Article type
Year
Abstract
Background & Objectives: The objective of this project is to summarise the evidence on the clinical effectiveness of the MiniMed Paradigm Veo System (Veo) and the Vibe and G4 PLATINUM CGM system (Vibe) in comparison with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII), both with either self-monitoring of blood glucose (SMBG) or with continuous glucose monitoring (CGM), for the management of type 1 diabetes (T1DM) in adults and children.
Methods: A systematic review was conducted following the principles of the Centre for Reviews and Dissemination guidance, and the NICE Diagnostic Assessment Programme manual. We searched 14 databases, three trial registries and two conference proceedings from inception up to September 2014. Also, reference lists of relevant systematic reviews were checked. In the absence of randomised controlled trials directly comparing the Veo or an integrated CSII plus CGM system such as Vibe with the comparators, indirect treatment comparisons were performed, where possible.
Results & Conclusions: Fifty-four publications of 19 studies were included in the review. However, in the UK insulin pumps are recommended for people with T1DM for whom MDI is not suitable. Therefore, there is a problem with the comparability of populations in studies evaluating insulin pumps and MDI. In addition, the Veo system has the ability to suspend insulin infusion temporarily to prevent hypoglycaemic events, especially at night. We found two studies comparing the Veo system to CSII plus CGM in patients who had experienced at least two nocturnal hypoglycaemic events previously; and to CSII plus SMBG in patients who had impaired awareness of hypoglycaemia. None of the trials looking at MDI were evaluated in such populations. This means the comparability of trials comparing pumps (in particular the Veo system) with MDI is complex.
Methods: A systematic review was conducted following the principles of the Centre for Reviews and Dissemination guidance, and the NICE Diagnostic Assessment Programme manual. We searched 14 databases, three trial registries and two conference proceedings from inception up to September 2014. Also, reference lists of relevant systematic reviews were checked. In the absence of randomised controlled trials directly comparing the Veo or an integrated CSII plus CGM system such as Vibe with the comparators, indirect treatment comparisons were performed, where possible.
Results & Conclusions: Fifty-four publications of 19 studies were included in the review. However, in the UK insulin pumps are recommended for people with T1DM for whom MDI is not suitable. Therefore, there is a problem with the comparability of populations in studies evaluating insulin pumps and MDI. In addition, the Veo system has the ability to suspend insulin infusion temporarily to prevent hypoglycaemic events, especially at night. We found two studies comparing the Veo system to CSII plus CGM in patients who had experienced at least two nocturnal hypoglycaemic events previously; and to CSII plus SMBG in patients who had impaired awareness of hypoglycaemia. None of the trials looking at MDI were evaluated in such populations. This means the comparability of trials comparing pumps (in particular the Veo system) with MDI is complex.