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Insulin Delivery Systems

Pumps Plus: Automated Insulin Delivery Systems Coming Soon

Pumps Plus: Automated Insulin Delivery Systems Coming Soon

Pumps Plus: Automated Insulin Delivery Systems Coming Soon How can we reduce the burden of type 1 diabetes? Automated insulin delivery systems could be the answer. Data from randomized controlled trials show that patients who use automated insulin delivery systems have greater time in target range, fewer glucose swings throughout the day and especially at night, and overall HbA1C improvements. Changes to the type 1 diabetes standard of care are on the horizon. The first FDA-approved automated insulin delivery system, the Medtronic 670G Hybrid Closed Loop (HCL) system, will enter the market this year. Additional innovative systems are expected to follow. A review article published in Pediatric Diabetes discusses these devices' challenges and clinical implications, as well as the learning curves experienced by patients and providers. Existing insulin pump devices are functionally similar, but newer automated delivery systems include pumps augmented with continuous glucose monitors and dosing algorithms. Each system is unique in subtle ways. Automated systems function in 2 ways: closed loop/auto mode (adjusting insulin delivery every 5 minutes) or standard open loop/pump mode (suspending insulin delivery for safety). The authors used the acronym CARE (calculate, adjust, revert, and educate) to simplify the understanding of automated insulin delivery. CALCULATE: Automated systems have fixed and modifiable parameters for dosing that may differ for auto and pump mode. Clinicians need to understand the parameters to dose patients properly. ADJUST: Users need to know how to adjust insulin to manage glycemic excursions. REVERT: Patients must know when the device reverts to pump mode automatically and how to manage this. Patients should also know when to manually revert to pump Continue reading >>

New Diabetes Products For 2017: Insulin Delivery Devices

New Diabetes Products For 2017: Insulin Delivery Devices

For the last year, Diabetes Self-Management has been following all the new innovations and products aimed at helping to improve the lives of those living with diabetes. From the latest glucometers and monitoring systems to insulin pumps, pens, and treatments, several major advancements made their impact on the diabetes community in 2016. When selecting some of the new products, we first talked to Gary Scheiner, MS, CDE, clinical director of Integrated Diabetes Services of Wynnewood, Pennsylvania. Scheiner, known as the MacGyver of diabetes products, has lived with Type 1 diabetes for more than 30 years. He tries out new products before recommending them to patients. “It’s important to see new products from the user’s point of view, not just from the [health-care practitioner’s] side of things,” said Scheiner. In 2016, the pace of innovation continued to race ahead with unbelievable technology right out of a Star Trek episode. The growing use of smartphone technology and mobile applications has led to better access to blood glucose readings, general health information, and much more. Read on to learn about the newest products. We guarantee you there’s something here for everyone, whether you live with Type 1 or Type 2 diabetes. In this installment, we look at insulin delivery devices that have recently hit the market. Insulin pumps, pens, and patches Joining its family of insulin pumps, Tandem Diabetes Care introduced the t:slim X2 Insulin Pump — similar to the t:slim — late last year. The new pump features an advanced two-way Bluetooth radio and uses technology to update software remotely, much like a mobile phone. The pump is compatible with the Tandem Device Updater, a new tool that allows users to update the software from a personal computer. The pump Continue reading >>

Insulin Delivery System For Diabetics - New

Insulin Delivery System For Diabetics - New

home / diabetes center / diabetes a-z list / insulin delivery system for diabetics - new article New Insulin Delivery System for Diabetics The Food and Drug Administration (FDA) has cleared the first device for diabetics which integrates a glucose meter and an insulin pump with a dose calculator into one device. The new device could be the first step in the development of a fully automated glucose monitoring and insulin delivery system. The product, made by Medtronic MiniMed, Inc., and Becton Dickinson, combines the Medtronic MiniMed Paradigm insulin pump with a Becton Dickinson glucose monitor and facilitates data interchange between the two. It has additionalcircuitry and software modifications that allow it to transmit glucose values tothe insulin pump and to transfer data between the insulin pump and a personalcomputer running the appropriate Medtronic MiniMed communications software. Since the glucose meter calculates and transmits information to the insulinpump automatically, it prevents the errors that sometimes can result whenpatients input this data manually. In addition, use of the integrated system isexpected to make it more convenient for people to manage their diabetes. "Due to the continuing advances in the ability to provide drug treatments exactly as needed, care for patients with diabetes is evolving," said FDA Commissioner Mark D. McClellan, M.D. Ph.D. "FDA is prepared tomeet the new opportunities of combination products by adapting its resources toaddress these new technologies." FDA cleared the device for marketing based on the safety and effectiveness ofthe separately marketed components and on reviews of the new deviceconfiguration, the software, and usability studies and electromagneticinterference compatibility testing conducted by the firms. Fo Continue reading >>

