American Diabetes Month and World Diabetes Day (November 14) help raise awareness of diabetes. Here […]
American Diabetes Month and World Diabetes Day (November 14) help raise awareness of diabetes. Here are some of the latest efforts to help manage the growing epidemic. Alternative Blood Draw Sites
Genteel LLC reports that its FDA 510(k) cleared stand-alone blood lancer is now available to a broader consumer base. The company’s device can draw capillary blood from any site on the body, such as the palm, forearm, wrist, stomach, knee, and other locations as well as from fingers.
Genteel reported in a news release that the device’s “precise depth control and vacuum technology” enable improvements over “commonly painful, spring-loaded ‘pokers’ that often leave fingers calloused, sore, or numb.” After sticking, the device pulls blood to the surface through vacuum, so users do not need to squeeze out blood.
Genteel is undertaking its second round of in-depth clinical studies to further verify these health benefit claims, it reported.
The company has expanded outreach into pharmacies and online drug stores and offers lower price-points. Noninvasive Glucose Monitoring
A new partnership could enable patients to measure glucose and other biochemicals noninvasively. PAVmed Inc. and its subsidiary Solys Diagnostics Inc. have entered into agreements with Airware Inc. and its subsidiary Liquid Sensing Inc. to develop and commercialize non-invasive diagnostic products using nondispersive infrared (NDIR) laser technology developed by laser technology pioneer Dr. Jacob Wong, founder and chief executive officer of Airware, PAVmed shared in a news release.
“For over fifty years, I have dedicated my professional life to improving the human condition through laser technology,” stated Wong in the release. “Twenty-five years ago, my colleagues and I first sought to tackle the unique challenges of using lasers to detect molecules, including glucose, in liquid and tissues. We have now honed the technology to the point where accurate, commercially viable, noninvasive measurement of blood glucose is around the corner. We are very excited to have found an ideal development and commercialization partner in PAVmed and look forward to being able to offer this technology to patients in the near future.”
Solys and Liquid Sensing will work together on a six-month research and development (R&D) program to advance the technology to a critical device accuracy milestone, based on established U.S. FDA and ISO 15197 standards for blood glucose diagnostic device accuracy, it was reported. PAVmed will manage the R&D program through Solys and will utilize its medical device design control development processes and quality management system. Once the accuracy milestone is reached, Solys will develop, seek regulatory clearance for, and commercialize products, the first of which is expected to be a device that non-invasively measures glucose in the intensive care setting.
Dr. Marc W. Gerdisch, chief of cardiovascular surgery at Franciscan St. Francis Health in Indianapolis, described the potential clinical benefit of such technology as follows: “By protocol, one hundred percent of my patients, and the hundreds of thousands of patients who undergo heart surgery each year, are placed on a continuous insulin infusion starting in the operating room and continuing for a period of 24-72 hours during which we check their blood glucose every hour. My patients complain bitterly about being awoken every hour throughout the day and night for finger sticks. A noninvasive device to measure blood glucose would be a gamechanger, a ‘must-have’ technology which would immediately improve the way we care for our patients, while lowering healthcare costs.” Diabetic Retinopathy Screening
A study demonstrated the ability to use smartphone-based retinal cameras from Remidio Innovative Solutions to screen patients with diabetes mellitus for diabetic retinopathy (DR).
Medios AI automatically analyzes images captured by Remidio’s smartphone camera and uses two different algorithms based on convolutional neural networks, one assessing the image-quality, and the other separating healthy images from images with referable DR (RDR), it was reported in a news release. In the study, the images were simultaneously graded by vitreoretinal specialists.
According to Diagnostic Accuracy of Community-Based Diabetic Retinopathy Screening With an Offline Artificial Intelligence System on a Smartphone, published in JAMA Ophthalmology, the study found that the clinical sensitivity and specificity of the Medios AI algorithm were 100% and 88.4% for RDR, 85.2% and 92.0% for any DR respectively, exceeding FDA’s superiority end points of an RDR sensitivity of 85% and specificity of 82.5%.
“The study paves the way in implementing large-scale models for screening for DR, even in locations with no Internet infrastructure,” stated Dr. Sundaram Natarajan, the lead author of the study, in the release. “This is a step ahead of the approach taken by Google and other AI companies that need their AI models to run on external servers, necessitating Internet access.”
Medios AI provides a retinal diagnosis report in less than 10 seconds. The device and automated AI are CE marked and available for use in the EU. Professional-Use Continuous Glucose Monitor
In October the Dexcom G6 Pro became the first and only single-use continuous glucose monitor (CGM) cleared by FDA for professionals to use to collect real-time glucose data from patients over a 10-day period.
