Claim: Development of a wearable medical device for type 2 diabetes
Verdict: REFUTES

Retrieved passages:
title: Medical device
text: safety of their devices. As recently as June 2011, security experts showed that by using readily available hardware and a user manual, a scientist could both tap into the information on the system of a wireless insulin pump in combination with a glucose monitor. With the PIN of the device, the scientist could wirelessly control the dosage of the insulin. Anand Raghunathan, a researcher in this study, explains that medical devices are getting smaller and lighter so that they can be easily worn. The downside is that additional security features would put an extra strain on the battery and size

title: Glucose meter
text: development of glucose meters that directly integrate cellular data transmission capability, enabling the user to both transmit glucose data to the medical caregiver and receive direct guidance from the caregiver on the screen of the glucose meter. The first such device, from Telcare, Inc., was exhibited at the 2010 CTIA International Wireless Expo, where it won an E-Tech award. This device is currently undergoing clinical testing in the US and internationally. In early 2014 Google reported testing prototypes of contact lenses that monitor glucose levels and alert users when glucose levels cross certain thresholds. Many glucose meters employ the oxidation

title: Minimed Paradigm
text: advancements as measured by Nobel prizes awarded in medicine, chemistry, and physics, and after more than 23 million people in the United States alone were diagnosed with diabetes in 2007, the industry continues to have the same basic description of a pump system in the marketplace, "a glucose sensor, a processor, and a pump" instead of "sensors, processors, and pumps". The ultimate long-term goal of future technology for a portable device for treating diabetes is to: a) eliminate all dependent peripheral devices, for example, calibration meter, injection syringes/pens, glucagon, etc.; b) manage very complex life situations with fully automated protocols,

title: Artificial pancreas
text: the levels be kept balanced when the body cannot produce insulin itself. The artificial pancreas is a broad term for different bio-engineering strategies currently in development to achieve these requirements. Different bio-engineering approaches under consideration include: The medical equipment approach involves combining a continuous glucose monitor and an implanted insulin pump that can function together with a computer-controlled algorithm to replace the normal function of the pancreas. The development of continuous glucose monitors has led to the progress in artificial pancreas technology using this integrated system. The original devices for use in type 1 diabetes were blood glucose meters. Continuous

title: Tandem Diabetes Care
text: began shipping its next-generation pump platform, the t:slim X2. The X2 will receive updates via the Tandem Product Updater product, with planned updates initially including integration with Dexcom's G5 and G6 Continuous Glucose Monitors, and eventually the integration of closed-loop technology which Tandem licensed from TypeZero in July 2016. Tandem Diabetes Care Tandem Diabetes Care is a public US medical device manufacturer based in San Diego, CA. The company develops medical technologies for the treatment of diabetes and specifically insulin infusion therapy. In 2006, a group of engineers recognized the need for new and improved methods of pumping insulin and

title: Blood glucose monitoring
text: the use of test strips have shown that the required self-injury acts as a psychological barrier restraining the patients from sufficient glucose control. As a result, secondary diseases are caused by excessive glucose levels. A significant improvement of diabetes therapy might be achieved with an implantable sensor that would continuously monitor blood sugar levels within the body and transmit the measured data outside. The burden of regular blood testing would be taken from the patient, who would instead follow the course of their glucose levels on an intelligent device like a laptop or a smart phone. Glucose concentrations do not

title: Diabetes management
text: the GlucoWatch biographer in 1999. This product is no longer sold. It was a retrospective device rather than live. Several live monitoring devices have subsequently been manufactured which provide ongoing monitoring of glucose levels on an automated basis during the day. For Type 1 diabetics there will always be a need for insulin injections throughout their life. However, both Type 1 and Type 2 diabetics can see dramatic effects on their blood sugars through controlling their diet, and some Type 2 diabetics can fully control the disease by dietary modification. As diabetes can lead to many other complications it is

title: Stretchable electronics
text: Seoul National University and MC10 (a flexible-electronics company that originated at MIT based in Lexington, Massachusetts) have developed a patch that is able to detect glucose levels in sweat and can deliver the medicine needed on demand (insulin or metformin). The patch consists of graphene riddled with gold particles and contains sensors that are able to detect temperature, pH level, glucose, and humidity. Stretchable electronics also permit developers to create soft robots. These soft robots can be used to implement minimal invasive surgeries in hospitals. Especially when it comes to surgeries of the brain and every millimeter is important, such

title: EHealth
text: has achieved his or her daily goal. Finally, it is also synced to an iPhone app which allows for tracking and sharing of personal record and achievements. Other monitoring devices have more medical relevance. A well-known device of this type is the blood glucose monitor. The use of this device is restricted to diabetic patients and allows users to measure the blood glucose levels in their body. It is extremely quantitative and the results are available instantaneously. However, this device is not as independent of a self-monitoring device as the Nike+ Fuelband because it requires some patient education before use.

