Automated Insulin Delivery: The Artificial Pancreas Technical Challenges.

BACKGROUND: The automation of glucose control has been an important goal of diabetes treatment for many decades. The first artificial pancreas experiences were in-hospital, closely supervised, small-scale, and short-term studies that demonstrated their superiority over continuous subcutaneous insulin infusion therapy. At present, long-term outpatient studies are being conducted in free-living scenarios. AREAS OF UNCERTAINTY: The integration of multiple devices increases patients' burden and the probability of technical risks. Control algorithms must be robust to manage disturbance variables, such as physical exercise, meal composition, stress, illness, and circadian variations in insulin sensitivity. Extra layers of safety could be achieved through remote supervision. Dual-hormone systems reduce the incidence and duration of hypoglycemia, but the availability of stable pumpable glucagon needs to be solved. Faster insulin analogues are expected to improve all types of artificial pancreas. THERAPEUTIC ADVANCES: Artificial pancreas safety and feasibility are being demonstrated in outpatient studies. Artificial pancreas use increases the time of sensor-measured glucose in near-normoglycemia and reduces the risk of hyperglycemia and hypoglycemia. The benefits are observed both in single- and dual-hormone algorithms and in full- or semi-closed loop control. A recent meta-analysis including 41 randomized controlled trials showed that artificial pancreas use achieves a reduction of time in hyperglycemia (2 hours less than control treatment) and in hypoglycemia (20 minutes less); mean levels of continuous glucose sensor fell by 8.6 mg/dL over 24 hours and by 14.6 mg/dL overnight. The OpenAPS community uses Do It Yourself artificial pancreas in the real world since 2013, and a recent retrospective cross-over study (n = 20) compared continuous glucose sensor readings before and after initiation: mean levels of blood glucose fell by 7.4 mg/dL over 24 hours and time in range increased from 75.8% to 82.2% (92 minutes more). CONCLUSIONS: The outpatient use of artificial pancreas is safe and improves glucose control in outpatients with type 1 diabetes compared with the use of any type of insulin-based treatment. The availability of open-source solutions and data sharing is needed to foster the development of new artificial pancreas approaches and to promote the wide use of Big Data tools for knowledge discovery, decision support, and personalization.

Design and Technical Validation of a Telemedicine Service for Rural Healthcare in Ecuador.

BACKGROUND: Telemedicine is becoming increasingly important in Ecuador, especially in areas such as rural primary healthcare and medical education. Rural telemedicine programs in the country need to be strengthened by means of a technological platform adapted to local surroundings and offering advantages such as access to specialized care, continuing education, and so on, combined with modest investment requirements. INTRODUCTION: This present article presents the design of a Telemedicine Platform (TMP) for rural healthcare services in Ecuador and a preliminary technical validation with medical students and teachers. MATERIALS AND METHODS: An initial field study was designed to capture the requirements of the TMP. In a second phase, the TMP was validated in an academic environment along three consecutive academic courses. Assessment was by means of user polls and analyzing user interactions as registered automatically by the platform. The TMP was developed using Web-based technology and open code software. RESULTS: One hundred twenty-four students and 6 specialized faculty members participated in the study, conducting a total of 262 teleconsultations of clinical cases and 226 responses, respectively. CONCLUSION: The validation results show that the TMP is a useful communication tool for the documentation and discussion of clinical cases. Moreover, its usage may be recommended as a teaching methodology, to strengthen the skills of medical undergraduates. The results indicate that implementing the system in rural healthcare services in Ecuador would be feasible.

Precision nutrition impact on metabolic health and quality of life in aging population after a 3-month intervention: A randomized intervention.

