ADA Scientific Sessions 2016: The Science!

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Whew -- we"re just returning from the gi-normous annual ADA Scientific Sessions, that took place in New Orleans this year. And like you all, we"re watching all the mainstream media coverage with great interest. Obviously, folks who don"t live with diabetes themselves will have different sensibilities about the headlines.

Every year the American Diabetes Association itself earmarks a list of what it deems the most newsworthy of the avalanche of new scientific studies presented. From there, we always like to showcase our own picks.

So from the 2016 ADA meeting, here are a handful of studies that stood out to us:

Tip 1) if you need a refresher on all that clinical study jargon, see our very own "Your Diabetes Research Primer" here.

Tip 2): be sure to read all the way to the bottom of this post, where the Dexcom and Medtronic"s latest CGM and closed-loop studies are explained.

Plus an Editor"s Note: The ADA has always been prickly about attendees taking photos of presentation slides or even posters, despite this material being on display for 16,000 attendees. We hereby note that we obtained express permission from every study designer before taking or sharing any photos.

Hypoglycemia Awareness

Intervention! - Amsterdam researchers conducted a "brief and partly web-based psychoeducational Intervention for adults with type 1 and Insulin-treated type 2 patients" in eight Dutch clinics. The basic question was, can long-term hypogylcemia unawareness be prevented and treated with education, to help patients re-discover signs of impending danger? They found that after participating in their "psychoeducational intervention" called HypoAware, participants experienced 35% fewer episodes of severe hypoglycemia than those in usual care, and the HypoAware graduates also significantly improved hypoglycemia awareness. Sounds like a very cool program that I hope they bring to the States sometime soon!

Diabetic Alert Dogs - We"ve long been in need of solid data to show the effectiveness of diabetic alert dogs in detecting hypoglycemia. This study out of Portland, OR, actualy compared the performance of these trained dogs in comparison to using a fingerstick meter or Dexcom CGM. While the study only included 8 subjects (with a huge age range from 4-48), the dogs did pretty darn well. They provided a timely alert (within 10 minutes before to 30 minutes after onset of hypoglycemia) in 36% (sensitivity) of all hypoglycemia events (N=45). The researchers note that "In events when both the dog alerted and blinded-CGM reached the hypoglycemia threshold (N=30), CGM would have alerted prior to the dog in 73% of events (median 22 minute difference). This is the first controlled study to evaluate the reliability of trained dogs to alert to hypoglycemia under real-life conditions." Good boys!

Insulin Options

A Sunday session called "Beyond Basal Insulin in Type 2 Diabetes—Treatment Intensification Options" included roughly half-a-dozen studies looking at the safety and efficacy of new insulins and insulin-combo drugs. Findings included:

• A study out of Denmark and Argentina found that T2 patients treated with IDegLira (investigational once-daily, single-injection combination of insulin degludec and liraglutide) have a greater chance of reaching glycemic targets without hypoglycemia and weight gain than with Insulin Glargine alone.

• Use of once-weekly Dulaglutide also showed improved A1c levels and weight loss in T2 patients in Europe.

• The LixiLan-L Trial conducted at multiple international centers evaluated this drug vs. insulin only in patients with T2. LixiLan is a "fixed-ratio combination" of insulin glargine (Gla100) and the GLP-1 lixisenatide, currently under development. The trial compared safety and efficacy of LixiLan with Gla100 over 30 weeks and found that LixiLan showed superior glycemic control, with a beneficial effect on body weight, no additional risk of hypoglycemia and a low rate of side effects like nausea and vomiting.

• A double-blinded trial looked at the efficacy of faster-acting insulin aspart (faster aspart) vs. insulin aspart (IAsp) in adults with uncontrolled T2 on basal insulin and oral diabetes drugs... and surprise! The faster-acting aspart did better in glucose control, even without increasing overall hypoglycaemia.

