WRITTEN BY: Mariana Gomez and T’ara Smith
The Beyond Type 1 team attended the 2019 Summer DiabetesMine™ D-Data ExChange at the American Diabetes Association Scientific Sessions Conference in San Francisco. Visit this page, our Facebook and Twitter to get the latest updates. For the latest breaking news at #ADA2019, click here.
The DiabetesMine™ D-Data ExChange is a biannual event where diabetes advocates, pharma leaders, developers, clinicians, designers, and other groups interested in diabetes tech for diabetes management, and of course a better quality of life, get together.
An event where people with diabetes can be heard, D-Data began in 2013 as a spinoff the DiabetesMine Innovation Summit and started the global #WeAreNotWaiting movement, which celebrates and recognizes DIY patient entrepreneurship. Because of D-Data, we’ve seen a rise in game-changing contributions to the diabetes industry by companies and organizations like the Nightscout Foundation, Tidepool, and DIY solutions.
Discover, Learn, and Try
At the DiabetesMine™ D-Data ExChange, participants can discover, learn about, and even try demos of new diabetes tech, some of which may be already be approved or going through the FDA approval process. Take a look below to read about the latest diabetes innovations on the horizon.
Diabetes Innovation Update by Alain Silk, FDA, Diabetes Diagnostic Devices Branch Chief
Alain Silk discussed the process of new technological developments for the management of diabetes and discussed how the regulatory process for approval could be more streamlined, especially when it comes to automated insulin delivery (AID). Some of the tips Silk recommended for device-makers when approaching the FDA with new products include:
- Get on their radar. Silk stated that the FDA can help you think long-term and tell you about any new regulatory processes.
- Interact with the FDA frequently. Build FDA interaction when you’re developing devices. Some people approach the FDA when their devices are near completion, which makes the approval process difficult, even delay it, because device-makers are less likely to listen to feedback.
- Share with the FDA. Device-makers are encouraged to share ongoing progress with the FDA and should know anything sent to the agency is confidential. Keeping the FDA updated on your progress allows the agency to provide feedback and understand what the product does. If you need to discuss confidentiality with them, they’re happy to go over it with you. Be frank in your struggles and barriers, even if they aren’t directly related to regulation.
- Know Your Audience. You’re the expert on your product/device, but the FDA is not. When explaining how it works, speak in plain language as if you’re speaking to non-experts.
- Be professional. Silk remarked to the audience that though this should go unsaid, he mentioned he’s encountered innovators who stonewall and withhold information or get defensive. He stated the FDA is simply doing its job and the vast majority of interactions the FDA has with device-makers are positive.
- There are no dumb questions. You never know where your question may lead. The FDA encourages all questions during the development + approval process.
Other points of discussion were the acceptance of pre-market submissions and improvements in efficiencies on how studies for devices were conducted. He also said some studies are designed for funding versus regulatory purposes. Silk also differentiated between regulations/requirements and guidance.
- Guidance: Allows people to propose new ways to develop products for FDA approval + be flexible.
- Requirements/Regulations: That’s the way it has to be done; there is no other way.
Silk made it clear the FDA needs detail and clarity to understand better the diabetes communities needs. The FDA encourages the communicating of challenges and needs and expects that developers will come together so they can streamline regulatory processes in terms of procedures and time.
What Will It Take to Actually Go ‘Beyond A1C’?
- Moderated by Adam Brown of Close Concerns
- Panelists: Aaron Kowalski of JDRF and Alain Silk from the FDA
The FDA uses Time in Range as evidence along with other variables but not yet as a determining factor to expedite the approval of some devices. The future of diabetes management requires that TIR is used as one of the most important variables: “Do not just think about A1C but Beyond A1C,” said JDRF President Aaron Kowalski.
Beyond A1C also means other variables like mental and emotional health. According to Kowalski, we are not yet addressing the psycho-emotional situation: depression, DKA, psychosocial aspects. What we can do to minimize all that will be a big step for our community. Also, the JDRF CEO remarked his goal at JDRF is to remove diabetes from our lives as humanly possible, saying he doesn’t want to think about diabetes every day.
“We need more Time in Range with less effort,” said Adam Brown. Brown also commented that while the use of CGMs is helpful in the path to behavior change, constant checking of blood glucose could lead to anxiousness.
New Tech Revealed
Geek Squad: A Bold Program to Expand CGM Access by Sean Sullivan, Helmsley Trust
The Helmsley Charitable trust was born in 2009 and has contributed to research aims. Technology has always been an important issue – this is a virtual clinic where the key component is the diabetes educator. In this scenario, primary care physicians will be able to refer patients to Geek Squad to receive diabetes education in terms of technology, using CGMs to choose the best course of action and educate.
