Hybrid Closed Loop Overcomes the Impact of Missed or Suboptimal Meal Boluses on Glucose Control in Children with Type 1 Diabetes Compared to Sensor-Augmented Pump Therapy.

Background: It is unclear whether hybrid closed-loop (HCL) therapy attenuates the metabolic impact of missed or suboptimal meal insulin bolus compared with sensor-augmented pump (SAP) therapy in children with type 1 diabetes in free-living conditions. Methods: This is an ancillary study from a multicenter randomized controlled trial that compared 24/7 HCL with evening and night (E/N) HCL for 36 weeks in children between 6 and 12 years old. In the present study, the 60 children from the E/N arm underwent a SAP phase, an E/N HCL for 18 weeks, then a 24/7 phase for 18 weeks, extended for 36 more weeks. The last 28-30 days of each of the four phases were analyzed according to meal bolus management (cumulated 6817 days). The primary endpoint was the percentage of time that the sensor glucose was in the target range (TIR, 70-180 mg/dL) according to the number of missed boluses per day. Findings: TIR was 54% ± 10% with SAP, 63% ± 7% with E/N HCL, and steadily 67% ± 7% with 24/7 HCL. From the SAP phase to 72 weeks of HCL, the percentage of days with at least one missed meal bolus increased from 12% to 22%. Estimated marginal (EM) mean TIR when no bolus was missed was 54% (95% confidence intervals [CI] 53-56) in SAP and it was 13% higher (95% CI 11-15) in the 24/7 HCL phase. EM mean TIR with 1 and ≥2 missed boluses/day was 49.5% (95% CI 46-52) and 45% (95% CI 39-51) in SAP, and it was 15% (95% CI 14-16) and 17% higher (95% CI 6-28), respectively, in the 24/7 HCL phase (P < 0.05 for all comparisons vs. SAP). Interpretation: HCL persistently improves glycemic control compared with SAP, even in case of meal bolus omission. ClinicalTrials.gov (NCT03739099).

Effects of advanced carbohydrate counting on glucose control and quality of life in children with type 1 diabetes.

OBJECTIVE: The effect of advanced carbohydrate counting (ACC) on metabolic and quality of life (QOL) outcomes is uncertain in children with type 1 diabetes. Our aim was to determine whether ACC would improve HbA1c and QOL scores as compared with standard nutrition in this population. METHODS: We randomized 87 patients using pump and rapid-acting analogs in a 1 year randomized multicenter study (age 9.6 ± 3.5 years, diabetes duration 4.6 ± 2.7 years, HbA1c 7.8 ± 0.5% [62 ± 5 mmol/mol]). The ACC group received CC education and the control group received traditional dietary education. HbA1c was measured every 3 months. At 0 and 1 year, general, diabetes-specific, and diet-related QOL were respectively assessed by the KIDSCREEN and WHO-5 questionnaires, the diabetes-specific module of the DISABKIDS, and the diet restriction items of the DSQOLS. RESULTS: Mean HbA1c was lower in the ACC than the control group at 3 months (P < .05) and tended to be lower at 6 months (P = .10), 9 months (P = .10), but not at 12 months. The mean of individual average HbA1c during the one-year study period (from M3 to M12) was 7.63 ± 0.43 in the ACC vs 7.85 ± 0.47% in the control group (60 ± 5 vs 62 ± 5 mmol/mol)(P < .05). ACC was associated with significantly higher scores at 1 year on the KIDSCREEN children's psychological scale and the KIDSCREEN parents' physical scale, the DISABKIDS children's treatment scale, and the children's and parents' dietary restriction scales of the DSQOLS (indicating better QOL or lower perceived diet restriction). CONCLUSIONS: ACC may be associated with small improvements in metabolic control and QOL scores in children.

Evaluation of health related quality of life in children with immune thrombocytopenia with the PedsQL™ 4.0 Generic Core Scales: a study on behalf of the pays de Loire pediatric hematology network.

