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.