Picoliter-volume inkjet printing into planar microdevice reservoirs for low-waste, high-capacity drug loading.

Oral delivery of therapeutics is the preferred route for systemic drug administration due to ease of access and improved patient compliance. However, many therapeutics suffer from low oral bioavailability due to low pH and enzymatic conditions, poor cellular permeability, and low residence time. Microfabrication techniques have been used to create planar, asymmetric microdevices for oral drug delivery to address these limitations. The geometry of these microdevices facilitates prolonged drug exposure with unidirectional release of drug toward gastrointestinal epithelium. While these devices have significantly enhanced drug permeability in vitro and in vivo, loading drug into the micron-scale reservoirs of the devices in a low-waste, high-capacity manner remains challenging. Here, we use picoliter-volume inkjet printing to load topotecan and insulin into planar microdevices efficiently. Following a simple surface functionalization step, drug solution can be spotted into the microdevice reservoir. We show that relatively high capacities of both topotecan and insulin can be loaded into microdevices in a rapid, automated process with little to no drug waste

The changing landscape of automated insulin delivery in the management of type 1 diabetes

Automated insulin delivery systems, also known as closed-loop o r ‘artificial pancreas’ systems, are transforming the management of type 1 diabetes. These systems consist of an algorithm which responds to real-time glucose sensor levels by automatically modulating insulin delivery through an insulin pump. We review the rapidly changing landscape of automated insulin-delivery systems over recent decades, from initial prototypes to the different hybrid closed-loop systems commercially available today. We discuss the growing body of clinical trials and real-world evidence demonst rating their glycaemic and psychosocial benefits. We also address future directions in auto mated insulin delivery such as dual-hormone systems and adjunct therapy as well as the chal lenges around ensuring equitable access to closed-loop technology

Objectives and methods of the ORCHESTRA FOUNDATION Registry study: a multicenter observational study of the use of insulin pump therapy in pregnant women with type 1 diabetes mellitus in Poland.

Background. The ORCHESTRA FOUNDATION Registry study was a prospective, multicenter, observational, post-market study investigating the use of an insulin pump with or without continuous glucose monitoring (CGM) [i.e., sensor-augmented pump (SAP) or sensor-integrated insulin pump (SIP)]; before, during, and after pregnancy, in women with type 1 diabetes mellitus (T1DM). Methods. Study participants enrolled in 24 centers, in Poland, and contributed intake and follow-up data for up to 22 months (i.e., up to 12 months pre-conception, throughout pregnancy, and 6 weeks after delivery). Participants who were already pregnant were enrolled up to the 16th week of pregnancy. Investigated outcomes included HbA1c before and during pregnancy, and serious adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, miscarriage, and hospitalization due to any bleeding or any symptoms suggesting premature delivery). Routine clinical data including maternal weight, body mass index, and daily insulin use were also recorded. The insulin delivery devices used in the study were the MiniMed™ Paradigm™ REAL-Time insulin pump with CGM (via the MiniMed Sof-sensor™ sensor) or without CGM, and the MiniMed Paradigm Veo™ with CGM (via the Enlite™ sensor). Results. Study enrollment began in May 2013 and the last patient completed the study in August 2017. Conclusions. The ORCHESTRA FOUNDATION Registry study provides an opportunity to assess the effects of automated insulin delivery in pregnant women with T1DM using insulin pumps with or without continuous glucose monitoring.Background. The ORCHESTRA FOUNDATION Registry study was a prospective, multicenter, observational, post-market study investigating the use of an insulin pump with or without continuous glucose monitoring (CGM) [i.e., sensor-augmented pump (SAP) or sensor-integrated insulin pump (SIP)]; before, during, and after pregnancy, in women with type 1 diabetes mellitus (T1DM). Methods. Study participants enrolled in 24 centers, in Poland, and contributed intake and follow-up data for up to 22 months (i.e., up to 12 months pre-conception, throughout pregnancy, and 6 weeks after delivery). Participants who were already pregnant were enrolled up to the 16th week of pregnancy. Investigated outcomes included HbA1c before and during pregnancy, and serious adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, miscarriage, and hospitalization due to any bleeding or any symptoms suggesting premature delivery). Routine clinical data including maternal weight, body mass index, and daily insulin use were also recorded. The insulin delivery devices used in the study were the MiniMed™ Paradigm™ REAL-Time insulin pump with CGM (via the MiniMed Sof-sensor™ sensor) or without CGM, and the MiniMed Paradigm Veo™ with CGM (via the Enlite™ sensor). Results. Study enrollment began in May 2013 and the last patient completed the study in August 2017. Conclusions. The ORCHESTRA FOUNDATION Registry study provides an opportunity to assess the effects of automated insulin delivery in pregnant women with T1DM using insulin pumps with or without continuous glucose monitoring

Cloud Bioinformatics in a private cloud deployment

This chapter describes service portability for a private cloud deployment, including a detailed case study about Cloud Bioinformatics services developed as part of the Cloud Computing Adoption Framework (CCAF). The Cloud Bioinformatics design and deployment is based on Storage Area Network (SAN) technologies, details of which include functionalities, technical implementation, architecture, and user support. Bioinformatics applications are written on the SAN-based private cloud, which can simulate complex biological sciences and present them in a way that anyone without prior knowledge can understand. Several bioinformatics results are discussed, particularly brain segmentation, which demonstrates different parts of the brain simulated by the private cloud. In addition, benefits of CCAF are illustrated using several bioinformatics examples such as tumour modelling, brain imaging, insulin molecules, and simulations for medical training. The Cloud Bioinformatics solution offers cost reduction, time-saving, and user friendliness. </jats:p

