Modelling sound particle motion in shallow watera).

Fish species and aquatic invertebrates are sensitive to underwater sound particle motion. Studies on the impact of sound on marine life would benefit from sound particle motion models. Benchmark cases and solutions are proposed for the selection and verification of appropriate models. These include a range-independent environment, with and without shear in the sediment, and a range-dependent environment, without sediment shear. Analysis of the acoustic impedance illustrates that sound particle velocity can be directly estimated from the sound pressure field in shallow water scenarios, except at distances within one wavelength of the source, or a few water depths at frequencies where the wavelength exceeds the water depth.

The effect of an mHealth intervention for adolescents with Type 1 diabetes and their parents.

BACKGROUND: Past research has demonstrated that adolescents with Type 1 diabetes (T1D) typically have a decline in health outcomes as they begin to assume more self-management activities. Mobile app interventions have been suggested as one possible way to improve this behavior. PURPOSE: The primary aim of this study was to address declines in health outcomes by pilot testing the satisfaction, use and feasibility of an app-based family communication intervention aimed to assist in adolescent self-management of T1D. METHODS: Thirty-three adolescent-parent pairs were enrolled in and completed the 12-week pilot study. Participants were randomized 2:1 to intervention (app use) or control group. Pre/post quantitative and qualitative data were collected, including HbA1c and surveys. Paired-sample t-tests and ANOVA statistics were conducted. RESULTS: The parents and adolescents reported high satisfaction with the app, and that it was easy to use. Results showed HbA1c stability in the intervention group and significant worsening in the control group. There were also significant improvements in adherence to diabetes management and quality of life for the parents in the intervention group. The adolescents did not show any improvement in quality-of-life measures. CONCLUSION: This study suggests that the app intervention is acceptable, shows promise for improving health outcomes for adolescents with T1D, and may improve family communication. The public health implications of this work are that app interventions have a potential role in positively influencing chronic disease outcomes. Additional research with a more extensive and diverse sample is needed to determine generalizability.

An mHealth-Based Intervention for Adolescents With Type 1 Diabetes and Their Parents: Pilot Feasibility and Efficacy Single-Arm Study.

BACKGROUND: Type 1 diabetes (T1D) affects more than 165,000 individuals younger than 20 years in the United States of America. The transition from parent management to parent-child team management, with the child taking on increased levels of self-care, can be stressful and is associated with a deterioration in self-management behaviors. Therefore, a mobile app intervention, MyT1DHero, was designed to facilitate diabetes-specific positive parent-adolescent communication and improve diabetes-related outcomes. The MyT1DHero intervention links an adolescent with T1D and their parent through 2 separate app interfaces and is designed to promote positive communication regarding T1D management. OBJECTIVE: The aim of this pilot study was to determine (1) the initial efficacy of the MyT1DHero intervention in improving diabetes outcomes in adolescents, specifically the hemoglobin A1c (HbA1c) levels, diabetes care adherence, and quality of life, and (2) the adolescents' overall satisfaction with this intervention. METHODS: This pilot study included 30 adolescent-parent pairs who used the MyT1DHero app in a 12-week single-arm clinical trial. Participants were recruited from the local pediatric endocrinology subspecialty clinic via snowball sampling. HbA1c levels, diabetes care adherence, quality of life, family conflict, and satisfaction levels were measured and analyzed using paired sample two-sided t tests and linear regression analyses. RESULTS: The final analysis included 25 families. The mean age of the adolescents was 12.28 (SD 1.62) years. Half of the participants (13/25) reported a diabetes diagnosis of less than 5 years. After 12 weeks of the intervention, diabetes care adherence significantly improved (before the study: mean 3.87 [SD 0.59]; after the study: mean 4.19 [SD 0.65]; t21=-2.52, P=.02, d=0.52) as did quality of life (before the study: mean 4.02 [SD 0.84]; after the study: mean 4.27 [SD 0.73]; t24=2.48, P=.01, d=0.32). HbA1c levels (before the study: mean 8.94 [SD 1.46]; after the study: mean 8.87 [SD 1.29]; t24=0.67, P=.51, d=0.04) and family conflict (before the study: mean 2.45 [SD 0.55]; after the study: mean 2.61 [SD 0.45]; t23=0.55, P=.14, d=0.32) changed in the hypothesized direction, but the change was not significant. However, higher use of the mobile app was associated with more improvement in HbA1c levels (F1,20=9.74, P<.005; R2=0.33). Overall, the adolescents were satisfied with the app intervention. CONCLUSIONS: In a 12-week pilot study of the mobile app intervention designed to facilitate parent-adolescent communication for improving diabetes outcomes, significant benefits were demonstrated in self-care adherence and quality of life. A randomized controlled trial with a longer intervention is needed to replicate these findings and to determine the stability of the intervention effects. TRIAL REGISTRATION: ClinicalTrials.gov NCT03436628; https://clinicaltrials.gov/ct2/show/NCT03436628.

