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Insulin Delivery Systems

World's First Automated Insulin-delivery Device Approved In The U.s.

World's First Automated Insulin-delivery Device Approved In The U.s.

MORE The Food and Drug Administration (FDA) has approved the first automated insulin-delivery system. This represents a step toward a so-called artificial pancreas that could automatically regulate blood sugar levels for people who have diabetes. The device, made by the manufacturer Medtronic, has been approved to treat people with type 1 diabetes who are ages 14 and older. The product is set to start shipping in the spring of 2017, according to Medtronic. "The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases, especially those that require day-to-day maintenance and ongoing attention," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin." [Bionic Humans: Top 10 Technologies] Though the new product, called the MiniMed 670G, has been dubbed an artificial pancreas, it's a far cry from a truly biological cure for diabetes, as it does not replace the cells destroyed by the body. The device's insulin-delivery system relies on three elements: a coin-size transmitter attached to a tiny needle inserted into the skin that continuously tracks glucose levels, a pump that delivers precise doses of insulin as they are needed through a separate catheter inserted into the skin, and a computer chip that uses data from both to optimize the delivery of insulin on a minute-by-minute basis. Elusive control In people with type 1 diabetes, the body mistakes the beta cells in the pancreas, which make insulin, for foreign invaders, and attacks and destroys them 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 >>

Insulin Delivery Methods: Past, Present And Future

Insulin Delivery Methods: Past, Present And Future

Go to: INTRODUCTION The prevalence of diabetes is increasing throughout the world. The International Diabetes Federation estimated 366 million people had diabetes in 2011 and is expected rise to 552 million by 2030.[1] Though type 2 diabetes mellitus (T2DM) accounts for 85-95% of diabetes, the prevalence of T1DM has increased by 2-3% in certain parts of Europe and USA.[1,2] Thus, diabetes has become one of the most common noncommunicable diseases worldwide. Discovery of insulin was one of the greatest medical discoveries of the last century. All patients with T1DM and many patients with long standing T2DM require insulin therapy to achieve good glycemic control.[3,4,5] The early insulins were derived from bovine and porcine pancreas and were associated with immunological reactions, lipodystrophy and unpredictable insulin absorption from subcutaneous tissue. Hence, initial research focused on the purification of insulin.[4] There has been marked progression in the development of insulins such as rapid and long acting insulin analogs in the last five decades.[4] The landmark Diabetes Control and Complication Trial (DCCT), demonstrated the importance of intensive insulin therapy (IIT) in T1DM for prevention of micro- and macro-vascular complications.[5] However, IIT results in increased risk for hypoglycemia, which is a major obstacle in achieving glycemic targets.[6,7] Therefore, emphasis has evolved to achieving tight glycemic control with minimal hypoglycemia by focusing on delivering insulin that mimics endogenous insulin secretion by the pancreas.[4] Insulin is a peptide hormone, therefore, destroyed by gastric acid if taken orally. Intradermal absorption of insulin is not reliable, and it cannot mimic physiological insulin secretion. In addition, intradermal, intramu 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 >>

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 >>

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 >>

Insulin Delivery

Insulin Delivery

There are different ways to inject insulin into your body; this is called insulin delivery. Syringes, pens, pumps, and jet injectors give many persons with diabetes options for their insulin delivery. Syringe A syringe is a device with a hollow center, plunger, needle, and removable needle guard. The outside of the syringe is marked with lines to assist you when drawing up the correct amount of insulin. Some tips for using the syringe and needle for insulin delivery: Shorter needles mean less injection discomfort. However, injection depth affects how quickly insulin takes effect. Coordinate syringe size (e.g., 1cc, 1/2cc, 3/10cc) to match insulin dose. Do not re-use a syringe. Do not share a syringe. Dispose of used syringes in a sealable and puncture-resistant container (e.g., empty detergent bottle or in a special container created to dispose of medical waste—a sharps container) or check for drop-off sites in your community (e.g., pharmacy). Insulin Pen An insulin pen resembles a large pen. It replaces the vial and syringe, assists people with poor eyesight, and helps avoid over- or under-dosing. Different companies manufacture these devices. Pens use insulin cartridges and disposable needles. You can select (dial) the proper dose, which is displayed in the pen’s window. Some models allow you to reselect the dose if a mistake is made. Needles simply screw into place and are easily removed to be properly discarded. Some pens: Do not require refrigeration after the first use Have a memory to recall past doses Are prefilled, disposable More durable than others Some tips for using an insulin pen: Avoided prolonged exposure to cold or heat—keep your pen at room temperature after the first use. Never carry an insulin pen with the needle attached Do not re-use needles 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 >>

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 >>

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 >>

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 >>

Hybrid Closed-loop Insulin Delivery Systems For Type 1 Diabetes Come Of Age

Hybrid Closed-loop Insulin Delivery Systems For Type 1 Diabetes Come Of Age

At 19 months old, Jamie Kurtzig was diagnosed with Type 1 diabetes. For the next 10 years, her parents would wake up every three hours during the night to prick their daughter’s finger so they could check her blood glucose level. If her blood glucose was too low, they gave her food to avoid seizures or a loss of consciousness. If it was too high, they gave her an insulin injection to bring the level down to a normal range. “It’s caused a kind of PTSD for my husband and me,” said Sara Kurtzig, who lives with her daughter and husband in Marin, California. But for the past year, they’ve been able to sleep through most nights. That’s because Jamie started using a hybrid closed-loop insulin delivery system in 2016, thanks to a clinical trial at Lucile Packard Children’s Hospital Stanford and Stanford Medicine that assessed the system’s use in children ages 7 to 14. “The closed-loop system has completely changed our lives,” Sara said. “It took me a month to trust it, but now I can go to bed at 11 p.m. and wake up at 6:30 a.m. almost every night.” The system is among the methods being tested by researchers at the School of Medicine and Lucile Packard Children’s Hospital in their efforts to find easier ways for younger children with Type 1 diabetes to get the doses of insulin they need. Bruce Buckingham, MD, professor of pediatric endocrinology, directs clinical trials of the closed-loop system, which modulates insulin delivery based on glucose sensor readings measured every five minutes. He called the system a “historic advance” for diabetes care. “With this system, patients can achieve very reliable and safe overnight glucose control, mitigating overnight highs and lows with minimal manual intervention,” said Buckingham, who treats patients a 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 >>

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