Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes.

Objective: Cystic fibrosis-related diabetes (CFRD) affects up to 50% of adults with cystic fibrosis and adds significant morbidity and treatment burden. We evaluated the safety and efficacy of automated insulin delivery with the iLet bionic pancreas (BP) in adults with CFRD in a single-center, open-label, random-order, crossover trial.

Research Design And Methods: Twenty participants with CFRD were assigned in random order to 14 days each on the BP or their usual care (UC).

Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes.

Background: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting.

Methods: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring).

Gut microbiome and breast-feeding: Implications for early immune development.

Establishment of the gut microbiome during early life is a complex process with lasting implications for an individual's health. Several factors influence microbial assembly; however, breast-feeding is recognized as one of the most influential drivers of gut microbiome composition during infancy, with potential implications for function. Differences in gut microbial communities between breast-fed and formula-fed infants have been consistently observed and are hypothesized to partially mediate the relationships between breast-feeding and decreased risk for numerous communicable and noncommunicable diseases in early life.

Promoting a gender-affirming environment in research: implications for research nurses.

Approximately 25 million people around the world identify as transgender, and the numbers are growing. While visibility of transgender communities has increased, significant healthcare disparities remain. Transgender individuals report being less inclined to share their sex assigned at birth due to fear of stigmatization and mistrust of the medical community.

Improvements in Glycemic Control Achieved by Altering the t Setting in the iLet Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial.

Introduction: We investigated the safety of, and glucose control by, the insulin-only configuration of the iLet bionic pancreas delivering fast-acting insulin aspart (faster aspart), using the same insulin-dosing algorithm but different time to maximal serum drug concentration (t) settings, in adults with type 1 diabetes.

Methods: We performed a single-center, single-blinded, crossover (two 7-day treatment periods) escalation trial over three sequential cohorts. Participants from each cohort were randomized to a default t setting (t [t = 65 min]) followed by a non-default t setting (t [t = 50 min; cohort 1], t [t = 40 min; cohort 2], t [t = 30 min; cohort 3]), or vice versa, all with faster aspart.

A Three-Way Accuracy Comparison of the Dexcom G5, Abbott Freestyle Libre Pro, and Senseonics Eversense Continuous Glucose Monitoring Devices in a Home-Use Study of Subjects with Type 1 Diabetes.

There is a dearth of comparative accuracy studies of continuous glucose monitoring (CGM) devices in the home-use setting, and none with the Eversense implantable CGM. We evaluated the accuracy of the Dexcom G5, Abbott Freestyle Libre Pro, and Senseonics Eversense during a 6-week free-living home-use bionic pancreas study involving 23 subjects with type 1 diabetes who wore all three devices concurrently. The primary outcome was the mean absolute relative difference (MARD) between CGM readings and point-of-care (POC) plasma-glucose (PG) values obtained approximately twice daily by the subjects.

Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial.

Background: The safety and effectiveness of a continuous, day-and-night automated glycaemic control system using insulin and glucagon has not been shown in a free-living, home-use setting. We aimed to assess whether bihormonal bionic pancreas initialised only with body mass can safely reduce mean glycaemia and hypoglycaemia in adults with type 1 diabetes who were living at home and participating in their normal daily routines without restrictions on diet or physical activity.

Methods: We did a random-order crossover study in volunteers at least 18 years old who had type 1 diabetes and lived within a 30 min drive of four sites in the USA.

Comparative Accuracy of 17 Point-of-Care Glucose Meters.

Background: The accuracy of point-of-care blood glucose (BG) meters is important for the detection of dysglycemia, calculation of insulin doses, and the calibration of continuous glucose monitors. The objective of this study was to compare the accuracy of commercially available glucose meters in a challenging laboratory study using samples with a wide range of reference BG and hemoglobin values.

Methods: Fresh, discarded blood samples from a hospital STAT laboratory were either used without modification, spiked with a glucose solution, or incubated at 37°C to produce 347 samples with an even distribution across reference BG levels from 20 to 440 mg/dl and hemoglobin values from 9 to 16 g/dl.

