Whew -- we're still getting settled after our return from the huge annual ADA Scientific Sessions, that took place last week in super-humid Orlando.
First, we covered the new new diabetes technology that was on display in the Exhibit Hall and was a hot topic in many of the presentations during #2018ADA. Now, we'd like to share what caught our eye on the science side of the SciSessions this year.
Note that you can peruse the HUNDREDS of scientific abstracts online at the ADA conference website, which over five days included 375 oral presentations; 2,117 poster presentations (47 moderated discussions); and 297 published-only abstracts.
There's also a Poster Hall displaying hundreds of additional research posters side by side. You can get lost in there, just wandering among the forest of studies. The ADA provides a detailed schedule of embargo times, specifying when the full research data can be publicly released. Each day, some of the scientists stand by their research posters and give presentations about their studies, to attendees listening via audio headsets, followed by Q&A. It's a pretty amazing way to learn and also meet leading researchers in the medical science community.
Note also that after the kerfuffle in 2017, this year the ADA revised its photo policy with a #RespectTheScientist approach, that allows photos of posters and presentation slides with the permission of the individual researcher. Most appeared to be allowing that, showing a slide granting permission at the beginning of their presentation.
While there was some headline-capturing research (such as Dr. Denise Faustman's controversial diabetes vaccine work), a majority of the science presented at this conference doesn't make the mainstream media. Here is a look at what we took note of at this year's SciSessions.
Access and Affordability Research
This was a big theme during throughout the 2018 conference.
In fact, during her opening address, the ADA's President of Medicine and Science Dr. Jane Reusch told the story of her own father who passed away from T2 years ago, noting how many in our D-Community are currently suffering and dying as a result of access struggles.
“Insulin affordability threatens lives and takes lives,” she said. “It’s crucial that the ADA, as part of its mission, keeps insulin affordability in the spotlight.”
Some of the research presentations that highlighted these issues included:
Rationing Insulin: The Yale Diabetes Center in Connecticut presented a study funded in part by the National Institutes of Health (NIH) about people who are rationing insulin due to cost, and the negative effects they experience as a result. Of the 199 PWDs (both type 1 and type 2) in the study, about 25% of them (51 people) reported using less insulin than prescribed in the past year because they couldn’t afford it. And in multi-variable analyses, researchers found that patients also had threefold greater odds of having an A1C of 9% or higher compared to PWDs who did not report insulin underuse. The problem was greatest among people making less than $100,000 a year, and wasn't associated with race or type of diabetes. Employer health coverage also was not protective, and patients who were covered by a mix of government and employer insurance were at greater risk of underuse, as well as those unable to work.
“These results highlight an urgent need to address high insulin prices,” investigator Darby Herkert said. "This may be done through greater transparency in pricing, advocacy for patients who can’t afford their prescriptions, use of alternative insulin options for some patients, and assistance programs."
Outcomes from Older Insulins: Another study looked at NPH compared to insulin analogues in type 2, and found that they were pretty much on par as far as hypoglycemia risk and ER visits for those individuals. Those T2 PWDs treated with the modern analogue basals did not have substantially better outcomes than those treated with the less-costly human insulin, according to this study by Yale School of Medicine researchers and colleagues at Kaiser Permanente.
Talking to Healthcare Teams: An eye-opening presentation showed that despite how big an issue cost and access are to PWDs in diabetes care, a majority don't mention it to their healthcare team. Seriously, the people writing prescriptions often just don't know about financial struggles because these conversations aren't taking place.
The data showed that two-thirds of patients who are restricting medication use due to affordability don't tell their HCPs, and less than 50% of patients are having even a general discussion with their doctors about cost concerns. Sadly, those that do have these conversations don't talk about cost-saving measures as a way to help PWDs experiencing financial woes.
Here are some tips presented during the cost-related "adherence session" on ways HCPs can have these conversations with patients:
Diabetes Technology Research
New data on the benefits of CGM use and new closed loop systems had a big presence, and there was also a larger-than-usual number of studies relying on CGM data to capture results about a variety of topics.
