Mert Sevil

Meal Detection and Carbohydrate Estimation Using Continuous Glucose Sensor Data

A meal detection and meal-size estimation algorithm is developed for use in artificial pancreas (AP) control systems for people with type 1 diabetes. The algorithm detects the consumption of a meal and estimates its carbohydrate (CHO) amount to determine the appropriate dose of insulin bolus for a meal. It can be used in AP systems without manual meal announcements, or as a safety feature for people who may forget entering meal information manually. Using qualitative representation of the filtered continuous glucose monitor signal, a time period labeled as meal flag is identified. At every sampling time during this time period, a fuzzy system estimates the amount of CHO. Meal size estimator uses both glucose sensor and insulin data. Meal insulin bolus is based on estimated CHO. The algorithm does not change the basal insulin rate. Thirty in silico subjects of the UVa/Padova simulator are used to illustrate the performance of the algorithm. For the evaluation dataset, the sensitivity and false positives detection rates are 91.3% and 9.3%, respectively, the absolute error in CHO estimation is 23.1%, the mean blood glucose level is 142 mg/dl, and glucose concentration stays in target range (70–180 mg/dl) for 76.8% of simulation duration on average.

Hypoglycemia Detection and Carbohydrate Suggestion in an Artificial Pancreas

Fear of hypoglycemia is a major concern for many patients with type 1 diabetes and affects patient decisions for use of an artificial pancreas system. We propose an alternative way for prevention of hypoglycemia by issuing predictive hypoglycemia alarms and encouraging patients to consume carbohydrates in a timely manner. The algorithm has been tested on 6 subjects (3 males and 3 females, age 24.2 ± 4.5 years, weight 79.2 ± 16.2 kg, height 172.7 ± 9.4 cm, HbA1C 7.3 ± 0.48%, duration of diabetes 209.2 ± 87.9 months) over 3-day closed-loop clinical experiments as part of a multivariable artificial pancreas control system. Over 6 three-day clinical experiments, there were only 5 real hypoglycemia episodes, of which only 1 hypoglycemia episode occurred due to being missed by the proposed algorithm. The average hypoglycemia alarms per day and per subject was 3. Average glucose value when the first alarms were triggered was recorded to be 117 ± 30.6 mg/dl. Average carbohydrate consumption per alarm was 14 ± 7.8 grams. Our results have shown that most low glucose concentrations can be predicted in advance and the glucose levels can be raised back to the desired levels by consuming an appropriate amount of carbohydrate. The proposed algorithm is able to prevent most hypoglycemic events by suggesting appropriate levels of carbohydrate consumption before the actual occurrence of hypoglycemia.

Adaptive and Personalized Plasma Insulin Concentration Estimation for Artificial Pancreas Systems

Background: The artificial pancreas (AP) system, a technology that automatically administers exogenous insulin in people with type 1 diabetes mellitus (T1DM) to regulate their blood glucose concentrations, necessitates the estimation of the amount of active insulin already present in the body to avoid overdosing. Method: An adaptive and personalized plasma insulin concentration (PIC) estimator is designed in this work to accurately quantify the insulin present in the bloodstream. The proposed PIC estimation approach incorporates Hovorka’s glucose-insulin model with the unscented Kalman filtering algorithm. Methods for the personalized initialization of the time-varying model parameters to individual patients for improved estimator convergence are developed. Data from 20 three-days-long closed-loop clinical experiments conducted involving subjects with T1DM are used to evaluate the proposed PIC estimation approach. Results: The proposed methods are applied to the clinical data containing significant disturbances, such as unannounced meals and exercise, and the results demonstrate the accurate real-time estimation of the PIC with the root mean square error of 7.15 and 9.25 mU/L for the optimization-based fitted parameters and partial least squares regression-based testing parameters, respectively. Conclusions: The accurate real-time estimation of PIC will benefit the AP systems by preventing overdelivery of insulin when significant insulin is present in the bloodstream.

Model-fusion-based online glucose concentration predictions in people with type 1 diabetes

Accurate predictions of glucose concentrations are necessary to develop an artificial pancreas (AP) system for people with type 1 diabetes (T1D). In this work, a novel glucose forecasting paradigm based on a model fusion strategy is developed to accurately characterize the variability and transient dynamics of glycemic measurements. To this end, four different adaptive filters and a fusion mechanism are proposed for use in the online prediction of future glucose trajectories. The filter fusion mechanism is developed based on various prediction performance indexes to guide the overall output of the forecasting paradigm. The efficiency of the proposed model fusion based forecasting method is evaluated using simulated and clinical datasets, and the results demonstrate the capability and prediction accuracy of the data-based fusion filters, especially in the case of limited data availability. The model fusion framework may be used in the development of an AP system for glucose regulation in patients with T1D.