Using User-Feedback to Develop a Website: MyT1DHope, for Parents of Children with T1D.

Effectively caring for a child with type-1 diabetes (T1D) can be extremely demanding and stressful for the entire family. The difficulties of caring for a child with T1D impact the psychological and physical well-being of the parents. Interventions aimed at reducing stress and increasing coping may improve parental outcomes. This project sought to develop a resource to be used as a preliminary intervention step for these parents. This research was conducted in two parts. Part 1 includes three stages of formative evaluation, including a focus group, interviews, and a survey with parents to examine the current landscape of diabetes websites as a resource. Using data from Part 1, Part 2 of the study included the identification of a theory to guide the design of a website, the development of the website, and an 8-week pilot study of the website with parents with a child with T1D. Significant improvements were found in diabetes knowledge and caregivers' satisfaction of life. No changes were found in social support, self-efficacy, or quality of life. Overall, the data show that the parents were generally satisfied with the website. Through this work, researchers were able to develop a deeper understanding of the needs of parents caring for a child with T1D to develop the initial component of a larger intervention.

Aspergillus fumigatus Cell Wall Promotes Apical Airway Epithelial Recruitment of Human Neutrophils.

Aspergillus fumigatus is a ubiquitous fungal pathogen capable of causing multiple pulmonary diseases, including invasive aspergillosis, chronic necrotizing aspergillosis, fungal colonization, and allergic bronchopulmonary aspergillosis. Intact mucociliary barrier function and early airway neutrophil responses are critical for clearing fungal conidia from the host airways prior to establishing disease. Following inhalation, Aspergillus conidia deposit in the small airways, where they are likely to make their initial host encounter with epithelial cells. Challenges in airway infection models have limited the ability to explore early steps in the interactions between A. fumigatus and the human airway epithelium. Here, we use inverted air-liquid interface cultures to demonstrate that the human airway epithelium responds to apical stimulation by A. fumigatus to promote the transepithelial migration of neutrophils from the basolateral membrane surface to the apical airway surface. Promoting epithelial transmigration with Aspergillus required prolonged exposure with live resting conidia. Swollen conidia did not expedite epithelial transmigration. Using A. fumigatus strains containing deletions of genes for cell wall components, we identified that deletion of the hydrophobic rodlet layer or dihydroxynaphthalene-melanin in the conidial cell wall amplified the epithelial transmigration of neutrophils, using primary human airway epithelium. Ultimately, we show that an as-yet-unidentified nonsecreted cell wall protein is required to promote the early epithelial transmigration of human neutrophils into the airspace in response to A. fumigatus Together, these data provide critical insight into the initial epithelial host response to Aspergillus.

The design and development of MyT1DHero: A mobile app for adolescents with type 1 diabetes and their parents.

INTRODUCTION: Type 1 diabetes impacts approximately 1.25 m Americans, many of them young children. As a child grows, there is a transition towards independence and they must learn to manage their diabetes independently. The objective of this study was to design, develop and conduct a prototype test to assess the satisfaction and feasibility of a mobile app for adolescents with type 1 diabetes and their parents to aid in this transition. METHODS: Ten parent/adolescent groups used MyT1DHero for four weeks. They were given a pre-test/post-test survey regarding family conflict with three tasks of diabetes management and the general tone of family communication. At post-test they were asked questions regarding their satisfaction and perception of ease of use of the app. They also participated in short interviews regarding the app. Additionally, we used server data to examine actual app usage. RESULTS: The parents' perceptions of conflict around the results of the blood sugar tests increased ( t(9) = 2.71, p = .02) as did perceptions of conflict around logging the blood sugar results ( t(9) = 3.67, p = .005). The adolescents perceived increased conflict surrounding the results around logging the blood sugars results ( t(9) = 3.09, p = .01).There was no change in the tone of general family communication. During the prototype testing, we discovered that the app crashed repeatedly and several of the functions were not working properly. In the interview data, three main themes emerged, app-crashing issues, problems with notifications and positive feedback. DISCUSSION: Through this process, all of the reported issues were corrected and new features were planned for subsequent versions. A smartphone application has the potential to be a novel intervention for engaging adolescents and their parents in positive communication to support type 1 diabetes management.

Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes.

OBJECTIVE: To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D). METHODS: Participants (N = 105, ages 7-13 years, mean age 10.8 ± 1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week baseline run-in phase in Manual Mode followed by a 3-month study phase with Auto Mode enabled. Sensor glucose (SG), glycated hemoglobin (HbA1c), percentage of SG values across glucose ranges, and SG variability, during the run-in and study phases were compared. Participants underwent frequent sample testing with i-STAT® venous reference measurement during a hotel period (6 days/5 nights) to evaluate the system's continuous glucose monitoring performance. RESULTS: Auto Mode was used a median of 81% of the time. From baseline to end of study, overall SG dropped by 6.9 ± 17.2 mg/dL (P < 0.001), HbA1c decreased from 7.9% ± 0.8% to 7.5% ± 0.6% (P < 0.001), percentage of time in target glucose range (70-180 mg/dL) increased from 56.2% ± 11.4% to 65.0% ± 7.7% (P < 0.001), and the SG coefficient of variation decreased from 39.6% ± 5.4% to 38.5% ± 3.8% (P = 0.009). The percentage of SG values within target glucose range was 68.2% ± 9.1% and that of i-STAT reference values was 65.6% ± 17.7%. The percentage of values within 20%/20 of the i-STAT reference was 85.2%. There were no episodes of severe hypoglycemia or diabetic ketoacidosis during the study phase. CONCLUSION: In-home use of MiniMed 670G system Auto Mode for 3 months by children with T1D, similar to MiniMed 670G system use by adolescents and adults with T1D, was safe and associated with reduced HbA1c levels and increased time in target glucose range, compared with baseline.

Using an mHealth App to Transition Care of Type 1 Diabetes from Parents to Teens: Protocol for a Pilot Study.

BACKGROUND: Type 1 diabetes mellitus (T1DM) afflicts approximately 154,000 people under the age of 20 in the United States. Most people with T1DM are diagnosed at a young age, and parents have to take on the responsibility of T1DM management. Eventually, the child must begin to transition to self-management. Adolescents often struggle to take on responsibility for all the necessary tasks to successfully self-manage their T1DM. In fact, approximately three-quarters of adolescents are not achieving American Diabetes Association-recommended glycated hemoglobin (HbA1c) targets. This lack of adherence can lead to negative health outcomes. OBJECTIVE: The goals of this interdisciplinary proposal are as follows: (1) to develop a unique and theory-driven technology using a mobile phone app to promote self-management behaviors for adolescents aged 10-15 years with T1DM and their parents and (2) to explore the feasibility and impact of the self-management mobile app. METHODS: This study has two phases: app development and pilot testing. In the app development phase, the app will be conceptualized and a prototype will be tested. In Phase 2, the mobile app will undergo pilot testing to determine its feasibility and impact on diabetes self-management. RESULTS: The pilot test was launched in September 2017. Data collection for the final pilot test is underway, and results are forthcoming. CONCLUSIONS: Adolescents with T1DM and their parents can have a difficult time managing the transition of diabetes care. It is hoped that this app can help. The focus groups and prototype testing have indicated promising outcomes of app use. TRIAL REGISTRATION: ClinicalTrials.gov NCT03436628; https://clinicaltrials.gov/ct2/show/NCT03436628 (Archived by WebCite at http://www.webcitation.org/72tHXTE2Z). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/10803.

In-Clinic Evaluation of the MiniMed 670G System "Suspend Before Low" Feature in Children with Type 1 Diabetes.

