Eleonora Losiouk

Randomized summer camp crossover trial in 5-to 9-year-old children: Outpatient wearable artificial pancreas is feasible and safe

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 (25th–75th 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.

Remote Blood Glucose Monitoring in mHealth Scenarios: A Review

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.

Evaluating the Experience of Children With Type 1 Diabetes and Their Parents Taking Part in an Artificial Pancreas Clinical Trial Over Multiple Days in a Diabetes Camp Setting

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.

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

Introduction In the past years, we developed a telemonitoring service for young patients affected by Type 1 Diabetes. The service provides data to the clinical staff and offers an important tool to the parents, that are able to oversee in real time their children. The aim of this work was to analyze the parents’ perceived usefulness of the service. Methods The service was tested by the parents of 31 children enrolled in a seven-day clinical trial during a summer camp. To study the parents’ perception we proposed and analyzed two questionnaires. A baseline questionnaire focused on the daily management and implications of their children’s diabetes, while a post-study one measured the perceived benefits of telemonitoring. Questionnaires also included free text comment spaces. Results Analysis of the baseline questionnaires underlined the parents’ suffering and fatigue: 51% of total responses showed a negative tendency and the mean value of the perceived quality of life was 64.13 in a 0–100 scale. In the post-study questionnaires about half of the parents believed in a possible improvement adopting telemonitoring. Moreover, the foreseen improvement in quality of life was significant, increasing from 64.13 to 78.39 (p-value = 0.0001). The analysis of free text comments highlighted an improvement in mood, and parents’ commitment was also proved by their willingness to pay for the service (median = 200 euro/year). Discussion A high number of parents appreciated the telemonitoring service and were confident that it could improve communication with physicians as well as the family’s own peace of mind.

An environment for representing and using medical checklists on mobile devices

Checklists have been recently introduced in the medical practice playing the role of summarized guidelines, streamlined for rapid consultations. However, there are still some barriers preventing their widespread diffusion. Those concern the representation, dissemination and update of their underlying knowledge, as well as the means currently adopted for their actual use, that is still mostly paper-based. In this paper we propose a new platform for the implementation and use of checklists. First, an editor supports domain experts in porting the checklist from the traditional paper-based format into an electronic one. Then, an application allows the distribution and usage of checklists on portable devices such as smartphones and tablets, exploiting their additional features in comparison with those made available by Personal Computers. The platform will be illustrated through some examples designed to support volunteers and paramedic staff in dealing with emergency situations.

A telemonitoring service supporting preterm newborns care in a neonatal intensive care unit

Glucose concentration in blood, better known as glycemia, is a very underestimated physiological parameter in neonatal intensive care units. Its value is currently monitored by performing few measurements per day, acquired through heel pricks or arterial samplings. Unfortunately, the frequency of those samplings is quite low in preterm newborns, who are very low birth weight infants, due to their fragility. As a result, hyper-or hypo-glycemia events occurring between two separate measurements remain often unnoticed. A medical research group working at the University Hospital of Padova already proved the clinical benefits of continuous glucose monitoring for preterm newborns hospitalized in the neonatal intensive care unit. However, glucose data are still sampled through individual devices that are not integrated into a central monitoring system. Thus the health care staff has to visit regularly the cradles, watch the glycemia trends and pay attention to alarms. Our contribution deals with the implementation of a system based on mobile technologies that sends the data acquired through commercial glucometers to a central database, so that they become available in real time for the staff in the ward room. Moreover, we also integrated into that system an algorithm described in the literature for recommending the most appropriate glucose infusion rates based on the last readings of the patient. The system runs on an Android device and has been successfully tested in two different clinical trials involving twelve and five patients respectively.

An mHealth app counseling patients and general practitioners about Multiple Myeloma

Improvements in health care are extending the life expectancy of cancer patients, up to the point that cancer survivors are sometimes considered as chronic patients. Mobile devices may support outpatients in managing chronic diseases, improving their quality of life and reducing health-care costs. This paper illustrates the design and implementation of a pair of mobile apps supporting patients and General Practitioners (GPs) in the management of Multiple Myeloma (MM). The patient app supports him in distinguishing the conditions that anticipate MM worsening from those arising as a side effect of the therapy or from those unrelated to the disease. The app for GPs helps them in properly applying standard practices for prescribing lab tests, radiological investigations, or referring to the hematologist. The goal is to reduce the number of accesses to the hematologists, emphasizing the central role of the GP. A randomized controlled trial is planned later this year to assess the reduction in visits.