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Diabetes Implant Device

New Implants Could Treat Type 2 Diabetes Without Needles

New Implants Could Treat Type 2 Diabetes Without Needles

Implants that deliver a constant metered dose of medication have plenty of promise. They’re especially useful for making sure patients don’t have to orient their daily schedule around their medication times. For the same reasons, they’re a potential solution for patients who tend to forget to take medications that have to be delivered right on schedule. Their major strength is being able to keep a patient’s serum concentration of their medication at a specific level. For example: Nexplanon, a hormonal contraceptive implant, delivers a constant dose of medication that keeps a woman’s progesterone levels within a particular range that prevents her from ovulating. Too high or too low a dose, and everything would get out of whack. But the implant keeps the serum concentration pretty stable. But because of the steady diffusion of the active substance, such drug-delivery implants aren’t fabulous for conditions that require medication only when symptoms appear. There hasn’t been a lot of luck with an implant for asthma, for example, because we haven’t surpassed the rescue inhaler for timely asthma treatment. Another condition that has resisted the implant approach is type 2 diabetes. Because type 2 is all about insulin insensitivity, and insulin is something that operates in a tight feedback loop with fluctuating blood glucose levels, you don’t necessarily want a blood insulin concentration that’s always held stable at the same level. Monitoring Blood Chemistry in Real Time Not to worry, though: the biotechnologists are on this. Scientists are developing implantable biomedical microelectromechanical systems (bioMEMS) that can monitor your blood chemistry in real time, deliver timed and quantized doses of medication, and phone home to your doctor to report o Continue reading >>

Pancreas Cell Implant Aims To Eliminate Insulin Injections

Pancreas Cell Implant Aims To Eliminate Insulin Injections

Encellin is working to eliminate insulin injections for diabetic patients with an insulin-producing implant containing live cells. A California startup hopes to eliminate insulin injections for diabetic patients with an insulin-producing implant containing live cells. The device is in preclinical trials and the company, Encellin, is preparing for clinical trials. The concept of packaging cells in semipermeable membranes could have other medical uses as well. Cells naturally produce small molecules, proteins, and hormones to keep a body functioning properly, Encellin CEO and co-founder Crystal Nyitray, who pioneered the technology, explained. Rather than relying on injections or pills to replace biomolecules not produced by diseased cells, she envisions medical treatments using encapsulated cells. “Cells are the ultimate smart machines,” Nyitray said. “The packages can hold molecular machines that secrete the necessary treatment.” About 20 million people worldwide have type-1 diabetes, which leaves them dependent on insulin injections to help regulate their blood sugar. The disease occurs when patients’ immune systems kills cells in the pancreas that produce the hormone insulin, which enables glucose, a form of sugar, to enter their cells. To replace the missing insulin, patients with type-1 diabetes inject themselves with insulin around mealtime. This helps their bodies utilize the surge of glucose that enters their bloodstream as they digest their food. Despite frequent monitoring of blood sugar levels and dose adjustments, insulin injections do not perfectly recreate the natural waves of insulin released from the pancreas. This leaves patients constantly working to avoid chronically high or low blood sugar, which can cause blindness, diabetic coma, or life-t Continue reading >>

Smartphone-controlled Cells Release Insulin On Demand In Diabetic Mice

Smartphone-controlled Cells Release Insulin On Demand In Diabetic Mice

A push of a button causes the cells implanted in this mouse's back to start making insulin. Here, the mouse is standing inside a coil that powers the implant. Future versions would need to be battery operated in order to work in humans. People with diabetes often need to inject themselves with insulin on a daily or weekly basis. But a new device, tested in mice, might one day eliminate the need for needles. In a study published today in Science Translational Medicine, Chinese researchers used a smartphone app to switch on insulin-producing cells implanted in a small group of diabetic mice. Less than two hours after the cells were switched on, the animals’ blood sugar stabilized, without making them hypoglycemic. Play Video Play Loaded: 0% Progress: 0% Remaining Time -0:00 This is a modal window. Foreground --- White Black Red Green Blue Yellow Magenta Cyan --- Opaque Semi-Opaque Background --- White Black Red Green Blue Yellow Magenta Cyan --- Opaque Semi-Transparent Transparent Window --- White Black Red Green Blue Yellow Magenta Cyan --- Opaque Semi-Transparent Transparent Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Dropshadow Font Family Default Monospace Serif Proportional Serif Monospace Sans-Serif Proportional Sans-Serif Casual Script Small Caps Defaults Done The most advanced version of this device uses a coin-sized hydrogel capsule, implanted under a mouse’s skin. Inside the capsule are LED lights and cells that are engineered to release insulin in response to far infrared light. When the mouse’s blood sugar gets too high, buttons on a custom-made Android app switch on the LEDs, triggering the cells to release insulin. The app allows the user to determine how bright the LEDs should shine, and for how l Continue reading >>