Uptake of Automated Insulin Delivery Systems: Costs and Insurance Reimbursement

Objective: In the next few years, many advances are expected in automated insulin delivery systems for patients with diabetes. However, these technologies will be expensive. With this, many questions surround the uptake of automated insulin delivery systems. This study examines the cost considerations for the uptake of these devices and the most important factors influencing insurance coverage from key stakeholder perspectives. Methods: This is a qualitative study based on interviews with individuals representing a diabetes professional organization, a device company and patients (Type 1 diabetics). Codes were assigned to interview responses, which were grouped by specific aim and stakeholder. A data matrix was used to identify reoccurring themes and patterns among stakeholders. Results: The main themes related to cost considerations were costs vs. benefits and complexity of the devices. The main factors influencing insurance coverage were a focus on short term outcomes, total cost of care for diabetics, an absence of research / data and upfront cost barriers for automated insulin delivery. Conclusions: To increase uptake of automated insulin delivery systems, my findings indicate the need to improve the technology largely by simplifying and reducing the complexity of the devices. Processes also need to be simplified for obtaining the device and securing ongoing supplies. Lastly, additional research is needed to show that automated insulin delivery is effective at improving outcomes for a broader range of Type 1 diabetics to support more extensive insurance coverage.Master of Science in Public Healt

Open source automated insulin delivery: addressing the challenge

Do-it-yourself automated insulin delivery systems for people living with type 1 diabetes use commercially available continuous glucose sensors and insulin pumps linked by unregulated open source software. Uptake of these systems is increasing, with growing evidence suggesting that positive glucose outcomes may be feasible. Increasing interest from people living with, or affected by, type 1 diabetes presents challenges to healthcare professionals, device manufacturers and regulators as the legal, governance and risk frameworks for such devices are not defined. We discuss the data, education, policy, technology and medicolegal obstacles to wider implementation of DIY systems and outline the next steps required for a co-ordinated approach to reducing variation in access to a technology that has potential to enable glucose self-management closer to target

Cele i metody Rejestru Klinicznego Fundacji ORKIESTRA : wieloośrodkowe badanie obserwacyjne dotyczące stosowania terapii z użyciem pompy insulinowej u kobiet w ciąży z cukrzycą typu 1 w Polsce

Background. The ORCHESTRA FOUNDATION Registry study was a prospective, multicenter, observational, post-market study investigating the use of an insulin pump with or without continuous glucose monitoring (CGM) [i.e., sensor-augmented pump (SAP) or sensor-integrated insulin pump (SIP)]; before, during, and after pregnancy, in women with type 1 diabetes mellitus (T1DM). Methods. Study participants enrolled in 24 centers, in Poland, and contributed intake and follow-up data for up to 22 months (i.e., up to 12 months pre-conception, throughout pregnancy, and 6 weeks after delivery). Participants who were already pregnant were enrolled up to the 16th week of pregnancy. Investigated outcomes included HbA1c before and during pregnancy, and serious adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, miscarriage, and hospitalization due to any bleeding or any symptoms suggesting premature delivery). Routine clinical data including maternal weight, body mass index, and daily insulin use were also recorded. The insulin delivery devices used in the study were the MiniMed™ Paradigm™ REAL-Time insulin pump with CGM (via the MiniMed Sof-sensor™ sensor) or without CGM, and the MiniMed Paradigm Veo™ with CGM (via the Enlite™ sensor). Results. Study enrollment began in May 2013 and the last patient completed the study in August 2017. Conclusions. The ORCHESTRA FOUNDATION Registry study provides an opportunity to assess the effects of automated insulin delivery in pregnant women with T1DM using insulin pumps with or without continuous glucose monitoring

The development and the perspective of Artificial Pancreas

Diabetes is characterized as a chronic hyperglycemic status caused by insulin insufficiency from pancreatic beta cells. The artificial pancreas is consisted of Continuous Glucose Monitoring (CGM) and insulin delivery according to the sensor glucose monitoring values. CGM does not monitor blood glucose concentration, but monitors subcutaneous glucose concentration, which is dispersed from blood vessel. The delay of glucose values of CGM is approximately 5 to 10 minutes compared with blood glucose values. Sensor augmented insulin pump 620G, which combines insulin pump and real time CGM is available from February 2015 in Japan. There are two more functions available from spring of 2017 in the United States, in addition to the 620G pump ; i.e. predictive low glucose suspend function, which suspend insulin delivery when hypoglycemia is predicted, and automated basal insulin increase when sensor glucose is high. The development of insulin infusion algorithm is still on the way, however, automated meal time insulin delivery will be introduced near future

Improving the clinical value and utility of CGM systems: issues and recommendations : a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionise the use of intensive insulin therapy in diabetes; however, progress towards that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardised format for displaying results and uncertainty on how best to use CGM data to make therapeutic decisions. This scientific statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes