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INTRODUCTION: A proper nutrition is essential for human life. Recently, special attention on this topic has been given in relation to three health statuses: obesity, malnutrition and specific diseases that can be related to food or treated with specific diets. Mobile technology is often used to assist users that wish to regulate their eating habits, and identifying which fields of application have been explored the most by the app developers and which main functionalities have been adopted can be useful in view of future app developments. METHODS: We selected 322 articles mentioning nutrition support apps through a literature database search, all of which have undergone an initial screening. After the exclusion of papers that were already reviews, not presenting apps or not focused on nutrition, not relevant or not developed for human subjects, 100 papers were selected for subsequent analyses that aimed at identifying the main treated conditions, outcome measures and functionalities implemented in the Apps. RESULTS: Of the selected studies, 33 focus on specific diseases, 24 on obesity, 2 on malnutrition and 41 on other targets (e.g., weight/diet control). Type 2 diabetes is the most targeted disease, followed by gestational diabetes, hypertension, colorectal cancer and CVDs which all were targeted by more than one app. Most Apps include self-monitoring and coaching functionalities, educational content and artificial intelligence (AI) tools are slightly less common, whereas counseling, gamification and questionnaires are the least implemented. Body weight and calories/nutrients were the most common general outcome measures, while glycated hemoglobin (HbA1c) was the most common clinical outcome. No statistically significant differences in the effectiveness of the different functionalities were found. CONCLUSION: The use of mobile technology to improve nutrition has been widely explored in the last years, especially for weight control and specific diseases like diabetes; however, other food-related conditions such as Irritable Bowel Diseases appear to be less targeted by newly developed smartphone apps and their related studies. All different kinds of functionalities appear to be equally effective, but further specific studies are needed to confirm the results.
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Diabetes Mellitus Tipo 2 , Desnutrición , Aplicaciones Móviles , Humanos , Teléfono Inteligente , Diabetes Mellitus Tipo 2/terapia , Inteligencia Artificial , Obesidad/terapiaRESUMEN
BACKGROUND: Since treatment with immune checkpoint inhibitors (ICIs) is becoming standard therapy for patients with high-risk and advanced melanoma, an increasing number of patients experience treatment-related adverse events such as fatigue. Until now, studies have demonstrated the benefits of using eHealth tools to provide either symptom monitoring or interventions to reduce treatment-related symptoms such as fatigue. However, an eHealth tool that facilitates the combination of both symptom monitoring and symptom management in patients with melanoma treated with ICIs is still needed. OBJECTIVE: In this pilot study, we will explore the use of the CAPABLE (Cancer Patients Better Life Experience) app in providing symptom monitoring, education, and well-being interventions on health-related quality of life (HRQoL) outcomes such as fatigue and physical functioning, as well as patients' acceptance and usability of using CAPABLE. METHODS: This prospective, exploratory pilot study will examine changes in fatigue over time in 36 patients with stage III or IV melanoma during treatment with ICI using CAPABLE (a smartphone app and multisensory smartwatch). This cohort will be compared to a prospectively collected cohort of patients with melanoma treated with standard ICI therapy. CAPABLE will be used for a minimum of 3 and a maximum of 6 months. The primary endpoint in this study is the change in fatigue between baseline and 3 and 6 months after the start of treatment. Secondary end points include HRQoL outcomes, usability, and feasibility parameters. RESULTS: Study inclusion started in April 2023 and is currently ongoing. CONCLUSIONS: This pilot study will explore the effect, usability, and feasibility of CAPABLE in patients with melanoma during treatment with ICI. Adding the CAPABLE system to active treatment is hypothesized to decrease fatigue in patients with high-risk and advanced melanoma during treatment with ICIs compared to a control group receiving standard care. The Medical Ethics Committee NedMec (Amsterdam, The Netherlands) granted ethical approval for this study (reference number 22-981/NL81970.000.22). TRIAL REGISTRATION: ClinicalTrials.gov NCT05827289; https://clinicaltrials.gov/study/NCT05827289. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49252.
