medwireNews: Researchers show that closed-loop insulin delivery achieves markedly better glucose control than standard insulin management in hospitalized patients with hyperglycemia receiving enteral or parenteral nutrition.
The randomized trial, which excluded people with type 1 diabetes, took place across two hospitals in Switzerland and the UK, similar to the team’s previous study of patients on general hospital wards.
This latest study focused on patients requiring nutritional support, whom Roman Hovorka (University of Cambridge, UK) and co-researchers describe as “one of the most challenging inpatient populations.”
The team used the FlorenceD2W-T2 automated closed-loop system, a fully closed-loop system that the team says “can accommodate the glycaemic challenges associated with enteral and parenteral nutrition—such as unanticipated dislodgement of feeding tubes, temporary discontinuation of nutrition, and cycling of enteral nutrition with oral intake.”
They also used faster-acting insulin aspart to improve the responsiveness of the system to changing insulin needs.
As reported in The Lancet Diabetes & Endocrinology, during an average 6.7 days of use the 21 patients receiving closed-loop insulin delivery spent 68.4% of their time within the target blood glucose range of 5.6–10.0 mmol/L, which was the primary outcome.
This was a 32.0 percentage point improvement over the 36.4% time in range achieved in the 22 patients in the control group, who continued their usual insulin regimen. This difference was driven by a 32.6 percentage point reduction in the amount of time patients spent in the hyperglycemia range.
Closed-loop delivery increased the overnight time in range by a similar extent, and also produced significant reductions in average blood glucose concentration and glycemic variability. Despite this difference in glycemic control, the average total daily insulin dose did not significantly differ between the groups, and was in fact numerically lower in the closed-loop group, at 53.9 versus 40.3 units.
In a linked commentary, Pieter Gillard (University Hospitals Leuven, Belgium) and co-authors note that the approach to insulin delivery in the control group was “pragmatic and done in accordance with local clinical practice” and suggest that use of a standardized protocol with clear glycemic targets might have narrowed the efficacy gap between that and closed-loop delivery.
They also point out that although closed-loop delivery theoretically simplifies glucose management, staff will have to learn to deal with technical issues and create and implement back-up protocols for these instances, and for other times when automated delivery must be suspended.
For example, closed-loop insulin delivery was suspended in four patients because of procedures or care transfers. In addition, three patients in the closed-loop delivery group discontinued treatment because of discomfort relating to the system, most often the additional finger-stick measurements required for calibration, as did seven patients in the control group (who also wore the continuous glucose monitoring device for assessment of time in range).
This suggests that “future work should focus on the acceptability of wearing these kinds of multifaceted devices and in motivating patients to do the necessary handling, such as finger-sticking, correctly,” say Gillard and colleagues.
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Lancet Diabetes Endocrinol 2019; doi:10.1016/S2213-8587(19)30061-0
Lancet Diabetes Endocrinol 2019; doi:10.1016/S2213-8587(19)30094-4