On the closed loop front, three big studies were presented on different devices under development:
Diabeloop: The Diabeloop DBLG1 system out of France isn't expected to hit the market for at least a couple years, but the research has been underway for years now. A new study, following up on their original three-day trial in 2016, was aimed at assessing whether people using this connected system with smart algorithm could achieve better glucose control at home compared to using a regular sensor-assisted pump device. Short answer: Yes. Conducted at 12 centers in France enrolling 68 adults with T1D who wore the system for 12 weeks, the study found those using the DBLG1 were in range (70-180 mg/dL) 69.3% of the time compared to 56.6% of the time for those not using a closed loop. The closed loop users also saw average lower glycemic levels, but that didn't lead to more hypo events. Lead study author Dr. Sylvia Franc, who's research director and VP of the Centre of Study and Research on Intensification of Treatment of Diabetes in France, said: "This system has the potential to substantially improve the glycemic control and the quality of life for patients with type 1 diabetes, decrease long-term chronic diabetes complications, and reduce the burden of the dozens of daily calculations and therapeutic decisions they currently have to make themselves.” Thumbs up!
OmniPod Horizon: Even though this future closed loop patch pump dubbed OmniPod Horizon from Insulet isn't set to hit the market before 2020 in its earliest form, there is already lots of research happening. At ADA, Insulet presented data from a recent five-day trial that ended in late 2017.
This newest study results assessed the safety and performance of this Omnipod hybrid closed-loop system in adults with T1D over five days in a supervised hotel setting under "free living" conditions, meaning that participants went about normal everyday activities. The study included 11 adults aged 18- 65 years with T1D, with an average A1C of 7.4%. Meals during the trial were unrestricted, with PWDs making their own food choices and delivering insulin as they thought appropriate per their usual routine. Presenting the results was Dr. Bruce Buckinham from Stanford University, who reported that subjects' time in range (70-180 mg/dL) was 11.2% higher than those in standard therapy. Also, the amount of hypoglycemia went down 1.9% during the daytime and .7% overnight. Bottom line, according to Dr. Buckingham: Horizon works well and is safe and effective. More thumbs up!
Dual-Hormone Treatment: Other new data presented suggests that adding the drug pramlintide (brand name Symlin) to a closed loop device, along with insulin, resulted in better outcomes for adults with type 1 diabetes compared with doses of insulin alone. Pramlintide is a synthetic version of the hormone amylin that releases into the bloodstream after eating to regulate post-meal BGs, but we PWDs don't produce it. Canadian researchers compared a Dual Artificial Pancreas device using both insulin and pramlintide with another just using insulin alone, and found that the med-combo showed greater improvement in BG levels. Those receiving both substances experienced glucose levels within target range 85% of the time, compared with 71% of the time for those using insulin alone.
DIY Diabetes Systems:
Absolutely awesome was the Do-It-Yourself community becoming a visible part of the program at SciSessions, from the poster hall to presentations and their very own study symposium! Dana Lewis, founder of the OpenAPS community of PWDs who've built their own homemade closed loop systems, presented on her own story of "closing the loop" in December 2015 and how it's changed her life. Naturally, she's quite the proponent of open sharing, so she encouraged photos during her talk and has shared her findings online (as always).
The #OpenAPSstudy presented at ADA was a retrospective cross-over analysis of continuous BG readings during two-week segments before and after starting use of this DIY tech. It showed a mean estimated A1C improved from 6.4 to 6.1%, while time-in-range (70-180 mg/dL) increased from 75.8% to 82.2%. Overall, time spent high and low were both reduced, in addition to other qualitative benefits that users experienced, like more and better sleep.
Over 710 people are now using these DIY closed loops worldwide, and it's making a huge difference in their lives and diabetes management! Check out this Quality of Life slide presented in the session by a D-Dad user Jason Wittmer, whose son has been using a DIY system:
Props to the #WeAreNotWaiting community!
Care and Feeding Diabetes Research Topics
Health Care Strategies for Improving Glycemic Control: We all know that patients and healthcare professionals differ on what it means to be “in control,” with T2 patients most frequently using behavioral criteria like sticking to lifestyle changes and/or treatment regimens, and HCPs most frequently using clinical criteria, like A1C levels and amount of hypoglycemia. One cross-sectional, web-based survey of 500 HCPs and 618 adults with T2D using basal insulin assessed perceptions, attitudes and behaviors associated with T2D management. The findings showed the diverging view between patients and HCPs, and PWDs with T2 are less likely to consider A1C value in determining "control." It was also interesting to see a data-point that 67% of patients felt it was their responsibility to control their diabetes, while only 34% of the HCPs felt that way and instead saw themselves as the ones largely responsible for D-care. All of this will hopefully help bridge the gap between differing views on key aspects of diabetes control and management between those HCPs and patients and potentially improve communication.