BACKGROUND: The Medtronic predictive low-glucose management (PLGM) algorithm automatically stops insulin delivery when sensor glucose (SG) is predicted to reach or fall below a preset low-glucose value within the next 30 min, and resumes delivery after hypoglycemia recovery. The present study evaluated the PLGM algorithm performance of the MiniMed™ 670G system SmartGuard™ "suspend before low" feature in children aged 7-13 years with type 1 diabetes (T1D). METHOD: Participants (N = 105, mean ± standard deviation of 10.8 ± 1.8 years) underwent an overnight in-clinic evaluation of the "suspend before low" feature with a preset low limit of 65 mg/dL. After exercise, frequent sample testing (FST) was conducted every 5 min if values were <70 mg/dL; every 15 min if 70-80 mg/dL; and every 30 min if >80 mg/dL. First-day performance of the Guardian™ Sensor 3 glucose sensor and continuous glucose monitoring system was also evaluated. RESULTS: Activation of the "suspend before low" feature occurred in 79 of the 105 participants, 79.7% (63/79) did not result in SG falling below 65 mg/dL. Mean glucose at activation was 102 ± 19 mg/dL and the initial insulin suspension duration was 87.5 ± 32.7 min. Four hours after insulin resumption, mean reference glucose was 130 ± 42 mg/dL. Mean absolute relative difference between the FST reference glucose and SG values on the first day of sensor wear was 11.4%. For the 26 participants in whom the "suspend before low" feature did not activate, none involved a reference glucose value ≤65 mg/dL, suggesting that the PLGM algorithm performed as intended. CONCLUSION: In children aged 7-13 years with T1D, the "suspend before low" feature of the MiniMed 670G system demonstrated a hypoglycemia prevention rate of nearly 80% after exercise and did not involve rebound hyperglycemia. There were no events of severe hypoglycemia during the evaluation.

Developing a Patient-Centered mHealth App: A Tool for Adolescents With Type 1 Diabetes and Their Parents.

BACKGROUND: Type 1 diabetes (T1D) afflicts approximately 154,000 people under 20 years of age. Three-quarters of adolescents are not achieving glycosylated hemoglobin (HbA1c) targets, which leads to negative health outcomes. Mobile health (mHealth), the use of technology in health, has been used successfully to improve health in many chronic conditions, including diabetes. OBJECTIVE: The purpose of this study was to use patient-centered research methods to inform and improve the design and functionality of our T1D app, MyT1DHero, and to provide insight for others who are designing a health app for adolescents and parents. METHODS: This study included data from focus groups with participants recruited from the Juvenile Diabetes Research Foundation (JDRF) southeast Michigan's family network. All data collected during the sessions were audio-recorded, transcribed, and coded. RESULTS: Four key themes were identified: (1) diabetes is unpredictable, (2) negative and frustrated communication, (3) motivations to use an app, and (4) feedback specific to our app. CONCLUSIONS: A patient-centered approach was used to assist in the development of an app for adolescents with T1D. Participants were satisfied with overall app design; customization, interactivity, and tangible rewards were identified as being necessary for continued use. Participants believed the app would help improve the communication between parents and adolescents. Many apps developed in the health context have not used a patient-centered design method or have seen vast improvements in health. This paper offers suggestions to others seeking to develop apps for adolescents and their parents.

Influence of all-out start duration on pulmonary oxygen uptake kinetics and high-intensity exercise performance.

The purpose of this study was to investigate the influence of the duration of an "all-out" starting strategy on O2 uptake kinetics and performance during high-intensity exercise. Following familiarization, 9 recreationally active men completed three 1500-m cycling time trials (TT) using different pacing strategies. In a randomized order, subjects completed a self-paced TT (SPTT), or a TT that was self-paced following an initial 15-second (15TT) or 90-second (90TT) all-out sprint. VO2 was measured during all tests. The 1500-m TT completion time was faster in 15TT than SPTT (136.1 ± 6.2 seconds vs. 140.3 ± 7.1 seconds; p ≤ 0.05), but 90TT (138.5 ± 8.5 seconds) was not significantly different from either SPTT or 15TT (p > 0.05). The V[Combining Dot Above]O2 mean response time (MRT) was shorter in 15TT (27 ± 7 seconds) and 90TT (30 ± 9 seconds) than SPTT (40 ± 10 seconds; p ≤ 0.05), but the peak V[Combining Dot Above]O2 was only higher in 15TT (3.77 ± 0.42 L·min-1) compared with SPTT (3.47 ± 0.44 L·min-1) (p ≤ 0.05). There was a significant correlation (r = 0.77, p ≤ 0.05) between the shorter MRT and the faster 1500-m completion time for 15TT compared with SPTT. These results support the use of a brief (∼15 seconds) all-out start to improve performance in short-duration (<180 seconds) athletic events and suggest that such a strategy may be ergogenic by increasing the rate of oxidative energy transfer during exercise while minimizing the extent of the concurrent muscle metabolic perturbation.

