ADA Postgrad 2019

February 22-24, 2019; New York, NY; Full Report – Draft

Executive Highlights

  • Greetings from New York, where ADA Postgrad 2019 recently wrapped up, highlighted by a fascinating panel that brought together representatives from the ADA, ACP (!), ACE/AACE, and The Endocrine Society to compare and contrast treatment guidelines. What were the biggest differences? Notably, ADA, ACP, and ACE/AACE guidelines do not agree regarding A1c targets. ADA generally recommends an A1c target <7%, ACP aims for between 7% and 8%, and ACE/AACE looks to get patients below 6.5% (if no increased hypoglycemia risk). ADA’s Dr. Will Cefalu also led these leaders through several case studies in which their organization’s respective guidelines were applied – this was intriguing and brought out some interesting commentary on the use of sulfonylureas in light of recently released CAROLINA results showing glimepiride did not increase CV risk relative to DPP-4 inhibitor Tradjenta. We hardly think CAROLINA should be the final word on SFUs, by the way.

  • A powerhouse panel on therapeutic inertia featured reps from key stakeholder groups across the diabetes landscape. Led by ADA’s Dr. Will Cefalu and including panelists Dr. John Cuddeback (American Medical Group Association, Alexandria, Virginia), Ms. Jennifer Trujillo (University of Colorado, Aurora, Colorado), Ms. Gretchen Youssef (MedStar Health, Washington, D.C.), and our very own Ms. Kelly Close (The diaTribe Foundation, San Francisco, California), the panel focused on how to move forward in addressing therapeutic inertia and change throughout a broader ecosystem. Notably, ADA has taken a specific interest in the topic recently, and this panel followed a very highly-regarded ADA-sponsored Therapeutic Inertia Summit in November 2018

  • Dr. Felicia Hill-Briggs gave an incredibly valuable talk on social determinants of health and highlighted the need for truly bold action on the macro-level. One of many impactful quotes from Dr. Hill-Briggs: “We don’t have these conversations [about social determinants and inequality] often at professional meetings. It’s uncomfortable here in the US to confront the policy and the history that have directly resulted in patterns of health inequities, but ultimately we cannot solve problems that we are not willing to identify or name.” We’re glad to see this focus from Dr. Hill-Briggs and ADA and commend the continued work to push forward meaningful solutions here.

  • With the NASH landscape continuing to heat up, University of Florida’s Dr. Kenneth Cusi provided a timely overview of NASH and diabetes care. Very notably, Dr. Cusi is bullish on the use of TZD pioglitazone in NASH and strongly advocated for its broader use – this is very interesting to think about given pioglitazone is generic, despite important negatives (i.e., fractures and weight gain), and upcoming branded NASH therapies may be very expensive. The price is right and we wonder what a low-dose combo might do. Dr. Cusi also expressed enthusiasm that for the first time ever, the ADA Standards of Care include a mention of NASH. Could NASH treatment also one day end up in the ADA/EASD consensus algorithm? Dr. Cusi hopes so – from our view, a lot will have to go right.

Greetings from New York, where our team recently attended ADA’s 2019 Postgrad meeting. We’ve broken down our ten highlights from this three-day gathering into four categories: (i) Clinical practice and treatment algorithms; (ii) Diabetes Technology; (iii) NASH and obesity; and (iv) Social determinants and mental health. Happy reading!

Table of Contents 

Clinical Practice and Treatment Algorithms

1. A1c Target Differences Highlighted in Panel Comparing Guidelines from ADA, ACP, ACE/AACE, and The Endocrine Society; Case Studies Indicate Growing Comfortability with Sulfonylureas in Light of CAROLINA Results

A fascinating panel brought together representatives from the ADA, ACP, ACE/AACE, and the Endocrine Society to compare and contrast treatment guidelines from each. Dr. Will Cefalu joked that “we all know there’s only true guidelines – the ADA’s” to loud chuckles from the room, and we were delighted to see the ADA bring in outside opinions to discuss this important topic. Representatives from each organization were given five minutes to explain their approach to guidelines, and case studies/discussion followed to compare and contrast major points:

