The OmniPod Insulin Management System: the latest innovation in insulin pump therapy

This review of insulin pump therapy focuses on the OmniPod® Insulin Management System (Insulet Corp., Bedford, MA, USA). The OmniPod System is the first commercially available “patch pump.” It is a fully integrated wearable pump, controlled wirelessly through a handheld device containing a built-in blood glucose meter. This is an evaluation of the OmniPod System, with the aim of providing an educational tool for physicians who are considering recommending this product to their patients. The review includes a discussion of the traditional insulin pump configuration and its limitations, a detailed overview of the OmniPod System, references to clinical study data, planned product enhancements, its use as an insulin delivery system in the Juvenile Diabetes Research Foundation’s Artificial Pancreas Project, and its use to deliver additional compounds

Omnipod® Insulin Management System - "patch-pump", as a breakthrough in the treatment of type 1 diabetes

Introduction: There are 425 million adults with diabetes worldwide, 10% of whom have type 1 diabetes. The treatment of choice in this group of patients is insulin delivery. In order to avoid disease-related metabolic disorders, insulin therapy should be planned so that their risk is minimized. This often involves multiple subcutaneous deliveries throughout the day. In order to improve patient satisfaction and comfort, , "smart pumps" have been developed. OmniPod® is the first commercially available pump of this type. Aim of the study:  The purpose of our work was to present an innovative form of treatment for type 1 diabetes, to demonstrate the advantages, disadvantages and results of treatment using it. Methods and materials: A literature review was conducted in the PubMed database, using the key words: "diabetes type 1"; "diabetes mellitus"; "OmniPod®"; "insulin"; Results: OmniPod® improves glycemic control and glycated hemoglobin (HbA1c) values over traditional therapies. The algorithm used in the pump ensures normal glycemic ranges throughout the day, without the risk of prolonged episodes of hypo- and hyperglycemia. It improves the quality of life (QOL) index thanks to, among other things, water resistance, lack of difficulties during sleep in contrast to conventional insulin pumps. Conclusion: OmniPod® significantly improves users' glycemic and HbA1c control. It allows users to forgo conventional insulin pumps or intensive insulin therapy by raising QOL and increasing patients' sense of proper disease control. Further research should be inclined to evaluate the utility of OmniPod® in other types of diabetes, as well as on the application of the technology in other disease entities

Precision and Accuracy: Omnipod Pdm® (O-Pdm) Versus Freestyle Lite Meter® (Fsl Meter) Utilizing Freestyle Lite (Fsl)® Test Strips in Multiple Patient Situations

Today, diabetes mellitus affects 8.3% of the people in the United States and is having detrimental effects on patient populations as well as health care. To this date, there are numerous monitors that all meet specific requirements and industry standards in order to aid patients in self-monitoring of blood glucose (SMBG). There is currently a large market for these monitors and efforts have been made to devise the monitors to be accurate and precise. Through this study, accuracy and precision were studied by evaluating the difference between the O-PDM and FSL meter monitoring systems. It was hypothesized that a difference in accuracy and precision may or may not occur when scented and unscented lotion residues are placed on the testing sites before glucose readings. By taking glucose readings with lancets at multiple sites using FSL test strips with both O-PDM and FSL meter monitors and then taking readings again once lotion residues were removed with alcohol, data were analyzed to determine if a change was present. It was concluded that changes were apparent when scented lotion and unscented lotion was present on the testing site. In addition, a statistically significant difference was present in the unscented lotions of both the O-PDM and FSL meter groups when compared to their respective controls. The alcohol data showed large differences when compared to the readings taken with lotion present, and the alcohol group presented data that was similar to the control groups. By understanding potential sources of error, such as lotion residues as well as other left over particles, health care professionals, as well as patients may utilize SMBG more effectively. The importance of hand washing as well as cleaning testing sites with alcohol before readings is encouraged for both patients and health care professionals in order that they may identify common errors and work towards improved diabetes care

A systematic review of interventions to improve outcomes for young adults with Type 1 diabetes.

