Safety and Glycemic Outcomes During the MiniMed Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes.

During MiniMed™ advanced hybrid closed-loop (AHCL) use by adolescents and adults in the pivotal trial, glycated hemoglobin (A1C) was significantly reduced, time spent in range (TIR) was significantly increased, and there were no episodes of severe hypoglycemia or diabetic ketoacidosis (DKA). The present study investigated the same primary safety and effectiveness endpoints during AHCL use by a younger cohort with type 1 diabetes (T1D). An intention-to-treat population ( = 160, aged 7-17 years) with T1D was enrolled in a single-arm study at 13 investigational centers.

Glycemic Outcomes During Early Use of the MiniMed™ 780G Advanced Hybrid Closed-Loop System with Guardian™ 4 Sensor.

Safety and significant improvement in overall glycated hemoglobin (A1C) and percentage of time spent in (TIR), below (TBR), and above (TAR) glucose range were demonstrated in the pivotal trial of adolescents and adults using the MiniMed™ advanced hybrid closed-loop (AHCL) system with the adjunctive, calibration-required Guardian™ Sensor 3. The present study evaluated early outcomes of continued access study (CAS) participants who transitioned from the pivotal trial investigational system to the approved MiniMed™ 780G system with the non-adjunctive, calibration-free Guardian™ 4 Sensor (MM780G+G4S). Study data were presented alongside those of real-world MM780G+G4S users from Europe, the Middle East, and Africa.

Geographic and demographic variability in serum PFAS concentrations for pregnant women in the United States.

Background: While major pathways of human PFAS exposure are thought to be drinking water and diet, other pathways and sources have also been shown to contribute to a person's cumulative exposure. However, the degree of contribution of these other sources to PFAS body burdens is still not well understood and occurrence data for PFAS in conssumer products and household materials are sparse. Questionnaire data concordant with biomonitoring may improve understanding of associations between other PFAS exposure pathways and exposure in human populations.

Improved Glycemia with Hybrid Closed-Loop Versus Continuous Subcutaneous Insulin Infusion Therapy: Results from a Randomized Controlled Trial.

To evaluate safety and effectiveness of MiniMed™ 670G hybrid closed loop (HCL) in comparison with continuous subcutaneous insulin infusion (CSII) therapy for 6 months in persons with type 1 diabetes (T1D). Adults (aged 18-80 years), adolescents, and children (aged 2-17 years) with T1D who were using CSII therapy were enrolled and randomized (1:1) to 6 months of HCL intervention (n = 151, mean age of 39.9 ± 19.

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).

Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial.

Objective: Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population.

Research Design And Methods: A total of 80 children aged 2.

Human exposure pathways to poly- and perfluoroalkyl substances (PFAS) from indoor media: A systematic review.

Background: Human exposure to per- and polyfluoroalkyl substances (PFAS) has been primarily attributed to contaminated food and drinking water. There is information indicating other sources and pathways of exposure in residential environments, but few studies report relationships between these indoor media and human biomonitoring measurements.

Methods: This study adapts existing systematic review tools and methodologies to synthesize evidence for PFAS exposure pathways from indoor environment media including consumer products, household articles, cleaning products, personal care products, and indoor air and dust.

Demonstrating a systems approach for integrating disparate data streams to inform decisions on children's environmental health.

Background: The use of systems science methodologies to understand complex environmental and human health relationships is increasing. Requirements for advanced datasets, models, and expertise limit current application of these approaches by many environmental and public health practitioners.

Methods: A conceptual system-of-systems model was applied for children in North Carolina counties that includes example indicators of children's physical environment (home age, Brownfield sites, Superfund sites), social environment (caregiver's income, education, insurance), and health (low birthweight, asthma, blood lead levels).

Safety and Glycemic Outcomes During the MiniMed™ Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes.

This trial assessed safety and effectiveness of an advanced hybrid closed-loop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D). This multicenter single-arm study involved an intent-to-treat population of 157 individuals (39 adolescents aged 14-21 years and 118 adults aged ≥22-75 years) with T1D. Study participants used the MiniMed™ AHCL system during a baseline run-in period in which sensor-augmented pump +/- predictive low glucose management or Auto Basal was enabled for ∼14 days.

Diabetes Technology Use in Remote Pediatric Patients with Type 1 Diabetes Using Clinic-to-Clinic Telemedicine.

Clinic-to-clinic telemedicine can increase visit frequency in pediatric patients with type 1 diabetes (T1D) living far from a diabetes specialty clinic, but the impact on adoption of diabetes technology is unclear. Pediatric patients with T1D in Colorado and surrounding states who received diabetes care using clinic-to-clinic telemedicine were enrolled. Medical records and surveys were reviewed to ascertain technology use, and data were compared to patients from the main clinic population.

Computational estimates of daily aggregate exposure to PFOA/PFOS from 2011 to 2017 using a basic intake model.

