Designing a Closed-Loop Automated Insulin Delivery System: Simplifying Life for People, Including Children, Living With Type 1 Diabetes.

Living with type 1 diabetes is challenging, especially for children and their caregivers. This article describes how Insulet, the global leader in tubeless insulin technology, has continuously innovated Omnipod, a discreet, wearable, waterproof insulin delivery system that simplifies life for people with diabetes.

Clinical Evaluation of a Novel CGM-Informed Bolus Calculator with Automatic Glucose Trend Adjustment.

Background: Expert opinion guidelines and limited data from clinical trials recommend adjustment to bolus insulin doses based on continuous glucose monitor (CGM) trend data, yet minimal evidence exists to support this approach. We performed a clinical evaluation of a novel CGM-informed bolus calculator (CIBC) with automatic insulin bolus dose adjustment based on CGM trend used with sensor-augmented pump therapy. Materials and Methods: In this multicenter, outpatient study, participants 6-70 years of age with type 1 diabetes (T1D) used the Omnipod® 5 System in Manual Mode, first for 7 days without a connected CGM (standard bolus calculator, SBC, phase 1) and then for 7 days with a connected CGM using the CIBC (CIBC phase 2). The integrated bolus calculator used stored pump settings plus user-estimated meal size and/or either a manually entered capillary glucose value (SBC phase) or an imported current CGM value and trend (CIBC phase) to recommend a bolus amount. The CIBC automatically increased or decreased the suggested bolus amount based on the CGM trend. Results: Twenty-five participants, (mean ± standard deviation) 27 ± 15 years of age, with T1D duration 12 ± 9 years and A1C 7.0% ± 0.9% completed the study. There were significantly fewer sensor readings <70 mg/dL 4 h postbolus with the CIBC compared to the SBC (2.1% ± 2.0% vs. 2.8 ± 2.7, P = 0.03), while percent of sensor readings >180 and 70-180 mg/dL remained the same. There was no difference in insulin use or number of boluses given between the two phases. Conclusion: The CIBC was safe when used with the Omnipod 5 System in Manual Mode, with fewer hypoglycemic readings in the postbolus period compared to the SBC. This trial was registered at ClinicalTrials.gov (NCT04320069).

Study protocol: content and perceived educational utility of different modalities of clinical teaching visit (CTV) workplace-based assessments within Australian general practice vocational training: a cross-sectional study.

INTRODUCTION: Clinical teaching visits (CTVs) are formative workplace-based assessments that involve a senior general practitioner (GP) observing a clinical practice session of a general practice registrar (specialist vocational GP trainee). These visits constitute a key part of Australian GP training. Despite being mandatory and resource-intensive, there is a paucity of evidence regarding the content and educational utility of CTVs. This study aims to establish the content and educational utility of CTVs across varying practice settings within Australia, as perceived by registrars and their assessors ('CT visitors'). In addition, this study aims to establish registrar, CT visitor and practice factors associated with CTV content and perceived CTV utility ratings. METHODS AND ANALYSIS: This study will collect data prospectively using online questionnaires completed soon after incident CTVs. Participants will be registrars and CT visitors of CTVs conducted from March 2020 to January 2021. The setting is three Regional Training Organisations across four Australian states and territories (encompassing 37% of Australian GP registrars).Outcome factors will be a number of specified CTV content elements occurring during the CTV as well as participants' perceptions of CTV utility, which will be analysed using univariate and multivariable regression. ETHICS AND DISSEMINATION: Ethics approval has been granted by the University of Newcastle Human Research Ethics Committee, approval number H-2020-0037. Study findings are planned to be disseminated via conference presentation, peer-reviewed journals, educational practice translational workshops and the GP Synergy research subwebsite.

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

Background: 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. Materials and Methods: This was a single-arm, multicenter, prospective clinical study. Data were collected over a 14-day standard therapy (ST) phase followed by a 14-day hybrid closed-loop (HCL) phase, where participants (n = 36) spent 72 h at each of three prespecified glucose targets (130, 140, and 150 mg/dL, 9 days total) then 5 days with free choice of glucose targets (110-150 mg/dL) using the Omnipod 5. Remote safety monitoring alerts were enabled during the HCL phase. Primary endpoints were difference in time in range (TIR) (70-180 mg/dL) between ST and HCL phases and proportion of participants reporting serious device-related adverse events. Results: Mean TIR was significantly higher among children in the free-choice period overall (64.9% ± 12.2%, P < 0.01) and when using a 110 mg/dL target (71.2% ± 10.2%, P < 0.01), a 130 mg/dL target (61.5% ± 7.7%, P < 0.01), and a 140 mg/dL target (64.8% ± 11.6%, P < 0.01), and among adults using a 130 mg/dL target (75.1% ± 11.6%, P < 0.05), compared to the ST phase (children: 51.0% ± 13.3% and adults: 65.6% ± 15.7%). There were no serious device-related adverse events reported during the HCL phase, nor were there episodes of severe hypoglycemia or diabetic ketoacidosis. Conclusion: The Omnipod 5 System was safe and effective when used at glucose targets from 110 to 150 mg/dL for 14 days at home in children and adults with T1D.

Monitoring the Extent of Reclamation of Small Scale Mining Areas Using Artificial Neural Networks.

