As you all know, we were in San Diego attending the ADA's 77th annual Scientific Sessions last week, and already reported on new technology we observed. At the heart of this gathering is of course the science -– loads of new studies completed around the country and the world over the past year that are now ready to be presented to medical peers.
The poster hall alone displayed a whopping 2,228 total research posters this year -- visiting which felt like being lost in a sea of research.
Some of the researchers regularly plant themselves next to their work to discuss with any curious passersby, while others have specific times scheduled to educate a crowd of people through audio earphones. Most of the information is embargoed, with late-breaking research being added each of the three days the poster hall is open.
Leading up to ADA, we scanned the mobile app and online program and abstracts for items of interest among the numerous official categories: complications, education, exercise, nutrition, psychosocial, clinical therapeutics, healthcare delivery/economics, pregnancy, pediatrics, epidemiology, immunology, insulin action, and obesity (just to name a few).
Needless to say, it's a lot to soak in.
From just a quick search: a few-hundred abstracts included variations of anything "cure" related -- from beta cell proliferation to islet transplantation and beyond. The terms "affordability" and "cost" generated a couple-hundred more results, of which roughly half dealt with the medication access and affordability issue on so many minds these days.
As we quietly observed the poster hall and also talked with some scientists, it was clear that cost and access for patients was one of the big themes (more on this tomorrow), along with concern about how the proposed federal budget cuts hitting the National Institutes of Health (NIH) could devastate the diabetes research community. We certainly hope not!
Celebrating research today, we'd like to share some of the topics that most caught our eye:
Affordability & Access to Diabetes Care
As noted, this was a big theme at this year's ADA conference, addressed in many research posters and weaved into presentations, panel discussions, and side conversations. Some specific studies that touched on this topic include:
Clinical Time Spent: In this first-of-its-kind study, researchers at the University of Washington Medical Center, including Dr. Irl Hirsch -- a fellow T1 PWD and vocal advocate on insulin pricing -- took a year-long look at the costs related to diabetes care in an academic clinic, specifically the "non-reimbursed time" that doctors and clinics spend on items such as prescription-filling, insurance prior authorizations, and patient interactions by email or telephone. The study involved 3,727 patients and 10,332 visits for the year, divided up between the team of 3.6 full-time staffers and using a web-based data analysis tool called Redcap.
The takeaway: A huge chunk more time is spent on non-billable tasks compared to those that are direct reimburseable patient hours, and this is clearly not a business model that clinics can keep up -- especially with diagnosis numbers rising.
State-by-State Costs: The CDC funded a study from the non-profit RTI International in North Carolina, examining both the direct and indirect D-costs in each state (all based on 2013 data). Indirect relates to missed work productivity, household production loss, and early death. No surprise that California had the highest indirect costs due to its size ($29.9B) while Vermont had the lowest ($339M); Washington D.C had the highest per-person costs, while South Dakota was lowest, and overall the inability to work came in at the highest level of all the issues related to D. In the end, researchers concluded that this data can be used to help motivate state governments and employers to focus on diabetes support among the workforce. A related study by the same group analyzed nursing home costs, with similar breakdowns and conclusions. The posters highlighted its new online toolkits for estimating economic burdens of diabetes and the potential impacts of D-interventions.
Considering Cost of Therapy: In this day and age where cost is so critically important to PWDs, it was interesting to see some clinical decision support software on display taking that topic into consideration. One was NC-based GlucosePath, software aimed at giving the healthcare providers more insight into pricetags as they're deciding what to prescribe for T2 PWDs. We found their research poster interesting, and certainly appreciated the presenters open-sharing and posing for pictures with their poster!
Competitive Bidding, YIKES Continued: In keeping with the ongoing saga of the Centers for Medicare and Medicaid Services (CMS)'s competitive bidding program, which we've reported on extensively over the years, new research showed it's only getting worse for patients -- as more people are dosing without doing the needed fingerstick tests or CGM monitoring thanks to a lack of access to supplies. This study provides fodder to the #SuspendBidding initiative to stop this competitive-bidding process until (at least) more research can be done on its effects.