Implanted Glucose Sensor Works For More Than One Year

Implanted Glucose Sensor Works For More Than One Year

The glucose sensor is featured on the cover of the July 28, 2010 issue of the journal Science Translational Medicine. CREDIT: C. BICKEL/SCIENCE TRANSLATIONAL MEDICINE Bioengineers at the University of California, San Diego and GlySens Incorporated have developed an implantable glucose sensor and wireless telemetry system that continuously monitors tissue glucose and transmits the information to an external receiver. The paper, published in the July 28, 2010 issue of the journal Science Translational Medicine, describes the use of this glucose-sensing device as an implant in animals for over one year. After human clinical trials and FDA approval, the device may be useful to people with diabetes as an alternative to finger sticking, and to short-term needle-like glucose sensors that have to be replaced every three to seven days. "The Science Translational Medicine paper shows our implanted sensors to be successful in animals. You can run the device for a year or more with it constantly working, and recording glucose quite satisfactorily. Now, we are focused on getting the human clinical trials going. We hope to begin the first human trial within in a few months," said Gough, the bioengineering professor from the UC San Diego Jacobs School of Engineering. "If all goes well with the human clinical trials, we anticipate that in several years, this device could be purchased under prescription from a physician." Glucose Sensor Could be Useful for People with either Type 1 or Type 2 Diabetes The long-term glucose sensor could be used by people with either Type 1 or Type 2 diabetes. People with Type 1 diabetes do not make enough insulin of their own. The long-term glucose sensors could be used to adjust the insulin dose and timing of the injection, and reduce the risk of taking Continue reading >>

Novel Devices For Delivering Diabetes Medications: Their Value And Some Coverage Considerations

Novel Devices For Delivering Diabetes Medications: Their Value And Some Coverage Considerations

Novel Devices for Delivering Diabetes Medications: Their Value and Some Coverage Considerations Department of Medicine, Case Western Reserve University School of Medicine; Medical Director, Population Health Management, Exchange Solutions, Conduent HR Services According to 2014 statistics from the CDC, diabetes affects 12.6% of the US adult population (CDC 2016), and of those individuals, fewer than half are deemed to be at their treatment goal (ODPHP 2016). Both patient-related and provider-related factors contribute to observed suboptimal outcomes. Patient-related factors include high out-of-pocket treatment costs that contribute to reduced adherence to medication regimens and outpatient monitoring of diabetes, particularly in the setting of high-deductible health plans (Fronstin 2013). Because individuals in the lowest socioeconomic category have the highest prevalence of diabetes, costs borne by patients are a major factor in adherence to diabetes medications and monitoring. Behavioral or cognitive factors, including health literacy and health care consumer engagement, are a particular concern for this subpopulation and may also influence treatment adherence in other subgroups as well. From the perspective of a health care delivery system, other factors likely influence diabetes treatment outcomes, including timeliness of therapeutic intensification, effectiveness of instruction regarding diabetes self-care, and attention to social determinants of health. High out-of-pocket costs for patients may reduce the frequency of physician visits for routine diabetes care, thereby limiting diabetes monitoring and management capabilities. The resulting suboptimal disease control is associated with an increased risk of diabetes-related complications and their associated costs. Continue reading >>

Smart Technology For Diabetes Self-care

Smart Technology For Diabetes Self-care

Wearables, Implants, and Apps, Oh My! If you have diabetes, you must consistently monitor your diet, lifestyle, and glucose levels, and keeping track of everything can be both inconvenient and difficult. Matters can become even more complicated if you have other health conditions with which to contend. Fortunately, technology can help. Technological innovations Strides have been made to ensure technology keeps pace with assisting people in self-managing their diabetes. By incorporating a personalized approach, technology has become a useful tool; in particular, mobile and Internet-ready smartphones have been found to be the most effective for integrating diabetes care into day-to-day living. A 2009 study conducted by Julie Polisena and her team at the Canadian Agency for Drugs and Technologies in Health found storing or sharing self-monitored blood glucose using home telehealth tools such as PDAs or fax machines, supported with physician feedback, showed improved glycemic levels and reduced hospitalizations. Technology now has evolved beyond telehealth. Smart technology exists as wearables, implants, and mobile applications to track glucose levels, share data, access relevant information, communicate with both health-care providers and others with diabetes, and, ultimately, guide you in making better decisions. Wearable technology Wearable technology comprises gadgets that can be worn and are equipped with sensors and wireless connectivity to assist with monitoring blood sugar levels, personalizing treatment, connecting with health-care providers, and even delivering medication into the body. It’s a huge departure from the traditional finger pricking method of glucose monitoring. Some wearables on the horizon for diabetes include smart skin patches, contact lens, and Continue reading >>

