Neal Kaufman is not only the husband of famed endocrinologist and Medtronic exec Fran Kaufman; he's also a diabetes guru of sorts in his own right. He's an experienced clinician and educator who founded a company called DPS Health (Diabetes Prevention Source), that offers an intense coaching program using technology + real-life interventions to help people with pre-diabetes and type 2 diabetes improve their lifestyles. Like us, he's extremely interested in all sorts of D-technologies and advancements, so when we heard he was again attending the big annual European conference on the topic this year, we tapped him for a report on the goings-on:
A Guest Post by Neal Kaufman, MD, CEO of DPS Health
American Diabetes Association Names New CEO
Non-profit leader Kevin L. Hagan named as new chief exec of national diabetes org after six-month search.
FDA Approves New Basal Insulin
Sanofi's Troujeo has 'flatter profile' of action that helps to avoid lows.
Daytona Win for Racecar Driver with Diabetes!
Type 1 driver Ryan Reed wins first NASCAR series race at Daytona on Feb. 21.
This past week it was my privilege to participate in the 6th annual Advanced Technologies & Treatments for Diabetes (ATTD) conference in Paris, France. The city was amazing and so were the meetings. As a health-technophile and advocate for people with diabetes, I found the meetings captivating.
First, some history of the ATTD conference: Eight years ago a group of diabetes professionals created a "Loop Club" to present technological advances needed to "close the loop" -- create an artificial pancreas which delivers precise doses of insulin based on the wearer's real-time sensor glucose values. Recognizing there was an opportunity to bring these innovations to a wider audience, the "Loop Club" organizers - Moshe Phillips from Israel and Tadej Battelino from Slovenia - started the ATTD conference. Their goal was to bring together clinicians and researchers from all over the world to learn about advances in how to prevent and treat diabetes. The first ATTD meeting was held in 2008 in Prague with 780 participants. Each year that number has increased (1,700 in 2012; 2,125 in 2013 from over 90 countries) as the science progressed.
Of course there are hundreds of meetings diabetes professionals can attend, many of them with similar themes and goals. What makes ATTD different is the focus on new technologies and the diversity of the clinicians, researchers and industry representatives who travel from far and wide to attend. The meeting brings together individuals from the fields of diabetes, endocrinology and metabolism, along with general and family medicine practitioners, and unites them with diabetes technology developers from research institutes and industry.
I love how ATTD enables me and the other participants to share experiences and expertise in ways that make sometimes unexpected advances possible. During a casual conversation with a colleague from Brazil, he mentioned his YouTube video in Portuguese on how to inject insulin had just had over 300,000 views. Through no extraordinary effort, 300,000 people found their way to his video...truly amazing! This led us both to contemplate if the online approach to obesity treatment my company has created could be brought to Brazil. Whether that project will happen is uncertain, but be assured, thousands of attendees had countless conversations like this one about other new and exciting projects...and you never know which ones will succeed and change the lives of people with diabetes.
The meetings started with a welcoming address from noted French diabetologist Gerard Reach who asked "Is it all about technology?" He made a great case for "no", stating what seems obvious to many, but can be difficult for technologists to grasp. The patient's needs, wants and desires must be at the center of all innovations. While those in attendance certainly agreed, it is a sentiment that has to resonate throughout the innovation pathway.
These meetings do not primarily address patients' perspectives or their needs for better education or support. Since this is a founding principal of my company, and a focus of much of my professional life, Dr. Reach's comments truly resonated with me. As a member of the ATTD organizing committee, I'm glad to have an ally in bringing more patient-oriented technology to future conferences. More importantly, we all need to redouble our efforts to increase the pressure on providers, health plans, employers, Pharma/device industry and governments to pay for patient-centered education and support that helps individuals successfully prevent and manage their diabetes.
One of the widest reaching aspects of ATTD is an annual yearbook that reviews top articles from the past year with comments by the chapter editors. While written for healthcare professionals, you might find the editor's comments of particular interest. Free copies of the chapters can be found here.