• Plus two much-anticipated studies on the use of SGLT-2 inhibitors alongside insulin: one study out of Japan looked at it SGLT-2 use with insulin and found it improved patient outcomes without increasing hypoglycemia and was well-tolerated with few side effects, and even low instance of UTIs. The other study out of Korea compared SGLT-2 Inhibitors and DPP-4 Inhibitors added to insulin therapy, and found the former achieved better glycemic control and greater weight reduction than DPP-4 inhibitors without increasing the risk of hypoglycemia. Go, pee drugs!

Inhaled Insulin - We can"t overlook MannKind Corp"s Afrezza, which has faced skepticism from critics and a ton of hype among the investment community. While the future remains unknown on how Afrezza will fare, data in late-breaking poster presentions (here and here) at ADA shows solid science that this inhaled option has 25-35 minute faster action than insulin lispro (aka Humalog). We were also excited to see the news in conjunction with the ADA conference that MannKind and JDRF are partnering to study Afrezza in the pediatric population! We plan to share more updates on Afrezza later this week.

Food

We saw so many different science presentations focused on food that it made our stomachs growl as we wandered the poster halls. Seriously, just try searching "food" in the ADA abstracts database... but out of them all, one that caught our eye in particular was focused on the low-carb trend:

Low-Carb Diets & Glucagon - this study surprisingly found that low-carb diets reduces the effect of glucagon on recovery during mild hypoglycemia in T1 patients. Weird, right? The data showed that especially for those eating a diet of less than 50 grams of carb per day (compared to a higher 150g+ carb diet) may experience and "impaired treatment effect of glucagon on mild hypoglycemia." This initial research only included 10 people over the course of a week, so the plan going forward is to include more patients and expand the timeline to see what happens after longer periods of eating low-carb. Makes you wonder, especially as we move into the arena of closed-loop tech, that may use built-in glucagon to boost BGs.

Youth and Diabetes

There was a lot of stuff about young people with diabetes this year.

Preventing DKA in Teens with T1D - a study out of Portland looked at putting a stop to the many preventable cases of DKA among youth with T1D. They evaluated a program called Novel Interventions in Children’s Healthcare (NICH), developed to address the social determinants of health in youth with T1D who are experiencing repeated hospitalizations deemed avoidable by medical providers. This intervention involves family-based skills training, care integration and coordination, and case management. Forty five youth were enrolled in a medical center close to home.
Results showed the program was "significantly associated with reductions in HbA1c and days spent in the hospital due to DKA, with a trending relationship for a reduction in yearly cost of diabetes care." Summary? "NICH...shows promise in improving care, improving health, and reducing costs."

High Prevalence of Early Complications - The SEARCH for Diabetes in Youth Study gathered data from 1,746 youth with T1D and 272 with T2D diagnosed under age 20, with an average duration of 7.9 years, and the prevalence of complications including kidney disease, retinopathy, peripheral neuropathy, and abnormalities in heart rate. They found all the complications except cardiovascular were more prevalent in T2D vs. T1D youth, with minority youth also having higher rates than their Caucasian counterparts. The researchers note: "These results highlight the substantial burden of early complications in youth with diabetes of short duration, especially among T2D and minority youth."

Reduced Brain Function in Youth with T2D - researchers in Ohio and Tennessee have found that youth with T2 have changes in brain structure and poorer cognitive function scores compared to their peers. They examined differences in total and regional brain gray matter volumes in 20 youth with T2 and found that compared to a control group, the T2 kids had: decreased total gray matter volume; ten regions (within the temporal lobe, occipital lobe, parietal lobe, cingulate gyrus, and basal ganglia) with significantly less gray matter volume than controls; and five regions (within the frontal lobe and basal ganglia) with significantly greater gray matter volume than controls. Wow, that sounds bad! But the researchers add: "Whether these findings explain poorer cognitive scores observed previously remains to be determined."