Day and night glycaemic control with a bionic pancreas versus conventional insulin pump therapy in preadolescent children with type 1 diabetes: a randomised crossover trial.

Background: The safety and efficacy of continuous, multiday, automated glycaemic management has not been tested in outpatient studies of preadolescent children with type 1 diabetes. We aimed to compare the safety and efficacy of a bihormonal bionic pancreas versus conventional insulin pump therapy in this population of patients in an outpatient setting.

Methods: In this randomised, open-label, crossover study, we enrolled preadolescent children (aged 6-11 years) with type 1 diabetes (diagnosed for ≥1 year) who were on insulin pump therapy, from two diabetes camps in the USA.

Outpatient glycemic control with a bionic pancreas in type 1 diabetes.

Background: The safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions.

Methods: In two random-order, crossover studies with similar but distinct designs, we compared glycemic control with a wearable, bihormonal, automated, "bionic" pancreas (bionic-pancreas period) with glycemic control with an insulin pump (control period) for 5 days in 20 adults and 32 adolescents with type 1 diabetes mellitus. The automatically adaptive algorithm of the bionic pancreas received data from a continuous glucose monitor to control subcutaneous delivery of insulin and glucagon.

Immunodepletion of albumin and immunoglobulin G from bovine plasma.

Current MS-based proteomics has facilitated the identification of large numbers of proteins from complex mixtures. The bovine plasma proteome has the potential to provide a wealth of information concerning the biological state of an animal. However, during MS-based experiments, higher abundance proteins such as albumin and immunoglobulin G (IgG) can hinder the identification of potentially important proteins that are present in much lower abundance.

The impact of stress factors in simulation-based laparoscopic training.

Background: This study aimed to quantify learner reactions manifesting from a realistic contextual stressor while training with a laparoscopic simulator, and to identify learner-derived stress-modifying behaviors. Stress factors are known to affect cognitive and psychomotor performance. Simulation-based medical training typically occurs in environments that are relatively stress free compared with the applied context.

Laparoscopic simulation training with proficiency targets improves practice and performance of novice surgeons.

Background: This study compares a laparoscopic skill training protocol without proficiency targets to the same protocol with explicit targets and notification of progress.

Methods: Fourteen surgery interns were randomized into 2 groups. The intervention group received task-specific proficiency criteria to guide practice.

Short-term outcomes and long-term impact of a programme in medical education for medical students.

Objectives: There is growing appreciation of the value of early preparation of future medical educators. Staff development programmes, conferences and workshops pertaining to the training of educators may be crucial to the pursuit of a school's larger educational mission to educate students, doctors and scholars and to provide comprehensive knowledge, research, patient care and service. This study examined the efficacy of a 1-week educational intervention aimed at preparing medical students to become effective doctor educators by building skills early in their careers.

Effects of gender on physiological responses during submaximal exercise and recovery.

Purpose: This investigation was conducted to compare the physiological responses of men and women, both during and following an exercise bout at the same relative submaximal intensity.

Methods: Ten untrained men (20.7+/-0.

Effects of various adjuvants on efficacy of a vaccine against Streptococcus bovis and Lactobacillus spp in cattle.

Objective: To determine efficacy of vaccines incorporating QuilA, alum, dextran combined with mineral oil, or Freund adjuvant for immunization of feedlot cattle against Streptococcus bovis and Lactobacillus spp.

Animals: 24 steers housed under feedlot conditions.

Procedure: Steers were randomly assigned to 4 experimental groups and a control group.

Increased ovulation rate in Merino ewes immunized against small synthetic peptide fragments of the inhibin alpha subunit.

