Human-in-the-Loop Insulin Dosing

Bequette, B. Wayne

doi:10.1177/1932296819891177

Cited by 12 publications

(9 citation statements)

References 14 publications

(13 reference statements)

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“…8 , 9 The increasing involvement of algorithms and automation in medical devices, in addition to improving precision and complexity (ie, overall system performance), is not necessarily associated with greater reliability. As discussed by Bequette 10 in a commentary focusing on automated insulin delivery devices (insulin pumps and continuous glucose monitoring systems), the presence “in the loop” of a human eye (or action) is critical when facing unusual situations or unexpected behavior of a system.…”

Section: Discussionmentioning

confidence: 99%

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<p>When a Ventilator Takes Autonomous Decisions without Seeking Approbation nor Warning Clinicians: A Case Series</p>

Dufour¹,

Fadel²,

Gelée³

et al. 2020

IMCRJ

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Background: Complexity and functions of automated medical devices used to support life (eg, ventilators, dialysis machines, monitors, insulin pump with continuous blood glucose monitoring system, etc.) increase over time. Until recently, devices were partially automated by very simple feedback loops, with no or few software dependence (such as the simplest home thermostat). For the last two decades, devices have been increasingly driven by complex algorithms devoted to improve patient's treatment and monitoring as well as users experience. Methods: We report the unexpected and inappropriate operation of two recent ventilators, associated to potential harmful consequences. We provide both a description of the clinical situations (five ICU patients, archetypal situations) and a test bench analysis. Results: While set in volume mode, these ventilators activated an algorithm dedicated to limit airway pressure when an increase in airway resistance occurred. In such situations, a pressure-like mode was activated (with decelerating inspiratory flow and set pressure, with target of volume). The main consequences observed were that the tidal volume was no longer guaranteed or delivered and that the pressure limitation operated by the algorithm prevented the airway pressure from reaching the high-pressure alarm threshold. Conclusion: This led to the silent takeover of commands by the ventilator without clinicians or nurses being aware of it and without any warnings or alarms emission adapted to the severity of the event. Generally speaking, such an algorithm questions the place of automation and its limit when users are not aware of its presence as well as the need for regulation and additional tests before its implementation. Intensivists and respiratory care specialists should remain vigilant regarding the risk of rare but critical events related to unexpected functioning or insufficiently tested equipment during the pre-clinical development phases. They should not neglect misunderstood critical events without having performed sufficient investigations.

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Section: Discussionmentioning

confidence: 99%

“…Otherwise, as observed in recent and tragic events related to the crashes of two Boeing 737 Max, if the pilot and the copilot do not know they are not alone to drive, nobody feels secure. 10 − 12…”

Section: Discussionmentioning

confidence: 99%

<p>When a Ventilator Takes Autonomous Decisions without Seeking Approbation nor Warning Clinicians: A Case Series</p>

Dufour¹,

Fadel²,

Gelée³

et al. 2020

IMCRJ

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“…Many articles written by clinicians have used the words “dosing” 1 and “delivery” 2 to describe automated insulin systems. Many researchers have also described these systems as performing “dosing” 3 or “delivery” 4 of insulin, and on occasion as performing both of these terms 5 in the same article.…”

Section: The Medical Literaturementioning

confidence: 99%

Automated Insulin Dosing Systems or Automated Insulin Delivery Systems? It is Time for Consistency

Klonoff

Shang

Zhang

2021

J Diabetes Sci Technol

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“…Other studies have already shown that closed-loop control systems were comparable with conventional insulin pump therapy [54]. Similar to artificial pancreas technologies, the development of such BioLogicChip designed as closed-loop drug-release device triggered by an enzymatic AND logic gate could prevent in a future application the variation of the glucose level during the continuous glucose sensing [55]. The Medtronic MiniMed 670G system is the first FDA (Food and Drug Administration) -approved closed-loop system that monitors glucose and automatically adjusts the delivery of insulin based on the glucose level [56].…”

Section: Insulin Sensormentioning

confidence: 99%

Coupling of Biomolecular Logic Gates with Electronic Transducers: From Single Enzyme Logic Gates to Sense/Act/Treat Chips

et al. 2017

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The integration of biomolecular logic principles with electronic transducers allows designing novel digital biosensors with direct electrical output, logically triggered drug‐release, and closed‐loop sense/act/treat systems. This opens new opportunities for advanced personalized medicine in the context of theranostics. In the present work, we will discuss selected examples of recent developments in the field of interfacing enzyme logic gates with electrodes and semiconductor field‐effect devices. Special attention is given to an enzyme OR/Reset logic gate based on a capacitive field‐effect electrolyte‐insulator‐semiconductor sensor modified with a multi‐enzyme membrane. Further examples are a digital adrenaline biosensor based on an AND logic gate with binary YES/NO output and an integrated closed‐loop sense/act/treat system comprising an amperometric glucose sensor, a hydrogel actuator, and an insulin (drug) sensor.

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Human-in-the-Loop Insulin Dosing

Cited by 12 publications

References 14 publications

<p>When a Ventilator Takes Autonomous Decisions without Seeking Approbation nor Warning Clinicians: A Case Series</p>

<p>When a Ventilator Takes Autonomous Decisions without Seeking Approbation nor Warning Clinicians: A Case Series</p>

Automated Insulin Dosing Systems or Automated Insulin Delivery Systems? It is Time for Consistency

Coupling of Biomolecular Logic Gates with Electronic Transducers: From Single Enzyme Logic Gates to Sense/Act/Treat Chips

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