Background: Human exposure to per- and polyfluoroalkyl substances has been modeled to estimate serum concentrations. Given that the production and use of these compounds have decreased in recent years, especially PFOA and PFOS, and that additional concentration data have become available from the US and other industrialized countries over the past decade, aggregate median intakes of these two compounds were estimated using more recent data.

Methods: Summary statistics from secondary sources were collected, averaged, and mapped for indoor and outdoor air, water, dust, and soil for PFOA and PFOS to estimate exposures for adults and children.

Initiating hybrid closed loop: A program evaluation of an educator-led Control-IQ follow-up at a large pediatric clinic.

Background: Control-IQ (Tandem Diabetes) is a hybrid closed-loop (HCL) system that users self-initiate after completing online training. Best practices for clinical follow-up are not known. Our quality improvement objective was to evaluate the usefulness of an educator-led follow-up program for new HCL users in a type 1 diabetes pediatric clinic.

First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes.

The objective of this study was to assess the safety and effectiveness of the first commercial configuration of a tubeless automated insulin delivery system, Omnipod 5, in children (6-13.9 years) and adults (14-70 years) with type 1 diabetes (T1D) in an outpatient setting. This was a single-arm, multicenter, prospective clinical study.

Children's Environmental Health: A Systems Approach for Anticipating Impacts from Chemicals.

Increasing numbers of chemicals are on the market and present in consumer products. Emerging evidence on the relationship between environmental contributions and prevalent diseases suggests associations between early-life exposure to manufactured chemicals and a wide range of children's health outcomes. Using current assessment methodologies, public health and chemical management decisionmakers face challenges in evaluating and anticipating the potential impacts of exposure to chemicals on children's health in the broader context of their physical (built and natural) and social environments.

Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes.

Despite the increasing adoption of insulin pumps and continuous glucose monitoring devices, most people with type 1 diabetes do not achieve their glycemic goals. This could be related to a lack of expertise or inadequate time for clinicians to analyze complex sensor-augmented pump data. We tested whether frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS) is as effective and safe as those guided by physicians in controlling glucose levels.

A Clinical Training Program for Hybrid Closed Loop Therapy in a Pediatric Diabetes Clinic.

Background: Hybrid closed loop (HCL) therapy is now available in clinical practice for treatment of type 1 diabetes; however, there is limited research on how to educate patients on this new therapy. The purpose of this quality improvement project was to optimize a HCL education program for pediatric patients with type 1 diabetes (T1D).

Methods: Our multidisciplinary team developed a novel HCL clinical training program for current insulin pump users, using a quality improvement process called the Plan-Do-Study-Act model.

Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes.

Background: This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D).

Materials And Methods: Subjects 2-18 years of age (mean ± standard deviation [SD] 13.1 ± 3.

Improving the Insulin Pump Initiation Process for Pediatric Patients with Type 1 Diabetes through Application of Lean Quality Improvement Methods.

Context: Our pediatric diabetes center initiated insulin pump therapy for more than 250 patients with type 1 diabetes in 2014, but onboarding was inefficient.

Objective: To decrease time from the decision to initiate pump therapy to the ambulatory encounter after pump start (lead time) for new pump users from 132.5 days to less than 110 days within 5 months.

Optimizing Hybrid Closed-Loop Therapy in Adolescents and Emerging Adults Using the MiniMed 670G System.

Objective: The MiniMed 670G System is the first commercial hybrid closed-loop (HCL) system for management of type 1 diabetes. Using data from adolescent and young adult participants, we compared insulin delivery patterns and time-in-range metrics in HCL (Auto Mode) and open loop (OL). System alerts, usage profiles, and operational parameters were examined to provide suggestions for optimal clinical use of the system.

Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor.

Background: This study evaluated the accuracy and performance of a fourth-generation subcutaneous glucose sensor (Guardian Sensor 3) in the abdomen and arm.

Methods: Eighty-eight subjects (14-75 years of age, mean ± standard deviation [SD] of 42.0 ± 19.

Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes.

Background: The safety and effectiveness of the in-home use of a hybrid closed-loop (HCL) system that automatically increases, decreases, and suspends insulin delivery in response to continuous glucose monitoring were investigated.

Methods: Adolescents (n = 30, ages 14-21 years) and adults (n = 94, ages 22-75 years) with type 1 diabetes participated in a multicenter (nine sites in the United States, one site in Israel) pivotal trial. The Medtronic MiniMed 670G system was used during a 2-week run-in phase without HCL control, or Auto Mode, enabled (Manual Mode) and, thereafter, with Auto Mode enabled during a 3-month study phase.

A survey of youth with new onset type 1 diabetes: Opportunities to reduce diabetic ketoacidosis.

Objective: Pediatric patients in Colorado with new onset type 1 diabetes (T1D) presenting with diabetic ketoacidosis (DKA) increased from 29.9% to 46.2% from 1998 to 2012.