“The G6 Professional is the only professional CGM that allows the option of being completely blinded so that you can start it and turn it on and the patient never interacts with it,” Walker told MD+DI last month. “The G6 gives a glucose reading every five minutes – 288 glucose readings a day for 10 days. You get a very dense glucose pattern.”
Davida Kruger, MSN, APN-BC, BC-ADM, diabetes specialist, Division of Endocrinology, Diabetes, Bone, and Mineral Disorders at Henry Ford Health System in Detroit, sees the benefits. “Dexcom G6 Pro will enable healthcare providers to set up their patients with CGM in minutes,” she stated in a news release posted by Dexcom. “This new professional system will serve as a simple way to obtain data from CGM naïve patients who need glucose insight, but don’t need or want to be monitored around the clock. It will give all my patients a chance to try the Dexcom G6 Pro under a healthcare provider’s supervision before they commit to a personal system.” Insulin Inhaler
A liquid formulation delivered via a soft-mist inhaler has shown an increase in insulin exposure and a rapid onset of action, according to data from recently completed phase 2 studies.
The soft-mist inhaler developed by Aerami Therapeutics for its inhaled insulin product product AER-501 (formerly Dance-501) is “unique” compared with other ways of delivering insulin through inhalation, Melissa Rhodes, PhD, chief development officer of Aerami Therapeutics (the new name for Dance Biopharm), told MD+DI. “It is special technology powered by a mesh that vibrates 128,000 times per second to aerosolize the liquid,” she said. The design of the inhaler itself also allows the aerosol flow to be laminar, instead of turbulent, so more particles are delivered to the lungs rather than to the back of the throat, she said.
Such a design results in a “record-breaking amount of material delivered to the deep lung,” she said. “A lot of inhalers get about 30 to 40% of a formulation to the lung, but our device gets closer to 80%.”
Using the inhaler may also be a “pleasant experience” when compared with other means of insulin delivery. “There is no needle,” Rhodes said, and “there is no coughing” associated with inhalation, as the inhaler delivers a “very gentle mist,” she said.
The inhaler also utilizes “smart technology” that senses whether patient inhalation is optimal for insulin delivery. It sends light signals to the patient as they are breathing in—a constant green light indicates optimal breathing, and the light flashes quickly or slowly if breathing is too fast or too slow, she said.
The soft-mist inhaler for AER-501 (formerly Dance-501) insulin is ready for phase 3 trials in the United States, Europe, and China, Rhodes reported. The company is looking for strategic partners for the phase 3 program. Phase 2 data were shared at the 55th annual meeting of the European Association for the Study of Diabetes.
Rhodes is hopeful Aerami’s technology can make an impact in patients’ lives. “Fifty percent of diabetes patients have uncontrolled [disease], so we are providing them a noninvasive option to get their levels stable.” Integrated System
Brighter seeks to ease diabetes management with an all-in-one system and subscription service. Its Actiste system integrates four components—a blood sugar monitor, test strips, a lancet, and the injection device.
“It’s an end-to-end service in terms of using the consumables, the test strips and needles, the lancets,” Brighter CEO Henrik Norström told MD+DI for an earlier article. “And because we provide that as part of the service, we know how many consumables patients are using, and we can also facilitate delivery to the patient’s home of renewable stock.”
The system gathers data and allows users track treatment and dosing history. They can use an iOS or Android app for tracking and sharing such treatment data.
Norström wants to ease patients’ experience. “Even if you’re only on one shot a day of insulin, it’s very convenient to have the Actiste solution because it reduces the barrier to comply to the treatment and automatically records all critical data,” he said. “And they don’t have to worry about it because it just works. The easier we can make it, the more successful we will be in increasing adherence, which leads to better quality of life.”
Brighter is currently focusing on Europe and the Middle East and has not yet begun the regulatory process in the United States. Expanding CGM Access
Access to continuous glucose monitors continuous appears to be expanding.
This month Walgreens announced a new billing solution to allow Medicare patients who use the Dexcom G6 Continuous Glucose Monitoring (CGM) System to fill their prescription at any of its more than 9,200 U.S. retail pharmacy locations, it reported in a news release.
Prescriptions for CGM devices covered by Medicare Part B are typically filled through durable medical equipment suppliers, manufacturers, or limited pharmacies, but with Walgreens new billing solution, patients can pick up their prescribed Dexcom G6 at local Walgreens pharmacies. And Walgreens is also looking to include other CGM products in the new Medicare billing model.