Self-regulating Insulin Delivery Systems I. Synthesis And Characterization Of Glycosylated Insulin

Self-regulating Insulin Delivery Systems I. Synthesis And Characterization Of Glycosylated Insulin

Volume 1, Issue 1 , September 1984, Pages 57-66 Self-regulating insulin delivery systems I. Synthesis and characterization of glycosylated insulin Get rights and content A design for a self-regulating insulin delivery system based on the competitive binding of glucose and glycosylated insulin to the lectin Concanavalin A is proposed. A differnt approach to diabetes therapy is the attempt to effect a permanent cure of the disease by supplementing the patient's defective pancreas with a normally functioning transplant. However, pancreatic transplantation in humans is still in its early stage, and the major problems including rejection of the transplants still remain unsolved. In phas one, eight glycosylated insulin derivatives were synthesized. Maltose was directly coupled to bovine insulin by reductive amination. Succinyl- and giutaryl-glucosamine derivatized insulins were synthesized by a mixed anhydride method using the appropriate substituted glucosamines. Monosaccharide derivatives p-aminophenyl--D-glucopyranoside and p-aminophenyl--D-mannopyranoside were also coupled to insulin via succinate and glutarate spacers p-D-(-D-glucopyranosyloxy)-phenyl-thiocarbawoyl insulin was obtained by reacting insulin with p-isothiocyanatophenyl--D-glucopyranoside, which was obtained through conversion of p-aminophenyl--D-glucopyranoside with thiophosgene. Unreacted maltose and other carbohydrate derivatives were removed by gel permeation chromatography or dialysis unmodified insulin was removed by affinity chromatography. The yield and purity of the carbohydrate derivatives were determined by IR, NMR and MS/GC. Continue reading >>

Fda Reflects On Clearing Its First Closed-loop Insulin Delivery System

Fda Reflects On Clearing Its First Closed-loop Insulin Delivery System

FDA reflects on clearing its first closed-loop insulin delivery system Heads of the FDAs Center for Devices and Radiological Health (CDRH) recently penned a blog post describing their previous and ongoing efforts with closed-loop artificial pancreas manufacturers to ensure proper testing and validation of the devices. In it, Courtney Lias, director of the Division of Chemistry and Toxicology Devices at CDRH, and Stayce Beck, chief of the Diabetes Diagnostics Branch at CDRH, wrote that the experience was fraught with assumptions that can arise when novel technological approaches lack a well-defined regulatory path. Without such guideposts, even well-intentioned scientists and businesses can make incorrect assumptions that can cost a lot of time and money, such as assuming FDA only will accept certain types of rigidly-defined data, they wrote. Such assumptions inevitably delay patient access to important devices. These concerns were at the forefront of the agency as it was preparing to approve Medtronics MiniMed device in 2016, Lias and Beck wrote. Diabetes and medical device communities did not believe that an insulin delivery device that works without human input would ever receive a nod from the FDA, and believed that the agencys caution would unnecessarily delay its availability. To correct these assumptions and open a line of communication between FDA and the diabetes community, we developed a proactive approach with patients, their caregivers, device developers, academia, and the many doctors and scientists who have devoted their careers to developing automated insulin dosing systems, Lias and Beck wrote. Along with reaching out to these stakeholders from 2012 onward, the FDAs artificial pancreas team met monthly with Medtronic to design an appropriate study based Continue reading >>