Plus some more bad news for young people with diabetes on the stress front:

Effect of Major Life Events - It"s no secret that major life events can disrupt daily life, affecting T1D treatment adherence, self-confidence, personal relationships, and quality of life. This study out of Boston assessed the frequency and type of these life events in "a contemporary sample of teens with T1D," and the impact on glycemic control, teen- and parent-reported treatment adherence, diabetes self-efficacy, family interactions, and overall quality of life. Parents of 184 teens with T1D completed their Life Events Checklist, and the most commonly cited events were hospitalization of a family member, getting a bad report card, serious arguments between parents, serious illness or injury in a family member, going to a new school, and family financial problems. Naturally, the more of these stressful events reported, the poorer the D-adherence: "More major life events significantly impacted health and psychosocial outcomes in teens with T1D." Yup! So researchers conclude that "screening for major life events in medical settings may identify teens at-risk for poor outcomes and suboptimal diabetes control, allowing for timely intervention."

Young Children and Stress - Did you know that stress is actually considered a possible precursor to islet autoimmunity and type 1 diabetes? The Environmental Determinants of Diabetes in the Young (TEDDY) study is following 8676 genetically at risk children from 3 months until 15 years for development of IA and T1D. Life stress data are collected by parent report every 3 months until age 4, and biannually thereafter. In this study with young children, researchers make a point of distinguishing between life events negatively impacting the parent from events negatively impacting the child. To make a long (science-y) story short, the researchers are concluding that the child"s cumulative life stress is indeed a risk factor for autoimmunity and therefore T1D.

Minorities and Diabetes

On Saturday morning, there was actually a whole session titled, "Race/Ethnic Differences Matter." It may not sound PC, but apparently race makes a difference when it comes to insulin resistance and other effects of the Big D.

Cardiovascular Disease (CVD) - this study used National Health Interview Survey data from 1997 to 2009, with mortality follow-up through the end of 2011, to estimate current decreases in CVD, heart disease, and stroke mortality by diabetes status. It looks like CVD death rate declines did not differ between men and women, but they did between blacks and whites. These good news is that overall, adults with diabetes are experiencing far fewer CVD-related deaths over the past decade, and the race-related disparity is decreasing too. "However, the lack of a reduction in CVD death rates among middle-aged adults (age 55-64) remains a concern that warrants further examination," the researchers state.

T2 Diabetes in Asian-Americans - Asians now collectively represent about 5% of the U.S. population. This study analyzed data from the 2013-2014 Behavioral Risk Factor Surveillance System to examine prevalence of diagnosed diabetes and risk factors in this population and found that in comparison to whites, many Asian subgroups had reduced incidence of diabetes and risk factors with the exception of Japanese and Chinese, where stats were similar to whites. "Among Asian Indians and Filipinos aged ≥65 years, multivariate-adjusted diabetes prevalence was ~40%. These findings suggest heterogeneity within the Asian populations in terms of risk factors for type 2 diabetes and prevalence of diabetes, with prevalence particularly high in Asian Indians and Filipinos."

Disparities in Medication Compliance and A1C - This study looked at whether providing free care "closes the gap" on outcomes among whites vs. minorities. In general, people from ethnic minorities in USA with T2 diabetes have reduced medication persistence and worse glycemic control. "The contribution of socioeconomic factors and healthcare barriers is unclear," researchers note. Their data shows that significant ethnic disparities do exist, independent of socioeconomic status, even in a system providing free care. "Research is needed to understand why, and to develop interventions to correct this."

Money and Access Issues

This of course is very timely, and a huge issue! We"ll be covering this more in-depth soon, but here"s some science that made our radar:

Estimating Progressive Diabetes Costs - There"s not a lot of population-based data on the trajectory of health care costs as a person moves from non-diabetic to diabetic status. Yet this data is crucial to estimate the economic benefits of prevention efforts, among other things. Using a 2001-2013 MarketScan dataset, researchers in Atlanta compared medical expenditures among a diabetes cohort 9 years before and after diagnosis with a matched cohort without diabetes. They found that per capita expenditures for the two groups increased annually by $382 and $177, respectively. Interestingly, the diabetes group had a 34% higher expenditure rate than the control cohort even 9 years before diagnosis (!) "This excess expenditure increased with the time to and duration of diabetes, with the largest difference ($6,845) occurring in the first year of diabetes diagnosis." So it looks like T2 prevention makes good economic aside from being the right thing to do.