Basal and bolus insulin requirements in children, adolescents, and young adults with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII): effects of age and puberty.

OBJECTIVE: Guidelines for insulin dosing, including the insulin to carbohydrate ratio (I/C), insulin sensitivity factor (ISF), and basal/bolus ratio guidelines, have been well established for adults with type 1 diabetes mellitus (T1DM). However, clinical experience suggests that these guidelines are not appropriate for children. The purpose of this study was to determine the continuous subcutaneous insulin infusion (CSII) settings in children with T1DM at different ages and stages of puberty. METHODS: A total of 154 patients data between the ages of 3 and 21 years with well-controlled T1DM according to American Diabetes Association guidelines were reviewed. Only patients on CSII who were not in the honeymoon period were included. RESULTS: Patients were divided into 8 groups according to age, gender, and/or pubertal stage. Insulin requirements increased with puberty in both sexes (0.69, 0.97, and 0.90 U/kg/day in children <7 years of age, midpubertal girls, and late-pubertal boys, respectively). Basal insulin requirement was lowest in the youngest group (34%; P<.01). The youngest group had the lowest I/C prediction factor (PF) (mean, 315.7 ± 79.4; P<.01 with all groups), and the ISF-PF was higher than that of the oldest group (mean, 2,588.3 ± 1,101.8; P<.01). CONCLUSION: CSII dose calculations vary with age and pubertal status in children with T1DM. These differences must be considered when calculating CSII dosing, especially for younger children.

Comparison of the effect of insulin glulisine to insulin aspart on breakfast postprandial blood glucose levels in children with type 1 diabetes mellitus on multiple daily injections.

OBJECTIVE: Rapid-acting insulins, including insulin aspart (NovoLog) and lispro (Humalog), do not seem to effectively control postprandial glycemic excursions in children with type 1 diabetes mellitus (T1DM). The objective of this study was to determine if insulin glulisine (Apidra), another rapid-acting insulin analog, would be superior in controlling postprandial hyperglycemia in children with T1DM. METHODS: Thirteen prepubertal children ages 4 to 11 years completed this study. Inclusion criteria included T1DM ≥6 months, glycosylated hemoglobin (HbA1C) 6.9 to 10%, blood glucose (BG) levels in adequate control for 1 week prior to study start, multiple daily injections (MDI) with insulin glargine or determir once daily and aspart or lispro premeal. If fasting BG was 70 to 180 mg/dL, subjects received insulin glulisine alternating with aspart prior to a prescribed breakfast with a fixed amount of carbohydrate (45, 60, or 75 g) for 20 days. Postprandial BG values were obtained at 2 and 4 hours. RESULTS: Mean baseline BG values for insulin glulisine (136.4 ± 15.7 mg/dL; mean ± SD) and aspart (133.4 ± 14.7 mg/dL) were similar (P = .34). Mean increase in 2-hour postprandial BG was higher in glulisine (+113.5 ± 65.2 mg/dL) than aspart (+98.6 ± 66.9 mg/dL), (P = .01). BG remained higher at 4 hours (glulisine: 141.9 ± 36.5 mg/dL, aspart: 129.0 ± 37.0 mg/dL) (P = .04). Although statistically insignificant, more hypoglycemic events occurred at 2- and 4-hours postprandial with insulin aspart. CONCLUSION: Insulin aspart appears to be more effective than insulin glulisine in controlling 2- and 4-hour postprandial BG excursions in prepubertal children with T1DM.

Prevention of ulceration, amputation, and reduction of hospitalization: outcomes of a prospective multicenter trial of tibial neurolysis in patients with diabetic neuropathy.

This is the first multicenter prospective study of outcomes of tibial neurolysis in diabetics with neuropathy and chronic compression of the tibial nerve in the tarsal tunnels. A total of 38 surgeons enrolled 628 patients using the same technique for diagnosis of compression, neurolysis of four medial ankle tunnels, and objective outcomes: ulceration, amputation, and hospitalization for foot infection. Contralateral limb tibial neurolysis occurred in 211 patients for a total of 839 operated limbs. Kaplan-Meier proportional hazards were used for analysis. New ulcerations occurred in 2 (0.2%) of 782 patients with no previous ulceration history, recurrent ulcerations in 2 (3.8%) of 57 patients with a previous ulcer history, and amputations in 1 (0.2%) of 839 at risk limbs. Admission to the hospital for foot infections was 0.6%. In patients with diabetic neuropathy and chronic tibial nerve compression, neurolysis can result in prevention of ulceration and amputation, and decrease in hospitalization for foot infection.