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BACKGROUND: Within the CAPABLE project the authors developed a multi-agent system that relies on a distributed architecture. The system provides cancer patients with coaching advice and supports their clinicians with suitable decisions based on clinical guidelines. OBJECTIVES: As in many multi-agent systems we needed to coordinate the activities of all agents involved. Moreover, since the agents share a common blackboard where all patients' data are stored, we also needed to implement a mechanism for the prompt notification of each agent upon addition of new information potentially triggering its activation. METHODS: The communication needs have been investigated and modeled using the HL7-FHIR (Health Level 7-Fast Healthcare Interoperability Resources) standard to ensure proper semantic interoperability among agents. Then a syntax rooted in the FHIR search framework has been defined for representing the conditions to be monitored on the system blackboard for activating each agent. RESULTS: The Case Manager (CM) has been implemented as a dedicated component playing the role of an orchestrator directing the behavior of all agents involved. Agents dynamically inform the CM about the conditions to be monitored on the blackboard, using the syntax we developed. The CM then notifies each agent whenever any condition of interest occurs. The functionalities of the CM and other actors have been validated using simulated scenarios mimicking the ones that will be faced during pilot studies and in production. CONCLUSION: The CM proved to be a key facilitator for properly achieving the required behavior of our multi-agent system. The proposed architecture may also be leveraged in many clinical contexts for integrating separate legacy services, turning them into a consistent telemedicine framework and enabling application reusability.
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Gestores de Casos , Telemedicina , Humanos , Registros Electrónicos de Salud , Estándar HL7 , ComunicaciónRESUMEN
The CAPABLE project has been funded by the EU Horizon 2020 Programme over the years 2020-24 to support home care. A system is being designed and implemented supporting remote monitoring and virtual coaching for cancer patients. The system is based on a distributed modular architecture involving many components encapsulating various knowledge. The Case Manager has been designed as a separate component with the aim of coordinating the problem solving strategies. A first version of the Case Manager has been released and used by the components in a prototypical scenario shown at the first project review.
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Gestores de Casos , Telemedicina , Humanos , Monitoreo Fisiológico , Solución de ProblemasRESUMEN
BACKGROUND AND OBJECTIVE: We illustrate a low-cost platform easing the estimation of spatio-temporal parameters (GA-STP) ready for large-scale deployment in fall prevention. METHODS: We used a commercial sensorized carpet with a limited cost and a very coarse resolution. An instrument validation test was accomplished: the Wilcoxon test for paired samples and the correlation test with Spearman method were used to compare the values computed by the platform with reference ones. Hierarchical clustering using Ward's method and ROC curves have been used to assess the performance in a pilot study enrolling patients. RESULTS: Validation shows no significant difference between computed and reference values of gait speed (ρ-value:0.99; p-value:2.2E-16), step number (ρ-value:0.91; p-value:5.8E-16) and stride-length (ρ-value:0.92; p-value:7.5E-9). The clinical pilot study confirms that the platform may also be used to track the improvements occurring during a rehabilitation program. CONCLUSIONS: We believe that the use of a commercial carpet makes the solution proposed ready to be deployed on a large scale for effectively bringing GA into the clinical practice.