Effect of High-Deductible Insurance - on acute diabetes complications. Another study evaluated high deductible health plans (HDHP), whose prevalence is already 46% and "about to explode.” They studied a national sample of 12,084 HDHP members with diabetes ages 12-64 enrolled for 1 year in a low deductible (≤$500) plan followed by 2 years in a HDHP (≥$1000) after an employer mandated switch. Outcomes included time to first acute diabetes complication and total costs of that first episode. The upshot is that HDHP members with diabetes, especially high morbidity patients, experienced "highly concerning delays in acute complication visits and increases in costs per complication." Right!

Psychosocial and Behavioral Stuff

Social Media Impact - A poster presented by an Arizona State University researcher tackled looked closely at our world of online diabetes (aka the DOC), including activity on forums like Diabetes Daily, TuDiabetes, DiabetesSisters, HealingWell.com, and the ADA"s website. Conclusions: those PWDs who are active on social media tend to seek and offer info to others to influence health, and those people tend to demonstrate greater "adherence" to diabetes management behaviors. That seems like a no-brainer to us of course, but nice to have it quantified!

Diabetes Stigma - We saw a handful of science posters highlighting this issue, either directly or indirectly as part of another focus. One researcher from Tokyo tackled the stigma issue head-on, finding that among 209 patients studied, those who were experiencing negative stigma did show a lower level of active self-care behaviors. The research isn"t specific on how to address that problem, but suggests that interventions aimed at self-esteem and self-efficacy could potentially improve attitudes and therefore D-management.

Stigma was also a big theme of a Team Novo Nordisk event we attended during ADA, which highlighted the research of Dr. Jessica Brown of the Australian Centre for Behaviorial Research in Diabetes, who"s developing and validating a diabetes stigma assessment survey tool for both T1 and T2. Again, it"s been long known that stigma impacts how we PWDs care for ourselves, but now it"s great to see this being validated in research that can be used to create interventions and even policy change.

Sleep and A1C? Yep, how we snooze makes a difference in our D-management and even how our A1Cs turn out, according to this study. This data shows best A1Cs at 7% or less came among PWDs those who snagged 7-10 hours of sleep, though interestingly those PWDs only getting a few hours less sleep achieved an average of 7.3% -- so it seems another hour or two definitely makes a difference. We"re off to bed earlier tonight, for sure!

Know Your A1C? That familiar mantra of "test, don"t guess" in the context of fingersticks is now being applied to A1C smarts. In the first study of its kind among T1s, researchers looked at patterns of A1C knowledge -- what PWDs thought their number is versus what lab results actually show. More than a quarter of people studied didn"t know their most recent A1C, and more people underestimated than overestimated the result; those who underestimate tend to have poorer management and glycemic control along with greater depression and distress. "Combined with lower education and pump use, this group perceives themselves as under better control than they actually are." Ugh.

Dexcom CGM Studies

Of course there were also a ton of oral and poster presentations on various diabetes technologies. From our keen interest in the #WeAreNotWaiting movement, we wanted to highlight the new CGM studies presented by Dexcom at this year"s ADA:

Risk of Using CGM for Treatment Decisions - Can CGM be safely used for treatment decisions without relying on fingerstick meter results? This study took on that $6M question, performing retrospective analyses to assess accuracy and risk of using the Dexcom Mobile G5 for CGM-based treatment decisions, among youth and adults. They focused on the risk of overcorrecting, which was 2.3% for youth, and 3.6% for adults when the CGM read within 20-30% higher than a lab analyzer value called YSI (Yellow Springs Instrument). "Despite differences in the glycemic characteristics between adults and youth, the risk assessment for dosing using the new CGM device was as small as 2-4% for overcorrection incidences," researchers concluded. "This study suggests that the CGM system is accurate enough to dose insulin without the need for SMBG confirmation and with minimal increased risk of overcorrection to patients." (!!)

