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Product summary and likely place in therapy
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The Space GlucoseControl system is intended to be used for controlling blood‑glucose levels of critically ill patients in intensive care.
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The Space GlucoseControl system would be used in place of manual protocols for planning the measurement of blood‑glucose levels.
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Effectiveness and safety
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Two prospective non‑controlled cohort studies of the Space GlucoseControl system were identified (n=50).
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Four randomised controlled trials and 1 non‑controlled cohort study of the proprietary insulin‑dosing computer algorithm used by the Space GlucoseControl system were identified. The 4 trials enrolled 34 to 120 people and the non‑controlled study enrolled 20.
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No evidence was available on the effectiveness of the Space GlucoseControl system in comparison with that of other glycaemic control protocols. No Space GlucoseControl system related severe adverse events were reported.
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The comparative trials on the eMPC algorithm varied in terms of the standard glucose management protocols, the aspects of glucose control measured, and the findings. In general, the eMPC algorithm performed at least as well as the standard protocols for achieving and retaining glucose control. The eMPC algorithm seemed to have a higher risk of hypoglycaemia, but no severe hypoglycaemia was reported. Both the total time and the percentage of time in hyperglycaemia were reduced.
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Technical factors
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Cost and resource use
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It costs £5,500 per unit to add the Space GlucoseControl module to an existing B. Braun system.
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For intensive care units not already using the manufacturer's proprietary insulin and nutrition infusion pumps, it costs £12,300 to equip an intensive care bed with the full system.
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No other consumables are needed.
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