OBJECTIVES: Innovative precision dietary procedures are required to promote healthy aging. This study aimed to evaluate the effects of a personalised strategy based on the inclusion of individualised foods and digital tools on overall health status and quality of life within a follow-up of 3 months in older adults with overweight or obesity. METHODS: 127 men and women aged between 50 and 80 years with overweight/obesity participated in the study-between January 2020 and September 2020 at the Center for Nutrition Research-University of Navarra and IMDEA-ALIMENTACIÓN-and were randomly assigned to a usual-care group (standard recommendations) or precision group (precision nutrition strategy based on the inclusion of individualised foods and a mobile application). Anthropometry, body fat percentage, biochemical parameters, diet, and quality of life (SF-36 Health Survey) were assessed at baseline and after 3 months. RESULTS: Both strategies were found to improve overall metabolic health; however, the precision approach demonstrated significantly better outcomes. The precision strategy reduced body weight at 3 months (-4.3 kg; p < 0.001) with significant improvements in body fat percentage, blood pressure and general metabolic health (glycated haemoglobin; alanine aminotransferase; aspartate aminotransferase; hepatic steatosis index) in comparison with the standard recommendations. The precision approach significantly enhanced the quality of life (SF-36) of individuals, with additional improvements in emotional well-being (p = 0.024) and vitality (p = 0.008). Adherence to the Mediterranean diet was significantly associated with a higher quality of life and vitality. CONCLUSION: These results support the benefit of precision nutrition approaches for promoting healthy aging and emotional well-being, enhancing the quality of life in aging populations, during the COVID-19 pandemic.

A Systematic Review of Collective Evidences Investigating the Effect of Diabetes Monitoring Systems and Their Application in Health Care.

Introduction: Diabetes monitoring systems (DMS) are a possible approach for regular control of glucose levels in patients with Type 1 or 2 diabetes in order to improve therapeutic outcomes or to identify and modify inappropriate patient behaviors in a timely manner. Despite the significant number of studies observing the DMS, no collective evidence is available about the effect of all devices. Goal: To review and consolidate evidences from multiple systematic reviews on the diabetes monitoring systems and the outcomes achieved. Materials and methods: Internet-based search in PubMed, EMBASE, and Cochrane was performed to identify all studies relevant to the research question. The data regarding type of intervention, type of diabetes mellitus, type of study, change in clinical parameter(s), or another relevant outcome were extracted and summarized. Results: Thirty-three out of 1,495 initially identified studies, involving more than 44,100 patients with Type 1, Type 2, or gestational diabetes for real-time or retrospective Continuous Glucose Monitoring (CGMS), Sensor Augmented Pump Therapy (SAPT), Self-monitoring Blood Glucose (SMBG), Continuous subcutaneous insulin infusion (CSII), Flash Glucose Monitoring (FGM), Closed-loop systems and telemonitoring, were included. Most of the studies observed small nominal effectiveness of DMS. In total 11 systematic reviews and 15 meta-analyses, with most focusing on patients with Type 1 diabetes (10 and 6, respectively), reported a reduction in glycated hemoglobin (HbA1c) levels from 0.17 to 0.70% after use of DMS. Conclusion: Current systematic review of already published systematic reviews and meta-analyses suggests that no statistically significant difference exists between the values of HbA1c as a result of application of any type of DMS. The changes in HbA1c values, number and frequency of hypoglycemic episodes, and time in glucose range are the most valuable for assessing the appropriateness and effectiveness of DMS. Future more comprehensive studies assessing the effectiveness, cost-effectiveness, and comparative effectiveness of DMS are needed to stratify them for the most suitable diabetes patients' subgroups.

Managing gestational diabetes mellitus using a smartphone application with artificial intelligence (SineDie) during the COVID-19 pandemic: Much more than just telemedicine.

We describe our experience in the remote management of women with gestational diabetes mellitus during the COVID-19 pandemic. We used a mobile phone application with artificial intelligence that automatically classifies and analyses the data (ketonuria, diet transgressions, and blood glucose values), making adjustment recommendations regarding the diet or insulin treatment.

Real-time continuous glucose monitoring together with telemedical assistance improves glycemic control and glucose stability in pump-treated patients.

