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Design and Clinical Evaluation of the Interoperable Artificial Pancreas System (iAPS) Smartphone App: Interoperable Components with Modular Design for Progressive Artificial Pancreas Research and Development.

ABSTRACT: BACKGROUND:There is an unmet need for a modular artificial pancreas (AP) system for clinical trials within the existing regulatory framework to further AP research projects from both academia and industry. We designed, developed, and tested the interoperable artificial pancreas system (iAPS) smartphone app that can interface wirelessly with leading continuous glucose monitors (CGM), insulin pump devices, and decision-making algorithms while running on an unlocked smartphone. METHODS:After algorithm verification, hazard and mitigation analysis, and complete system verification of iAPS, six adults with type 1 diabetes completed 1 week of sensor-augmented pump (SAP) use followed by 48?h of AP use with the iAPS, a Dexcom G5 CGM, and either a Tandem or Insulet insulin pump in an investigational device exemption study. The AP system was challenged by participants performing extensive walking without exercise announcement to the controller, multiple large meals eaten out at restaurants, two overnight periods, and multiple intentional connectivity interruptions. RESULTS:Even with these intentional challenges, comparison of the SAP phase with the AP study showed a trend toward improved time in target glucose range 70-180?mg/dL (78.8% vs. 83.1%; P?=?0.31), and a statistically significant reduction in time below 70?mg/dL (6.1% vs. 2.2%; P?=?0.03). The iAPS system performed reliably and showed robust connectivity with the peripheral devices (99.8% time connected to CGM and 94.3% time in closed loop) while requiring limited user intervention. CONCLUSIONS:The iAPS system was safe and effective in regulating glucose levels under challenging conditions and is suitable for use in unconstrained environments.

SUBMITTER: Deshpande S

PROVIDER: S-EPMC6350072 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Design and Clinical Evaluation of the Interoperable Artificial Pancreas System (iAPS) Smartphone App: Interoperable Components with Modular Design for Progressive Artificial Pancreas Research and Development.

Deshpande Sunil S Pinsker Jordan E JE Zavitsanou Stamatina S Shi Dawei D Tompot Randy R Church Mei Mei MM Andre Camille C Doyle Francis J FJ Dassau Eyal E

Diabetes technology & therapeutics 20181214 1

<h4>Background</h4>There is an unmet need for a modular artificial pancreas (AP) system for clinical trials within the existing regulatory framework to further AP research projects from both academia and industry. We designed, developed, and tested the interoperable artificial pancreas system (iAPS) smartphone app that can interface wirelessly with leading continuous glucose monitors (CGM), insulin pump devices, and decision-making algorithms while running on an unlocked smartphone.<h4>Methods</ ...[more]

PMID: 30547670

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Project description:Synthetic biology efforts have largely focused on small engineered gene networks, yet understanding how to integrate multiple synthetic modules and interface them with endogenous pathways remains a challenge. Here we present the design, system integration, and analysis of several large scale synthetic gene circuits for artificial tissue homeostasis. Diabetes therapy represents a possible application for engineered homeostasis, where genetically programmed stem cells maintain a steady population of ?-cells despite continuous turnover. We develop a new iterative process that incorporates modular design principles with hierarchical performance optimization targeted for environments with uncertainty and incomplete information. We employ theoretical analysis and computational simulations of multicellular reaction/diffusion models to design and understand system behavior, and find that certain features often associated with robustness (e.g., multicellular synchronization and noise attenuation) are actually detrimental for tissue homeostasis. We overcome these problems by engineering a new class of genetic modules for 'synthetic cellular heterogeneity' that function to generate beneficial population diversity. We design two such modules (an asynchronous genetic oscillator and a signaling throttle mechanism), demonstrate their capacity for enhancing robust control, and provide guidance for experimental implementation with various computational techniques. We found that designing modules for synthetic heterogeneity can be complex, and in general requires a framework for non-linear and multifactorial analysis. Consequently, we adapt a 'phenotypic sensitivity analysis' method to determine how functional module behaviors combine to achieve optimal system performance. We ultimately combine this analysis with Bayesian network inference to extract critical, causal relationships between a module's biochemical rate-constants, its high level functional behavior in isolation, and its impact on overall system performance once integrated.

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Dataset Information

Design and Clinical Evaluation of the Interoperable Artificial Pancreas System (iAPS) Smartphone App: Interoperable Components with Modular Design for Progressive Artificial Pancreas Research and Development.

Publications

Design and Clinical Evaluation of the Interoperable Artificial Pancreas System (iAPS) Smartphone App: Interoperable Components with Modular Design for Progressive Artificial Pancreas Research and Development.

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