Multi-level supervision and modification of artificial pancreas control system

Artificial pancreas (AP) systems provide automated regulation of blood glucose concentration (BGC) for people with type 1 diabetes (T1D). An AP includes three components: a continuous glucose monitoring (CGM) sensor, a controller calculating insulin infusion rate based on the CGM signal, and a pump delivering the insulin amount calculated by the controller to the patient. The performance of the AP system depends on successful operation of these three components. Many APs use model predictive controllers that rely on models to predict BGC and to calculate the optimal insulin infusion rate. The performance of model-based controllers depends on the accuracy of the models that is affected by large dynamic changes in glucose-insulin metabolism or equipment performance that may move the operating conditions away from those used in developing the models and designing the control system. Sensor errors and missing signals will cause calculation of erroneous insulin infusion rates. And the performance of the controller may vary at each sampling step and each period (meal, exercise, and sleep), and from day to day. Here we describe a multi-level supervision and controller modification (ML-SCM) module is developed to supervise the performance of the AP system and retune the controller. It supervises AP performance in 3 time windows: sample level, period level, and day level. At sample level, an online controller performance assessment sub-module will generate controller performance indexes to evaluate various components of the AP system and conservatively modify the controller. A sensor error detection and signal reconciliation module will detect sensor error and reconcile the CGM sensor signal at each sample. At period level, the controller performance is evaluated with information collected during a certain time period and the controller is tuned more aggressively. At the day level, the daily CGM ranges are further analyzed to determine the adjustable range of controller parameters used for sample level and period level. Thirty subjects in the UVa/Padova metabolic simulator were used to evaluate the performance of the ML-SCM module and one clinical experiment is used to illustrate its performance in a clinical environment. The results indicate that the AP system with an ML-SCM module has a safer range of glucose concentration distribution and more appropriate insulin infusion rate suggestions than an AP system without the ML-SCM module.

Social and competition stress detection with wristband physiological signals

Stress causes many physiological changes in the body and has significant effects on physiology. Various types of acute stress include social, competition, emotional and mental stress. Several studies and experiments have been conducted to investigate stress detection and measurement with physiological signals. We designed social and competition stress experiments to test our algorithms to discriminate between stress and non-stress states with physiological signals from an Empatica wristband. The algorithms were successful in detecting the presence of stress with approximately 87% accuracy.

Communication challenges in a multi-sensor closed-loop artificial pancreas system

This paper describes the communication challenges associated with implementation of a multi-sensor artificial pancreas system on a smartphone device and presents solutions for potential communication losses. In particular, a standardized development framework on an Android device supporting multiple sensors is introduced in order to facilitate a multi-variable closed-loop AP algorithm. Package losses and communication link errors pose major challenges for the AP systems to overcome. The proposed solution offers a conservative model, wherein the controller application on the host smartphone requests status updates, resending of packages if necessary, and ultimately, warnings are issued to the user when data cannot be recovered.

Incorporating Unannounced Meals and Exercise in Adaptive Learning of Personalized Models for Multivariable Artificial Pancreas Systems

Background: Despite the recent advancements in the modeling of glycemic dynamics for type 1 diabetes mellitus, automatically considering unannounced meals and exercise without manual user inputs remains challenging. Method: An adaptive model identification technique that incorporates exercise information and estimates of the effects of unannounced meals obtained automatically without user input is proposed in this work. The effects of the unknown consumed carbohydrates are estimated using an individualized unscented Kalman filtering algorithm employing an augmented glucose-insulin dynamic model, and exercise information is acquired from noninvasive physiological measurements. The additional information on meals and exercise is incorporated with personalized estimates of plasma insulin concentration and glucose measurement data in an adaptive model identification algorithm. Results: The efficacy of the proposed personalized and adaptive modeling algorithm is demonstrated using clinical data involving closed-loop experiments of the artificial pancreas system, and the results demonstrate accurate glycemic modeling with the average root-mean-square error (mean absolute error) of 25.50 mg/dL (18.18 mg/dL) for six-step (30 minutes ahead) predictions. Conclusions: The approach presented is able to identify reliable time-varying individualized glucose-insulin models.

Hardware and Software Implementation of an Artificial Pancreas System on a Mobile Device

In this work, an artificial pancreas AP system, implemented on a mobile device is described. The proposed AP platform integrates hardware insulin pump, glucose monitor, various sensors for vital signs and physical activities and software closed-loop control algorithm, sensor fusion, data storage and remote server access components via smartphone that is running a dedicated Operating System designed for AP systems. Interfacing with this OS and custom application development steps are presented. Closed loop operation is demonstrated with case studies.

Implementation of an artificial pancreas system on a mobile device

In this work, an artificial pancreas (AP) system, implemented on a mobile device is described. The proposed AP platform integrates hardware (insulin pump, glucose monitor, various sensors for vital signs and physical activities) and software (closed-loop control algorithm, sensor fusion, data storage and remote server access) components via smartphone that is running a dedicated Operating System designed for AP systems. Interfacing with this OS and custom application development steps are presented. Closed loop operation is demonstrated with case studies.