BACKGROUND: Real-time continuous glucose monitoring (CGM) has recently been incorporated into routine diabetes management because of the potential advantages it offers for glycemic control. The aim of our study was to evaluate the impact of the use of real-time CGM together with a telemedicine system in hemoglobin A1c and glucose variability in patients with type 1 diabetes treated with insulin pumps. METHODS: Ten patients (five women, 41.2 [range, 21-62] years old, duration of diabetes 14.9 [range, 3-52] years) were included in this randomized crossover study. Patients used the DIABTel telemedicine system throughout the study, and real-time CGM was used for 3 days every week during the intervention phase. At the end of the control phase, a blind 3-day CGM was performed. Glucose variability was evaluated using the Glucose Risk Index (GRI), a comparative analysis of continuous glucose values over two consecutive hours. RESULTS: Hemoglobin A1c decreased significantly (8.1 +/- 1.1% vs. 7.3 +/- 0.8%; P = 0.007) after the intervention phase, while no changes were observed during the control phase. The mean number of daily capillary glucose readings was higher during the intervention phase (4.7 +/- 1.1 vs. 3.8 +/- 1.0; P < 0.01), because of an increase in random analyses (1.22 +/- 0.3 vs. 0.58 +/- 0.1; P < 0.01), and there was also a significant increase in the mean number of bolus doses per day (5.23 +/- 1.1 vs. 4.4 +/- 0.8; P < 0.05). The GRI was higher during the control phase than during the experimental phase (9.6 vs. 6.25; P < 0.05). CONCLUSIONS: Real-time CGM in conjunction with the DIABTel system improves glycemic control and glucose stability in pump-treated patients with type 1 diabetes.

Decision Support in Diabetes Care: The Challenge of Supporting Patients in Their Daily Living Using a Mobile Glucose Predictor.

BACKGROUND: In type 1 diabetes mellitus (T1DM), patients play an active role in their own care and need to have the knowledge to adapt decisions to their daily living conditions. Artificial intelligence applications can help people with type 1 diabetes in decision making and allow them to react at time scales shorter than the scheduled face-to-face visits. This work presents a decision support system (DSS), based on glucose prediction, to assist patients in a mobile environment. METHODS: The system's impact on therapeutic corrective actions has been evaluated in a randomized crossover pilot study focused on interprandial periods. Twelve people with type 1 diabetes treated with insulin pump participated in two phases: In the experimental phase (EP) patients used the DSS to modify initial corrective decisions in presence of hypoglycemia or hyperglycemia events. In the control phase (CP) patients were asked to follow decisions without knowing the glucose prediction. A telemedicine platform allowed participants to register monitoring data and decisions and allowed endocrinologists to supervise data at the hospital. The study period was defined as a postprediction (PP) time window. RESULTS: After knowing the glucose prediction, participants modified the initial decision in 20% of the situations. No statistically significant differences were found in the PP Kovatchev's risk index change (-1.23 ± 11.85 in EP vs -0.56 ± 6.06 in CP). Participants had a positive opinion about the DSS with an average score higher than 7 in a usability questionnaire. CONCLUSION: The DSS had a relevant impact in the participants' decision making while dealing with T1DM and showed a high confidence of patients in the use of glucose prediction.

Objective motor assessment for personalized rehabilitation of upper extremity in brain injury patients.

BACKGROUND: The increasing number of patients with acquired brain injury and the current subjectivity of the conventional upper extremity (UE) assessment tests require new objective assessment techniques. OBJECTIVE: This research proposes a novel objective motor assessment (OMA) methodology based on the Fugl-Meyer assessment (FMA). The goals are to automatically calculate the objective scores (OSs) of FMA-UE movements (as well as a global OS) and to interpret the estimated OSs. METHODS: Fifteen patients participated in the study. The OMA algorithm was designed to detect small-scale variations in UE movements. The OSs for 14 FMA-UE movements and the global OSs were automatically calculated using the algorithm and evaluated by 2 therapists. The interpretation of the global OSs was performed at 3 levels: by item, movement and globally. RESULTS: The global OSs calculated by our algorithm had a significant correlation with the therapists' scores (0.783 and 0.938, p <  0.01). All OSs for each movement were correlated with the scores given by the therapists. The correlation coefficient can reach values as high as 0.981 (p <  0.01). CONCLUSIONS: We provide a new objective assessment tool for therapists to help them improve the diagnostic accuracy and to achieve a more personalized and potentially effective physical rehabilitation of brain injury patients.

Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results.