Dexcom's Implantable Blood Sugar Monitor Sales Rise

Dexcom's Implantable Blood Sugar Monitor Sales Rise

Summary Inadequate monitoring of glucose levels is responsible for most serious diabetes complications, especially those that require hospitalization. Dexcom received FDA approval for a seven day realtime glucose monitor implant that is compatible with iPhone (Android by mid 2017). Expansion in sales both foreign and domestic has led to company estimates of potential profitability in 2018. Dexcom Incorporated (NASDAQ:DXCM) is a medical device company focused on transforming diabetes care. The company is a leader in using implant technology to improve glucose management, with a novel specialized "therapeutic" glucose monitor enabling real-time tracking via cellular phone. Inadequate glucose monitoring is associated with serious complications of diabetes, including hospitalization and cardiovascular morbidity. The technology works as a "once per week" discrete sensor that is placed under the skin which connects to a transmitter that sends a signal to a display device. Glucose levels are able to be tracked over time to provide diabetic patients (or their remote families) information about daily or event-driven glucose fluctuations. Diabetes is a profile of diseases that center around the hormone insulin and its modulatory effects on blood sugar. It is surrounded by a vast number of complications and comorbidity factors. A specific cell type in the endocrine pancreas, called Beta cells, are responsible for insulin production. In type 1 diabetes no insulin is produced, and is associated with an early onset in age. The more common type 2 diabetes has a later onset and is characterized by low insulin production. Prediabetes includes a subset of people beginning to show signs of type 2 diabetes with higher than normal levels of blood glucose, but not high enough to meet the thr Continue reading >>

Diabetes Patients Test Insulin-releasing Implants

Diabetes Patients Test Insulin-releasing Implants

A pilot study underway at the University of Alberta is using small implants filled with stem cells to regulate insulin in a handful of diabetic patients -- a technology that, if proven effective, could replace injections. Five Edmonton patients are among 17 others involved in the trial, which is the world’s first experiment of the innovative new treatment. And while the research is in its initial stages, one doctor involved in the research calls the early indicators “terribly exciting.” “So far it’s been very safe and it looks like it’s working the way we hoped it would,” Dr. James Shapiro told CTV News. Type 1 diabetes results when a person’s immune system destroys insulin-producing beta cells in the pancreas. Patients with diabetes must regularly test their blood sugar levels and manually inject insulin to balance out their systems. The testing and injection routine -- alongside dietary restrictions -- can be complicated and worrisome, which is why many patients are excited about the prospect of a self-releasing insulin implant. The innovative new treatment involves implanting small plastic pouches filled with millions of insulin-producing cells under a patient’s skin. Blood vessels then grow around the implants, allowing the stem cells inside the pouch to release the necessary dose of insulin based on the patient’s blood sugar levels. The technology has already proved effective on lab mice. Doctors are now testing whether the method is safe for humans. For one Edmonton man involved in the study, the method offers hope. Chris Townsend, 38, says he watches his sugar levels and needs daily insulin injections and blood tests. “It would be incredible. Like, just to be able to not worry anymore,” he said. Townsend had eight of the plastic pouches im Continue reading >>

Beta Cell Replacement

Beta Cell Replacement

Imagine a future where people with type 1 diabetes (T1D) won’t need to take insulin for months, possibly years, at a time thanks to a small implant. Why it matters Managing T1D and keeping blood glucose within a safe range is a complicated, time-consuming task. Everyone living with the disease experiences high- and low-blood-sugar episodes, because insulin therapy is an imperfect science. Encapsulated beta cell replacement therapies could be a game changer. They could liberate people with T1D from the burdens of managing their disease all day, every day. These therapies involve wrapping insulin-producing islet cells in a protective barrier before implanting them into the body. The barrier shields the cells from being destroyed by an attack from the immune system, but the cells are still able to sense changes in blood-sugar levels and release insulin and other required hormones whenever they’re needed. Our pioneering research Successful encapsulated beta cell replacement therapies will bring the same benefits as islet cell transplantation—a treatment that, not long ago, created tremendous excitement in the T1D community. Research has shown that many recipients of these transplants can achieve normalized blood-glucose control for up to five years or longer. But widespread use of islet transplants is not possible for two reasons: not enough islets are available; and transplant recipients must take powerful drugs to prevent the immune system from destroying the transplanted cells. Encapsulated beta cell replacement therapies have the potential to overcome both obstacles. Beta cells are the islet cells responsible for producing insulin. JDRF has been a driving force behind beta cell replacement research that could make beta cell replacement a widely available option fo Continue reading >>

