A nonparametric approach for model individualization in an artificial pancreas

The identification of patient-tailored linear time invariant glucose-insulin models is investigated for type 1 diabetic patients, that are characterized by a substantial inter-subject variability. The individualized linear models are identified by considering a novel kernel-based nonparametric approach and are compared with a linear time invariant average model in terms of prediction performance by means of the coefficient of determination, fit, positive and negative max errors, and root mean squared error. Model identification and validation are based on in-silico data collected from the adult virtual population of the UVA/Padova simulator. The data generation involves a protocol designed to produce a sufficient input excitation without compromising patient safety, compatible also with real life scenarios. The identified models are exploited to synthesize an individualized Model Predictive Controller (MPC) for each patient, which is used in an Artificial Pancreas to maintain the blood glucose concentration within an euglycemic range. The MPC used in several clinical studies, synthesized on the basis of a non-individualized average linear time invariant model, is also considered as reference. The closed-loop control performance is evaluated in an in-silico study on the adult virtual population of the UVA/Padova simulator in a perturbed scenario, in which the MPC is blind to random variations of insulin sensitivity in each virtual patient. © 2015, IFAC (International Federation of Automatic Control) Hosting by Elsevier Ltd. All rights reserved

Parental evaluation of a telemonitoring service for children with Type 1 Diabetes

Introduction In the past years, we developed a telemonitoring service for young patients affected by Type 1 Diabetes. That service provides data to the clinical staff and offers an important tool to the parents, that are able to oversee in real time their children. The aim of this work was to analyze the parents' perceived usefulness of the service. Methods The service was tested by the parents of 31 children enrolled in a seven-day clinical trial during a summer camp. To study the parents' perception we proposed and analyzed two questionnaires. A baseline questionnaire focused on the daily management and implications of their children's diabetes, while a post-study one measured the perceived benefits of telemonitoring. Questionnaires also included free text comment spaces. Results Analysis of the baseline questionnaires underlined the parents' suffering and fatigue: 51% of total responses showed a negative tendency and the mean value of the perceived quality of life was 64.13 in a 0-100 scale. In the post-study questionnaires about half of the parents believed in a possible improvement adopting telemonitoring. Moreover, the foreseen improvement in quality of life was significant, increasing from 64.13 to 78.39 ( p-value\u2009=\u20090.0001). The analysis of free text comments highlighted an improvement in mood, and parents' commitment was also proved by their willingness to pay for the service (median\u2009=\u2009200\u2009euro/year). Discussion A high number of parents appreciated the telemonitoring service and were confident that it could improve communication with physicians as well as the family's own peace of mind

Accuracy of a CGM Sensor in Pediatric Subjects With Type 1 Diabetes. Comparison of Three Insertion Sites: Arm, Abdomen, and Gluteus

Patients with diabetes, especially pediatric ones, sometimes use continuous glucose monitoring (CGM) sensor in different positions from the approved ones. Here we compare the accuracy of Dexcom\uae G5 CGM sensor in three different sites: abdomen, gluteus (both approved) and arm (off-label)

First Use of Model Predictive Control in Outpatient Wearable Artificial Pancreas

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A case study in open source innovation: developing the Tidepool Platform for interoperability in type 1 diabetes management.

OBJECTIVE:Develop a device-agnostic cloud platform to host diabetes device data and catalyze an ecosystem of software innovation for type 1 diabetes (T1D) management. MATERIALS AND METHODS:An interdisciplinary team decided to establish a nonprofit company, Tidepool, and build open-source software. RESULTS:Through a user-centered design process, the authors created a software platform, the Tidepool Platform, to upload and host T1D device data in an integrated, device-agnostic fashion, as well as an application ("app"), Blip, to visualize the data. Tidepool's software utilizes the principles of modular components, modern web design including REST APIs and JavaScript, cloud computing, agile development methodology, and robust privacy and security. DISCUSSION:By consolidating the currently scattered and siloed T1D device data ecosystem into one open platform, Tidepool can improve access to the data and enable new possibilities and efficiencies in T1D clinical care and research. The Tidepool Platform decouples diabetes apps from diabetes devices, allowing software developers to build innovative apps without requiring them to design a unique back-end (e.g., database and security) or unique ways of ingesting device data. It allows people with T1D to choose to use any preferred app regardless of which device(s) they use. CONCLUSION:The authors believe that the Tidepool Platform can solve two current problems in the T1D device landscape: 1) limited access to T1D device data and 2) poor interoperability of data from different devices. If proven effective, Tidepool's open source, cloud model for health data interoperability is applicable to other healthcare use cases

The bio-inspired artificial pancreas for type 1 diabetes control in the home: System architecture and preliminary results

