Remote Blood Glucose Monitoring in mHealth Scenarios: A Review <s> Artificial Pancreas in Adolescents <s> Objective To examine the relation of parent stress to parent mental health and child mental and physical health. Methods We interviewed children with type 1 diabetes (n ¼132; mean age 12 years) annually for 5 years and had one parent complete a questionnaire at each assessment. Parents completed measures of general life stress, stress related to caring for a child with diabetes, benefit finding, and mental health. Child outcomes were depressive symptoms, self-care behavior, and glycemic control. Multilevel modeling was used to examine concurrent and longitudinal relations. Results Greater parent general stress and greater parent diabetes-specific stress were associated with poorer parent mental health. Overall, greater parent general stress was associated with poorer child outcomes, whereas greater parent diabetes-specific stress was associated with better child outcomes. Conclusions Families with high levels of general life stress should be identified as they are at risk for both poor parent and child health outcomes. <s> BIB001 </s> Remote Blood Glucose Monitoring in mHealth Scenarios: A Review <s> Artificial Pancreas in Adolescents <s> BACKGROUND ::: The Control to Range Study was a multinational artificial pancreas study designed to assess the time spent in the hypo- and hyperglycemic ranges in adults and adolescents with type 1 diabetes while under closed-loop control. The controller attempted to keep the glucose ranges between 70 and 180 mg/dL. A set of prespecified metrics was used to measure safety. ::: ::: ::: RESEARCH DESIGN AND METHODS ::: We studied 53 individuals for approximately 22 h each during clinical research center admissions. Plasma glucose level was measured every 15-30 min (YSI clinical laboratory analyzer instrument [YSI, Inc., Yellow Springs, OH]). During the admission, subjects received three mixed meals (1 g of carbohydrate/kg of body weight; 100 g maximum) with meal announcement and automated insulin dosing by the controller. ::: ::: ::: RESULTS ::: For adults, the mean of subjects' mean glucose levels was 159 mg/dL, and mean percentage of values 71-180 mg/dL was 66% overall (59% daytime and 82% overnight). For adolescents, the mean of subjects' mean glucose levels was 166 mg/dL, and mean percentage of values in range was 62% overall (53% daytime and 82% overnight). Whereas prespecified criteria for safety were satisfied by both groups, they were met at the individual level in adults only for combined daytime/nighttime and for isolated nighttime. Two adults and six adolescents failed to meet the daytime criterion, largely because of postmeal hyperglycemia, and another adolescent failed to meet the nighttime criterion. ::: ::: ::: CONCLUSIONS ::: The control-to-range system performed as expected: faring better overnight than during the day and performing with variability between patients even after individualization based on patients' prior settings. The system had difficulty preventing postmeal excursions above target range. <s> BIB002 </s> Remote Blood Glucose Monitoring in mHealth Scenarios: A Review <s> Artificial Pancreas in Adolescents <s> SUMMARY Closed-loop clinical trials have resulted in significant advances with continuous glucose monitoring and control systems modulating insulin delivery. Those trials were performed in closely supervised clinical research settings; while adults with Type 1 diabetes were initially targeted, studies in children with Type 1 diabetes have followed in both clinical research units and pediatric diabetes camps. These studies have been conducted as multicenter and multinational efforts. Pediatric studies have since been piloted in home settings overnight for control during sleep. The stage is now set for accelerating efforts, extending the number of patients enrolled, the amount of time during which the system is active daily and the duration of the clinical trials. <s> BIB003 </s> Remote Blood Glucose Monitoring in mHealth Scenarios: A Review <s> Artificial Pancreas in Adolescents <s> 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. <s> BIB004
Since 2015, our AP system has been tested mostly in adult patients and only one experiment was performed on other populations: namely a one-day study on hospitalized adolescents BIB002 . Stimulated by the highly positive results achieved during the AP@home project, we decided to investigate the use of the AP also in pediatric subjects, starting from prepubertal children at school age. Unlike adolescents that were the subject of more than 19 studies BIB003 , this fragile population has received relatively little attention in the AP literature due to its very challenging nature. Thus, in 2015, we conducted a clinical trial testing our AP system on 30 children, 5-9 years old, and compared its performance with the traditional micro-infusion pump therapy manually operated by the patient's parents. The study was conceived as a randomized crossover trial, that took place during a summer camp in a resort village in Bardonecchia, a small city located in northern Italy. Patients were enrolled in five different major centers in Italy. As soon as the patients were admitted at the camp, they were randomly assigned to one of the two arms: one arm used the AP in the first part of the study and the traditional manually operated pump in the second, while the other arm did the opposite. Each part lasted for three days (72 h) and the two were separated by a one-day wash-out period BIB004 . The architecture adopted for the adolescent camp was almost the same as that already adopted for AP@home, with the difference that this time the Dexcom G4 Platinum with Share was used as a CGM sensor. This version of the Dexcom G4 natively offered Bluetooth Low Energy connectivity, thus eliminating the need for the additional USB to Bluetooth converter and enhancing the robustness of the system. The architecture is shown in Figure 5 . In this project, the telemedicine system served a double role: on one hand, it was used by the study team to supervise the study, especially overnight, exactly as it happened during AP@home. On the other hand, it was also used by the parents, especially those who were not attending the camp, to remotely monitor their children. Indeed, it is known from the literature that the unawareness of the BGL of their children is the cause of great concern in parents BIB001 , especially for children in the age range of those enrolled by our study. This is eloquently testified by the success of the Nightscout project, previously mentioned in Section 3. To this aim, the remote monitoring system had been updated in order to allow different access levels depending on the role of its users. The members of the staff had complete and unrestricted access to all the subjects enrolled in the trial. Thus, they could access all the summary panels containing the alarms as well as the detailed views of any patient, including the possibility of manually updating the information through the web and downloading data. The parents of each patient were allowed instead to access a read-only view only reporting the real-time situation of their child, and were denied the possibility of modifying any data. To assess the parents' perception of the remote monitoring system, we administered some questionnaires before and after the trial. Even though parents could use the system just for the very limited period of the study, the survey showed that they would be willing not only to use it regularly but also to pay a fee for that. Figure 5 . The remote monitoring architecture used for the adolescents camp held in Bardonecchia. The system was used by the clinical and technical staff for safety and research purposes and was proposed to the parents as a means of managing the disease of their children.