Clinical Use of CGM Results - A different study looked at the fact that CGM users are undoubtedly already using this data to make therapy decisions, despite the fact that this is not yet FDA approved and no published studies have yet evaluated outcomes when CGM is used as a replacement for BGM. Researchers reviewed 11 CGM outcome studies since 2008 for reported changes in fingerstick test frequency. Six trials did not report frequency of BGM use while 5 trials reported quantified reductions. They also note that "data from the T1DExchange demonstrates that patients across a range of ages are reducing BGM frequency after initiating CGM therapies and CGM outcome trials that quantify SMBG frequency demonstrate improved glucose control and decreased dependence on BGM." Their conclusion: "Improving CGM technologies should engender greater trust and result in greater reliance on CGM-based decisions."

Similar Estimated A1c Results with Pumps and MDI - This study compared results of patients using CGM who were either on an insulin pump or multiple daily injections. All were using the Dexcom SHARE system, gathering a grand total of 67 million records of glucose values collected over a 6 month period from 1587 CGM users (MDI - 648, CSII - 939). Results showed that average A1c outcomes were similar, while the standard deviation of glucose was slightly lower for MDI (!). Estimated A1c in ages 2-6 was 8.3% for MDI and 8.2% for CSII, 7-12 estimated 7.9% and 8.1%, and 13-18 estimated 7.5% and 7.8% respectively. Summary: "Although there are small differences in glucose variation, patients on CGM showed similar glucose control (A1c) with both therapies."

Patient Data from Real-Time CGM - This retrospective data analysis evaluated the impact of CGM threshold alerts -- low, high, and rate of change, and the settings chosen by patients on their CGM devices, including average daily screen views. There were 17.5 M records of data and the average time of CGM use was 78 ± 72 days. 92% of users set their electable alerts; 77% of users chosen a low alert at 80 mg/dL or lower; and 79% of users used a high setting of 180 mg/dL or higher. "On average, participants checked the CGM screen 29 ±18 times daily. The data reveal that glucose average and standard deviation correlated with their most frequent low and high levels... When users set their glucose alert levels lower, their average and variation of the CGM glucose decreased significantly." Good to know!

Also, a hearty congrats to Dexcom for celebrating its 10-year anniversary of their first commercial product! To mark this milestone, last week they sent out a letter to their entire user base offering to make a $10 donation to a diabetes charity of each customers" choice. Nice move, Dexcom!

Closing the Loop

Last not least in our line-up, the big buzz of this ADA conference was of course Artificial Pancreas studies, with much discussion going on about how clinical trials (several dozen happening across the globe) will move forward to get these systems FDA approved and to market.

Medtronic Next-Gen Pivotal Data - Most significantly, the diabetes industry"s largest pump-CGM maker unveiled pivotal trial data on its hybrid closed loop system, known for now as the 670G. With patients using this system for a total 12,389 days during the three-month trial, it"s huge that no adverse events with hypos or high BGs came back and the PWDs stayed in range 73% of the time. Also, A1Cs dropped across the board from 7.4% to 6.9%. This study used the company"s fourth-gen sensor (aka Enlite 3) that will be included with the device the company plans to file with the FDA soon. Aside from pivotal trial data, Medtronic also presented a handful of other studies related to its predictive glucose technology.

OpenAPS - It"s huge that our friends Dana Lewis and Scott Leibrand were able to pay the very steep fee to have a late-breaking poster on display about the #OpenAPS system they invented. More than 80 are currently using the system. For the poster, over 40 contributed data over the course of six months, totaling 80,000 hours of closed loop experience. Self-reported outcomes showed incredible improvements, from A1Cs dropping from 7.1% to 6.2% (!) and time in range from 58% to 81%, to improved sleep quality (see the above-mentioned study on sleep). It"s very exciting to see this research being shared with the established medical community, hopefully convincing them that this open-source tech is a scientifically valid wave of the future. (You can also read more about OpenAPS here.)

Do We Really Want an AP? - Of course, with all this chatter about closed loop, this study asks the big question of whether PWDs actually want this technology. The data from a 101-person survey found that 67% of people wanted an AP, while 27% have doubts and 6% flat out reject the idea. Pretty much the "desire curve" for any new-fangled product of any kind, we"d venture to guess.

More on #2016ADA from the technology and product side to come later this week...

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn"t adhere to Healthline"s editorial guidelines. For more information about Healthline"s partnership with Diabetes Mine, please click here.

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