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Clinical Trial
. 2019 Sep;13(5):941-948.
doi: 10.1177/1932296819832876. Epub 2019 Mar 10.

Insulin-Based Infusion System: Advancing the Development

Nasseh Hashemi  1   2 , Tim Valk  3 , Kim Houlind  4 , Niels Ejskjaer  2   5
Affiliations
Clinical Trial

Insulin-Based Infusion System: Advancing the Development

Nasseh Hashemi et al. J Diabetes Sci Technol. 2019 Sep.

Abstract

Background: Deviations in glucose control in critical care have been shown to increase mortality and morbidity. However, optimal glucose control through present technologies has shown to be a challenge. The insulin balanced infusion system (IBIS) is a new and emerging technology.

Methods: The closed loop system was tested in a stress trial to evaluate glucose stability in response to various conditions in nonrandomized people with type 1 diabetes mellitus (n=12). The prototype used in this trial was based on intermittent capillary measurements.

Results: Induced stresses in the study using unpredicted stimuli of intravenous or oral glucose and intravenous insulin boluses, was contained with glucose remaining in target 43.8% of the time. Mean increase in glucose concentration after glucose load was 17.4 mg/dl; after insulin bolus, no hypoglycemia (blood glucose less than 70 mg/dl) occurred.

Conclusion: The use of IBIS proved safe and feasible under a wide range of conditions. The sensing and stress response of the IBIS demonstrated noticeable features.

Keywords: automated glucose monitoring; closed loop glucose control; critical care glucose control; stress trial.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Tim Valk is full-time employee of Admetsys.

Figures

Figure 1.
Figure 1.
Aggregate analysis with repeated stabilization and extended maintenance of the stress trial population.
Figure 2.
Figure 2.
The distribution for time to normalization across all trials.
Figure 3.
Figure 3.
Aggregated analysis of the carbohydrate loading event. The left side of the figure shows glucose levels from the time of administration of the high-carbohydrate meal till the time of restoration of the normoglycemic target range. The right side of figure depicts the following two hours after restoration of the normoglycemic target range.
Figure 4.
Figure 4.
Plot of the summary statistics for the intravenous glucose infusion response. The left chart shows the glucose levels at the time of administration and the following two hours, and the right chart shows the subsequent two hours.
Figure 5.
Figure 5.
The descriptive statistics summarizing intravenous insulin bolus response, from administration to the following hour.
See this image and copyright information in PMC

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