An ongoing clinical trial is testing the efficacy of web telematic support in a structured program for obesity treatment and diabetes prevention. Participants were recruited from two tertiary-care hospitals and randomized to receive either a telematic intervention (TI) supported by PREDIRCAM2 web platform or a non-telematic intervention (NTI). All receive 1-year follow-up. Both interventions consist of tailored dietary and exercise prescriptions, based on a Mediterranean dietary pattern and general WHO exercise recommendations for adults. At 6 months, both groups have received 7 contacts, 3 exclusively telematic for the TI group. This is a preliminary result intention-to-treat analysis. One hundred eighty-three participants were recruited, with a mean body mass index of 34.75 ± 2.75 kg/m2. General dropout rate at 6 months was 26.8%. Weight changes were statistically significant at months 3 and 6 compared to baseline, -2.915 ± 0.24 kg, -3.29 ± 0.36 kg, respectively (P < 0.001), but not statistically significant between the 3- and 6-month time points -0.37 ± 0.21 kg (P = 0.24). Mean group differences showed that the TI group lost 1.61 ± 1.88 kg more than the NTI group (P = 0.39). Waist, waist/hip ratio, resting heart rate, blood pressure, HbA1c, and low-density lipoprotein cholesterol also showed statistically significant changes at 6 months, with no significant differences between groups. Weight loss in the TI group shows similar results as the usual care NTI group for weight loss and control of obesity comorbidities. At completion of the clinical trial, these results will be reevaluated to assess the potential role of web support in weight-loss maintenance and its cost-effectiveness.

A web-based clinical decision support system for gestational diabetes: Automatic diet prescription and detection of insulin needs.

BACKGROUND: The growth of diabetes prevalence is causing an increasing demand in health care services which affects the clinicians' workload as medical resources do not grow at the same rate as the diabetic population. Decision support tools can help clinicians with the inspection of monitoring data, providing a preliminary analysis to ease their interpretation and reduce the evaluation time per patient. This paper presents Sinedie, a clinical decision support system designed to manage the treatment of patients with gestational diabetes. Sinedie aims to improve access to specialized healthcare assistance, to prevent patients from unnecessary displacements, to reduce the evaluation time per patient and to avoid gestational diabetes adverse outcomes. METHODS: A web-based telemedicine platform was designed to remotely evaluate patients allowing them to upload their glycaemia data at home directly from their glucose meter, as well as report other monitoring variables like ketonuria and compliance to dietary treatment. Glycaemia values, not tagged by patients, are automatically labelled with their associated meal by a classifier based on the Expectation Maximization clustering algorithm and a C4.5 decision tree learning algorithm. Two finite automata are combined to determine the patient's metabolic condition, which is analysed by a rule-based knowledge base to generate therapy adjustment recommendations. Diet recommendations are automatically prescribed and notified to the patients, whereas recommendations about insulin requirements are notified also to the physicians, who will decide if insulin needs to be prescribed. The system provides clinicians with a view where patients are prioritized according to their metabolic condition. A randomized controlled clinical trial was designed to evaluate the effectiveness and safety of Sinedie interventions versus standard care and its impact in the professionals' workload in terms of the clinician's time required per patient; number of face-to-face visits; frequency and duration of telematics reviews; patients' compliance to self-monitoring; and patients' satisfaction. RESULTS: Sinedie was clinically evaluated at "Parc Tauli University Hospital" in Spain during 17 months with the participation of 90 patients with gestational diabetes. Sinedie detected all situations that required a therapy adjustment and all the generated recommendations were safe. The time devoted by clinicians to patients' evaluation was reduced by 27.389% and face-to-face visits per patient were reduced by 88.556%. Patients reported to be highly satisfied with the system, considering it useful and trusting in being well controlled. There was no monitoring loss and, in average, patients measured their glycaemia 3.890 times per day and sent their monitoring data every 3.477days. CONCLUSIONS: Sinedie generates safe advice about therapy adjustments, reduces the clinicians' workload and helps physicians to identify which patients need a more urgent or more exhaustive examination and those who present good metabolic control. Additionally, Sinedie saves patients unnecessary displacements which contributes to medical centres' waiting list reduction.

Modelling the effect of insulin on the disposal of meal-attributable glucose in type 1 diabetes.

