Medical technology, also referred to as medtech, promises to make massive amounts of data available to the individual about his or her state of health. It might even enable individualized management of chronic conditions like diabetes, moving us away from a one-size-fits-all approach. This is the starting point for this episode where Scott and Corinna touch on the promise of more real-time health data, data overwhelm, the need for training to understand the data, CGMs, patient access, putting people first, and more.
Dana Lewis is one of the creators of the DIY Pancreas System, or DIYPS.
In this episode Corinna Cornejo and Mila Ferrer talk about the promise and perils DYIPS represents.
Diagnosed at age 14 with type 1, Dana Lewis had the usual experience of years of frustration of dealing with diabetes devices that did not communicate with each other. She often imagined a system that would take data from each device, run it through the algorithm that every person with diabetes uses in their head dozens (or hundreds) of times a day, and automate some of the decision-making process. In late 2013, this became a reality after someone shared their code to help pull data off of a CGM in real-time. Dana and her now-husband Scott Leibrand used the CGM data to create a decision-assist system they called #DIYPS, the “Do-It-Yourself Pancreas System”.
We share highlights from Emily Cole’s interview with Dana Lewis in this podcast. You can find the complete interview in the TuDiabetes archives..
Mila Ferrer is the community manager for our Spanish-language community EsTuDiabetes.org. She blogs at Jaime, Mi Dulce Guerrero. And her son Jaime lives with type 1 diabetes. In this episode Corinna and Mike discuss how diabetes can become a challenge for families, and we play an interview from our archives with Mila Ferrer.
Locemia Solutions is a Canadian-based pharmaceutical development company, which sole focus is on innovating the rescue treatment of severe hypoglycemia. The team at Locemia is working on providing people with diabetes and those that touch their lives, with a simple, needle-free glucagon rescue product for the treatment of severe hypoglycemia, which would be easy to teach, easy to carry and easy to use – helping to expand the number of people who feel confident in dealing with the unpredictability of hypoglycemia, and providing peace of mind for people who use insulin every day. Locemia’s passion and promise – driven by its members personal involvement and investment in the diabetes community – is to fill an unmet need through innovation, awareness and empowerment—rooted in needle-free simplicity, for everyone to be able to help anyone—quickly and easily— deal with severe low blood sugar.
Kelly L. Close is the founder and Chair of the Board of The diaTribe Foundation, a nonprofit dedicated to improving the lives of people living with diabetes and prediabetes, and advocating for action. Since 2006, she has been the Editor-in-Chief of diaTribe, our free newsletter focused on making people with diabetes healthier and happier and advocating for action. She has also run Close Concerns since 2002, a healthcare information firm exclusively focused on diabetes and obesity. Kelly and her colleagues attend over 40 scientific, regulatory, and economic conferences globally focused on diabetes and obesity, read key medical literature in the field, and write regularly about 50-plus private and public companies and nonprofit organizations in the area. Kelly’s passion for diabetes comes from her extensive professional work as well as her personal experience as a patient with type 1 diabetes for over 25 years. Prior to starting Close Concerns, Kelly worked in the financial sector, writing about medical technology companies, and worked at McKinsey & Company, where a majority of her work focused in the healthcare practice. Kelly is widely viewed as an expert on diabetes and obesity markets and as a frequent speaker on the public health implications of diabetes and obesity, she is a tireless supporter of patients. A longtime diabetes advocate, Kelly is on the board of directors of the Diabetes Hands Foundation and the Behavioral Diabetes Institute and was previously on the Executive Board of the SF Bay Area JDRF. Kelly is a graduate of Amherst College and Harvard Business School. She lives in San Francisco with her children Coco, Lola, and Valentino and husband John, with whom she runs Close Concerns.
Adam Brown joined diaTribe in 2010 as a Summer Associate, became Managing Editor in 2011, and now serves as Senior Editor. Adam brings nearly 15 years of experience with type 1 diabetes to all of his work at diaTribe, especially in testing out new technology like glucose meters, CGMs, insulin pumps, automated insulin delivery, and mobile apps. Adam also writes an acclaimed column for diaTribe, Adams Corner, which focuses on actionable tips for living well with diabetes. Through his work at Close Concerns and diaTribe, Adam has brought a patient perspective to numerous venues, including FDA meetings, scientific and industry conferences, and patient events. Adam graduated summa cum laude from the Wharton School of the University of Pennsylvania in 2011 pursuing concentrations in marketing and health care management & policy. He is passionate about exercise, nutrition, psychology, and wellness, and spends his free time cycling in San Francisco.