BACKGROUND: Artificial pancreas (AP) technology has been proven to improve glucose and patient-centered outcomes for people with type 1 diabetes (T1D). Several approaches to implement the AP have been described, clinically evaluated, and in one case, commercialized. However, none of these approaches has shown a clear superiority with respect to others. In addition, several challenges still need to be solved before achieving a fully automated AP that fulfills the users' expectations. We have introduced the Bio-inspired Artificial Pancreas (BiAP), a hybrid adaptive closed-loop control system based on beta-cell physiology and implemented directly in hardware to provide an embedded low-power solution in a dedicated handheld device. In coordination with the closed-loop controller, the BiAP system incorporates a novel adaptive bolus calculator which aims at improving postprandial glycemic control. This paper focuses on the latest developments of the BiAP system for its utilization in the home environment. METHODS: The hardware and software architectures of the BiAP system designed to be used in the home environment are described. Then, the clinical trial design proposed to evaluate the BiAP system in an ambulatory setting is introduced. Finally, preliminary results corresponding to two participants enrolled in the trial are presented. RESULTS: Apart from minor technical issues, mainly due to wireless communications between devices, the BiAP system performed well (~88% of the time in closed-loop) during the clinical trials conducted so far. Preliminary results show that the BiAP system might achieve comparable glycemic outcomes to the existing AP systems (~73% time in target range 70-180 mg/dL). CONCLUSION: The BiAP system is a viable platform to conduct ambulatory clinical trials and a potential solution for people with T1D to control their glucose control in a home environment

A Bibliometric Analysis of Research Productivity on Diabetes Modeling and Artificial Pancreas 2001 to 2020

The prevalence of diabetes apparently increases all over the world. Thus, significant research works have been carried out in all aspects of the disease to control and mitigate its effects. Many researchers looked to the disease as a biomedical control engineering problem where the main task is identifying the model that can be used to mimic the healthy person\u27s metabolism and therefore relieving the lives of millions of diabetics. This work aims to explore the dynamics of the produced scientific research in the area of diabetes modeling and control from a bibliometric method. In this work, a comprehensive bibliometric analysis of published research is carried out to give a guide to scientists in the field to explore research productivity and highlight the trends and tendencies besides showing the gaps for future research. The data were extracted from Scopus, a largest indexing and abstracting database of scientific literature. The analysis showed the field\u27s leading countries, institutes, journals, articles, authorships, keywords, collaboration research networks, leading scholars, and a three-factor analysis of leading countries, institutions, and keywords

Devices And Systems For Medical Fluid Treatment

The devices and systems are medical fluid treatment therapies. The device and systems are configured and capable of operating based on small volumes of fluids. The devices and systems include a pump configured for small volume of a fluid. The pump may include a first conduit configured for inflow of the fluid; a second conduit configured for outflow of the fluid; a fluid chamber configured to move the fluid through the pump; a diaphragm configured to force the fluid through the fluid chamber by indirectly exerting force on the fluid chamber; and a connector configured to removably attach the pump to a motor.Emory UniversityGeorgia Tech Research Corporatio

Day and night closed-loop control in adults with type 1 diabetes: a comparison of two closed-loop algorithms driving continuous subcutaneous insulin infusion versus patient self-management.

OBJECTIVE: To compare two validated closed-loop (CL) algorithms versus patient self-control with CSII in terms of glycemic control. RESEARCH DESIGN AND METHODS: This study was a multicenter, randomized, three-way crossover, open-label trial in 48 patients with type 1 diabetes mellitus for at least 6 months, treated with continuous subcutaneous insulin infusion. Blood glucose was controlled for 23 h by the algorithm of the Universities of Pavia and Padova with a Safety Supervision Module developed at the Universities of Virginia and California at Santa Barbara (international artificial pancreas [iAP]), by the algorithm of University of Cambridge (CAM), or by patients themselves in open loop (OL) during three hospital admissions including meals and exercise. The main analysis was on an intention-to-treat basis. Main outcome measures included time spent in target (glucose levels between 3.9 and 8.0 mmol/L or between 3.9 and 10.0 mmol/L after meals). RESULTS: Time spent in the target range was similar in CL and OL: 62.6% for OL, 59.2% for iAP, and 58.3% for CAM. While mean glucose level was significantly lower in OL (7.19, 8.15, and 8.26 mmol/L, respectively) (overall P = 0.001), percentage of time spent in hypoglycemia (<3.9 mmol/L) was almost threefold reduced during CL (6.4%, 2.1%, and 2.0%) (overall P = 0.001) with less time ≤2.8 mmol/L (overall P = 0.038). There were no significant differences in outcomes between algorithms. CONCLUSIONS: Both CAM and iAP algorithms provide safe glycemic control