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Pisos y Cubiertas de Piso , Análisis de la Marcha/instrumentación , Análisis de la Marcha/métodos , Marcha , Rehabilitación/métodos , Accidentes por Caídas/prevención & control , Anciano , Algoritmos , Análisis por Conglomerados , Femenino , Voluntarios Sanos , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Curva ROC , Rehabilitación/instrumentación , Procesamiento de Señales Asistido por Computador , Análisis Espacio-TemporalRESUMEN
BACKGROUND: Multidisciplinary treatment for head and neck carcinoma offers the best curative results but generates acute toxicities, which negatively affect both patients' quality of life and treatment compliance. Usually, the patient's clinical condition is recorded during scheduled, time-limited office visits and patients might forget to discuss symptoms occurred weeks before. They could also have difficulties contacting their clinicians outside of these limited encounters. Technology-based interventions for oncological patients have already been proved to encourage accurate symptoms report through regular inquiries of their clinical conditions. OBJECTIVES: The aim of this work is to present the results of a pilot study about the assessment of a novel mobile application for reporting clinical parameters, quality of life, and symptoms of home patients affected by head and neck carcinoma, during chemo-radiotherapy and the subsequent follow-up period. Results will inform app designers about the necessary modifications to face a full-scale trial. METHODS: Ten patients used the app for the foreseen period (up to 65 days, median 50.5), at the end of which they answered a paper questionnaire addressing user satisfaction with the app. The questionnaire included 8 questions and a free text comment field. Patients were followed by three clinicians, who also answered a similar paper questionnaire at the end of the pilot study. Questionnaires total score ranged 0-25 and a threshold of 16 was set in the study protocol to represent an overall positive outcome. However, to consider the individual constructs, questions about usability, perceived usefulness and user acceptance were also analyzed separately, and association among them was investigated. Finally, the feasibility of the intervention was analyzed in terms of the actual use of the app, i.e. dropout rates and compliance with the required data input. Statistics were only performed on patients' data, due to the small number of doctors involved in the study. RESULTS: The median of the total score per patient was 18.5 (interquartile range 11.2-20.5), and per doctor was 16 (range 11-20), thus showing a positive overall satisfaction with the app. Concerning patients, only 4 out of a total of 80 answers (10 patientsâ¯×â¯8 questions) expressed a definite negative feeling. Perceived usefulness was a critical issue for some patients. It was positively correlated with usability, and both aspects were independent predictors of acceptance. Feasibility was demonstrated by the low percentage of dropouts (9%) and noncompliance with assignments (10%). A significant (pâ¯=â¯0.007) negative correlation between the severity of reported symptoms and the EuroQoL questionnaire scores was found, supporting the consistency of the entered data. Free comments were reported by 6 Patients. CONCLUSIONS: This study was meant to explore the context of outpatients' remote monitoring through the collection of patient-reported outcomes. The intervention for a proactive approach to symptoms monitoring in curatively treated head and neck cancer patients resulted feasible and acceptable by both patients and oncologists. The study revealed a criticality on the perceived usefulness, but, at the same time, the patients' comments suggested how to improve this aspect. Further actions will need to focus on measuring the impact of HeNeA on the process of care and on the health outcomes.
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Quimioradioterapia , Neoplasias de Cabeza y Cuello/terapia , Teléfono Inteligente , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Aplicaciones Móviles , Cooperación del Paciente , Proyectos Piloto , Calidad de Vida , Encuestas y Cuestionarios , Factores de TiempoRESUMEN
In this work we exploited an algorithm, already present in the literature, and based on the notion of signal permutation entropy, to analyze a very long time series of sleep data from a single subject. The aim of the work is to explore methods for personalizing alerts related to sleep anomalies, and recommendations for improving sleep quality. As a matter of fact, sleep duration and sleep quality may differently affect daily performance of different people, as well as daily activities may differently affect sleeping during the night. Data have been collected from a Fitbit Alta HR activity tracker worn by the subject for about three years. Results show that personalized inferences may be very different from the generic (population-based) ones, and that correlations found may suggest subject-specific life-style modifications useful to improve sleep quality.
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Monitores de Ejercicio , Sueño , Dispositivos Electrónicos Vestibles , Entropía , Voluntarios Sanos , HumanosRESUMEN
OBJECTIVE: To develop and validate a new risk score for intraventricular hemorrhage (IVH) in preterm neonates based on continuous glucose monitoring (CGM). STUDY DESIGN: We retrospectively analyzed CGM traces obtained from 50 very preterm neonates, grouped into two sub-cohorts started on CGM within 12 and 48 h of birth, respectively. A CGM linked to an Artificial Intelligence Risk (CLAIR) index was developed to quantify glucose variability during the first 72 h of life in neonates with and without IVH. Brain-US was performed at least twice a day for the first 5 days of birth. An integrated remote monitoring platform was developed to capture major clinical events in real time and gather data for the risk index. The new score performance was further compared with other measures of glucose variability (coefficient of variation [CV] and standard deviation [SD]) and with a clinical risk index for babies II (CRIB-II) as a predictor of IVH event. The two cohorts were analyzed separately for internal validation of the method. RESULTS: The primary cohort consisted of 26 neonates (gestational age 30 [28, 31] weeks; BW1275 g[1090, 1750]). Controls (n = 23) exhibited higher CLAIR index than cases (P = 0.004). A cut-off of 0.69 for the new CLAIR index allowed a 100% sensitivity and an 83% specificity for IVH prediction. The CLAIR index was the sole significant predictor for IVH (P = 0.003) when compared with clinical variables, CV, SD, and CRIB-II. In a subgroup analysis in very low-birth-weight infants, the CLAIR index was the sole variable significantly associated with IVH (P = 0.009). Analysis on the secondary cohort (five cases and 16 controls) confirmed a higher CLAIR index in the controls (P = 0.008), in the absence of a difference for CV, SD, and CRIB-II between the two groups. CONCLUSION: CGM, combined with the AI-algorithm, provides a high-sensitivity index for risk detection of IVH that reflects the glycemic impairment preceding IVH.
