Clinical Opportunities for Continuous Biosensing and Closed-Loop Therapies

Li, Jason; Liang, Jia Y.; Laken, Steven J.; Langer, Róbert; Traverso, Giovanni

doi:10.1016/j.trechm.2020.02.009

Cited by 46 publications

(47 citation statements)

References 188 publications

(260 reference statements)

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“…The open-source algorithm of oref1, used in both OpenAPS and AndroidAPS, with unannounced meal feature and SMBs performs admirably under full closed loop conditions and should be considered by all when designing future algorithms. Moreover, with the advent of new biosensor technologies, closed loop control may become possible for other pharmacotherapy applications (e.g., immunosuppressants, 35 pain management drugs, 36 antiepileptic drugs, 37 and anticoagulants). 35 There is potential that our efforts to explore algorithm performance may potentially inform the development of systems for future applications of closed loop control of other molecules.…”

Section: Discussionmentioning

confidence: 99%

Full closed loop open‐source algorithm performance comparison in pigs with diabetes

Lal

Maikawa

Lewis³

et al. 2021

Clinical & Translational Med

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Understanding how automated insulin delivery (AID) algorithm features impact glucose control under full closed loop delivery represents a critical step toward reducing patient burden by eliminating the need for carbohydrate entries at mealtimes. Here, we use a pig model of diabetes to compare AndroidAPS and Loop open‐source AID systems without meal announcements. Overall time‐in‐range (70–180 mg/dl) for AndroidAPS was 58% ± 5%, while time‐in‐range for Loop was 35% ± 5%. The effect of the algorithms on time‐in‐range differed between meals and overnight. During the overnight monitoring period, pigs had an average time‐in‐range of 90% ± 7% when on AndroidAPS compared to 22% ± 8% on Loop. Time‐in‐hypoglycemia also differed significantly during the lunch meal, whereby pigs running AndroidAPS spent an average of 1.4% (+0.4/−0.8)% in hypoglycemia compared to 10% (+3/−6)% for those using Loop. As algorithm design for closed loop systems continues to develop, the strategies employed in the OpenAPS algorithm (known as oref1) as implemented in AndroidAPS for unannounced meals may result in a better overall control for full closed loop systems.

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Section: Discussionmentioning

confidence: 99%

Full closed loop open‐source algorithm performance comparison in pigs with diabetes

Lal

Maikawa

Lewis³

et al. 2021

Clinical & Translational Med

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“…While therapeutic delivery is a well-documented field, the combination of biosensing and therapeutic delivery mechanisms through the use of synthetic biology can create hassle-free treatment options for patients with limited access to medical facilities. Such closed-loop therapy systems include a continuous sensor for an analyte or signal of interest, a control algorithm for determining needed therapeutic dosing based on the input signal, and an actuator to drive therapeutic delivery to the patient in response to the controller without the need for external intervention 126 . An area of particular interest that we discuss here is the coupling of synthetic biology advancements with closed-loop delivery to develop whole-cell solutions for both detection and subsequent treatment against bacterial infections.…”

Section: Closed-loop Living Therapeutics and Probiotic Deliverymentioning

confidence: 99%

Applications, challenges, and needs for employing synthetic biology beyond the lab

2021

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Synthetic biology holds great promise for addressing global needs. However, most current developments are not immediately translatable to ‘outside-the-lab’ scenarios that differ from controlled laboratory settings. Challenges include enabling long-term storage stability as well as operating in resource-limited and off-the-grid scenarios using autonomous function. Here we analyze recent advances in developing synthetic biological platforms for outside-the-lab scenarios with a focus on three major application spaces: bioproduction, biosensing, and closed-loop therapeutic and probiotic delivery. Across the Perspective, we highlight recent advances, areas for further development, possibilities for future applications, and the needs for innovation at the interface of other disciplines.

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“…A very important objective of the development of implantable continuous glucose sensors is the extension of the technology to closed‐loop systems that allow the glucose levels to control insulin delivery, considered to be a prime example of precision medicine (Gray et al, 2018). Their development and opportunities have been recently discussed (Scholten & Meng, 2018; Li et al, 2020). In late 2020, the results of the first clinical trial with this closed‐loop system in children with type I diabetes were published (Breton et al, 2020), in which, over 16 weeks, the glucose level was in the target range for a greater percentage of time than in the control group with sensor‐augmented insulin pumps.…”

Section: The Triad Of Biocompatibility Device Functionality and Biolmentioning

confidence: 99%

Assessing the triad of biocompatibility, medical device functionality and biological safety

Williams

2020

Med Devices & Sens

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Biomaterials, defined as 'materials designed to take a form that can direct, through interactions with living systems, the course of any therapeutic or diagnostic procedure' (Zhang & Williams, 2019), are used in an increasing number of medical applications (Williams, 2014a). From both engineering and regulatory perspectives, the 'form' that the biomaterials take is usually referred to as a 'device'; the interaction with living systems may occur in vivo or ex vivo. The devices have functions that range from mechanical (joint replacements, heart valves), optical (intra-ocular lenses) and electrical (cardiac pacemakers, deep brain stimulators) to those of complex systems that may incorporate the delivery of molecules to the body (prolonged release of drugs) or involve diagnostic character (imaging contrast agents, continuous glucose measurement).Of all the required properties of the biomaterials and devices, two are of profound importance. These are biocompatibility and functionality. Biocompatibility, defined as 'the ability of a material to perform with an appropriate host response in a specific application', (Zhang & Williams, 2019) encompasses all types of interaction that can occur between the material / device and the host. These interactions can be considered negatively in the sense that they may inhibit the appropriate host response, for example being responsible for blood clots forming within intravascular devices, or positively if they promote superior host responses, for example enhanced bonding with bone in orthopaedic devices. The full spectrum of potential mechanisms of biocompatibility has not yet been identified, but much progress has been made in recent years (Williams 2008;Williams 2017a;Villanueva-Flores et al. 2020). It is difficult to itemize the required functionality characteristics of medical devices since they vary from one applications to another,

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Clinical Opportunities for Continuous Biosensing and Closed-Loop Therapies

Cited by 46 publications

References 188 publications

Full closed loop open‐source algorithm performance comparison in pigs with diabetes

Full closed loop open‐source algorithm performance comparison in pigs with diabetes

Applications, challenges, and needs for employing synthetic biology beyond the lab

Assessing the triad of biocompatibility, medical device functionality and biological safety

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