Medicare Part D To Cover Omnipod Insulin Delivery System

Medicare Part D To Cover Omnipod Insulin Delivery System

Medicare Part D to Cover Omnipod Insulin Delivery System The Omnipodinsulin management system (Insulet Corporation) may be covered now under the Medicare Part D (prescription drug) program, according to the Centers for Medicare and Medicaid Services (CMS). Omnipod performs the same functions as a traditional insulin pump, but with a different design. Rather than a pump that attaches via tubing connected to an infusion site on the body, the insulin-containing "pods" are worn directly on the body and insulin infusion is controlled wirelessly by a "personal diabetes manager [PDM]" that also houses a glucose meter. Because of its unique design the PDM is nondisposable, but the pods that delivers the insulin are replaced every 3 days the system does not meet the criteria for durable medical equipment under Medicare Part B, the way other insulin pumps are covered. Instead, CMS has deemed the system reimbursable under Part D as a medical supply "associated with the injection of insulin," a category that also includes syringes and pens, needles, and alcohol swabs. Another insulin delivery device, the V-Go (Valeritas), is also covered under Medicare Part D. "We expect that technology will continue to advance and 'medical supplies associated with the injection of insulin' will become significantly more sophisticated. Part D sponsors may include such supplies in their benefit," Jennifer R Shapiro, Acting Director of the Medicare Drug Benefit and C&D Data Group, Baltimore, Maryland, wrote in a letter to Part D Plan carriers. But coverage isn't mandatory, she said. "While CMS recognizes such products as medical supplies that are alternatives to insulin syringes, CMS does not require Part D sponsors to include them on their formularies, and sponsors may apply utilization management Continue reading >>

Oral Insulin Delivery Systems Based On Complexation Polymer Hydrogels

Oral Insulin Delivery Systems Based On Complexation Polymer Hydrogels

Oral insulin delivery systems based on complexation polymer hydrogels Author links open overlay panel M.Morishita1 Get rights and content The potential of complexation hydrogels composed of poly(methacrylic acid) grafted with poly(ethylene glycol) (P(MAA-g-EG)) for oral dosage forms of insulin is reviewed. The complexation hydrogels exhibit unique pH-responsive characteristics in which interpolymer complexes are formed and dissociated, respectively, in acidic and neutral/basic environments. The hydrogels are capable of highly incorporating and rapidly releasing insulin in vitro and possess mucoadhesive properties and calcium binding capacities which affect the proteolytic activity of calcium- dependent enzymes. The insulin-loaded P(MAA-g-EG) (ILP) successfully enhanced oral insulin absorption without detectable mucosal damage following administration to normal, type 1 and 2 diabetic rats via oral route. Furthermore, ILP significantly suppressed the postprandial rise in blood glucose and showed continuous hypoglycemic effects following multiple oral administration to type 1 and 2 diabetic rats in the presence of foods. These results indicate that the blood glucose levels of diabetics can be effectively controlled by oral ILP administration. Based on these data it is anticipated that the complexation hydrogels will be used for clinical development of oral insulin delivery system, as clinical application of ILP may avoid suffering from injection pain and poor compliance for diabetic patients. Continue reading >>

A Study Of An Automated Insulin Delivery System In Participants With Type 1 Diabetes Mellitus (t1dm)

A Study Of An Automated Insulin Delivery System In Participants With Type 1 Diabetes Mellitus (t1dm)

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT03367390 Information provided by (Responsible Party): Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as it was designed to. This study will last approximately 12-18 days, not including screening. Screening is required within 28 days prior to the start of the study. An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus Experimental: AID System Containing Insulin Lispro The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component. Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia. Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Informatio Continue reading >>

Self-regulating Insulin Delivery Systems I. Synthesis And Characterization Of Glycosylated Insulin

Self-regulating Insulin Delivery Systems I. Synthesis And Characterization Of Glycosylated Insulin

Volume 1, Issue 1 , September 1984, Pages 57-66 Self-regulating insulin delivery systems I. Synthesis and characterization of glycosylated insulin Get rights and content A design for a self-regulating insulin delivery system based on the competitive binding of glucose and glycosylated insulin to the lectin Concanavalin A is proposed. A differnt approach to diabetes therapy is the attempt to effect a permanent cure of the disease by supplementing the patient's defective pancreas with a normally functioning transplant. However, pancreatic transplantation in humans is still in its early stage, and the major problems including rejection of the transplants still remain unsolved. In phas one, eight glycosylated insulin derivatives were synthesized. Maltose was directly coupled to bovine insulin by reductive amination. Succinyl- and giutaryl-glucosamine derivatized insulins were synthesized by a mixed anhydride method using the appropriate substituted glucosamines. Monosaccharide derivatives p-aminophenyl--D-glucopyranoside and p-aminophenyl--D-mannopyranoside were also coupled to insulin via succinate and glutarate spacers p-D-(-D-glucopyranosyloxy)-phenyl-thiocarbawoyl insulin was obtained by reacting insulin with p-isothiocyanatophenyl--D-glucopyranoside, which was obtained through conversion of p-aminophenyl--D-glucopyranoside with thiophosgene. Unreacted maltose and other carbohydrate derivatives were removed by gel permeation chromatography or dialysis unmodified insulin was removed by affinity chromatography. The yield and purity of the carbohydrate derivatives were determined by IR, NMR and MS/GC. Continue reading >>

Hybrid Closed Loop System.