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Inteligencia Artificial , Automonitorización de la Glucosa Sanguínea/estadística & datos numéricos , Hemorragia Cerebral/diagnóstico , Recien Nacido Prematuro/sangre , Medición de Riesgo/métodos , Femenino , Edad Gestacional , Humanos , Recién Nacido , Masculino , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Ketogenic Diet (KD) is a high-fat diet used to treat refractory epilepsy in patients, also including children. Because of the inherent differences with a balanced diet, patients starting KD face an abrupt switch of dietary habits. Moreover, KD is associated with several side effects that should be closely monitored. In this paper, we propose an mHealth application for training and empowering patients in managing KD. The application also acts as a bridge connecting patients with the health care staff for coaching and monitoring purposes.
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Dieta Cetogénica , Epilepsia/dietoterapia , Monitoreo Fisiológico , Protocolos Clínicos , Humanos , Telemedicina , Resultado del TratamientoRESUMEN
OBJECTIVES: We propose an architecture for monitoring outpatients that relies on mobile technologies for acquiring data. The goal is to better control the onset of possible side effects between the scheduled visits at the clinic. METHODS: We analyze the architectural components required to ensure a high level of abstraction from data. Clinical practice guidelines were formalized with Alium, an authoring tool based on the PROforma language, using SNOMED-CT as a terminology standard. The Alium engine is accessible through a set of APIs that may be leveraged for implementing an application based on standard web technologies to be used by doctors at the clinic. Data sent by patients using mobile devices need to be complemented with those already available in the Electronic Health Record to generate personalized recommendations. Thus a middleware pursuing data abstraction is required. To comply with current standards, we adopted the HL7 Virtual Medical Record for Clinical Decision Support Logical Model, Release 2. RESULTS: The developed architecture for monitoring outpatients includes: (1) a guideline-based Decision Support System accessible through a web application that helps the doctors with prevention, diagnosis and treatment of therapy side effects; (2) an application for mobile devices, which allows patients to regularly send data to the clinic. In order to tailor the monitoring procedures to the specific patient, the Decision Support System also helps physicians with the configuration of the mobile application, suggesting the data to be collected and the associated collection frequency that may change over time, according to the individual patient's conditions. A proof of concept has been developed with a system for monitoring the side effects of chemo-radiotherapy in head and neck cancer patients. CONCLUSIONS: Our environment introduces two main innovation elements with respect to similar works available in the literature. First, in order to meet the specific patients' needs, in our work the Decision Support System also helps the physicians in properly configuring the mobile application. Then the Decision Support System is also continuously fed by patient-reported outcomes.
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Sistemas de Apoyo a Decisiones Clínicas , Monitoreo Fisiológico , Pacientes Ambulatorios , Guías de Práctica Clínica como Asunto , Femenino , Humanos , Masculino , Fumar/efectos adversos , Interfaz Usuario-ComputadorRESUMEN
OBJECTIVE: To explore the experiences of children with type 1 diabetes and their parents taking part in an artificial pancreas (AP) clinical trial during a 7-day summer camp. RESEARCH DESIGN AND METHODS: A semistructured interview, composed of 14 questions based on the Technology Acceptance Model, was conducted at the end of the clinical trial. Participants also completed the Diabetes Treatment Satisfaction Questionnaire (DTSQ, parent version) and the AP Acceptance Questionnaire. RESULTS: Thirty children, aged 5-9 years, and their parents completed the study. A content analysis of the interviews showed that parents were focused on understanding the mechanisms, risks, and benefits of the new device, whereas the children were focused on the novelty of the new system. The parents' main concerns about adopting the new system seemed related to the quality of glucose control. The mean scores of DTSQ subscales indicated general parents' satisfaction (44.24 ± 5.99, range 32-53) and trustful views of diabetes control provided by the new system (7.8 ± 2.2, range 3-12). The AP Acceptance Questionnaire revealed that most parents considered the AP easy to use (70.5%), intended to use it long term (94.0%), and felt that it was apt to improve glucose control (67.0%). CONCLUSIONS: Participants manifested a positive attitude toward the AP. Further studies are required to explore participants' perceptions early in the AP development to individualize the new treatment as much as possible, and to tailor it to respond to their needs and values.
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Diabetes Mellitus Tipo 1/psicología , Diabetes Mellitus Tipo 1/terapia , Páncreas Artificial/psicología , Padres/psicología , Adulto , Acampada , Niño , Preescolar , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Femenino , Humanos , Masculino , Relaciones Padres-Hijo , Aceptación de la Atención de Salud , Percepción , Encuestas y CuestionariosRESUMEN
Glucose concentration in the blood stream is a critical vital parameter and an effective monitoring of this quantity is crucial for diabetes treatment and intensive care management. Effective bio-sensing technology and advanced signal processing are therefore of unquestioned importance for blood glucose monitoring. Nevertheless, collecting measurements only represents part of the process as another critical task involves delivering the collected measures to the treating specialists and caregivers. These include the clinical staff, the patient's significant other, his/her family members, and many other actors helping with the patient treatment that may be located far away from him/her. In all of these cases, a remote monitoring system, in charge of delivering the relevant information to the right player, becomes an important part of the sensing architecture. In this paper, we review how the remote monitoring architectures have evolved over time, paralleling the progress in the Information and Communication Technologies, and describe our experiences with the design of telemedicine systems for blood glucose monitoring in three medical applications. The paper ends summarizing the lessons learned through the experiences of the authors and discussing the challenges arising from a large-scale integration of sensors and actuators.
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Técnicas Biosensibles/métodos , Glucemia/análisis , Humanos , Internet , Monitoreo FisiológicoRESUMEN
The paper illustrates a pilot study involving nurses and paramedic staff to evaluate a mobile platform for rendering and distributing emergengy care protocols. Its specific features were developed to simplify the consultation and reduce the factors that negatively affect the adherence to standards. The study was planned to last one month and two questionnaires are administered to the participants: one at the starting phase, pre-intervention, and one at the end, post-intervention. Here we report the results and considerations coming from the first administration.