The management of postprandial glucose excursions in type 1 diabetes has a major impact on overall glycaemic control. In this work, we propose and evaluate various mechanistic models to characterize the disposal of meal-attributable glucose. Sixteen young volunteers with type 1 diabetes were subject to a variable-target clamp which replicated glucose profiles observed after a high-glycaemic-load ([Formula: see text]) or a low-glycaemic-load ([Formula: see text]) evening meal. [6,6-[Formula: see text]] and [U-[Formula: see text];1,2,3,4,5,6,6-[Formula: see text]] glucose tracers were infused to, respectively, mimic: (a) the expected post-meal suppression of endogenous glucose production and (b) the appearance of glucose due to a standard meal. Six compartmental models (all a priori identifiable) were proposed to investigate the remote effect of circulating plasma insulin on the disposal of those glucose tracers from the non-accessible compartments, representing e.g. interstitium. An iterative population-based parameter fitting was employed. Models were evaluated attending to physiological plausibility, posterior identifiability of their parameter estimates, accuracy-via weighted fitting residuals-and information criteria (i.e. parsimony). The most plausible model, best representing our experimental data, comprised: (1) a remote effect x of insulin active above a threshold [Formula: see text] = 1.74 (0.81-2.50) [Formula: see text] min[Formula: see text] [median (inter-quartile range)], with parameter [Formula: see text] having a satisfactory support: coefficient of variation CV = 42.33 (31.34-65.34) %, and (2) steady-state conditions at the onset of the experiment ([Formula: see text]) for the compartment representing the remote effect, but not for the masses of the tracer that mimicked endogenous glucose production. Consequently, our mechanistic model suggests non-homogeneous changes in the disposal rates for meal-attributable glucose in relation to plasma insulin. The model can be applied to the in silico simulation of meals for the optimization of postprandial insulin infusion regimes in type 1 diabetes.

Assessment of a personalized and distributed patient guidance system.

OBJECTIVES: The MobiGuide project aimed to establish a ubiquitous, user-friendly, patient-centered mobile decision-support system for patients and for their care providers, based on the continuous application of clinical guidelines and on semantically integrated electronic health records. Patients would be empowered by the system, which would enable them to lead their normal daily lives in their regular environment, while feeling safe, because their health state would be continuously monitored using mobile sensors and self-reporting of symptoms. When conditions occur that require medical attention, patients would be notified as to what they need to do, based on evidence-based guidelines, while their medical team would be informed appropriately, in parallel. We wanted to assess the system's feasibility and potential effects on patients and care providers in two different clinical domains. MATERIALS AND METHODS: We describe MobiGuide's architecture, which embodies these objectives. Our novel methodologies include a ubiquitous architecture, encompassing a knowledge elicitation process for parallel coordinated workflows for patients and care providers; the customization of computer-interpretable guidelines (CIGs) by secondary contexts affecting remote management and distributed decision-making; a mechanism for episodic, on demand projection of the relevant portions of CIGs from a centralized, backend decision-support system (DSS), to a local, mobile DSS, which continuously delivers the actual recommendations to the patient; shared decision-making that embodies patient preferences; semantic data integration; and patient and care provider notification services. MobiGuide has been implemented and assessed in a preliminary fashion in two domains: atrial fibrillation (AF), and gestational diabetes Mellitus (GDM). Ten AF patients used the AF MobiGuide system in Italy and 19 GDM patients used the GDM MobiGuide system in Spain. The evaluation of the MobiGuide system focused on patient and care providers' compliance to CIG recommendations and their satisfaction and quality of life. RESULTS: Our evaluation has demonstrated the system's capability for supporting distributed decision-making and its use by patients and clinicians. The results show that compliance of GDM patients to the most important monitoring targets - blood glucose levels (performance of four measurements a day: 0.87±0.11; measurement according to the recommended frequency of every day or twice a week: 0.99±0.03), ketonuria (0.98±0.03), and blood pressure (0.82±0.24) - was high in most GDM patients, while compliance of AF patients to the most important targets was quite high, considering the required ECG measurements (0.65±0.28) and blood-pressure measurements (0.75±1.33). This outcome was viewed by the clinicians as a major potential benefit of the system, and the patients have demonstrated that they are capable of self-monitoring - something that they had not experienced before. In addition, the system caused the clinicians managing the AF patients to change their diagnosis and subsequent treatment for two of the ten AF patients, and caused the clinicians managing the GDM patients to start insulin therapy earlier in two of the 19 patients, based on system's recommendations. Based on the end-of-study questionnaires, the sense of safety that the system has provided to the patients was its greatest asset. Analysis of the patients' quality of life (QoL) questionnaires for the AF patients was inconclusive, because while most patients reported an improvement in their quality of life in the EuroQoL questionnaire, most AF patients reported a deterioration in the AFEQT questionnaire. DISCUSSION: Feasibility and some of the potential benefits of an evidence-based distributed patient-guidance system were demonstrated in both clinical domains. The potential application of MobiGuide to other medical domains is supported by its standards-based patient health record with multiple electronic medical record linking capabilities, generic data insertion methods, generic medical knowledge representation and application methods, and the ability to communicate with a wide range of sensors. Future larger scale evaluations can assess the impact of such a system on clinical outcomes. CONCLUSION: MobiGuide's feasibility was demonstrated by a working prototype for the AF and GDM domains, which is usable by patients and clinicians, achieving high compliance to self-measurement recommendations, while enhancing the satisfaction of patients and care providers.

Customized Monitoring and Interaction Devices in Virtual Environments for Upper Limb Rehabilitation After Brain Injury.

This paper introduces a new approach for upper limb neurorehabilitation based on customized devices for monitoring and interacting with virtual environments. A proof-of-concept test involving eight patients at the Guttmann Neurorehabilitation Hospital shows patient's good acceptance and usability scores and demonstrates the technically feasibility of the devices. The final goal is to achieve a more personalized, monitored, intensive and ecological rehabilitation procedures for ABI patients.

Quantifying the acute changes in glucose with exercise in type 1 diabetes: a systematic review and meta-analysis.

BACKGROUND: The acute impact of different types of physical activity on glycemic control in type 1 diabetes has not been well quantified. OBJECTIVES: Our objective was to estimate the rate of change (RoC) in glucose concentration induced acutely during the performance of structured exercise and at recovery in subjects with type 1 diabetes. METHODS: We searched for original articles in the PubMed, MEDLINE, Scopus, and Cochrane databases. Search terms included type 1 diabetes, blood glucose, physical activity, and exercise. Eligible studies (randomized controlled trials and non-randomized experiments) encompassed controlled physical activity sessions (continuous moderate [CONT], intermittent high intensity [IHE], resistance [RESIST], and/or a resting reference [REST]) and reported excursions in glucose concentration during exercise and after its cessation. Data were extracted by graph digitization to compute two RoC measures from population profiles: RoCE during exercise and RoCR in recovery. RESULTS: Ten eligible studies were found from 540 publications. Meta-analyses of exercise modalities versus rest yielded the following: RoCE -4.43 mmol/L h(-1) (p < 0.00001, 95% confidence interval [CI] -6.06 to -2.79) and RoCR +0.70 mmol/L h(-1) (p = 0.46, 95% CI -1.14 to +2.54) for CONT vs. REST; RoCE -5.25 mmol/L·h(-1) (p < 0.00001, 95 % CI -7.02 to -3.48) and RoCR +0.72 mmol/L h(-1) (p = 0.71, 95% CI -3.10 to +4.54) for IHE vs. REST; RoCE -2.61 mmol/L h(-1) (p = 0.30, 95% CI -7.55 to +2.34) and RoCR -0.02 mmol/L h(-1) (p = 1.00, 95% CI -7.58 to +7.53) for RESIST vs. REST. CONCLUSIONS: Novel RoC magnitudes RoCE, RoCR reflected rapid decays of glycemia during CONT exercise and gradual recoveries immediately afterwards. RESIST showed more constrained decays, whereas discrepancies were found for IHE.

Design and technical evaluation of an enhanced location-awareness service enabler for spatial disorientation management of elderly with mild cognitive impairment.

The progressive ageing of population has turned the mild cognitive impairment (MCI) into a prevalent disease suffered by elderly. Consequently, the spatial disorientation has become a significant problem for older people and their caregivers. The ambient-assisted living applications are offering location-based services for empowering elderly to go outside and encouraging a greater independence. Therefore, this paper describes the design and technical evaluation of a location-awareness service enabler aimed at supporting and managing probable wandering situations of a person with MCI. Through the presence capabilities of the IP multimedia subsystem (IMS) architecture, the service will alert patient's contacts if a hazardous situation is detected depending on his location. Furthermore, information about the older person's security areas has been included in the user profile managed by IMS. In doing so, the service enabler introduced contribute to "context-awareness" paradigm allowing the adaptation and personalization of services depending on user's context and specific conditions or preferences.

Service for the Pseudonymization of Electronic Healthcare Records Based on ISO/EN 13606 for the Secondary Use of Information.

The availability of electronic health data favors scientific advance through the creation of repositories for secondary use. Data anonymization is a mandatory step to comply with current legislation. A service for the pseudonymization of electronic healthcare record (EHR) extracts aimed at facilitating the exchange of clinical information for secondary use in compliance with legislation on data protection is presented. According to ISO/TS 25237, pseudonymization is a particular type of anonymization. This tool performs the anonymizations by maintaining three quasi-identifiers (gender, date of birth, and place of residence) with a degree of specification selected by the user. The developed system is based on the ISO/EN 13606 norm using its characteristics specifically favorable for anonymization. The service is made up of two independent modules: the demographic server and the pseudonymizing module. The demographic server supports the permanent storage of the demographic entities and the management of the identifiers. The pseudonymizing module anonymizes the ISO/EN 13606 extracts. The pseudonymizing process consists of four phases: the storage of the demographic information included in the extract, the substitution of the identifiers, the elimination of the demographic information of the extract, and the elimination of key data in free-text fields. The described pseudonymizing system was used in three telemedicine research projects with satisfactory results. A problem was detected with the type of data in a demographic data field and a proposal for modification was prepared for the group in charge of the drawing up and revision of the ISO/EN 13606 norm.

Management of patients with diabetes through information technology: tools for monitoring and control of the patients' metabolic behavior.

BACKGROUND: The junction of telemedicine home monitoring with multifaceted disease management programs seems nowadays a promising direction to combine the need for an intensive approach to deal with diabetes and the pressure to contain the costs of the interventions. Several projects in the European Union and the United States are implementing information technology-based services for diabetes management using a comprehensive approach. Within these systems, the role of tools for data analysis and automatic reminder generation seems crucial to deal with the information overload that may result from large home monitoring programs. The objective of this study was to describe the automatic reminder generation system and the summary indicators used in a clinical center within the telemedicine project M2DM, funded by the European Commission, and to show their usage during a 7-month on-field testing period. METHODS: M2DM is a multi-access service for management of patients with diabetes. The basic functionality of the technical service includes a Web-based electronic medical record and messaging system, a computer telephony integration service, a smart-modem located at home, and a set of specialized software modules for automated data analysis. The information flow is regulated by a software scheduler, called the Organizer, that, on the basis of the knowledge on the health care organization, is able to automatically send e-mails and alerts notifications as well as to commit activities to software agents, such as data analysis. Thanks to this system, it was possible to define an automatic reminder system, which relies on a data analysis tool and on a number of technologies for communication. Within the M2DM system, we have also defined and implemented a number of indexes able to summarize the patients' day-by-day metabolic control. In particular, we have defined the global risk index (GRI) of developing microangiopathic complications. RESULTS: The system for generating automatic alarms and reminders coupled with the indexes for evaluating the patients' metabolic control has been used for 7 months at the Fondazione Salvatore Maugeri (FSM) in Pavia, Italy. Twenty-two patients (43 +/- 16 years old, 12 men and 10 women) have been involved; six dropped out from the study. The average number of monthly automatic messages was 29.44 +/- 9.83, i.e., about 1.8 messages per patient per month. The number of monthly alarm reminders generated by the system was 16.44 +/- 4.39, so that the number of alarms per patient was about 1. The number of messages sent by patients and physicians during the project was about 13 per month. The GRI analysis shows, during the last trimester, a slight improvement of the performance of the FSM clinic, with a decrease in the percentage of badly controlled values from 33% to 27%. Finally, we found the presence of a linear increasing correlation between the mean GRI values and the number of alarms generated by the system. CONCLUSIONS: A telemedicine system may incorporate features that make it a suitable technological backbone for implementing a disease management program. The availability of data analysis tools, automated messaging system, and summary indicators of the effectiveness of the health care program may help in defining efficient clinical interventions.