“Research continues to demonstrate CGM should be the standard of care for all diabetes patients on intensive insulin therapy,” stated Kevin Sayer, executive chairman president and CEO of Dexcom, in the release. “Getting the Dexcom G6 into the hands of Medicare patients through Walgreens pharmacies is a significant step forward in increasing access to the most powerful diabetes management tool available.”
Another example of expanding access is recent news on Senseonics Holdings’s continuous glucose monitoring system, which recently gained coverage from Health Care Service Corporation (HCSC) – Blue Cross Blue Shield.
“Having HCSC recognize Eversense as one of their covered diabetes management tools demonstrates that more payers are seeing the value that our long-term CGM brings to their members with diabetes,” Tim Goodnow, PhD, president and CEO of Senseonics, said in a release quoted in this MD+DI October article. “Increasing patient access for Eversense has been a top corporate priority and this is a significant milestone in helping us reach approximately 100 million covered lives on our path to widespread insurance coverage. With each new coverage decision, we are able to reduce the financial barriers and help millions of people with diabetes experience the freedom that Eversense brings for up to 90 days of continuous glucose readings.” Patch-Like Basal-Bolus Insulin Delivery Device
This month Valeritas Holdings Inc. announced data showing positive clinical outcomes for patients with type 2 diabetes who switched to V-Go Wearable Insulin Delivery Device from traditional insulin injection therapy regimens. Worn like a patch, the V-Go is an all-in-one basal-bolus insulin delivery option that administers a continuous preset basal rate of insulin over 24 hours.
The VERDICT study grouped patients based on their prior regimen total daily dose (TDD) into three insulin strata: < 50 U/day, 50 to 100 U/day, or > 100 U/day to evaluate clinical outcomes. “After a mean duration of five months of V-Go use, significant mean reductions in A1c of 1.3%; p<0.05 were observed for each strata,” the company reported in a news release. “In addition, the strata prescribed higher baseline doses of insulin (50 to 100 U/day and > 100 U/day) benefited from a significant reduction in TDD of 19%; p<0.0001 and 47%; p<0.0001, respectively, after switching to V-Go.”
“We are excited to share these positive clinical data from the VERDICT study,” stated John Timberlake, president and CEO of Valeritas, in the release. “We believe these results further demonstrate that, regardless of baseline insulin dose, the use of V-Go can offer patients with type 2 diabetes significant clinical benefit when switching from other insulin regimens.”
Trisha Zeidan, MD, Principal Investigator of the VERDICT Study, stated: “Optimizing insulin delivery has been shown to reduce insulin requirements and can have positive implications on patient acceptance and adherence. In my practice, I have been able to successfully switch patients from a variety of insulin regimens and a wide range of insulin doses to V-Go. Not only has V-Go been well accepted by my patients, it has shown to improve glycemic control and, in many cases, lower insulin requirements in those previously prescribed higher doses.” (Zeidan is affiliated with Premier Physician Network, Bull Family Diabetes Center.) Collaborations
Announced in September, Abbott Laboratories and Sanofi are teaming up to integrate glucose sensing and insulin delivery technologies. The two companies described plans to devise solutions that combine Abbott’s FreeStyle Libre technology with Sanofi′s insulin dosing information.
“This strategic relationship with Abbott is representative of the next evolution of our commitment for better diabetes care by incorporating digital tools into the daily life of people living with diabetes,” stated Gustavo Pesquin, senior vice president global diabetes and cardiovascular franchise at Sanofi, in a news release. “By partnering with Abbott, we are a step closer to realizing our connected ecosystem, which would help improve control and the quality of life decision cycle for patients through individualized glycemic management of diabetes.”
It’s not Abbott’s only collaboration in the diabetes space as of late. In October Abbott and Tandem Diabetes Care shared plans to develop integrated diabetes solutions that combine Abbott’s glucose-sensing technology with Tandem’s insulin delivery systems. At-Home Testing Enable Biosciences, a diagnostics company commercializing licensed technology from UC Berkeley, has been awarded a Phase II Small Business Innovative Research (SBIR) grant for $1,487,764 from the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK) division of the National Institutes of Health (NIH). The company will develop lab techniques to test samples collected at home for type 1 diabetes risk.
The at-home collection method would establish the likelihood of progressing to type 1 diabetes to prevent diabetic ketoacidosis and promote preventive therapies, Enable Biosciences reported in a news release. “The ability to collect samples in the convenience of the home is a major step to ensure that all patients reap the benefits of breakthrough therapies. The NIDDK’s support for this project will lower the barrier to universal screening,” stated Enable Biosciences’ COO, Peter Robinson, PhD, in the release.
Original Article: (https://www.mddionline.com/10-new-ways-medtech-could-keep-diabetes-check)
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