Small scale mining is mainly widespread in developing and underdeveloped countries. Although it is a source of livelihood for several people, it causes environmental degradation. Reclamation is needed to restore mined areas to an acceptable condition. This study uses ANN to monitor reclamation activities in small scale mining area. Landsat satellite images of study area (2007, 2011 and 2016), ground truth data and ESRI shapefile of the study area were used for the analyses. Two ANN classification methods, Unsupervised Self - Organized Mapping (SOM) and Supervised Multilayer Perceptron (MLP), were used for the classification of the satellite images. Normalized Difference Vegetation Index (NDVI) change maps were generated in order to help confirm where actual change had occurred and to what extent it had occurred. The results show disturbance and revegetation in the study area between 2007 and 2016. The Barelands/mined areas class increased by 60.4% and a decrease in the vegetation class by 18.7% from 2007 to 2011. There was revegetation from 2011 to 2016 with the Barelands/Mined Area decreasing by 51.7% and the vegetation increasing by 3.9%. The study shows an increase in the settlement class by 87.3%. The research concludes that the application of ANN be strongly encouraged for image classification and mine reclamation monitoring in the country due to the size and quality of training data, network architecture, and training parameters as well as the ability to improve the accuracy and fine tune information obtained from individual classes as compared to other classification methods.

Case Report of a Migrating Bullet: An Unusual Cause of Postmortem Confusion.

Migrating bullets are rare sequelae of penetrating gunshot wounds. Such cases have been described in the neurosurgical literature because they can produce complications in the management of patients such as decline in neurologic status, delays in rehabilitation, and difficulties in bullet removal. In contrast, few postmortem reports have described this phenomenon. We report a case of a gunshot wound in which the projectile entered the left side of the head and traversed to the right frontal area as documented by CT scan on hospital admission. At autopsy, the bullet was noted to have migrated back to the left side of the head from where it was recovered. Medical examiners need to be aware of this unusual phenomenon of retained intracranial projectiles.

Post-Traumatic Stress Disorder, Depression and Anxiety among North Korean Refugees: A Meta-Analysis.

OBJECTIVE: Post-traumatic stress disorder is common among North Korean refugees who have fled their country for economic, financial and humanitarian reasons. Co-morbid depression and anxiety are also common among North Korean refugees, due to the difficulties they have faced within their country and during their escape journey. Depression and anxiety complicate treatment for post-traumatic stress disorder, and lead to poorer outcomes. Thus, the aim of the present study was to provide a meta-analysis of studies investigating post-traumatic stress disorder, depression, and anxiety among North Korean refugees. METHODS: Selected articles were published in English, and included measures of post-traumatic stress, and/or depression and anxiety. 10 studies were included in the depression meta-analysis, and 6 in the anxiety meta-analysis. RESULTS: A random-effects model revealed strong, significant associations between post-traumatic stress and depression, r=0.63, 95% CI (0.51, 0.72), p<0.001, z=8.33, and anxiety, r=0.51, 95% CI (0.36, 0.63), p<0.001, z=6.07. The relationships between post-traumatic stress, depression and anxiety were higher among adults and those with more than five years outside of North Korea. CONCLUSION: Depression appears to be an important treatment focus for North Korean refugees with post-traumatic stress.

Percutaneous Screw Fixation of Lateral Condylar Humeral Fractures.

Lateral condylar humeral fractures are the second most common elbow injury in children and commonly occur between the ages of 5 and 10 years. There are several systems for classification of this fracture, including those of Milch (fracture line location) and Jakob et al. (displacement). Although nonoperative management is indicated for nondisplaced or minimally displaced fractures (<2 mm), operative fixation is indicated for greater displacement. Traditionally, open reduction and internal fixation has been the method used to ensure adequate reduction. However, closed reduction and internal fixation techniques for displaced fractures have been receiving increasing attention, with recent studies showing promising results. Several constructs (multiple smooth pins, a single lag screw, and threaded pins) for closed reduction and internal fixation have been described. Smooth-pin fixation has the advantage of a small diameter and easy removal, whereas threaded pins combine a small diameter with compressive properties. Compression of these small, articular fractures is important, and the optimal mode of fixation for maintaining fracture reduction is debated. Fixation with a partially threaded lag screw works by achieving metaphyseal compression, preventing loss of reduction of the distal fragment. In our experience, the compressive abilities of smooth and threaded pins are limited in the soft osteocartilaginous lateral condyle. Partially threaded lag screw fixation is indicated for pediatric patients with a substantially displaced (Jakob type-II or III) lateral condylar fracture. The major steps of the procedure are (1) preoperative planning with anteroposterior, lateral, and oblique radiographs; (2) supine positioning of the patient with the shoulder in abduction; (3) closed reduction with manual pressure; (4) guide-pin insertion through the lateral column of the distal part of the humerus; and (5) exchange of the guide pin with a lag screw. Postoperatively, the elbow is immobilized with a bivalved long-arm fiberglass cast or a posterior splint. The cast or splint is removed after interval healing is demonstrated on radiographs, and the lag screw is removed after complete fracture union is demonstrated. Complications are rare, and patients are expected to have decreased infection and open-reduction rates compared those treated with pin fixation.