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FutureStarrApple Developing Blood Glucose Monitor
According to a new report, Apple is developing a blood glucose monitor that can continuously measure your levels without the need for needles or skin punctures. This technology could benefit millions of diabetics around the world.
This effort is part of a secret project that's been underway for years, reportedly beginning when Steve Jobs was still at the helm. It falls under the umbrella of Exploratory Design Group, or XDG.
The concept of a needle-free blood glucose monitor has been around for years. It could be especially beneficial to those living with diabetes, who must carefully adjust their diet and inject insulin in order to keep their glucose levels from rising too high or dropping too low.
Unfortunately, this endeavor has yet to materialize for several reasons. Glucose - the chemical responsible for diabetes - is a colorless fluid with few distinguishing features, making it difficult to measure noninvasively.
Many companies are working on solutions, from skin patches that detect glucose through sweat changes to wrist bands sending wireless readings directly to an app. Unfortunately, none of these products is yet available for use in the U.S.
John Bonnette, an industry analyst with PitchBook, notes that the FDA has a stringent approval process for noninvasive glucose monitoring devices. Acquiring Class III approval can be costly and take years of testing, so convincing insurers to cover them can be difficult.
It could be challenging to sell a device like this to consumers, who may be wary of investing in an invasive device that could prove detrimental in the long run. Insurance companies might also feel this way; that the expense of providing continuous glucose monitors would outweigh their value.
Bonnette reports a large market for this technology. He estimates that approximately 30 million Americans have diabetes, and many use glucometers - similar to test strips - to monitor their blood sugar levels.
There are also more sophisticated systems, like the FreeStyle Libre Flash Glucose Monitoring System that has been approved in the United States. This involves attaching a sensor to an upper arm and waving a reader device over it; measurements take place every few minutes and are sent directly to a smartphone app for analysis.
Nemaura Medical is developing the noninvasive CGM SugarBEAT, which is already approved in Europe and available as a peel-and-place patch that sticks on your skin for 24 hours and transmits wireless glucose data via Bluetooth to its companion app. Nemaura Medical is developing this device and plans to submit it for approval in the U.S. later this year.
Bloomberg reports that Apple is working on a blood glucose monitor that would allow diabetics to monitor their health without needing to prick or use patches. According to people familiar with the project, Apple has completed a proof-of-concept device for the system which uses light to measure glucose levels in interstitial fluid beneath the skin.
The technology reportedly works by using laser, optical absorption spectroscopy and an algorithm to detect glucose levels in interstitial fluid. According to the company, they plan on developing this device so people with pre-diabetes or type 2 diabetes can be warned they are at increased risk for developing full-blown diabetes and provided with lifestyle changes to help prevent it.
According to reports, the device is approximately the size of an iPhone and can be attached to someone's bicep. Engineers are now striving to reduce its size so it will fit inside an Apple Watch.
For years, many companies have been working to develop noninvasive glucose monitoring systems. Some have integrated with insulin pumps while others created patches that connect directly to the body's natural blood flow. But all have some drawbacks, including that users must wear the device during usage.
Apple's Glucose system will rely on a set of silicon photonics chips and sensors designed by the company. Its primary chip supplier is Taiwan Semiconductor Manufacturing Co. (TSMC), which already manufactures the main chips for iPhone and iPad models.
The system would be powered by a chip that reflects and absorbs light from molecules in blood, then bounces it back onto a sensor. The chip has been said to possess "high precision" due to its use of optical absorption spectroscopy.
But it also claims to measure glucose concentrations in blood, which is essential for diabetics when it comes to determining an accurate dosage of insulin. This marks a huge leap forward over existing systems which rely on finger prick testing and regular blood tests for this purpose.
A feasibility study is an essential first step in developing a clinical trial and should be undertaken by all members of the research team. It should address all aspects of the trial, such as patient population, accrual targets, timeline, procedures and human subject involvement.
Feasibility studies often involve site visits, but some can be conducted remotely. For instance, sponsors can send basic questionnaires to sites using the Shared Investigator Platform and then utilize online portals for more in-depth evaluations - saving them both time and money by not needing to schedule meetings at each location.
Sponsors must guarantee they select an appropriate site for the trial, while adhering to budget and timeline restrictions. This requires performing a site feasibility assessment, which measures whether or not a proposed location can adequately conduct the trial at its highest standard while guaranteeing data integrity and participant safety.
When conducting a feasibility assessment for a clinical trial, an analysis should be made of the site's capabilities such as infrastructure and prior experience with clinical trials. This will help decide if it's suitable for conducting the trial and facilitate development of study plans and protocols.
Furthermore, it should help predict the quality of data produced at a site. This depends on the investigator's experience, availability of trained technical clinical trial staff members and facilities at the location.
Another critical element of the feasibility process is patient recruitment. According to estimates, more than 80% of clinical trials fail to meet their recruitment deadlines and one-third of phase III studies end due to patient enrollment difficulties.
A successful clinical trial must address and overcome these challenges before beginning the study. By conducting a well-designed feasibility, it is possible to anticipate issues and collaborate with sites, investigators, and country agencies on developing processes and practices that reduce risks while fostering the success of the endeavor.
Apple is said to have a team of biomedical engineers working on a blood glucose monitor that would be revolutionary for those living with diabetes. CNBC reports the company is developing a non-invasive device that uses light to detect glucose levels in skin tissue - an impressive accomplishment since no such biomedical device has yet been able to accurately detect such concentrations.
This could pave the way for Apple Watches that diabetics can use without needing a needle to draw blood - an incredible step forward for millions of people around the world. Current glucose monitors that require needles are available, but they're uncomfortable for some patients and often give inaccurate readings.
Integrity Applications, whose device GlucoTrack is currently being used by patients to monitor their blood sugar levels, are working hard to develop non-invasive alternatives that will save users from having to take medication every day and from experiencing unpleasant side effects from injections. Furthermore, these devices are convenient and cost-effective; additionally, they eliminate the need to visit a doctor for routine checkups.
Another advantage of needle-free monitoring systems is their portability - they can be worn around the body instead of on skin, making them ideal for people living with diabetes who need to manage their condition better. Furthermore, these small wireless monitors send signals to a phone or computer and make taking blood sugar tests much simpler and more affordable than traditional finger pricking methods.
These technologies are essential as they offer medical professionals a way to monitor patients in real time and provide them with the correct treatment. Furthermore, they have the potential for preventing health issues and providing early warnings before they become serious issues.
Apple has consistently employed experts in their field to help create innovative products. This strategy has proved successful over the years.
Apple's designers and engineers are responsible for some of its most successful products. Instead of relying on market research, employees at Apple are encouraged to think about what they would want if they had their own product in development. This approach has proved highly advantageous when designing or engineering a product as it allows the company to create something that customers will love.