Hybrid Closed Loop System.

NEW! The Suspend before low§ option avoids lows and rebound highs proactively by automatically stopping insulin 30 minutes before you reach your pre-selected low limits, then automatically restarts insulin when your levels recover, all without bothersome alerts. NEW! The Auto Mode‡ option automatically adjusts your basal insulin delivery every 5 minutes based on your sugar levels to keep you in target range, all day and night. Watch Video View Brochure Get Started NEW! Guardian® Sensor 3 continuous glucose monitoring sensor. Introducing the most accurate sensor from Medtronic, now with up to 7 day wear and easy insertion. It is the FIRST and ONLY continuous glucose monitoring sensor FDA approved and trusted to control insulin dosing. Exclusive CONTOUR®NEXT LINK 2.4 meter1 Get easy and accurate CGM calibration, insulin dosing and remote bolusing with our exclusive meter. “This device will mean peace of mind, in knowing a person will be in normal blood sugar range a great majority of the time,” “It’s a medical device with the potential to change the lives of more than 1 million Americans who suffer from Type 1 diabetes.” KEEP YOUR GLUCOSE IN RANGE SMARTGUARD® HCL TECHNOLOGY. Quick and easy access to your glucose and insulin information, all from the home screen. Bright color screen for easy readability - day or night. Waterproof - so you can enjoy underwater activities. Quick and easy bolus from your meter. Fewer shots than multiple daily injections. The only sensor FDA approved and trusted to control insulin dosing. Easy to insert. Know at all times where your glucose levels are trending. Click here for assistance if your insurance does not currently cover the MiniMed 670G system. * Mean Absolute Relative Difference. ** 3-4 calibrations per day required. Continue reading >>

Types Of Insulin Delivery Systems

Types Of Insulin Delivery Systems

You need insulin to control your diabetes. But there are a few decisions you and your doctor still need to make, including how you take that insulin. The options include pens, syringes, pumps, jet injectors, and an inhaler. Choosing an Insulin Delivery System People often make their choice based on what their health insurance will cover, says Vivian Fonseca, MD, professor of medicine at Tulane University School of Medicine. Your insurance may only pay for one type of insulin delivery system. If you want a different option, you'll have to pay for it on your own. Aside from your insurance coverage, your choice should be based on which system you feel most comfortable with, Fonseca says. "There are people who handle syringes better than others," he says. "And while many do well with pumps, some patients either don't like them or don't manage to use them effectively." Insulin Syringes You use one of these to inject insulin into your body with a very fine needle. Pros: Flexibility. You can choose from different types of needles and syringes. You can also use them with just about any kind of insulin. Cost savings. A box of 100 syringes costs about $10 to $15. They’re also more likely than other delivery systems to be covered by your insurance. Cons: Time. "The real problem with the syringe is the amount of steps you have to take," Fonseca says. Before injecting you need to fill the syringe with air, attach the needle, and draw the correct dose of insulin into the syringe. Dosing mistakes. "The syringe is totally manual, and it possibly leads to more errors," Fonseca says. It's up to you to make sure you inject the right dose. Continue reading >>

A Study Of An Automated Insulin Delivery System In Participants With Type 1 Diabetes Mellitus (t1dm)

A Study Of An Automated Insulin Delivery System In Participants With Type 1 Diabetes Mellitus (t1dm)

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT03367390 Information provided by (Responsible Party): Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system and to test whether the AID System functions as it was designed to. This study will last approximately 12-18 days, not including screening. Screening is required within 28 days prior to the start of the study. An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus Experimental: AID System Containing Insulin Lispro The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component. Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia. Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Informatio Continue reading >>

