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Glycemia risk index (GRI) is a novel composite metric for the evaluation of the safety of glycemic management and control. The aim of this study was to evaluate GRI and its correlations with continuous glucose monitoring (CGM) metrics by analyzing real-life CGM data in 1067 children/adolescents with type 1 diabetes (T1D) using four different treatment strategies (intermittently scanned CGM [isCGM]-multiple daily injections [MDIs]; real-time CGM-MDIs; rtCGM-insulin pump; hybrid closed-loop [HCL] therapy). GRI was positively correlated with high blood glucose index, low blood glucose index, mean glycemia, its standard deviation, coefficient of variation, and HbA1c. The four treatment strategy groups showed significantly different GRI with the lowest value in the HCL group (30.8) and the highest in the isCGM-MDIs group (68.4). These findings support the use of GRI for the assessment of the glycemic risk and the safety of specific treatment in pediatric subjects with T1D.

Background: Glycemia following pizza consumption is typically managed with a dual-wave insulin bolus. This study evaluated the effect of a simple bolus on glycemia following consumption of traditionally prepared pizzas with long (24 h) or short (8 h) dough fermentation periods. Research Design and Methods: On two separate evenings, children with type 1 diabetes ( n  = 38) receiving sensor-integrated pump therapy consumed traditionally prepared pizza with either short (pizza A) or long (pizza B) dough fermentation, and blood glucose was monitored over 11 h. A simple insulin bolus was administered 15 min preprandially. The carbohydrate and amino acid contents of the two types of pizza were analyzed by liquid chromatography and high-resolution mass spectrometry (LC-HRMS). Results: The mean (±standard deviation) time in range 3.9-10.0 mmol/L was 73.2% ± 23.2%, and 50.8% ± 26.7% of glucose measurements were within the range 3.9-7.8 mmol/L. However, during the 2 h after bolus administration, the mean time in range 3.9-7.8 mmol/L was significantly greater with pizza B than with pizza A (73.3% ± 31.5% vs. 51.8% ± 37.4%, respectively, P  = 0.009), and the time in hyperglycemia (>10 mmol/L) was significantly shorter (mean percentage 6.1% ± 19.0% vs. 17.7% ± 29.8%, respectively, P  = 0.019). LC-HRMS analysis showed that long fermentation was associated with a lower carbohydrate content in the pizza, and a higher amino acid content. Conclusions: Glycemia following consumption of traditionally prepared pizza can be managed using a simple bolus 15 min before eating. Glycemic control can be further improved by increasing the dough fermentation time. Study registration: NCT03748251, Clinicaltrials.gov.

Background: Continuous subcutaneous insulin infusion (CSII) is increasing worldwide, mostly because of improved technology. The aim of this study was to evaluate the current status of CSII in Italy., Materials and Methods: Physicians from 272 diabetes centers received a questionnaire investigating clinical features, pump technology, and management of patients on CSII., Results: Two hundred seventeen centers (79.8%) joined the study and, by the end of April 2013, gave information about 10,152 patients treated with CSII: 98.2% with type 1 diabetes mellitus, 81.4% adults, 57% female, and 61% with a conventional pump versus 39% with a sensor-augmented pump. CSII advanced functions were used by 68% of patients, and glucose sensors were used 12 days per month on average. Fifty-eight percent of diabetes centers had more than 20 patients on CSII, but there were differences among centers and among regions. The main indication for CSII was poor glucose control. Dropout was mainly due to pump wearability or nonoptimal glycemic control. Twenty-four hour assistance was guaranteed in 81% of centers. A full diabetes team (physician+nurse+dietician+psychologist) was available in 23% of adult-care diabetes centers and in 53% of pediatric diabetes units., Conclusions: CSII keeps increasing in Italy. More work is needed to ensure uniform treatment strategies throughout the country and to improve pump use.

Background: Choosing the right infusion set site can be an important factor in obtaining good glycemic control, especially in very young children. In an attempt to identify the best infusion site, we performed a crossover study in six preschool children with type 1 diabetes using insulin pump therapy., Subjects and Methods: We enrolled six patients 5.2±0.7 years old (range, 4-6 years), with type 1 diabetes for more than 1.5 years, using insulin pump therapy for at least 6 months. For each patient, body mass index, glycated hemoglobin, and all data downloaded from the system were evaluated on two occasions: the first with the infusion set placed on the buttock and the second on the abdomen, each for 3 days. The order of infusion set placement was randomized. Mean capillary blood glucose, mean continuous glycemia, mean area under the curve (AUC) using the trapezoidal rule for both >140 mg/dL and <70 mg/dL, insulin daily dose, carbohydrate/insulin ratio, total basal insulin, total bolus insulin, and mean amplitude of glucose excursions (MAGE) were evaluated., Results: Mean glycemic values, mean AUC >140 mg/dL, and MAGE were significantly lower when the infusion set was placed on the buttock versus the abdomen (144.6±31.9 mg/dL vs. 166.0±34.8 mg/dL [P=0.000], 28.4±18.3% vs. 48.8±28.2% [P=0.000], and 32±10 vs. 60±15 mg/dL [P<0.001], respectively), whereas mean AUC <70 mg/dL was higher (1.47±2.77% vs. 0.87±1.03% [P<0.001])., Conclusions: The present findings suggest that preschool children with type 1 diabetes using insulin pump therapy could benefit from inserting the infusion set in the buttock instead of the abdomen.