Todd Hobbs, MD, is chief medical officer (CMO) for Novo Nordisk in North America. In this role, Dr. Hobbs focuses on the implications of diabetes for the company and for patients, for healthcare professionals and for healthcare systems. He provides medical guidance and input to the clinical development and life cycle management strategies for diabetes and obesity-related projects, as well as input into the R&D pipeline and participate in consultant advisory boards.
Dr. Hobbs began his career at Novo Nordisk in 2004 as a Field Medical Scientific Director. In 2010, he moved to the in-house position of Senior Medical Director of Diabetes. Prior to being named North American CMO, he led Medical Affairs activities for all insulin products and devices at Novo Nordisk, including strategy and tactical activities in support of current and future products.
Dr. Hobbs is a physician with a clinical focus in Diabetes. After internship and residency, he established his clinical practice focusing on the intensive management of patients of all ages with diabetes. During his 10 year clinical career based in Louisville, Kentucky, he cared for more than 2,500 adults and children with diabetes, including outpatient, inpatient and intensive care patients. During his clinical practice, he also served as Chairman of the Medicine Department for Baptist Hospital Medical Center in Kentucky.
“At Novo Nordisk, we are intensely focused on the patient experience and are committed to finding solutions to help those living with diabetes achieve their goals,” said Anne Phillips, MD, senior vice president, clinical medical & regulatory affairs for Novo Nordisk. “As a patient and parent of a child living with diabetes, Todd brings a unique perspective and shares our passion for patient centricity.”
His personal dedication to the treatment of diabetes began nearly 25 years ago when he was diagnosed with type 1 diabetes and intensified with the diagnosis of one of his sons with the same condition at the age of 5.
Sernova is a clinical-stage company developing products for the treatment of chronic diseases using therapeutic cells transplanted into an implanted medical device to replace missing proteins or hormones.
Sernova’s device forms a natural environment promoting the long-term function of therapeutic cells. The company’s first therapeutic indication is for the treatment of insulin-dependent diabetes.
Dr. Philip Toleikis is a seasoned biotechnology executive, with over 20 years of experience in the therapeutic, medical device and combination product sectors. He has been President and CEO of Sernova Corp. a clinical stage company since 2009, successfully gaining financing for the company through grants and equity funding of over $10M, and has been leading the development of a natural and immune-protected environment for delivering therapeutic cells to patients with chronic diseases such as insulin-dependent diabetes and haemophilia.
Dr. Toleikis headed a successful consulting company for the medical device and combination product field and was previously Vice President, R&D Pharmacology and Drug Screening, at Angiotech Pharmaceuticals, Inc., where he built and oversaw product development teams working on novel combination products to improve technologies for restenosis, surgical adhesions, device related infections, and orthopedic indications as well as led the team in the development of a novel treatment for immune inflammatory disease with completed Phase II clinical studies in multiple sclerosis, psoriasis, and rheumatoid arthritis.
He also headed multiple corporate collaborations and in seeking in-licensing technologies. Dr. Toleikis is an author of multiple issued patents and over 110 patent applications. His research training and experience includes biochemical pharmacology, diabetes, oncology, inflammatory diseases (psoriasis, multiple sclerosis, surgical adhesions, Alzheimer’s disease and rheumatoid arthritis), osteoarthritis, neurological diseases and cardiovascular conditions including ischemic heart disease, cardiomyopathy, hypertension and aneurysms.
His career philosophy is in developing and empowering closely integrated product development teams and linking those to the physicians and patients who are in need of novel products to build a strong passion for success. He has been a volunteer for many years for regional science fairs, as well as Diabetes, and Heart and Stroke Foundations and on the grant writing committee for a local school council. Dr. Toleikis has earned advanced degrees from the University of Michigan and the University of British Columbia, where he completed his Ph.D.
Christopher Jacobs holds a PhD in Bio-medical Engineering, pioneering early work in cardiac pacemakers, renal dialysis, and advanced methods of evaluating the effectiveness and usability of a wide variety of medical equipment. He holds over 40 patents, all designed to improve people’s lives. At the pleadings of a good friend with T2 diabetes, who had lost tactile sensation, Dr. Jacobs began research on a device that could effectively and reliably draw blood from both alternate sites and fingers, completely without pain. He reasoned that if he could accomplish that goal, those with diabetes would test more often, and improve their health. In 2012, he formed Genteel LLC, and in June of 2014, Genteel, the “gentle lancing instrument” was on the market. Mission accomplished!