Heart Risk in T2: One of the biggest talking points for diabetes medications this year involved cardiovascular risk being cut down thanks to a variety of different drugs. In a hailed set of studies dubbed CANVAS, research showed the entire class of SGLT-2 inhibitors such as Invokana cut down the hospitalization CV risk for type 2 by 33% and renal failure by 40%, even though there's a concern about amputations as a result and experts debate whether these SGLT-2 drugs are interchangeable. Some believe this shows we're moving past the "era of metformin" in T2 treatment, though that remains a debatable point. There was also some question of whether Invokana should be used in type 1, but that wasn't a research-heavy topic at this year's sessions.
Closed Loop R&D: With Medtronic announcing the full launch of its Minimed 670G in the days before the SciSessions, and many other companies outlining their progress, closed loop and AP research were in full bloom. It didn't hit the overload point as it did in 2016, but there was some clear science showing the benefits of this next-generation technology; Medtronic alone had nine presentations while Insulet's OmniPod Horizon closed loop platform was a big talking point for that company. There are still almost two-dozen of these systems in the works worldwide, and it's exciting to see that all in progress. We were also happy to see our #WeAreNotWaiting friends Dana Lewis and Scott Leibrand proudly showing off their OpenAPS poster at this year's conference!
Psychosocial Effects: This has been a big topic for the ADA over the past several months, especially after the organization released its first-ever psychosocial position statement on this topic in November. We covered this a month ago, and at the SciSessions it certainly had a number of research backing it up and specific presentations delving into that science side. One study looked at depression in T2 and how interventions can help ward off those depressive feelings, while another study focused on eating disorders in youth with both T1 and T2 and showed how serious and widespread this issue this really is.
Words Matter: There isn't much research out there on this, but the stigma associated with language used is a growing trend in the diabetes science world and those practicing. Dr. Al Powers, the ADA's president of Medicine and Science, emphasized in his presentation that practitioners must be careful how they discuss diabetes issues and our entire D-ecosystem must tread lightly when it comes to painting a picture for the general public on diabetes. Another presentation that included three powerhouses -- T1-CDE Jane Dickinson, Susan Guzman and Melinda Maryniuk of Joslin Diabetes Center -- focused on how the words we use in diabetes care have both a direct and indirect impact on patient outcomes, even stopping some PWDs from going to see their healthcare team, out of fear they'll be judged or not properly cared for. They'll be releasing a joint ADA-AADE consensus statement on D-language later this summer, so we'll be on the watch for that.
D-Pregnancy: Interestingly, new data from the CONCEPTT (Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy) trial out of Toronto found that multiple daily injections (MDI) may be more effective than insulin pumping during pregnancy, to lower A1C and prevent some of the potential pregnancy-related issues that can happen. They studied 123-125 women with T1 in their early 30s on pumps and MDI for this trial.
Insulin Action: By and large, insulin developments weren't a big-ticket item at this year's Sessions. Sure, a whole bunch of posters and presentations discussed various aspects of how one brand compares to another, and new faster-acting next-generation varieties under development. But it wasn't a show-stealing topic. MannKind and its inhaled Afrezza insulin mostly flew under the radar, though the company did have an exhibit hall booth and Afrezza came up periodically in some of the insulin-related panels and discussions -- for example, at the popular TCOYD-Close Concerns forum and at a JDRF/NIH Closed Loop dinner event, where it was mentioned briefly as being effective, but not a game-changer. One insulin session that did catch our eye was Eli Lilly's Dr. Christoff Kazda on a "novel formulation" of Humalog and two add-on chemicals designed to accelerate the absorption rate of the insulin. This so-called LY mixture is designed to be a fast meal-time insulin, and while the results weren't blockbuster-like, it supported the continued R&D on this for PWDs with T1D.
Glucagon, Too: While there also wasn't much talk of glucagon developments, the Lilly nasal glucagon (which I puffed up my nose in a clinical trial back in 2014) had some science showing it's effective, but it's still in clinical trials and Lilly remains non-committal about its plans for bringing this nasal glucagon originally created by Locemia to market. Also, Xeris Pharmaceuticals presented data on its stable liquid formulation and mini-dose glucagon under development, highlighting how effective that appears to be in studies.