A Bold New Data-Driven Approach to Type 2 Diabetes Care by Amy McKenzie, Virta Health
Type 2 diabetes management requires diabetes education and behavioral changes, particularly dietary ones, to achieve optimal blood sugar ranges. Virta Health‘s personalized treatment aims to do that. Virta Health is a clinically-proven weight loss and glucose management method that can reverse T2D and prediabetes. Virta Health bills itself as producing fast results that last. Some of the company’s claims include:
- 87 percent of insulin users reduced or eliminated usage after 10 weeks
- 60 percent of patients reversed their Type 2 diabetes after 1 year
- 1.0 percent average HBA1c reduction after 10 weeks
Part of Virta Health’s approach to achieving these results is through nutritional ketosis. Nutritional ketosis occurs when our bodies use fat and ketones as the primary energy source. Normally, our bodies would use carbohydrates but during nutritional ketosis, as these nutrients are replaced, our body will burn fat and produce ketones. There is evidence that supports this nutritional approach and clinical data that shows that these diets will improve insulin sensitivity, lower A1cs, and improve overall metabolic health.
It is nutritional medical therapy. Many biomarkers including weight, glucose and other variables are included. Changes in diet are verified by multidisciplinary teams to evaluate results. Nutritional therapy is reduced in carbohydrates and changes in lifestyle and behavior.
This model also provides continuous remote care, meaning it connects patients with the team (doctor and coach) and their phone has access to the app where they can find all their information, resources, and necessary contacts. It is individualized treatment, providing care to thousands of patients with data analysis and analytics. Finally, McKenzie stated patients pay for the service only if their treatment has been successful.
“A Disruptive Clinic: Personalizing Diabetes Care Using Data” -Henrik Berggren
Henrik Berggren is the CEO and founder of Steady Health, a new remote and physical clinic in San Francisco that uses data analysis and new diabetes tech to personalize care. Steady Health consists of a multidisciplinary team of nurses, diabetes educators, and coaching specialists. Data analysis is based on CGM reports and the user receives remote feedback and coaching from experts. Henrik Berggren also lives with Type 1 Diabetes. Steady Health opened up their first clinic in Downtown San Francisco.
Demos: New #DData Players at DiabetesMine™ D-Data ExChange
EndoTool® Glucose Management System is a provider of precision insulin dosing technology for improved patient outcomes and in-patient insulin dosing. This software will help caregivers to calculate insulin dosing in a hospital environment for patients. This includes 70 decision points, an algorithm that promises to reduce infection, reduce hypoglycemic and hyperglycemic episodes – a worthwhile tool for hospitals and physicians.
EOFlow, a South Korean-based company, produced a tubeless insulin pump. This is a tubeless insulin pump. EOPancreas System (closed loop option) was granted Breakthrough Device Designation by the U.S. Food and Drug Administration. The insulin “patch” will be integrated with continuous glucose monitors (CGM), included with the system, and will work based on an algorithm in EOCloud. This integration will automate insulin delivery and allow users to control basal and bolus dosages. EOFlow calls its new system the smallest, lightest, and safest pump.
Technology Knowledge Optimization in T1D (TeKnO T1D) is an online educational curriculum created to improve provider and patient knowledge about the use of T1D technologies. Brynn Marks is an endo pediatrician and lives with T1D. This is an app built for Diabetes Education for HCP.
Made by the creators of Afrezza, the inhalable insulin, BluHale is a wireless pressure sensing technology that attaches to dry powder delivery systems and measures the exertion by patients during inhalation. The data is transmitted using an app or a multi-colored LED on a smartphone. The technology may soon include data sharing capabilities.
Liam McMorrow is a PhD student at the University of Aberdeen and was diagnosed with Type 1 in 2002. He is working on the creation of an app that will use financial incentives for teenagers with T1D. This, according to McMorrow, will promote behavior change.
Fresh Tri is an app designed to make behavioral changes easier and more fun by using a simple and positive approach to habit formation. Created by neuroscience design firm engagedIN and Walmart, Fresh Tri allows users to select which habits they want to change, identify why those changes are important to them, list actionable steps to create those habits and make any adjustments that work for them. Fresh Tri’s mantras are “Practice Makes Progress” and “there is no ‘fail’ – only practice and iteration.”
Tidepool announced that they have partnered with Dexcom as the first iCGM partner for the Tidepool Loop project, as well as Medtronic, which joins Insulet as a pump partner. The Tidepool Loop is currently in development to build and support an FDA-regulated version of Loop that will work with commercially available insulin pumps and CGMs. Both announcements were made at #DData19. Further coverage coming soon!
This article is part of Beyond Type 1’s ADA 2019 coverage. For full ADA 2019 coverage, click here.