title: Mohamed Osman Baloola
text: monitoring and control system for diabetes symptoms. He set about creating an artificial pancreas and a remote system to monitor the stability of glucose levels in diabetics. The device, which can be linked to a hospital database system as well as family and friends, enables an immediate response if a medical situation arises. Mohamed Osman Baloola Mohamed Osman Baloola ( born April 14, 1981) is a Sudanese scientist and inventor who was named among "The World's 500 Most influential Arabs in 2012 and 2013" for his work on diabetes. Eng Mohamed Osman has been a Teaching Assistant of Biomedical Engineering

title: GlySens ICGM
text: available glucose monitor capable of withstanding 12+ months of continual use. As the global population of diabetics approached 400 million, this device can dramatically improve the quality of diabetic care. The technology that goes into the ICGM system consists of two parts. Primarily is the internal sensor which utilizes chemical reactions to determine blood glucose levels. Additionally is an external receiver used to display glucose readings and patterns in real-time, helping reduce the level of care needed in diabetics. An internal glucose sensor, measuring at 38mm across and 16 mm thick. The implant consists of an integrated glucose sensor with

title: Artificial pancreas
text: evaluate the efficacy of the product. ViaCyte has also been receiving financial support from JDRF on this project. In the United States in 2006, JDRF (formerly the Juvenile Diabetes Research Foundation) launched a multi-year initiative to help accelerate the development, regulatory approval, and acceptance of continuous glucose monitoring and artificial pancreas technology. Grassroots efforts to create and commercialize a fully automated artificial pancreas system have also arisen directly from patient advocates and the diabetes community. Bigfoot Biomedical, a company founded by parents of children with T1D have created algorithms and are developing a closed loop device that monitor blood sugar

title: Tandem Diabetes Care
text: to market the t:slim Insulin Pump, the first ever touch-screen insulin pump. In February 2013, the company received FDA clearance to market the t:connect Diabetes Management Application, a Mac and PC-compatible data management application that provides t:slim Pump users and their healthcare providers a way to display data from the pump and supported blood glucose meters on a cloud-based platform. In January 2015, Tandem announced FDA clearance of the t:flex Insulin Pump, the largest capacity insulin pump on the market. In July 2014, Tandem announced that it had submitted a PMA for the t:slim G4, which integrates t:slim Pump technology

title: Dan Riskin
text: technology innovation at Stanford University. Upon completion of his training, Riskin was promoted to Consulting Assistant Professor of Surgery at Stanford University with later promotion to Adjunct Professor of Surgery and Adjunct Professor of Biomedical Informatics Research. While a student at MIT, Riskin described a wearable sensor to measure metabolism and physical performance. He worked with Roche Diagnostics to build, gain FDA approval, and commercialize these early efforts. Subsequently, as a fellow at Stanford, he designed and was issued US patents and FDA approval for a painless wound closure device. Riskin cofounded Wadsworth Medical Technologies, which commercialized the product under

title: Yossi Gross
text: The U.S. is also a source for capital and partners. In 2007, Leon Recanati and Gross, together with Cohen-Arazi, reviewed a series of Gross's ideas and chose 15 technologies on which to focus. Below follows a list of some of the early stage startup companies that Rainbow has established out of these 15 by segment. The products of these companies are all at the pre-clinical stage of development. CardioVascular: Enopace Biomedical, treatment for congestive heart failure; Vascular Dynamics, implantable stent for the treatment of hypertension. Diabetes: GluSense, continuous glucose biosensor for diabetes patients. Ophthalmology: PharmaLight, ocular drug delivery platform that

title: Glucose meter
text: test strips used, otherwise, the accuracy of the blood glucose meter may be compromised due to lack of calibration. One noninvasive glucose meter has been approved by the U.S. FDA: The GlucoWatch G2 Biographer made by Cygnus Inc. The device was designed to be worn on the wrist and used electric fields to draw out body fluid for testing. The device did not replace conventional blood glucose monitoring. One limitation was that the GlucoWatch was not able to cope with perspiration at the measurement site. Sweat must be allowed to dry before measurement can resume. Due to this limitation and

title: Minimed Paradigm
text: for durable medical benefit. Competitive devices includes Deltec Cozmo, Animas Ping, Tandem Diabetes Care, Inc., Insulet OmniPod, Accu-chek Spirit Combo, and Sooil DiabecareIIS. It was 1996 when three Russian biomedical engineers (Bobylev, Gromova, Toloknov) wrote, "To date, the feedback principle of insulin therapy is not fully implemented because the number of monitored physiological parameters is insufficient ... In the early 1960's, Kadish used a system consisting of a glucose sensor, a processor, and a pump to control glycemia in patients with diabetes." Later, this system was developed by Albisser. Today, nearly 50 years after Dr. Arnold Kadish's system, and after

title: JDRF
text: do so by Jeffrey Brewer, who had founded and sold Citysearch and had become intensely interested in juvenile diabetes and medical devices after his son was diagnosed with the condition. The project brought together academic researchers and medical device companies. The focus was on integrating continuous glucose monitors (CGM's) and insulin pumps via a computerized program that would use blood glucose levels obtained through the CGM to calculate an insulin dosage to be dispensed through the insulin pump. The first such device was approved in 2016. JDRF has advocated for stem cell research; in a 2004 article in "The Wall

title: Tandem Diabetes Care
text: Care, Inc. that was formed with a focus on promoting a comprehensive, user-centric, and integrated approach to diabetes product development and customer care. Tandem Diabetes Care felt that incorporating enhanced ease of use and attractive design—often associated with consumer electronics development—would also encourage more patients to consider the clinical benefits of insulin pump therapy. Tandem Diabetes Care interviewed more than 4,000 insulin pump users and health care providers to design its first device, the t:slim Insulin Pump. In 2016, the company was ranked #39 on the Deloitte Fast 500 North America list. In November 2011, the company received FDA clearance

title: Continuous glucose monitor
text: element in the development of a "closed-loop" system for the treatment of type I diabetes. A closed-loop system involves blood glucose monitored by CGM and the data sent to an insulin pump for calculated delivery of insulin without user intervention. Continuous glucose monitor A continuous glucose monitor is a device used for monitoring blood glucose on a continual basis by people with either type I or type II diabetes. A continuous glucose monitor (CGM) takes a reading on set intervals with a small electrode placed under the skin and held in place by an adhesive. A transmitter attached to the