Four experiments were carried out in Merino ewes during a period of 4 years to determine the long-term effects of immunization against different synthetic peptides mimicking the amine terminal of the alpha subunit of porcine inhibin. Peptides were conjugated to human serum albumin and 100-200 micrograms emulsified in Freund's complete adjuvant for the primary immunization. Usually two booster injections were given at monthly intervals with 50-100 micrograms conjugated peptide using either incomplete Freund's adjuvant or Montanide:Marcol.

Effect of crossed beams on Stokes gain and interaction length in stimulated Raman gain spectroscopy.

We have numerically calculated the change in spatial resolution and Stokes gain for stimulated Raman gain experiments that use two crossed laser beams. The laser beams are modeled as diffraction-limited, Gaussian TEM(00) beams. Results for interaction length and relative Stokes gain are presented for crossing angles of 0-15°, focusing ƒ/#'s 2-250, and mismatches in the positions of the focal points of the two beams.

Immunological manipulation of ovulation rate for twinning in cattle.

Unlike in sheep, in which immunization against androstenedione causes mild and reasonably controlled increased ovulation rate, in similar studies cattle showed highly variable responses ranging from increased ovulation rate and fertility through to anovulation/anoestrous or superovulation. As a consequence, interest in manipulation of ovulation rate through this approach has declined and is now focused on immunological manipulation of endogenous inhibin following successful studies in sheep. Studies have concentrated on developing a prototype inhibin-based vaccine to be used for twinning in the Australian beef industry.

Fertility of superovulated ewes after intrauterine or oviducal insemination with low numbers of fresh or frozen-thawed spermatozoa.

Two experiments investigated the effects of number of spermatozoa inseminated and time and site of insemination of fresh and frozen-thawed semen on fertility in Merino ewes treated with intravaginal progestagen pessaries and a combination of pregnant mare serum gonadotrophin and follicle stimulating hormone. In Experiment 1, ewes were inseminated in the uterus or oviducts with totals of 10(4), 10(5), 10(6) or 10(7) fresh spermatozoa 44 or 68 h after pessary removal. Ova recovered 48 h later were classified as fertilized if they had cleaved.

Planar Rayleigh scattering results in helium-air mixing experiments in a Mach-6 wind tunnel.

Planar Rayleigh scattering measurements with an argon-fluoride excimer laser are performed to investigate helium mixing into air at supersonic speeds. The capability of the Rayleigh scattering technique for flow visualization of a turbulent environment is demonstrated in a large-scale, Mach-6 facility. The detection limit obtained with the present setup indicates that planar, quantitative measurements of density can be made over a large cross-sectional area (5 cm x 10 cm) of the flow field in the absence of clusters.

Rorschach assessment of purging and nonpurging bulimics.

Research in bulimia has flourished in recent years, and yet minimal attention has been devoted to explorations of the bulimic's basic personality organization. We utilized the Rorschach to differentiate between purging and nonpurging bulimics and controls. There were 15 subjects in each group.

Rorschach evaluation of adolescent bulimics.

It has become apparent that the excessive dieting engaged in by many girls when they reach puberty frequently serves as an impetus for the later development of eating disorders. While the existence of bulimia nervosa has been well documented in late-adolescent girls, only minimal research has been devoted to delineating the personality characteristics that distinguish bulimics from normal adolescents. The present study utilized the Rorschach to contrast 12 DSM-III-R diagnosed adolescent bulimics with 12 female adolescent controls.

Immunization of merino ewes with a synthetic inhibin peptide or with preparations obtained from bovine and porcine follicular fluids by immunoaffinity chromatography result in different effects on ovulation rate and on plasma gonadotrophin concentrations.

Ewes were immunized with either a synthetic peptide (peptide 1-32) that has an amino acid sequence identity with the first 32 amino acids at the amino terminal of the alpha-subunit of porcine inhibin, or with bovine or porcine monoclonal antibody purified inhibin (bMPI and pMPI respectively), obtained by immunochromatography from follicular fluids. The peptide 1-32 was conjugated to albumin before use. Peptide 1-32 and bMPI increased ovulation rate and number of follicles (greater than or equal to 5 mm diameter).