BACKGROUND: Many young adults with Type 1 diabetes experience poor outcomes. The aim of this systematic review was to synthesize the evidence regarding the effectiveness of interventions aimed at improving clinical, behavioural or psychosocial outcomes for young adults with Type 1 diabetes. METHODS: Electronic databases were searched. Any intervention studies related to education, support, behaviour change or health service organizational change for young adults aged between 15-30 years with Type 1 diabetes were included. A narrative synthesis of all studies was undertaken due to the large degree of heterogeneity between studies. RESULTS: Eighteen studies (of a possible 1700) were selected and categorized: Health Services Delivery (n = 4), Group Education and Peer Support (n = 6), Digital Platforms (n = 4) and Diabetes Devices (n = 4). Study designs included one randomized controlled trial, three retrospective studies, seven feasibility/acceptability studies and eight studies with a pre/post design. Continuity, support, education and tailoring of interventions to young adults were the most common themes across studies. HbA1c was the most frequently measured outcome, but only 5 of 12 studies that measured it showed a significant improvement. CONCLUSION: Based on the heterogeneity among the studies, the effectiveness of interventions on clinical, behavioural and psychosocial outcomes among young adults is inconclusive. This review has highlighted a lack of high-quality, well-designed interventions, aimed at improving health outcomes for young adults with Type 1 diabetes. This article is protected by copyright. All rights reserved

Insulin Patch Pumps in Type 2 Diabetes

• DM is a leading cause of death in Americans • A HbA1c above 6.5% is diagnostic for DM because it is at this level the patient is at risk for retinopathy and other microvascular disease • The purpose of this study is to determine alternative methods of maintaining tighter control on HbA1c to lessen the effects of type II diabetes.https://commons.und.edu/pas-grad-posters/1107/thumbnail.jp

Deep dip teardown of tubeless insulin pump

This paper introduces a deep level teardown process of a personal medical device - the OmniPod wireless tubeless insulin pump. This starts with mechanical teardown exposing the engineering solutions used inside the device. Then the electronic part of the device is analysed followed by components identification. Finally, the firmware extraction is performed allowing further analysis of the firmware inside the device as well as real-time debugging. This paper also evaluates the security of the main controller IC of the device. It reveals some weaknesses in the device design process which lead to the possibility of the successful teardown. Should the hardware security of the controller inside the device was well thought through, the teardown process would be far more complicated. This paper demonstrates what the typical teardown process of a personal medical device involves. This knowledge could help in improving the hardware security of sensitive devices

Privacy Concerns Related to Data Sharing for European Diabetes Devices

Background: Individuals with diabetes rely on medical equipment (eg, continuous glucose monitoring (CGM), hybrid closed-loop systems) and mobile applications to manage their condition, providing valuable data to health care providers. Data sharing from this equipment is regulated via Terms of Service (ToS) and Privacy Policy documents. The introduction of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Union has established updated rules for medical devices, including software. Objective: This study examines how data sharing is regulated by the ToS and Privacy Policy documents of approved diabetes medical equipment and associated software. It focuses on the equipment approved by the Norwegian Regional Health Authorities. Methods: A document analysis was conducted on the ToS and Privacy Policy documents of diabetes medical equipment and software applications approved in Norway. Results: The analysis identified 11 medical equipment and 12 software applications used for diabetes data transfer and analysis in Norway. Only 3 medical equipment (OmniPod Dash, Accu-Chek Insight, and Accu-Chek Solo) were registered in the European Database on Medical Devices (EUDAMED) database, whereas none of their respective software applications were registered. Compliance with General Data Protection Regulation (GDPR) security requirements varied, with some software relying on adequacy decisions (8/12), whereas others did not (4/12). Conclusions: The study highlights the dominance of non-European Economic Area (EEA) companies in medical device technology development. It also identifies the lack of registration for medical equipment and software in the EUDAMED database, which is currently not mandatory. These findings underscore the need for further attention to ensure regulatory compliance and improve data-sharing practices in the context of diabetes management