Insulin Pump Overview

Insulin Pump Overview

As people with diabetes know, keeping blood sugar levels in a safe range is extremely important. Good blood sugar control not only makes you feel well, but also helps prevent long-term diabetes complications, such as blindness, kidney failure and heart disease. People with type 1 diabetes don’t produce insulin, a hormone that helps the body use sugar (glucose), a key source of energy that comes from carbohydrates. If you have type 1 diabetes you must make up for the lack of insulin with insulin therapy. Meanwhile, people with type 2 diabetes produce insulin, but their bodies don’t use insulin properly, or they don’t produce enough insulin. Diet, exercise and medication can often work to control glucose levels. However, in certain cases, these measures aren’t enough, and insulin therapy is needed to better control blood sugar levels. While insulin can be given by self-injection, people who take multiple daily injections of insulinmay also consider using an insulin pump. An insulin pump provides continuous delivery of short acting insulin all day long. The insulin pump substitutes the need for long acting insulin. A pump also replaces the need for multiple daily injections with a continuous insulin infusion, and also helps to improve your blood sugar levels. How Do Insulin Pumps Work? Insulin pumps are small, computerized devices that mimic the way the human pancreas works by delivering small doses of short acting insulin continuously (basal rate). The device also is used to deliver variable amounts of insulin when a meal is eaten (bolus). The basal insulin rates are usually set up in your pump with your doctor, and you can have one or multiple basal settings programmed in your pump, based on your needs. You program the amount of insulin for your mealtime bolus di Continue reading >>

U.s. Pivotal Trial Starts For Senseonics Glucose Monitor Implant With Data Due In June

U.s. Pivotal Trial Starts For Senseonics Glucose Monitor Implant With Data Due In June

Upstart Senseonics ($SENH) expects to be the first to introduce a long-term implant to continuously monitor glucose levels in diabetics. It's already under review for a CE mark after disclosing pivotal European data in October. Now, it's detailed the plans for the pivotal U.S. study of its Eversense Continuous Glucose Monitoring System. The company previously has said it plans to submit for PMA approval from the FDA in the second half of this year, with a potential approval anticipated within 6 to 18 months. The company recently reverse merged to become public and then filed to raise up to $52 million. The U.S. pivotal trial has started for the 90-day Eversense implant with final data slated for June, according to a description of the trial. Dubbed PRECISE II, the study will include 90 adult diabetes patients who have had a diagnosis for more than one year. It's a non-randomized, single-arm study at up to 10 U.S. sites. "This U.S. based PRECISE II study will continue to demonstrate the system's safety and effectiveness enabling us to submit necessary data to the U.S. Food and Drug Administration for our PMA approval," said Dr. Tim Goodnow, CEO and President of Senseonics. The PRECISE II study will compare the Eversense CGM results with those from standard, reference measurements. The investigation will include both clinic visits and home system use with the all of the CGM glucose results, alarms and alerts blinded to the subject for the length of the trial. The European PRECISE trial met all its primary endpoints. In 44 subjects over a 90-day period, Senseonics found that Eversense had a mean absolute relative difference of 11.4% in the 75-400 mg/dL range when compared to YSI blood reference values. Sensor values were within 20% of the reference values 84% of the time, Continue reading >>

Intarcia To Submit Its Glp-1 Mini-pump Implant Device For Type 2 Diabetes To Fda Later This Year

Intarcia To Submit Its Glp-1 Mini-pump Implant Device For Type 2 Diabetes To Fda Later This Year

