Alberto Sabbion

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.

Diet, physical, and biochemical characteristics of children and adolescents with type 1 diabetes: relationship between dietary fat and glucose control

Maffeis C, Morandi A, Ventura E, Sabbion A, Contreas G, Tomasselli F, Tommasi M, Fasan I, Costantini S, Pinelli L. Diet, physical, and biochemical characteristics of children and adolescents with type 1 diabetes: relationship between dietary fat and glucose control.

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.

Epidemiology of type 1 diabetes mellitus in the pediatric population in Veneto Region, Italy

We assessed the prevalence and incidence of type 1 diabetes mellitus (T1DM) in Veneto Region in Italy. The average prevalence and incidence rates were 1.26/1000 subjects and 16.5/100,000 person-years, respectively. This study shows that the Veneto Region is an area with intermediate-high risk of T1DM.

A rare case of granuloma annulare in a 5-year-old child with type 1 diabetes and autoimmune thyroiditis.

Granuloma annulare (GA) has rarely been reported in childhood, and its etiology still remains unclear. Its association with type 1 diabetes (T1D) and other chronic systemic diseases such as autoimmune thyroiditis (AT) or rheumatoid arthritis has been reported. There is no description in the literature of pediatric cases and the simultaneous association of GA and multiple autoimmune diseases in the same subject. We report the case of a 5-year-old girl who presented onset signs and symptoms of T1D. The diagnosis of T1D was confirmed by the presence of autoimmune T1D antibodies. Moreover, AT was also diagnosed by autoantibodies and positive ultrasound. One month later, coin-size erythematous lesions appeared initially on the trunk but soon spread over the body. Once dermatophytosis had been excluded, a skin biopsy confirmed a diagnosis of GA. Although a clear mechanism remains still unknown, clinicians must take into consideration an association of GA in patients with T1D or AT to avoid unnecessary medical investigations and/or inadequate pharmacological treatment.

Anxiety, Depression and Quality of Life in Italian Youths with Type 1 Diabetes Mellitus

Background: Psychological problems and low quality of life (QoL) in children with type 1 Diabetes Mellitus T1DM) were reported as correlated with T1DM. This study wants to test if the prevalence of anxiety and depression is higher in young patients with T1DM than in controls, if the level of QoL is lower and if anxiety and QoL correlate with glyco-metabolic control. Methods: A total of 100 children with T1DM, aged 8-13 years, were recruited and 114 healthy children were recruited as controls. All children with T1DM were receiving a routine psychological support. Patients and controls underwent three questionnaires [the Self Administrated Psychiatric Scale Scales for Children and Adolescents (SAFA), the Children’s Depression Inventory (CDI) and the Pediatric Quality of Life Inventory (PedsQL)]. Diabetes–related, physical and socio-demographic parameters were also collected. Results: SAFA, CDI and PedsQL mean score were not statistically different in T1DM and in control group. Just the “separation anxiety” scale showed significantly higher mean score in the T1DM than in the control group (43.77 ± 10.34 vs. 23.11 ± 18.25, p<0.01). A significant correlation between QoL and metabolic control (HbA1c) (r=0.21, p<0.05) was found. HbA1c increased with the mother’s education (r=0.42, p<0.05) and occupation level (r=0.35, p<0.05), and with the number of siblings (r = 0.20, p<0.05). Conclusions: T1DM is not a condition promoting per se more psychological discomfort even if a higher level of separation anxiety was shown. Interestingly, a higher level of self-perceived QoL was associated with worse glycometabolic control. Significant findings of the study: 1. The anxiety, depression and QoL levels were not significantly different in children with T1DM vs healthy peers even if children with T1DM showed higher separation anxiety 2. There was not association between psychological parameters and the glycometabolic control (HbA1c) What this study adds: The self-perceived QoL, in subjects with T1DM, was higher in subjects with worse glycometabolic control and lower in patients with better glycometabolic control Psycho-educational and therapeutic programs should sustain parents and children with T1DM

The role of socio-economic and clinical factors on HbA1c in children and adolescents with type 1 diabetes: an Italian multicentre survey.

To identify the role of the familys socio‐economic and clinical characteristics on metabolic control in children and adolescents with type 1 diabetes.

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.

Difficult management of glucose homeostasis in a 21-month-old child with type 1 diabetes and unknown glutaric aciduria type I: a case report.

A 21-month-old boy with previously diagnosed type 1 diabetes was admitted to our unit, presenting with glycometabolic failure (pH 7.30; base excess −11.9 mmol/L; blood glucose 17.3 mmol/L; HbA1c 10.4% [90 mmol/mol]; glycosuria; and ketonuria). During physical examination he was dehydrated and pale and presented with axial hypotonia with hyposthenia, poor head control, hypotonic legs, and hyporeflexia. His neurological clinical status became compromised after the diagnosis of type 1 diabetes when he was 15 months old. During hospitalization, the management of blood glucose homeostasis was difficult because of a high level of glycemic variability. Hypo- and hyperglycemic episodes were associated with acute encephalopathic crises characterized by hypotonia, dyskinetic movements, difficulty swallowing, and episodes of opisthotonus with no loss of consciousness. For better control of blood glucose, subcutaneous insulin treatment was …