Eating and Low Carb:Food is always a big topic at the SciSessions, and this year was no exception. A number of talks presented research looking at food choices and diabetes, low carb and related meal plans. In one session, data showed that very low carb eating has been found to increase "good" (HDL) cholesterol and lower triglycerides while improving insulin resistance. It was interesting to hear a discussion about whether low carb could be seen in itself as a treatment for type 1 diabetes, on par with medications (!) That same session presented data from a self-reported #Typeonegrit survey of over 300 youth with T1D on a very low carb diet, and it pointed out that many families of these CWDs don't actually tell their doctors they're going low carb because they worry about being judged or discouraged.
TEDDY Trial: Known officially as the Environmental Determinants of Diabetes in the Young, this is a major study that showed data from over 13 years that includes 8,500+ kids at risk of type 1 diabetes. TEDDY is one of the largest studies of its kind looking at infants who are at the highest risk of developing the autoimmune condition and examining the environmental factors that may play a part. Yet, to the disappointment of many watching these results, the data did not show that two key environmental factors -- omega 3 and Vitamin D -- play a part in the development of T1D. This may throw off a major hypothesis, so additional research is needed.
Clincial Inertia in T2 Diagnosis: Researchers examining a large, national database found that doctors often fail to aggressively increase therapy for T2D patients, even when clinical indicators show they should. Data from this study of 281,000 patients over a five-year period from diagnosis showed this. Six months after patients had an A1C greater than 8%, 55% of the them showed no sign that medication had been prescribed or increased, or other action taken. A new diabetes prescription was seen in just 35% of the patients, with a percentage of them achieving an A1C < 8%. The researchers noted that reasons associated with clinical inertia (i.e. no action on the part of doctors), at both the six-month and two-year timeframe included racial aspects as the PWDs were African-American, not having insurance, having a "normal" body mass index, and being on bolus insulin already. Within two years, the clinical inertia was reduced to 19% -- indicating that inertia can eventually wear off as HCPs become more familiar with the challenges of T2D and willing to prescribe more medications as needed.
SLGT Inhibitors for Type 1: New research showed that SGLT inhibitors normally used for T2s could also be used successfully by T1D patients along with insulin, improving glucose control to possibly usher in "a new era" for the type 1 community. Yet, this brings increased risk of DKA (diabetic ketoacidossis). These are the class of oral drugs that include AstraZeneca's Farxiga/Forxiga, Boehringer Ingelheim's Jardiance, and Sanofi's SGLT-1/SGLT-2 inhibitor Lexicon. In two different trials looking at the various drugs, PWDs saw significantly improved A1C results without an increase in hypoglycemia and a lower amount of glycemic variability after mealtimes. Not to mention some weight loss. However, they did see an elevated risk of DKA when using these drugs along with insulin. The study authors -- Dr. John Buse of the University of North Carolina Chapel Hill and Dr. Chantal Mathieu from the University of Leuven in Belgium -- both felt the study data shows an overall benefit that outweighs the DKA risk and other possible side effects, like diarrhea and genital infention (um, no thanks).
Autism Risk? In a study of a connection never before explored, Kaiser Permanente researchers found that children born to mothers with diabetes have a higher risk of being on the autism spectrum. Results showed that risk of Autism Spectrum Disorder (ASD) was higher in children exposed during pregnancy to females with pre-existing T1D, T2D and gestational diabetes diagnosed by 26 weeks, compared with moms without diabetes. And for moms with T1D during pregnancy, the risk was twice as high. The research looked at 17 years worth of data from 1995-2012, including children born between 28-44 weeks over in Southern California hospitals. Of 419,425 eligible children, a total of 5,827 children were diagnosed with ASD over that period. Even with the higher risk, though, the researchers emphasized that the likelihood is still very small -- so the message is NOT that diabetic pregnancy is not safe.
Beta Cell Function: Dr. Michael Haller at the University of Florida, unveiled results of a clinical trial that tested Thymoglobulin -- a combo of already FDA-approved drugs known as anti-thymocyte globulin (ATG) and the immune system activator Neulasta (GCSF), an immune activator, also called GCSF. The study looked at whether this combo could preserve beta cell function in new onset T1D, in 89 participants between ages 12 and 45. It found that a short duration, low-dose of ATG alone did preserve beta cell function and improved insulin production throughout the entire one-year study period. Moreover, the people who got the ATG+GCSF combination had significantly lower A1Cs than those given a placebo. Dr. Haller pointed out that these results suggest ATG, alone or in combination, should be considered as a potential means of slowing T1D progression and preserving beta cell mass for those newly diagnosed with type 1. More search is needed, but this early data seems promising. Final results at the end of the full two-year trial are expected in 2019.
So, those are some of the standout topics of this year's ADA science.
Here's to all the clinicians and scientists devoting their lives to these (and many other) important research paths!