Angela Zanfardino

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.

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.

Refractory rheumatoid factor positive polyarthritis in a female adolescent already suffering from type 1 diabetes mellitus and Hashimoto's thyroiditis successfully treated with etanercept.

Type 1 diabetes mellitus may be associated with many autoimmune diseases with the common autoimmune pathogenesis. We describe the case of a girl suffering from Type 1 diabetes mellitus and autoimmune Hashimotos thyroiditis since the childhood and, due to the onset of Juvenile Idiopathic Arthritis during adolescence, for three years practiced therapy with an anti-TNF drug, etanercept . Currently her inflammatory markers are normal, arthritis is inactive and diabetes is well controlled. During the treatment with anti-TNF drug we observed a significative reduction of insulin dose, probably due to an increased tissue sensitivity secondary to the suppression of the activity of TNF-alpha. Several clinical trials that have evaluated the effect of immunomodulatory agents in diabetic patients, especially in those with recent onset of disease, were already performed but further studies of longer duration on a larger population are needed to assess the role of biologic drugs and immunotherapy in this group of patients.

The evaluation of body image in children with type 1 diabetes: A case-control study

This study evaluated the body image perception in children with type 1 diabetes in order to identify symptoms of disordered eating behaviours early. Children with type 1 diabetes and controls showed underestimation and dissatisfaction with body size. The patients, especially girls, were more accurate in their perception of body size than the control group. The study sheds light on some of the underlying factors that may contribute to the development of disordered eating behaviours in adolescence. The causes of the differences of perception of body size are discussed.

Celiac disease negatively influences lipid profiles in young children with type 1 diabetes: Effect of the gluten-free diet

The association between low HDL cholesterol (HDL-C) concentrations and increased cardiovascular risk is well established. Low HDL-C levels were found in subjects with type 1 diabetes (T1D) who presented complications (1) and in untreated subjects with celiac disease (CD). The association between TID and CD might therefore enhance this lipid abnormality and accelerate the atherosclerotic process. We collected data from 13 centers belonging to the Italian Society of Pediatric Endocrinology and Diabetology (ISPED) of a large number of children with both T1D and concurrent biopsy-proven CD, at the exact time point a gluten-free diet (GFD) was initiated and after 1 year of a GFD, verified by means of CD-related antibodies. A total of 201 children with T1D diagnosed at age of 5.8 ± 3.8 years and CD diagnosed at age of 7.5 ± 4.5 years were enrolled. …

Psychological outcomes of injection port therapy in children and adolescents with type 1 diabetes and their primary caregivers

For children with type 1 diabetes (T1DM), the large number of daily injections can induce discomfort, pain, and distress and have been described as one of the negative predictors of adherence to insulin therapy [1]. Poor adherence to diabetes regimens impairs good metabolic control, which is described as significantly associated with better youth-rated quality of life and lower perceived family burden [2]. Advances in insulin delivery systems and diabetes technology, such as the insulin pump (CSII) and continuous glucose monitoring system, have been found to improve glycemic control and positively impact quality of life for children and family with T1DM [3]. Similarly, evidence describes indwelling catheters as insulin infusion devices as able to minimize distress during injections [4]. To further explore the psychosocial impact of such implantable devices in youth patients with T1DM, this study evaluated the effects of injection port usage on participants’ quality of life and on caregivers’ burden and treatment satisfaction. Methods

High frequency of diabetic ketoacidosis at diagnosis of type 1 diabetes in Italian children: a nationwide longitudinal study, 2004–2013

This longitudinal population-based study analyses the frequency of diabetic ketoacidosis (DKA) at type 1 diabetes diagnosis in Italian children under 15 years of age, during 2004–2013. DKA was defined as absent (pH ≥ 7.30), mild/moderate (7.1 ≤ pH < 7.30) and severe (pH < 7.1). Two multiple logistic regression models were used to evaluate the time trend of DKA frequency considered as present versus absent and severe versus absent, adjusted for gender, age group and geographical area of residence at diagnosis. Overall, 9,040 cases were ascertained. DKA frequency was 40.3% (95%CI: 39.3–41.4%), with 29.1% and 11.2% for mild/moderate and severe DKA, respectively. Severe DKA increased significantly during the period (OR = 1.03, 95%CI: 1.003–1.05). Younger-age children and children living in Southern Italy compared to Central Italy were at significantly higher risk of DKA and severe DKA. Family history of type 1 diabetes and residence in Sardinia compared to Central Italy were significantly associated with a lower probability of DKA and severe DKA. The high frequency of ketoacidosis in Italy over time and high variability among age groups and geographical area of residence, strongly suggests a continuing need for nationwide healthcare strategies to increase awareness of early detection of diabetes.