The meetings (and the yearbook) included presentations on the following areas:
- Self-Monitoring of Blood Glucose (SMBG)
- Continuous glucose monitoring (CGM)
- New insulins
- Insulin pens
- Insulin pumps
- Closing the loop
- Immune interventions
- New oral therapies
- Exercise and physical activity
- Human factors in designing devices
- Pregnancy and technology
- Pediatric technologies
- Health information technologies ( A chapter I was lucky enough to edit)
The main topic of discussion was about progress toward "closing the loop" — toward the creation of the artificial pancreas... a subject which has been addressed extensively by others.
You readers here already know that progress in science doesn't typically happen rapidly. More commonly there are incremental advances which when combined, get closer and closer to the desired result. That is exactly what is happening on the path to the artificial pancreas. Glucose sensors are getting better. New insulin analogues are under development that will be more rapid acting. Devices are smarter with respects to how they deliver insulin. Mathematical formulas used to predict a patient's future blood glucose are being refined. Slowly, progress is being made creating patient-facing, clinician-enabling technology so essential for patients to be able to successfully use the technology. Evidence is emerging that the artificial pancreas can improve glucose control. Reimbursement for pumps and sensors — the platform upon which the artificial pancreas is built -- is slowly becoming a reality in more and more countries. All of these elements, and many others, are beginning to come together to make the artificial pancreas a reality in the near future. Right now, there is no precise estimate for when the artificial pancreas might be ready... but every day we do get closer.
A few of the key papers presented at this year's event included:
BETA-CELL REPLACEMENT Dr. Jay Skyler, MD (University of Miami Miller School of Medicine, Miami, FL) provided an update on the status of beta-cell replacement therapy indicating that he expects clinical trials with a range of new approaches to be started soon. Approaches include: 1) animal derived cells; 2) cells reprogrammed genetically to produce insulin; 3) cells biopsied from a patient's own organ (e.g. liver) manipulated into becoming beta cells then given back to the same individual; and 4) islets derived from human embryonic stem cells. The research continues in a search for a cellular cure for type 1 diabetes.
HIGH INTENSITY INTERVAL PHYSICAL ACTIVITY Michael Riddell, PhD (York University, Toronto, Canada) presented a most interesting study in which people with type 2 diabetes, after only two weeks of high intensity interval training (1 to 2 minute bouts with 30 second rest periods for a total of 10-15 minutes - equaling about 60 minutes in 2 weeks) had post-prandial glucose which was ~30 mg/dl lower than the control group. Average glucose was also lower and a muscle biopsy showed that markers of the efficiency of muscle glucose metabolism were improved. (Little et al., J Appl Physiol 2011). If these results hold out, it could lead to a major change in the approach to exercise that may lead to more people doing it and to better diabetes control.
COMPUTER ASSISTED SELF-MANAGEMENT SUPPORT I presented a paper by Dr. Russell Glasgow and colleagues, in which computer assisted self-management support (CASM) for diabetes showed improved health compared to usual care. The 12-month program studied 463 people with diabetes who were randomized to usual care, or CASM at high or low intensity (Glasgow et al., Patient Education and Counseling 2012). High intensity CASM included such aspects as feedback, rewards, and relapse prevention. Regular CASM included things like psychosocial support, goal setting, and tracking. Although it was a year-long trial, most patients' use of the tools decreased after six months. Use of the tools did improve health, but the 12-month impact was small, although enough to have a meaningful public health impact. The keys to success were tailored education, integration to primary care, and links to community resources. I commented that the authors could have also upgraded their educational curriculum, added small steps to success and additional key elements of diet and physical activity. We need more of these types of interventions and we need them to be reimbursed so patients can get access to them.
DIABETES WIRELESS AP CONSORTIUM (DREAM) INFRASTRUCTURE FOR ARTIFICIAL PANCREAS AT HOME Drs. Prof. Tadej Battelino (University Children's Hospital, Ljubljana, Slovenia) Moshe Phillip MD (Tel Aviv University, Petah Tikva, Israel), and Thomas Danne, MD (Kinderkrankenhaus auf der Bult, Hannover, Germany) presented the DREAM project (referring to their recent New England Journal of Medicine Publication February 28, 2013). The project is a four-step approach to bringing overnight closed-loop control to the home environment and is comprised of a feasibility study (DREAM 1), an inpatient overnight study (DREAM 2), an overnight study at a diabetes camp (DREAM 3), and an overnight home study (DREAM 4). The control algorithm seeks to emulate the way master diabetes clinicians make insulin treatment decisions. The team presented DREAM 3 results and interim DREAM 4 results. Patients did better the night they were on the overnight closed loop compared to when they were on an insulin pump and glucose sensor that wasn't a closed loop. This is a great example of the incremental advances that might lead to the artificial pancreas.
STATUS OF ULTRA-FAST INSULINS Howard Zisser, MD (Sansum Diabetes Research Institute, Santa Barbara, CA) presented the status of ultra-fast insulins presenting a variety of approaches to accelerating insulin delivery. He mentioned BD (developing "kink- and occlusion-free disposables" for subcutaneous insulin pumps, as well as intradermal micro-needles), Halozyme (studying the "spreading agent" PH20 for injection at the time of infusion set change and separately for co-formulation with injected insulin), Roche (about to enact the European launch of its second-generation DiaPort, a port that enables the Spirit pump to deliver insulin into the abdomen), MannKind (studying inhalable Technosphere insulin, aka Afrezza, in pivotal trials for both type 1 and type 2 diabetes), InsuLine (developing products to heat the sites of insulin infusion or insulin injection, to improve absorption), Novo Nordisk (initiating phase 3 trials for its ultra-rapid version of insulin aspart, FIAsp,), and Thermalin (conducting preclinical studies of ultra-rapid insulin analogs that use artificial amino acids). A lot going on but time will tell if these approaches are able to blunt the post-prandial rise in blood sugar all too common now.
ROLE OF INCRETIN THERAPY IN IMPROVING A1C WITHOUT HYPOGLYCEMIA OR WEIGHT GAIN Richard Bergenstal, MD (International Diabetes Center at Park Nicollet, Minneapolis, MN) presented that GLP-1 receptor agonists consistently outperform other agents in aggregate metrics such as percentage of patients who achieve A1c of 7.0% without weight gain or hypoglycemia (Zinman et al., Diabetes Obes Metab 2011; Bergenstal et al., Diabetes Obes Metab 2013). According to proposed quality performance standards for diabetes management, Accountable Care Organizations would be evaluated based on the percentage of patients who meet the target for all five of: A1c, blood pressure, LDL cholesterol, not smoking, and taking aspirin.) This would be a major enhancement in the way outcomes are conceived and measured.
One of the recurrent themes (and a source of frustration for many of us) is the rapid pace innovative products are able to get to patients outside of the United States. For example, Medtronic's combined insulin pump and glucose sensor ("Veoâ„¢) has been available in Europe since 2009, but is not yet approved by the FDA (hopefully soon!). This will be the first system in the U.S. with the low-glucose suspend (LGS) feature, which automatically suspends insulin delivery for up to 2 hours when sensor sugar is low mitigating hypoglycemia without increasing high blood sugar levels. This is but one example of many promising diabetes treatments that are not available to patients in the U.S.
There are widespread fears that the FDA's approach is so time-consuming and costly many of the companies and researchers responsible for future innovations will have no choice but to abandon the U.S. market. I hope this does not come true since it would truly hurt our chances to improve care and outcomes here in the U.S. It is my belief that the market will eventually force FDA to be more nimble, and it is already taking steps in that direction, such as taking part in a new public-private partnership called the Medical Device Innovation Consortium (MDIC), which aims to develop better tools for evaluating medical technologies, and do so more quickly.
All in all, these meetings are a great place to learn about recent advances, share with colleagues, reminisce how past innovations have improved lives for people with diabetes, and contemplate how future innovations will improve life further. I am happy to report that the spirit of innovation lives on despite the many roadblocks created by the rigors of science and the regulatory process... so be on the lookout for new and novel uses of technology which will make preventing and managing diabetes easier and more effective.
Special thanks to Neal for this great update from gay Paris!