The 'C' Word (and Prevention)
While it wasn't a key theme, research focusing on a diabetes cure and prevention efforts certainly carried its weight at the ADA event.
Faustman's Vaccine: Dr. Denise Faustman presented a poster at this year's ADA showing the progress on her Phase II clinical study for a vaccine that could prevent type 1. We reported on this back in 2015 when she was just starting her second phase, a five-year trial expected to run through 2020. With the latest interim results from her research, Dr. Faustman continues to believe the century-old TB vaccine could change white blood cells at a genetic level, basically "resetting them" and thereby reversing / preventing T1D.
Making Beta Cells Great Again: Yep, this was an actual title of some research presented. Different researchers were showing interventions discovered during decades of studies from trial sites across the globe, looking at preventative insulin treatments that could be used to boost the immune system and stop the attack on beta cells that causes T1D. One study looked at a longtime cancer drug Gleevec for its immunosuppressive aspects for possibly slowing the onset of type 1, while another explored the antigen GAD that in animals has shown to help build up the immune tolerance and possibly stop autoimmune conditions like T1D. These were all JDRF-funded studies.
Prevention, Of Course: The theme of T2D prevention alone returned 191 results in the abstract database -- as mentioned in a speech by ADA President of Healthcare and Education Brenda Montgomery's who also praised the national Medicare coverage of the Diabetes Prevention Program starting in January 2018. And yes, despite our D-Community's continued cry to stop using that language, many of the presentations and posters referenced "reversing" T2D. Oh well... hopefully these cries won't continue to fall on deaf ears...
Exploring Diversity Among Patients
Disparities Exist: Yep, they do. Researchers presented a handful of science on this across the board -- from data on hospital visits in the U.S., to Medicare-age cardiovascular events by state, to minority populations in different states and regions. Among those studies was one tackling an issue that has little research to date: how diabetes develops differently in certain races and ethnicities. Researchers used data from TrialNet's Pathway to Prevention Study screening program, covering more than 4,000 T1D PWDs and relatives between ages 1 and 49 -- 12% Hispanic/Latino; 3% African American; 1.4% Asian/Pacific Islanders; 79.3% were white; and 4.3% "other."
"The differences in type 1 diabetes development among races/ethnicities discovered in this study are striking," said Dr. Mustafa Tosur of Texas Children's Hospital at Baylor College of Medicine. "Especially of interest is the dramatic differential effect of being overweight/obese for Hispanic/Latino children younger than 12 years of age, compared to non-Hispanic white children in the same age group. The research demonstrates that racial and ethnic differences should be taken into consideration when counseling family members who are at-risk of developing type 1 diabetes, and when designing preventive care and treatment options. Considering the obesity epidemic in children, which is more prevalent among minorities, and the frequency of type 1 diabetes is growing most in Hispanics in the U.S., these findings have important public health implications."
Health Literacy: While this is also an ever-increasing topic of discussion in healthcare it seems, we only saw four abstracts focusing on it this year. And the results were not surprising, showing that for patients in lower socioeconomic circumstances, using modern tech tools such as mobile apps and telemedicine isn't always feasible. And yes, it can impact BG monitoring and behaviors relating to D-care. There's little help for those who don't understand some of the basics in diabetes care, particularly in rural and minority communities, and published literature today (not to mention staff resources, insulin and education) is limited at hospitals and clinics in some of the poorest places in the world.
Across the Globe: A handful of posters addressed diabetes care around the world; it's good to see the global perspective being represented. One study from the IDF (International Diabetes Federation) looked at the rising prevalence of adults getting diabetes around the world. Other studies focused on the insulin access crisis in many places, including hospitals worldwide.
Note: Audio of a handful of presentations from the SciSesions are available online, and some webcasts will be available in the coming weeks (though it's not clear if these will be accessible for ADA members only).
We're not quite done with #2017ADA coverage yet, so stay tuned for more later this week...