Background: We evaluated the impact of a 2-year chat line involving adolescents with type 1 diabetes regarding quality of life and metabolic control., Methods: We enrolled 193 children, 10-18 years of age (mean ± SD, 13.6 ± 2.7 years), with type 1 diabetes for 1.2-6 years (3.6 ± 2.4 years), body mass index of 23.2 ± 4.1 kg/m(2), insulin requirement of 0.7 ± 0.3 U/kg/day, and glycated hemoglobin (HbA1c) of 7.8 ± 1.1%, who participated in a weekly physician-moderated chat line for a 2-year follow-up period. Each patient completed the Diabetes Quality of Life for Youth Inventory (DQOLY) at baseline and after 1 and 2 years. A measure of glycemic control (HbA1c) was also collected. Data from 17 patients who discontinued using the chat line were not included in the analysis. As controls, 203 patients with type 1 diabetes, age- and sex-matched, with similar HbA1c at baseline and socioeconomic status, were randomly selected among 834 patients who refused to participate in the chat sessions., Results: DQOLY responses from youth with type 1 diabetes showed a significant improvement (P = 0.0001) only in patients who participated in chat sessions. We observed a decrease of 0.4% in HbA1c in patients who participated in chat session (7.8 ± 1.1% vs. 7.4 ± 0.5%, P < 0.0001) compared with the 0.1% of the controls (7.9 ± 1.9% vs. 7.8 ± 1.8%, P = 0.668). No difference was observed in HbA1c between the two groups (P = 0.056)., Conclusions: A chat line is also a cheap and effective tool that helps improve diabetes compliance. The chat line could help the diabetes team understand and treat their patients more comprehensively; moreover, it could help patients cope better with their daily life.

Background: Continuous subcutaneous insulin infusion is considered a safe and effective way to administer insulin in pediatric patients with type 1 diabetes, but achieving satisfactory and stable glycemic control is difficult. Several factors contribute to control, including fine-tuning the basal infusion rate and bolus type and timing. We evaluated the most effective type and timing of a pump-delivered, preprandial bolus in children with type 1 diabetes for a pizza "margherita" meal., Subjects and Methods: We assessed the response of 38 children with type 1 diabetes to a meal based on pizza "margherita" (with mozzarella cheese and tomato sauce) after different types and timings of a bolus dose., Results: The glucose levels for 6 h after the meal were lower (i.e., closer to the therapeutic target of <140 mg/dL) when the bolus doses were administered as a simple bolus 15 min before the meal (area under the curve [AUC] 0-6 h, 6.9 ± 14.9 mg/dL/min) versus a simple bolus administered immediately before the meal (AUC 0-6 h, 4.2 ± 25.9 mg/dL/min) (P = not significant) versus a double-wave bolus 30/70 extended over a 6-h period administered 15 min before the meal (AUC 0-6 h, 1.9 ± 21.3 mg/dL/min) (P = not significant) versus a double-wave bolus 30/70 extended over a 6-h period administered immediately before the meal (AUC 0-6 h, 13.3 ± 15.6 mg/dL/min) (P = 0.01)., Conclusions: In the case of a pizza "margherita," our data support the injection of the simple bolus 15 min before a meal, rather than immediately before or delivered as a double-wave bolus, to control the glycemic rise usually observed.

Background: Insulin pumps and real-time continuous glucose monitoring devices have recently been combined into the sensor-augmented pump (SAP) system. The objective of this study was the evaluation of the clinical use of SAP in a large series of children with type 1 diabetes using insulin pump therapy., Methods: A questionnaire was administered in all pediatric diabetologic centers in Italy; data were analyzed only regarding patients 18 years old or younger and using SAP for 6 months or more., Results: Among all patients using an insulin pump, 129 (13.5 ± 3.8 years old, with a disease duration of 6.3 ± 3.4 years) have been using SAP for 1.4 ± 0.7 years. Four hundred ninety-three patients (12.9 ± 3.4 years old, with a disease duration of 6.2 ± 3.3 years) using conventional insulin pump therapy for 1.7 ± 0.5 years have been evaluated as the control group. After 0.5-3 years of using SAP or conventional insulin pump therapy, glycosylated hemoglobin significantly improved (8.0 ± 1.5% vs. 7.4 ± 0.8% [P = 0.002] and 8.0 ± 1.6% vs. 7.7 ± 1.1% [P = 0.006], respectively); the improvement was higher with SAP (P = 0.005). Insulin requirement showed a significant decrease only in SAP patients (0.88 ± 0.25 vs. 0.7 ± 0.23 U/kg/day, P = 0.003). Body mass index did not change during the observation period. No diabetic ketoacidosis episodes were observed during the follow-up, and severe hypoglycemia significantly decreased in SAP patients (P = 0.04)., Conclusions: The increased availability of continuous glucose sensors is likely to have a significant impact on pediatric diabetes therapy and education in the near future. In daily settings, patients using SAP can achieve a better control than patients using conventional insulin pump.