Recent Challenges In Insulin Delivery Systems: A Review

Recent Challenges In Insulin Delivery Systems: A Review

Recent Challenges in Insulin Delivery Systems: A Review Department of Pharmaceutics, Faculty of Pharmacy and Health Sciences, Ajman University of Science and Technology Network, P.O. Box 2202, Al-Fujairah, UAE Department of Pharmaceutics, Faculty of Pharmacy and Health Sciences, Ajman University of Science and Technology Network, P.O. Box 2202, Al-Fujairah, UAE 1Faculty of Pharmacy, Philadelphia University, P.O.Box 1, Postal Code 19392, Jordan *For correspondence E-mail: [email protected] Received 2007 Mar 23; Revised 2008 Feb 21; Accepted 2008 May 9. Copyright Indian Journal of Pharmaceutical Sciences This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. This article has been cited by other articles in PMC. Relatively, a large percentage of world population is affected by diabetes mellitus, out of which approximately 5-10% with type 1 diabetes while the remaining 90% with type 2. Insulin administration is essential for type 1 patients while it is required at later stage by the patients of type 2. Current insulin delivery systems are available as transdermal injections which may be considered as invasive. Several non-invasive approaches for insulin delivery are being pursued by pharmaceutical companies to reduce the pain, and hypoglycemic incidences associated with injections in order to improve patient compliance. While any new insulin delivery system requires health authorities' approval, to provide long term safety profile and insuring patients' acceptance. The inhalation delivery system Exubera has already become clinically available in the United States and Europe for patients with diabetes a Continue reading >>

Pumps Plus: Automated Insulin Delivery Systems Coming Soon

Pumps Plus: Automated Insulin Delivery Systems Coming Soon

Pumps Plus: Automated Insulin Delivery Systems Coming Soon How can we reduce the burden of type 1 diabetes? Automated insulin delivery systems could be the answer. Data from randomized controlled trials show that patients who use automated insulin delivery systems have greater time in target range, fewer glucose swings throughout the day and especially at night, and overall HbA1C improvements. Changes to the type 1 diabetes standard of care are on the horizon. The first FDA-approved automated insulin delivery system, the Medtronic 670G Hybrid Closed Loop (HCL) system, will enter the market this year. Additional innovative systems are expected to follow. A review article published in Pediatric Diabetes discusses these devices' challenges and clinical implications, as well as the learning curves experienced by patients and providers. Existing insulin pump devices are functionally similar, but newer automated delivery systems include pumps augmented with continuous glucose monitors and dosing algorithms. Each system is unique in subtle ways. Automated systems function in 2 ways: closed loop/auto mode (adjusting insulin delivery every 5 minutes) or standard open loop/pump mode (suspending insulin delivery for safety). The authors used the acronym CARE (calculate, adjust, revert, and educate) to simplify the understanding of automated insulin delivery. CALCULATE: Automated systems have fixed and modifiable parameters for dosing that may differ for auto and pump mode. Clinicians need to understand the parameters to dose patients properly. ADJUST: Users need to know how to adjust insulin to manage glycemic excursions. REVERT: Patients must know when the device reverts to pump mode automatically and how to manage this. Patients should also know when to manually revert to pump Continue reading >>

Future Of Automated Insulin Delivery Systems

Future Of Automated Insulin Delivery Systems

Original ArticlesOpen AccessOpen Access license Future of Automated Insulin Delivery Systems Advances in continuous glucose monitoring (CGM) have brought on a paradigm shift in the management of type 1 diabetes. These advances have enabled the automation of insulin delivery, where an algorithm determines the insulin delivery rate in response to the CGM values. There are multiple automated insulin delivery (AID) systems in development. A system that automates basal insulin delivery has already received Food and Drug Administration approval, and more systems are likely to follow. As the field of AID matures, future systems may incorporate additional hormones and/or multiple inputs, such as activity level. All AID systems are impacted by CGM accuracy and future CGM devices must be shown to be sufficiently accurate to be safely incorporated into AID. In this article, we summarize recent achievements in AID development, with a special emphasis on CGM sensor performance, and discuss the future of AID systems from the point of view of their inputoutput characteristics, form factor, and adaptability. Advances in continuous glucose monitoring (CGM) technology have brought in the era of automated insulin delivery (AID). AID involves CGM values feeding into a closed-loop control (CLC) algorithm running on an insulin pump (embedded AID) or on a smart phone (Mobile AID). Advanced CLC algorithms typically use CGM data, feedback from insulin delivery (e.g., insulin-on-board, or IOB, calculation), and potentially other signals to modify the insulin delivery rate. Due to its promise to optimize diabetes control, AID may soon emerge as the standard of care for managing type 1 diabetes. One challenge of managing diabetes without significant hypoglycemia relates to the wide fluctuation in Continue reading >>

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