New trends in diabetes management: mobile telemedicine closed-loop system.

The rapid growth and development of information technologies over recent years, in the areas of mobile and wireless technologies is shaping a new technological scenario of telemedicine in diabetes. This telemedicine scenario can play an important role for further acceptance by diabetic patients of the existing continuous glucose monitoring systems and insulin pumps with the final goal of improving current therapeutic procedures. This paper describes a Personal Smart Assistant integrated in a multi-access telemedicine architecture for the implementation of a mobile telemedicine closed-loop system for diabetes management. The system is being evaluated within the European Union project named INCA ("Intelligent Control Assistant for Diabetes").

Patient-oriented Computerized Clinical Guidelines for Mobile Decision Support in Gestational Diabetes.

The risks associated with gestational diabetes (GD) can be reduced with an active treatment able to improve glycemic control. Advances in mobile health can provide new patient-centric models for GD to create personalized health care services, increase patient independence and improve patients' self-management capabilities, and potentially improve their treatment compliance. In these models, decision-support functions play an essential role. The telemedicine system MobiGuide provides personalized medical decision support for GD patients that is based on computerized clinical guidelines and adapted to a mobile environment. The patient's access to the system is supported by a smartphone-based application that enhances the efficiency and ease of use of the system. We formalized the GD guideline into a computer-interpretable guideline (CIG). We identified several workflows that provide decision-support functionalities to patients and 4 types of personalized advice to be delivered through a mobile application at home, which is a preliminary step to providing decision-support tools in a telemedicine system: (1) therapy, to help patients to comply with medical prescriptions; (2) monitoring, to help patients to comply with monitoring instructions; (3) clinical assessment, to inform patients about their health conditions; and (4) upcoming events, to deal with patients' personal context or special events. The whole process to specify patient-oriented decision support functionalities ensures that it is based on the knowledge contained in the GD clinical guideline and thus follows evidence-based recommendations but at the same time is patient-oriented, which could enhance clinical outcomes and patients' acceptance of the whole system.

Artificial pancreas using a personalized rule-based controller achieves overnight normoglycemia in patients with type 1 diabetes.

OBJECTIVE: This study assessed the efficacy of a closed-loop (CL) system consisting of a predictive rule-based algorithm (pRBA) on achieving nocturnal and postprandial normoglycemia in patients with type 1 diabetes mellitus (T1DM). The algorithm is personalized for each patient's data using two different strategies to control nocturnal and postprandial periods. RESEARCH DESIGN AND METHODS: We performed a randomized crossover clinical study in which 10 T1DM patients treated with continuous subcutaneous insulin infusion (CSII) spent two nonconsecutive nights in the research facility: one with their usual CSII pattern (open-loop [OL]) and one controlled by the pRBA (CL). The CL period lasted from 10 p.m. to 10 a.m., including overnight control, and control of breakfast. Venous samples for blood glucose (BG) measurement were collected every 20 min. RESULTS: Time spent in normoglycemia (BG, 3.9-8.0 mmol/L) during the nocturnal period (12 a.m.-8 a.m.), expressed as median (interquartile range), increased from 66.6% (8.3-75%) with OL to 95.8% (73-100%) using the CL algorithm (P<0.05). Median time in hypoglycemia (BG, <3.9 mmol/L) was reduced from 4.2% (0-21%) in the OL night to 0.0% (0.0-0.0%) in the CL night (P<0.05). Nine hypoglycemic events (<3.9 mmol/L) were recorded with OL compared with one using CL. The postprandial glycemic excursion was not lower when the CL system was used in comparison with conventional preprandial bolus: time in target (3.9-10.0 mmol/L) 58.3% (29.1-87.5%) versus 50.0% (50-100%). CONCLUSIONS: A highly precise personalized pRBA obtains nocturnal normoglycemia, without significant hypoglycemia, in T1DM patients. There appears to be no clear benefit of CL over prandial bolus on the postprandial glycemia.