Lower limbs edema by insulin glargine treatment: two other cases in pediatrics

Marta, 13 years aged, suffered from type 1 diabetes from the age of 9 years. She was admitted in our clinic for a progressive appearance of edema in both legs (Fig. 1). The edema was located in the pretibial and ankle region, bilaterally, mainly on the left; the skin was normal, not hot and not erythematous. Femoral and popliteal pulses were normal. Left and right ankle diameters were, respectively, 29.5 and 28 cm. The family history was negative for diseases associated with edema. The metabolic control has always been good (yearly mean HbA1c 7.5 % 58 mmol/mol). She was on multi-daily injections (MDI) therapy, and the need of insulin was 0.7 U/kg/day. Up to 3 months before the occurrence of edema, she had been treated with human insulin (Humulin R and Humulin I ). During the adolescence, as the lifestyle was changing, we decided to start basal bolus therapy. Boluses of fast analogues were administered on the arms and in abdomen, while insulin glargine was administered exclusively on both thighs, alternating the right and the left thigh every day. All the most common causes of edema have been ruled out with specific investigations: Color Doppler ultrasound of the arteries and veins of the limbs excluded vascular diseases; ECG and transthoracic echocardiography excluded cardiac failure. Blood count, C-reactive protein (CRP) and VES, serum electrolytes, protein electrophoresis and the liver, thyroid and kidney function tests were within the normal range. Moreover, we rejected other causes of edema due to infection diseases. To exclude obstruction of the inferior vena cava or the thoracic duct, the patient underwent, respectively, abdominal ultrasound and chest X-rays, which did not show pathognomonic features. In addition, we also ruled out the Turner syndrome with the high-definition karyotype study. Medical history, clinical examination and laboratory findings excluded the involvement of systemic diseases. No other medicaments except for insulin had been assumed so, suspecting that the cause of the edema could have been the local mechanism of absorption of basal insulin, we replaced insulin glargine with rapid and intermediate human insulin. After 1-month edema was still present, but significantly reduced (diameter 25 cm in both legs). The complete resolution occurred after 3 months from the suspension of glargine even if a slight worsening of metabolic control (HbA1c 8.5 % 69 mmol/mol) was observed. Managed by Antonio Secchi.

Changes in body image and onset of disordered eating behaviors in youth with type 1 diabetes over a five-year longitudinal follow-up

OBJECTIVE To examine changes over a five-year period in body image accuracy and dissatisfaction, as well as relationships with disordered eating behaviors (DEBs), in young patients with type 1 diabetes. METHODS Of 81 children (42 male, 39 female) with type 1 diabetes first assessed at ages 5.1-10.06 years, 67 (83%) were re-enrolled and interviewed as adolescents (aged 10.07-15.08 years) at follow-up. DEBs were assessed using a parent-report standardized measure. Height and weight were determined, and BMI was calculated. Glycemic control was assessed by glycated hemoglobin. RESULTS BMI increased from childhood to adolescence. The general tendency towards body size underestimation (i.e., perceiving the body to be smaller than it is) and dissatisfaction, already described at baseline, was found unchanged at follow-up, revealing continuing attitude towards body image problems. Body-size perception accuracy, degree of body-size dissatisfaction, and HbA1c did not increase significantly over five years, but the presence of DEBs was observed. Degree of body dissatisfaction was found to be a significant predictor for DEBs (standardized beta = 0.272, p < 0.05). CONCLUSION Body image problems persisted over the five-year study period and were found associated with higher levels of DEBs. Identification of such body image characteristics may be useful in developing strategies for intervention early in the course of illness.

Not Autoimmune Diabetes Mellitus in Paediatrics

The rooted conviction according to which the childhood diabetes should only be an autoimmune diabetes is gradually disappearing, thanks to the discovery of not autoimmune paediatric diabetes.