Matchstick-sized device implanted under the skin every 6-12 months. New data in over 4,000 people demonstrates it is safe for heart health. Could it launch by late 2017? Intarcia recently released reassuring results from a heart safety study of ITCA 650 – a small GLP-1 mini-pump device to treat type 2 diabetes – showing it meets the FDA’s heart safety pre-approval requirements. The device continuously releases exenatide (a well known GLP-1 agonist) through a small mini-pump the size of a matchstick, which is implanted under the skin just once or twice a year in a quick procedure (within a matter of minutes). The “FREEDOM-CVO” trial studied over 4,000 people with type 2 diabetes randomly assigned to take ITCA 650 or a placebo (in addition to other diabetes drugs), measuring ITCA 650’s impact on heart safety (including death, heart attack, stroke, and chest pain). The results? ITCA 650 met its primary and secondary endpoints and was found to be “non-inferior” to placebo – meaning that at minimum it didn’t worsen heart health. These results mean that ITCA 650 meets the FDA’s pre-approval heart safety requirements for new diabetes drugs, allowing Intarcia to submit ITCA 650 for review in the second half of 2016. If all goes well, ITCA 650 could be available for patients as soon as the end of 2017. We spoke with Intarcia CEO Mr. Kurt Graves to learn more about the results. Mr. Graves emphasized that the trial was sized and designed only to show non-inferiority, not “superiority” – which would indicate that ITCA 650 improves heart health. Other GLP-1 agonists have shown superiority in trials. But in order to evaluate and potentially show superiority, we note that the trial would likely have needed to be larger and have a longer treatment duration ( Continue reading >>

10 Advances Transforming The Lives Of Diabetics Worldwide

10 Advances Transforming The Lives Of Diabetics Worldwide

10 advances transforming the lives of diabetics worldwide From an oral insulin capsule to a noninvasive glucose monitor, Israeli entrepreneurs and researchers are making life easier for diabetics. November 14 is World Diabetes Day and the month of November is National Diabetes Month in the United States. While there is not yet a cure for diabetes, many Israeli researchers and companies offer improved approaches for avoiding, managing and treating the condition. Diabetes is a chronic disease that occurs when the pancreas cannot make insulin the hormone that regulates blood sugar or when the body cannot make good use of the insulin it makes. As of 2015, approximately 415 million adults in the world have diabetes and that number is expected to rise to 642 million by 2040. At least 90 percent of cases are type 2 diabetes, characterized by insulin resistance and/or deficiency. In addition, more than 542,000 children in the world live with type 1 diabetes, an autoimmune condition where the body attacks its own insulin-making cells. Diabetes is the leading cause of heart disease, stroke, kidney failure, non-traumatic lower-limb amputations and new cases of blindness among adults. Those with diabetes have twice the normal risk of death; in 2014, diabetes was listed as the seventh leading cause of death in the United States. Here are some significant diabetes developments reported in Israel in recent years. Oramed Pharmaceuticals hopes to revolutionize the treatment of type 1 and type 2 diabetes through its proprietary oral insulin capsule developed through research at Jerusalems Hadassah Medical Center. Currently, insulin must be injected. The company has completed multiple Phase II clinical trials under an Investigational New Drug application with the US Food and Drug Adminis Continue reading >>

New Implantable Cgm Receives Approval

New Implantable Cgm Receives Approval

Senseonics’ Eversense™ 90-day implantable CGM approved in Europe. The first long-term implantable CGM (continuous glucose monitor) will be launched this month in Norway and Denmark. How does it compare to current CGMs? Eversense will be the “world’s first long-term wear sensor.” Current CGMs in market include glucose sensors from Abbott (FreeStyle Libre-only available in Europe), Dexcom (G4, G5), and Medtronic (Enlite, Enlite 2), which require a new insertion every 7-14 days. The Eversense CGM uses a 90-day implanted sensor that is placed in the upper arm in a 5-10 minute in-office procedure. A rechargeable transmitter device is worn on top of the skin, directly over the sensor, which powers the implant and sends the current glucose value and trend arrow to a smartphone. The transmitter is removable (users can take it off/put it back on without wasting a sensor), though it must be on in order to get glucose readings. Based on fluorescence technology embedded within a tiny sensor, the Eversense CGM System measures glucose from interstitial fluid below the skin surface. The sensor wirelessly sends glucose data to the smart transmitter worn on the upper arm above where the sensor is implanted. In turn, the smart transmitter calculates the current glucose value along with the direction it’s headed, how fast, and whether glucose values are expected to exceed pre-set low and high targets. Data and alerts are simultaneously sent to the smartphone app that provides real-time tracking, intuitive displays to help identify patterns, and information to help stay in control. No part of the sensor sticks through or shows through the skin surface. Encased in a biocompatible material, the sensor utilizes a unique fluorescent, glucose-indicating polymer. A light emitting dio Continue reading >>

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