Background: Continuous subcutaneous insulin infusion is considered a safe and effective way to administer insulin in pediatric patients with type 1 diabetes, but achieving satisfactory and stable glycemic control is difficult. Several factors contribute to control, including fine-tuning the basal infusion rate and bolus timing. We evaluated the most effective timing of a pump-delivered, preprandial bolus in children with type 1 diabetes., Methods: We assessed the response of 30 children with type 1 diabetes to a standard meal after different timing of a bolus dose., Results: The glucose levels for 3 h after the meal were lower (i.e., closer to the therapeutic target of <140 mg/dL) when the bolus doses were administered 15 min or immediately before the meal, rather than after the meal. However, these differences were not statistically significant, except at the 1-h postprandial time point: bolus just after meal, 177 +/- 71 mg/dL (9.83 +/- 3.94 mmol/L); 15 min before meal, 136 +/- 52 mg/dL (7.55 +/- 2.89 mmol/L) (P = 0.044); and just before meal, 130 +/- 54 mg/dL (7.22 +/- 3.00 mmol/L) (P = 0.024). The area under the curve (AUC) (in mg/min) did not differ significantly with different bolus times, but the SD of the AUC was the lowest with the bolus given 15 min before the meal., Conclusions: These data support injection of the bolus before, rather than after, eating, even if the patient is hypoglycemic before meals.

Background: Compared to older children and adolescents very young patients with type 1 diabetes represent a unique population. We analyzed the age-dependent characteristics and parameters of continuous subcutaneous insulin infusion (CSII) in children under 6 years of age with type 1 diabetes., Methods: We evaluated metabolic control and pump-dependent characteristics in 46 children with type 1 diabetes after 0.89 +/- 0.62 years of CSII., Results: Metabolic control significantly improved after CSII initiation (glycosylated hemoglobin, 8.12 +/- 1.24% vs. 7.30 +/- 0.67%; P < 0.05), without increased risk for diabetic ketoacidosis or hypoglycemia. Interestingly, very young patients required bigger boluses than expected, especially in the morning and at the afternoon snack., Conclusions: These data support the need to personalize pump-dependent characteristics, especially in very young children with type 1 diabetes, in order to optimize CSII therapy in this unique age group of patients.

The aim of this study was to compare glucose measurements between fingertip and forearm using the blood glucose (BG) monitoring system One Touch Ultra (LifeScan), an electrochemical sensor that requires only a very small drop of blood (1 microL). Patients with type 1 or type 2 diabetes were identified in five outpatient diabetes clinics. Participants were requested to use the One Touch Ultra at home for 1 week for the measurement of BG levels from both sites. Patients filled in a questionnaire about their experience with testing blood samples from fingertip and forearm. The agreement between the measurements from the two sites was assessed using linear regression analysis, mean absolute relative error (MARE), the Bland-Altman method, and Error Grid Analysis (EGA). Overall, 112 patients were recruited, of whom 58% had type 1 diabetes. Linear regression analysis showed an intercept of 17.7, statistically different from 0 (p<0.0001). The slope was 0.956, and the Pearson correlation coefficient was 0.95. A MARE of 12.1% (SD=11.8%) was obtained, with a greater deviation of the forearm values from the fingertip ones in the hypoglycemic range (MARE=22.3%; SD=21.7%). The Bland-Altman bias plot showed a mean bias of 10.2 mg/dL (SD=23.1), with no correlation between mean difference and average BG levels (r=0.02). The EGA showed that 89.2% of the values fell in zone A, 10.4% in zone B, and 0.4% in zone C. The vast majority of patients (71%) declared that the collection of blood from the forearm caused no pain or less pain than the traditional site. Only 17% of the patients declared that it was impossible to obtain any blood from the forearm, while 63% reported with satisfaction that the quantity requested was small. At the end of the study period, 32% of the participants indicated the forearm as the preferred test site. Alternative site testing on the arm, with a BG meter that requires only a very small drop of blood, is feasible and reliable under routine clinical conditions. When testing with the express purpose of detecting hypoglycemia, the finger still remains the recommended test site.