A positive Tinel sign as predictor of pain relief or sensory recovery after decompression of chronic tibial nerve compression in patients with diabetic neuropathy.

Predictive ability of a positive Tinel sign over the tibial nerve in the tarsal was evaluated as a prognostic sign in determining sensory outcomes after distal tibial neurolysis in diabetics with chronic nerve compression at this location. Outcomes were evaluated with a visual analog score (VAS) for pain and measurements of the cutaneous pressure threshold/two-point discrimination. A multicenter prospective study enrolled 628 patients who had a positive Tinel sign. Of these patients, 465 (74%) had VAS >5. Each patient had a release of the tarsal tunnel and a neurolysis of the medial and lateral plantar and calcaneal tunnels. Subsequent, contralateral, identical surgery was done in 211 of the patients (152 of which had a VAS >5). Mean VAS score decreased from 8.5 to 2.0 (p <0.001) at 6 months, and remained at this level for 3.5 years. Sensibility improved from a loss of protective sensation to recovery of some two-point discrimination during this same time period. It is concluded that a positive Tinel sign over the tibial nerve at the tarsal tunnel in a diabetic patient with chronic nerve compression at this location predicts significant relief of pain and improvement in plantar sensibility.

Effectiveness of sensor-augmented pump therapy in children and adolescents with type 1 diabetes in the STAR 3 study.

OBJECTIVE: Maintenance of appropriate A1C values and minimization of hyperglycemic excursions are difficult for many pediatric patients with type 1 diabetes. Continuous glucose monitoring (CGM) sensor-augmented pump (SAP) therapy is an alternative to multiple daily injection (MDI) therapy in this population. RESEARCH DESIGN AND METHODS: Sensor-augmented pump therapy for A1C reduction (STAR 3) was a 1-yr trial that included 82 children (aged 7-12) and 74 adolescents (aged 13-18) with A1C values ranging from 7.4 to 9.5% who were randomized to either SAP or MDI therapy. Quarterly A1C values were obtained from all subjects. CGM studies were carried out at baseline, 6 months, and 12 months to quantify glycemic excursions [calculated as area under the glucose concentration-time curve (AUC)] and variability. In the SAP group, sensor compliance was recorded. RESULTS: Baseline A1C values were similar in subjects randomized to the SAP (8.26 ± 0.55%) and MDI groups (8.30 ± 0.53%). All subsequent A1C values showed significant (p < 0.05) treatment group differences favoring SAP therapy. Compared with the MDI group, subjects in the SAP group were more likely to meet age-specific A1C targets and had lower AUC values for hyperglycemia with no increased risk of hypoglycemia. Glucose variability improved in the SAP group compared to the MDI group. Children wore CGM sensors more often and were more likely to reach age-specific A1C targets than adolescents. CONCLUSIONS: SAP therapy allows both children and adolescents with marginally or inadequately controlled type 1 diabetes to reduce A1C values, hyperglycemic excursions, and glycemic variability in a rapid, sustainable, and safe manner.

Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month continuation phase.

OBJECTIVE To examine the effects of crossing over from optimized multiple daily injection (MDI) therapy to sensor-augmented pump (SAP) therapy for 6 months, and the effects of 18 months' sustained use of SAP. RESEARCH DESIGN AND METHODS The 6-month, single-crossover continuation phase of Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) provided SAP therapy to 420 subjects who completed the 1-year randomized study. The primary outcome was change in A1C in the crossover group. RESULTS A1C values were initially lower in the continuing-SAP group than in the crossover group (7.4 vs. 8.0%, P < 0.001). A1C values remained reduced in the SAP group. After 3 months on the SAP system, A1C decreased to 7.6% in the crossover group (P < 0.001); this was a significant and sustained decrease among both adults and children (P < 0.05). CONCLUSIONS Switching from optimized MDI to SAP therapy allowed for rapid and safe A1C reductions. Glycemic benefits of SAP therapy persist for at least 18 months.

Reliability of early iodine 123 uptake for treatment of Graves disease in children.