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Ambulancias/normas , Lista de Verificación/normas , Protocolos Clínicos , Servicio de Urgencia en Hospital/normas , Aplicaciones Móviles/normas , Pase de Guardia/organización & administración , Técnicos Medios en Salud/normas , Actitud del Personal de Salud , Adhesión a Directriz/normas , Humanos , Relaciones Interprofesionales , Italia , Enfermeras y Enfermeros/normas , Guías de Práctica Clínica como Asunto , Calidad de la Atención de Salud/organización & administraciónRESUMEN
OBJECTIVE: After testing of a wearable artificial pancreas (AP) during evening and night (E/N-AP) under free-living conditions in patients with type 1 diabetes (T1D), we investigated AP during day and night (D/N-AP) for 1 month. RESEARCH DESIGN AND METHODS: Twenty adult patients with T1D who completed a previous randomized crossover study comparing 2-month E/N-AP versus 2-month sensor augmented pump (SAP) volunteered for 1-month D/N-AP nonrandomized extension. AP was executed by a model predictive control algorithm run by a modified smartphone wirelessly connected to a continuous glucose monitor (CGM) and insulin pump. CGM data were analyzed by intention-to-treat with percentage time-in-target (3.9-10 mmol/L) over 24 h as the primary end point. RESULTS: Time-in-target (mean ± SD, %) was similar over 24 h with D/N-AP versus E/N-AP: 64.7 ± 7.6 vs. 63.6 ± 9.9 (P = 0.79), and both were higher than with SAP: 59.7 ± 9.6 (P = 0.01 and P = 0.06, respectively). Time below 3.9 mmol/L was similarly and significantly reduced by D/N-AP and E/N-AP versus SAP (both P < 0.001). SD of blood glucose concentration (mmol/L) was lower with D/N-AP versus E/N-AP during whole daytime: 3.2 ± 0.6 vs. 3.4 ± 0.7 (P = 0.003), morning: 2.7 ± 0.5 vs. 3.1 ± 0.5 (P = 0.02), and afternoon: 3.3 ± 0.6 vs. 3.5 ± 0.8 (P = 0.07), and was lower with D/N-AP versus SAP over 24 h: 3.1 ± 0.5 vs. 3.3 ± 0.6 (P = 0.049). Insulin delivery (IU) over 24 h was higher with D/N-AP and SAP than with E/N-AP: 40.6 ± 15.5 and 42.3 ± 15.5 vs. 36.6 ± 11.6 (P = 0.03 and P = 0.0004, respectively). CONCLUSIONS: D/N-AP and E/N-AP both achieved better glucose control than SAP under free-living conditions. Although time in the different glycemic ranges was similar between D/N-AP and E/N-AP, D/N-AP further reduces glucose variability.
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Glucemia/análisis , Ritmo Circadiano/fisiología , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Páncreas Artificial , Adulto , Algoritmos , Glucemia/efectos de los fármacos , Automonitorización de la Glucosa Sanguínea/métodos , Estudios Cruzados , Estudios de Factibilidad , Femenino , Humanos , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Insulina/efectos adversos , Masculino , Persona de Mediana Edad , Condiciones Sociales , Adulto JovenRESUMEN
OBJECTIVE: The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5- to 9-year-old children during a camp. RESEARCH DESIGN AND METHODS: A total of 30 children, 5- to 9-years old, with type 1 diabetes completed an outpatient, open-label, randomized, crossover trial. Three days with an artificial pancreas (AP) were compared with three days of parent-managed sensor-augmented pump (SAP). RESULTS: Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25(th)-75(th) percentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P = 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P = 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P = 0.002). Overall, the AP granted a threefold reduction of time-in-hypoglycemia (P < 0.001) at the cost of decreased time-in-target, 56.8% (13.5) vs. 63.1% (11.0) (P = 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001). CONCLUSIONS: This trial, the first outpatient single-hormone AP trial in a population of this age, shows feasibility and safety of MMPC in young children. Algorithm retuning will be performed to improve efficacy.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Páncreas Artificial , Algoritmos , Glucemia/análisis , Niño , Preescolar , Estudios Cruzados , Estudios de Factibilidad , Femenino , Humanos , Hipoglucemia/epidemiología , Hipoglucemia/prevención & control , Sistemas de Infusión de Insulina , MasculinoRESUMEN
BACKGROUND: An artificial pancreas (AP) that can be worn at home from dinner to waking up in the morning might be safe and efficient for first routine use in patients with type 1 diabetes. We assessed the effect on glucose control with use of an AP during the evening and night plus patient-managed sensor-augmented pump therapy (SAP) during the day, versus 24 h use of patient-managed SAP only, in free-living conditions. METHODS: In a crossover study done in medical centres in France, Italy, and the Netherlands, patients aged 18-69 years with type 1 diabetes who used insulin pumps for continuous subcutaneous insulin infusion were randomly assigned to 2 months of AP use from dinner to waking up plus SAP use during the day versus 2 months of SAP use only under free-living conditions. Randomisation was