BACKGROUND: Immune thrombocytopenia (ITP) is a childhood disorder that is often life-altering for children and their parents. Health related quality of life (HRQL) has never been chronologically monitored in children with ITP. We initiated a prospective study to assess HRQL from diagnosis to six months and define factors that influence this outcome in children with ITP. METHODS: 73 children with acute ITP aged from 2 to 18 years were prospectively enrolled in the study. According to the presence of bleeding, they were or were not given a 4-day course of corticosteroid treatment. The PedsQL™ 4.0 Generic Core Scale was completed by children and parents upon their inclusion in the study and 6 months after diagnosis. RESULTS: Over the six month period, quality of life improved in terms of their global, physical and psychosocial well-being for 54.5%, 35.6% and 36.2% of patients respectively. This improvement is clinically relevant compared to scores at diagnosis, corresponding at least to a minimal clinically important difference (MCID). Factors such as sex, age, platelet count, bleeding scores, bone marrow aspiration and persistence of ITP at 6 months were not significantly associated with HRQL scores. However, preceding viral infection was identified to have an impact on HRQL. CONCLUSIONS: This first longitudinal study assessing HRQL in children with ITP reveals a global improvement in PedSQL™ 4.0. However, these results should be considered with caution since our data also confirm that self-report HRQL scores are not influenced by any analyzed biologic or clinical parameters. Others tools, such as Kids' ITP Tools, would probably be required to assess the HRQL of this population. TRIAL REGISTRATION: Trial registration clinical trials.gov Identifier: NCT00331357.

Reproducibility of liver stiffness measurement by ultrasonographic elastometry.

BACKGROUND & AIMS: Fibroscan is a noninvasive device that assesses liver fibrosis by liver stiffness evaluation (LSE) with ultrasonographic elastometry. We evaluated LSE reproducibility and its influencing factors. METHODS: LSE was performed by 4 experienced physicians (>100 LSEs) in 46 patients with chronic liver disease at 4 different anatomic sites. Additional LSEs were performed for ancillary aims, so that 534 LSEs were available. RESULTS: Overall interobserver agreement for LSE results was considered as excellent, with intraclass coefficient correlation (Ric) of 0.93. Low LSE level, nonrecommended sites, LSE interquartile range >25%, and body mass index > or =25 independently decreased agreement. Thus, agreement was fair (Ric = 0.53) for LSE <9 kilopascals and excellent (Ric = 0.90) beyond. The best measurement site for LSE reproducibility was the median axillary line on the first intercostal space under the liver dullness upper limit, with the patient lying in dorsal decubitus. When LSE results were categorized into fibrosis Metavir stages, interobserver discordance was noticed in about 25% of the cases and was the highest for F2 and F3 stages and the lowest for F4. Intraobserver (Ric = 0.94), intersite (Ric = 0.92-0.98), and interequipment (Ric = 0.92) agreements for LSE results were excellent. Preliminary standard ultrasonography or probe pressure changes did not improve interobserver agreement. CONCLUSIONS: The best measurement site for LSE is the one generally used for liver biopsy. Reproducibility of LSE is globally excellent but is fair in patient with low liver stiffness. The fibrosis diagnosis by ultrasonographic elastometry in low stages or categorized into fibrosis Metavir stages must be interpreted with caution.

Learning curve and interobserver reproducibility evaluation of liver stiffness measurement by transient elastography.

BACKGROUND/AIMS: Fibroscan allows liver stiffness examination (LSE) that is well correlated with fibrosis stages. Our main objective was to evaluate LSE learning curve. METHODS: LSE results of five novice observers with different medical status were compared with those of five expert observers (physicians with >100 examinations) in 250 patients with chronic liver disease. Each novice-expert pair had to blindly examine 50 consecutive patients divided into five consecutive subgroups of 10 patients. RESULTS: In each observer group, novice-expert agreement [intraclass correlation coefficient (Ric)] for LSE results was excellent from the first to the last subgroup. Novice-expert agreement for LSE results varied with liver stiffness level: <9 kPa: Ric=0.49; >or=9 kPa: Ric=0.87. Relative difference (%) between novice and expert LSE results was independently associated with the number of valid LSE measurements, and stabilizes around 20-30% after the fourth valid measurement. In each observer group, novice-expert agreement (Ric) for LSE success rate progressively increased as a function of time. CONCLUSION: LSE requires no learning curve: a novice is able to obtain a reliable result after a single training session, whatever the professional status. However, success rate will progressively increase. An LSE with less than four valid measurements should not be considered as reliable.