guidance 2021 (run in 2014). Two reviewers screened titles and abstracts and assessed the eligibility of studies. Studies that satisfied the following criteria were included. Populations People (of any age) who have type 1 diabetes and are having difficulty managing their condition despite prior use of at least one of the following technologies: CSII, rtCGM, is CGM.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR133547

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/JYPL3536

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/JYPL3536

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk