Glucose Variability Analysis in Two Large-Scale and Real-World Data Sets of Open-Source Automated Insulin Delivery Systems.

BACKGROUND: Open-source automated insulin delivery (OS-AID) systems combine commercially available insulin pumps and continuous glucose monitors with open-source algorithms to automate insulin dosing for people with insulin-requiring diabetes. Two data sets (OPEN and the OpenAPS Data Commons) contain anonymized OS-AID user data. METHODS: We assessed glycemic variability (GV) outcomes in the OPEN data set and characterized it alongside a comparison to the n = 122 version of the OpenAPS Data Commons. Glucose data are analyzed using an unsupervised machine learning algorithm for clustering, and GV metrics are quantified using statistical tests for distribution comparison. Demographic data are also analyzed quantitatively. RESULTS: The n = 75 OPEN data set contains 36 827 days worth of data. Mean TIR is 82.08% (TOR < 70: 3.66%; TOR > 180: 14.3%). LBGI (P < .05) differs by gender whereas HBGI distributions are similar (P > .05). GV metrics (except TOR < 70, LBGI) show a statistically significant difference (P < .05) between data sets. CONCLUSIONS: Both the OPEN and OpenAPS Data Commons data sets show TOR < 70, TIR, and TOR > 180 within recommended goals, adding additional evidence of real-world efficacy of OS-AID. Future research should evaluate in more detail potential data set differences and relationships between individual patterns of user behaviors and GV outcomes.

Survey of Pancreatic Enzyme Replacement Therapy Dosing Experiences in Adults with Exocrine Pancreatic Insufficiency.

OBJECTIVES: Pancreatic enzyme replacement therapy (PERT) is essential for treating exocrine pancreatic insufficiency (EPI), a condition where the pancreas does not produce adequate enzymes for digestion. This study delves into the real-world experiences of individuals with EPI regarding their PERT usage. METHODS: A study was executed using a tailored survey targeting individuals with EPI. Quantitative data analysis assessed factors such as age, duration of EPI, elastase levels, choice of PERT, perceived effectiveness of titration, and the time taken for effective titration. RESULTS: The study comprised 111 participants, predominantly female (93%) and hailing from North America (79%). Of these, 36.7% had been diagnosed with EPI for 3 or more years. A significant 72% felt they were not consistently consuming adequate enzymes, with only 22% believing their intake was sufficient. There were 44 participants (42%) still in the process of adjusting their enzyme doses. In contrast, 17 participants (16%) took a few weeks, 21 (20%) a few months, 11 (10%) over six months, 10 (9%) more than a year, and 3 (3%) several years for dose adjustment. Regarding enzyme titration advice, 30 participants (29%) received vague guidance, while 22 (21%) found the advice beneficial. CONCLUSIONS: This study underscores the pressing need for enhanced PERT dosing guidance. The insights gleaned spotlight the prevalent undertreatment across the entire EPI demographic, including in those with lesser-studied co-conditions.

Long-Term Glucose Forecasting for Open-Source Automated Insulin Delivery Systems: A Machine Learning Study with Real-World Variability Analysis.

Glucose forecasting serves as a backbone for several healthcare applications, including real-time insulin dosing in people with diabetes and physical activity optimization. This paper presents a study on the use of machine learning (ML) and deep learning (DL) methods for predicting glucose variability (GV) in individuals with open-source automated insulin delivery systems (AID). A three-stage experimental framework is employed in this work to systematically implement and evaluate ML/DL methods on a large-scale diabetes dataset collected from individuals with open-source AID. The first stage involves data collection, the second stage involves data preparation and exploratory analysis, and the third stage involves developing, fine-tuning, and evaluating ML/DL models. The performance and resource costs of the models are evaluated alongside relative and proportional errors for 17 GV metrics. Evaluation of fine-tuned ML/DL models shows considerable accuracy in glucose forecasting and variability analysis up to 48 h in advance. The average MAE ranges from 2.50 mg/dL for long short-term memory models (LSTM) to 4.94 mg/dL for autoregressive integrated moving average (ARIMA) models, and the RMSE ranges from 3.7 mg/dL for LSTM to 7.67 mg/dL for ARIMA. Model execution time is proportional to the amount of data used for training, with long short-term memory models having the lowest execution time but the highest memory consumption compared to other models. This work successfully incorporates the use of appropriate programming frameworks, concurrency-enhancing tools, and resource and storage cost estimators to encourage the sustainable use of ML/DL in real-world AID systems.

Toward Systems Models for Obesity Prevention: A Big Role for Big Data.

The relation among the various causal factors of obesity is not well understood, and there remains a lack of viable data to advance integrated, systems models of its etiology. The collection of big data has begun to allow the exploration of causal associations between behavior, built environment, and obesity-relevant health outcomes. Here, the traditional epidemiologic and emerging big data approaches used in obesity research are compared, describing the research questions, needs, and outcomes of 3 broad research domains: eating behavior, social food environments, and the built environment. Taking tangible steps at the intersection of these domains, the recent European Union project "BigO: Big data against childhood obesity" used a mobile health tool to link objective measurements of health, physical activity, and the built environment. BigO provided learning on the limitations of big data, such as privacy concerns, study sampling, and the balancing of epidemiologic domain expertise with the required technical expertise. Adopting big data approaches will facilitate the exploitation of data concerning obesity-relevant behaviors of a greater variety, which are also processed at speed, facilitated by mobile-based data collection and monitoring systems, citizen science, and artificial intelligence. These approaches will allow the field to expand from causal inference to more complex, systems-level predictive models, stimulating ambitious and effective policy interventions.

Glycemic Variability Assessment in Newly Treated Exocrine Pancreatic Insufficiency With Type 1 Diabetes.

BACKGROUND: Thirty-nine percent of people with type 1 diabetes may have lowered pancreatic elastase levels, correlated with exocrine pancreatic insufficiency (EPI or PEI). EPI is treated with oral supplementation of pancreatic enzymes. Little is known about the glycemic impact of pancreatic enzyme replacement therapy (PERT) in people with diabetes. This article demonstrates a method of assessing glycemic variability (GV), glycemic outcomes, and other changes in an individual with type 1 diabetes using open-source automated insulin delivery (AID). METHOD: Macronutrient, PERT intake, and EPI-related symptoms were self-tracked; diabetes data were collected automatically via an open-source AID system. Diabetes data were uploaded via Nightscout to Open Humans and downloaded for analysis alongside self-tracked data (food, PERT). Glycemic outcomes, macronutrients, PERT dosing, and a variety of GV metrics following meals were evaluated for one month before and one month after PERT commencement. Breakfast was assessed independently across both time periods. RESULTS: In an n = 1 individual using an open-source AID, time in range was already above goal and improved further after PERT commencement. Glucose rate of change and excursions >180 mg/dL were reduced; mean high blood glucose index was reduced overall and more so specifically at breakfast following PERT commencement. CONCLUSIONS: GV can aid in assessing response to new-onset medications, as was demonstrated in this article for n = 1 individual with type 1 diabetes (using an open-source AID) after commencing PERT for newly identified EPI. GV may be useful for evaluating the efficacy of new-onset medications for people with insulin-requiring diabetes.

Large-Scale Data Analysis for Glucose Variability Outcomes with Open-Source Automated Insulin Delivery Systems.

Open-source automated insulin delivery (AID) technologies use the latest continuous glucose monitors (CGM), insulin pumps, and algorithms to automate insulin delivery for effective diabetes management. Early community-wide adoption of open-source AID, such as OpenAPS, has motivated clinical and research communities to understand and evaluate glucose-related outcomes of such user-driven innovation. Initial OpenAPS studies include retrospective studies assessing high-level outcomes of average glucose levels and HbA1c, without in-depth analysis of glucose variability (GV). The OpenAPS Data Commons dataset, donated to by open-source AID users with insulin-requiring diabetes, is the largest freely available diabetes-related dataset with over 46,070 days' worth of data and over 10 million CGM data points, alongside insulin dosing and algorithmic decision data. This paper first reviews the development toward the latest open-source AID and the performance of clinically approved GV metrics. We evaluate the GV outcomes using large-scale data analytics for the n = 122 version of the OpenAPS Data Commons. We describe the data cleaning processes, methods for measuring GV, and the results of data analysis based on individual self-reported demographics. Furthermore, we highlight the lessons learned from the GV outcomes and the analysis of a rich and complex diabetes dataset and additional research questions that emerged from this work to guide future research. This paper affirms previous studies' findings of the efficacy of open-source AID.

A Two-Stage De-Identification Process for Privacy-Preserving Medical Image Analysis.

Identification and re-identification are two major security and privacy threats to medical imaging data. De-identification in DICOM medical data is essential to preserve the privacy of patients' Personally Identifiable Information (PII) and requires a systematic approach. However, there is a lack of sufficient detail regarding the de-identification process of DICOM attributes, for example, what needs to be considered before removing a DICOM attribute. In this paper, we first highlight and review the key challenges in the medical image data de-identification process. In this paper, we develop a two-stage de-identification process for CT scan images available in DICOM file format. In the first stage of the de-identification process, the patient's PII-including name, date of birth, etc., are removed at the hospital facility using the export process available in their Picture Archiving and Communication System (PACS). The second stage employs the proposed DICOM de-identification tool for an exhaustive attribute-level investigation to further de-identify and ensure that all PII has been removed. Finally, we provide a roadmap for future considerations to build a semi-automated or automated tool for the DICOM datasets de-identification.

Big Data Warehouse for Healthcare-Sensitive Data Applications.

Obesity is a major public health problem worldwide, and the prevalence of childhood obesity is of particular concern. Effective interventions for preventing and treating childhood obesity aim to change behaviour and exposure at the individual, community, and societal levels. However, monitoring and evaluating such changes is very challenging. The EU Horizon 2020 project "Big Data against Childhood Obesity (BigO)" aims at gathering large-scale data from a large number of children using different sensor technologies to create comprehensive obesity prevalence models for data-driven predictions about specific policies on a community. It further provides real-time monitoring of the population responses, supported by meaningful real-time data analysis and visualisations. Since BigO involves monitoring and storing of personal data related to the behaviours of a potentially vulnerable population, the data representation, security, and access control are crucial. In this paper, we briefly present the BigO system architecture and focus on the necessary components of the system that deals with data access control, storage, anonymisation, and the corresponding interfaces with the rest of the system. We propose a three-layered data warehouse architecture: The back-end layer consists of a database management system for data collection, de-identification, and anonymisation of the original datasets. The role-based permissions and secured views are implemented in the access control layer. Lastly, the controller layer regulates the data access protocols for any data access and data analysis. We further present the data representation methods and the storage models considering the privacy and security mechanisms. The data privacy and security plans are devised based on the types of collected personal, the types of users, data storage, data transmission, and data analysis. We discuss in detail the challenges of privacy protection in this large distributed data-driven application and implement novel privacy-aware data analysis protocols to ensure that the proposed models guarantee the privacy and security of datasets. Finally, we present the BigO system architecture and its implementation that integrates privacy-aware protocols.