Cynthia Rice is Senior Vice President for Advocacy and Policy for JDRF. She is responsible for JDRF’s advocacy to Congress, the executive branch, regulatory agencies, and health plans to accelerate therapies to cure, treat, and prevent type 1 diabetes.
JDRF is the leading global organization funding type 1 diabetes research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with the disease, JDRF’s goal is to progressively remove the impact of T1D from people’s lives until we achieve a world without T1D.
Ms. Rice joined JDRF, then known as the Juvenile Diabetes Research Foundation, in 2005 and led a cross-departmental staff team that developed the Artificial Pancreas Project. She was promoted to Vice President, Government Relations in 2009 and to her current role in 2013.
The Issue and What’s Being Done
Thousands of people are benefiting daily from tighter glucose control reached with the help of a continuous glucose monitor. The use of CGM technologies is recommended by national diabetes clinical guidelines and covered by nearly all private health plans. To date, Medicare does not cover CGM devices, regardless of the wide coverage by private health plans and the evidence of clinical benefit, leaving seniors with diabetes vulnerable. It’s time for Medicare to cover CGMs.
JDRF has been working closely with other interested stakeholders for more than a year to encourage Medicare to cover CGM devices, and has made Medicare coverage of CGM devices one of their top Advocacy priorities. While JDRF continues to work with Medicare in hopes of resolving this issue quickly, they ask that you join them in building support within Congress for Medicare coverage of CGMs. To learn more, read their coalition fact sheet.
Glen Tullman is the Chairman and Chief Executive Officer of Livongo HealthTM. He is also a successful entrepreneur and co-founder and Managing Partner of 7wire Ventures, a Chicago-based investment firm focused on healthcare and education. Tullman most recently served as Chief Executive Officer of Allscripts (NASDAQ: MDRX), the leading global provider of Electronic Health Records, Practice Management and Electronic Prescribing systems. He led Allscripts’ IPO and secondary offerings.
“We want people with diabetes to spend more time living their lives. That’s why we offer a bold, new program that requires less time managing the busywork. Livongo for Diabetes empowers people with the right information and tools to live better. That’s good for all of us: the person, their family and friends, their employer, their physicians and those who pay for the care.”
Fractyl is a Massachusetts based company who is working on the first procedure to directly treat the underlying digestive causes of insulin resistance in patients with uncontrolled type 2 diabetes. Basically, the procedure is designed to treat the root cause of the disease by resurfacing the damaged lining of the upper intestine (duodenum). The goal is to reset the hormone regulation and improve glucose control with the potential to make type 2 diabetes a treatable digestive disease instead of a lifelong, chronic struggle.
Dr. Harith Rajagopalan is Co-founder and CEO of Fractyl, having started the company while serving as an Entrepreneur-in-Residence at General Catalyst Partners. Prior to founding Fractyl, Harith was an academic cardiologist and physician-scientist. He received his B.S. in Chemistry from Stanford University and went on to obtain M.D. and Ph.D. degrees from Johns Hopkins School of Medicine. At Johns Hopkins, Harith did groundbreaking and award-winning research on intestinal cancers that was published in top medical journals, including Nature and Science. After medical school, Harith trained in internal medicine and clinical cardiology at Brigham and Women’s Hospital and completed a research fellowship at Harvard Medical School.
Azurite Technologies, Inc. is an early stage biotech company located in the San Francisco Bay Area, California. Founded in 2013, its mission is to develop the world’s first noninvasive blood glucose sensor. The company was founded by two Georgetown grads after a summer internship at one of the national laboratories, where they realized a technology one of the co-founders was working with had a huge potential application in completely noninvasive blood glucose sensing. Building on this idea, the team at Azurite completed the National Science Foundation’s Innovation Corps program, an intensive two-month entrepreneurial training program.
The company’s goal is to leverage their technology to be used as a continuous real-time blood glucose monitor, as a stand-alone device and as part of an artificial pancreas, when fully ready.
Laura Andrews, MS Biotechnology
Laura co-founded Azurite Technologies, Inc. in November 2013. She has a background in molecular biology and the business of biotechnology. As the business lead for this venture, she has worked previously at Immunomic Therapeutics, Inc. and at DOE’s Lawrence Livermore National Laboratory in the Industrial Partnerships Office