achieved with a computer-generated allocation sequence with random block sizes of two, four, or six, masked to the investigator. Patients and investigators were not masked to the type of intervention. The AP consisted of a continuous glucose monitor (CGM) and insulin pump connected to a modified smartphone with a model predictive control algorithm. The primary endpoint was the percentage of time spent in the target glucose concentration range (3·9-10·0 mmol/L) from 2000 to 0800 h. CGM data for weeks 3-8 of the interventions were analysed on a modified intention-to-treat basis including patients who completed at least 6 weeks of each intervention period. The 2 month study period also allowed us to asses HbA1c as one of the secondary outcomes. This trial is registered with ClinicalTrials.gov, number NCT02153190. FINDINGS: During 2000-0800 h, the mean time spent in the target range was higher with AP than with SAP use: 66·7% versus 58·1% (paired difference 8·6% [95% CI 5·8 to 11·4], p<0·0001), through a reduction in both mean time spent in hyperglycaemia (glucose concentration >10·0 mmol/L; 31·6% vs 38·5%; -6·9% [-9·8% to -3·9], p<0·0001) and in hypoglycaemia (glucose concentration <3·9 mmol/L; 1·7% vs 3·0%; -1·6% [-2·3 to -1·0], p<0·0001). Decrease in mean HbA1c during the AP period was significantly greater than during the control period (-0·3% vs -0·2%; paired difference -0·2 [95% CI -0·4 to -0·0], p=0·047), taking a period effect into account (p=0·0034). No serious adverse events occurred during this study, and none of the mild-to-moderate adverse events was related to the study intervention. INTERPRETATION: Our results support the use of AP at home as a safe and beneficial option for patients with type 1 diabetes. The HbA1c results are encouraging but preliminary. FUNDING: European Commission.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hiperglucemia/prevención & control , Hipoglucemia/prevención & control , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Páncreas Artificial , Adolescente , Adulto , Anciano , Glucemia/metabolismo , Automonitorización de la Glucosa Sanguínea , Estudios Cruzados , Diabetes Mellitus Tipo 1/sangre , Femenino , Humanos , Sistemas de Infusión de Insulina , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico , Teléfono Inteligente , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
An increasing prevalence of chronic diseases is observed, among which cancer is now included because of its survival rates. That trend requires new ways of supporting outpatients and improving their compliance to treatments. This paper introduces HeNeA, a mobile application designed to support patients affected by Head and Neck cancer during their treatments. The application leverages on the mHealth features described in the literature and has been reviewed by a small set of patients during its development. Further evaluation is expected to occur when it will be offered to every eligible patient discharged from the Head and Neck division of a major Italian cancer centre.
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Atención Ambulatoria/métodos , Neoplasias de Cabeza y Cuello/rehabilitación , Aplicaciones Móviles , Autocuidado/métodos , Telemedicina/métodos , Cuidados Posteriores/métodos , Enfermedad Crónica , Estudios de Seguimiento , Italia , Consulta Remota/métodos , Interfaz Usuario-ComputadorRESUMEN
The paper describes the adaptation of a mobile platform initially developed for designing and administering questionnaires to a new context supporting checklists in emergency care. We took part in the checklists formalization process together with the domain experts and recognized that some tasks would highly benefit from the inherent features offered by the mobile technology. Thus we exploited the robustness of the model already designed for navigating among questionnaires and implemented additional functionalities that improved the usability of the mobile application, making it suitable for the paramedic staff and the volunteers that manage emergency cases.
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Lista de Verificación/métodos , Lista de Verificación/normas , Servicios Médicos de Urgencia/métodos , Aplicaciones Móviles , Guías de Práctica Clínica como Asunto , Interfaz Usuario-Computador , Sistemas de Apoyo a Decisiones Clínicas/normas , ItaliaRESUMEN
The Colibri project is introduced, whose aim is setting up a shared database of Magnetic Resonance images concerning pediatric patients affected by neurological rare disorders. The project involves 19 Italian centers of excellence in pediatric neuro-radiology and is supported by the nationwide coordinating center for the Information and Communication Technology research infrastructure. After the first year devoted to the design and the implementation, in November 2014 the system finally went into service at the centers involved in the project. This paper illustrates the initial assessment of the user perception and provides some preliminary statistics about its use.