OBJECTIVE: To determine the reliability of early radioiodine uptake (RAIU) in calculation of the radioiodine ablation dose for pediatric patients with Graves disease. METHODS: This retrospective review of medical records involved 22 pediatric patients with Graves disease, who had undergone early (4 to 8 hours) and late (24 to 26 hours) RAIU studies and were treated with iodine 131 (131I). Quantitative data are reported as mean ± standard error of the mean. Early and late RAIU and actual administered versus calculated 131I ablation doses were compared by using the paired t test. The correlation between early and late RAIU was assessed by curvilinear regression analysis. Significance was assessed at P<.05. RESULTS: Mean early RAIU was 57.1% ± 18.2%, and mean late RAIU was 72.1% ± 14.4% (P<.05). Curvilinear regression analysis showed the following: late RAIU = 7.13 + 1.71 × (early RAIU) - 0.01 x (early RAIU)2; r2 = 0.75. The mean ablation dose of 131I based on late RAIU was 9.3 ± 2.0 mCi. The calculated radioiodine dose would have been, on average, 32% higher (12.3 ± 3.8 mCi; P<.05) had early RAIU been used. CONCLUSION: In children, early RAIU can be much lower than late RAIU. This may be misleading for ablation dose calculations. Therefore, late RAIU should be used to avoid overtreatment in children with Graves disease.

Comparison of low-dose and high-dose cosyntropin stimulation testing in children.

BACKGROUND: There is no consensus among pediatric endocrinologists in using low-dose (LD) versus high-dose (HD) cosyntropin to test for secondary/tertiary adrenal insufficiency. This paper compares LD and HD cosyntropin stimulation testing in children for evaluation of hypothalamic-pituitary-adrenal axis (HPAA) and suggests a new peak cortisol cut-off value for LD stimulation testing to avoid false positivity. METHODS: Data of 36 children receiving LD (1 µg) and HD (249 µg) cosyntropin consecutively during growth hormone (GH) stimulation testing were analyzed in two groups. Group A were patients who passed GH stimulation testing and were not on oral, inhaled or intranasal steroids (intact hypothalamic-pituitary axis, n= 19). Group B were patients who failed GH stimulation testing and/or were on oral, inhaled or intranasal steroids (impaired hypothalamic-pituitary axis, n= 17). RESULTS: In group A, the mean peak cortisol response in LD cosyntropin was 18.5 ± 2.4 µg/dL and that for the HD cosyntropin was 24.8 ± 3.1 µg/dL (r: 0.76, P≤ 0.05). In group B, the mean peak cortisol response in LD cosyntropin was 15.7 ± 6.1 µg/dL and that for HD cosyntropin was 21.7 ± 7.9 µg/dL (r: 0.98, P≤ 0.05). When a standard cut-off of 18 µg/dL was used, 37% of the patients with intact HPAA failed LD cosyntropin testing, but a cut-off of 14 µg/dL eliminated false positive results. CONCLUSIONS: LD cosyntropin stimulation testing results should be interpreted cautiously when used alone to prevent unnecessary long-term treatment. Using a lower cut-off for LD (≥14 µg/dL) seems to avoid false positive results and still detects most cases of impaired HPAA.

Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes.

BACKGROUND: Recently developed technologies for the treatment of type 1 diabetes mellitus include a variety of pumps and pumps with glucose sensors. METHODS: In this 1-year, multicenter, randomized, controlled trial, we compared the efficacy of sensor-augmented pump therapy (pump therapy) with that of a regimen of multiple daily insulin injections (injection therapy) in 485 patients (329 adults and 156 children) with inadequately controlled type 1 diabetes. Patients received recombinant insulin analogues and were supervised by expert clinical teams. The primary end point was the change from the baseline glycated hemoglobin level. RESULTS: At 1 year, the baseline mean glycated hemoglobin level (8.3% in the two study groups) had decreased to 7.5% in the pump-therapy group, as compared with 8.1% in the injection-therapy group (P<0.001). The proportion of patients who reached the glycated hemoglobin target (<7%) was greater in the pump-therapy group than in the injection-therapy group. The rate of severe hypoglycemia in the pump-therapy group (13.31 cases per 100 person-years) did not differ significantly from that in the injection-therapy group (13.48 per 100 person-years, P=0.58). There was no significant weight gain in either group. CONCLUSIONS: In both adults and children with inadequately controlled type 1 diabetes, sensor-augmented pump therapy resulted in significant improvement in glycated hemoglobin levels, as compared with injection therapy. A significantly greater proportion of both adults and children in the pump-therapy group than in the injection-therapy group reached the target glycated hemoglobin level. (Funded by Medtronic and others; ClinicalTrials.gov number, NCT00417989.)