  • ADA, ACP, and ACE/AACE guidelines do not agree when it comes to A1c targets. Yale’s Dr. Silvio Inzucchi, speaking on behalf of the ADA, noted that ADA guidelines generally target an A1c <7%, but that this target should be individualized based on a variety of patient and disease factors (hypoglycemia risk is a major consideration here). Somewhat differently, Dr. Devan Kansagara (speaking on behalf of the American College of Physicians [ACP]), noted that the organization’s guidelines recommend an A1c target of between 7% and 8% in most patients. The rationale behind this relatively conservative target is that ACP sees little evidence for a benefit with further A1c lowering. Dr. Kansagara explained that where benefit has been seen with more intensive A1c lowering, the evidence of benefit is small and inconsistent, whereas the evidence of hypoglycemia risk is consistent and worrisome. Moreover, according to ACP, there is an increased risk of death associated with targeting an A1c <6.5%. On this front, ACP also recommends that clinicians deintensify pharmacological therapy in patients that achieve an A1c target below 6.5%. There are so many pieces to this that we do not support from a patient perspective – we will save this for our full report. Speaking for ACE/AACE, Dr. Guillermo Umpierrez (Emory University) explained that the organization has an individualized A1c target: for patients without concurrent serious illness and at low risk of hypoglycemia (presumably driven by therapy – smart), an A1c of <6.5% should be targeted. Conversely, for patients with a concurrent illness and/or at risk for hypoglycemia, an A1c target of above 6.5% is allowable. We were pleased to see Dr. Umpierrez underscore data from the DCCT and UKPDS showing that intensive glucose control yields improved microvascular outcomes (macrovascular too). Dr. Rita Kalyani (Johns Hopkins University School of Medicine), speaking for the Endocrine Society, noted that the organization has not developed any specific guidelines or glycemic targets yet, but that these are in the works and will hopefully soon be released. We hope they go for Time in Range targets while they are at it.

    • Q: With all of these various A1c goals between organizations, how do you envision that working out with insurance companies going to more quality based payment schedules?

    • A: Dr. Silvio Inzucchi: “We addressed this in the ADA’s 2015 position statement, explicitly saying that a ‘one-size-fits-all’ target doesn’t make much sense. However, regulators continue to say that we need to hit one target. I don’t think I have an answer for this. We will need more advocacy on this front to change minds.” This should be data-driven and making it therapy-driven totally makes sense.

  • Dr. Will Cefalu led the panel through several case studies to determine the path of treatment each organization would recommend. One particularly interesting (and widely applicable) case was as follows: a 45-year-old male who is a part-time worker, diagnosed with type 2 diabetes two years ago, and currently on metformin 1000 mg BID. He has a history of hypertension but is in good control with an ACE inhibitor and a blood pressure of <130/80 mmHg. His BMI is 31 kg/m^2. Notably, he is not on medical insurance and does not qualify for Medicaid. Due to resource constraints, he only self-monitors his home blood glucose twice weekly. See below for how each panelist responded in terms of how they would treat this patient. We were particularly interested in discussion of recently released CAROLINA results, and how this impacted decision making.

    • Dr. Guillermo Umpierrez (AACE/ACE): “This is what I see everyday! We have to emphasize that lifestyle intervention is the best way to achieve glycemic control. In terms of pharmacotherapy, my first choice is to use sulfonylurea – either glimepiride or gliclazide. We just learned that sulfonylureas don’t have increased CV risk [in the CAROLINA trial], so I would feel especially comfortable using them here than before. (Editor’s note – it was our impression that we learned they did not have additional risk vs. a DPP-4 inhibitor …) We could also use a TZD, but this would cause some weight gain, and I don’t think the patient would be too happy with that. In terms of A1c goals, I would target the lowest I can get – I don’t think we should set an absolute number. [When pressed by Dr. Cefalu to give a number, Dr. Umpierrez conceded that he would go for a number “close to 7”].

    • Dr. Silvio Inzucchi (ADA): “I would give him both a sulfonylurea (glimepiride) based off of recent CAROLINA data (this is exactly why we’d love Wal-Mart or Costco to be selling a GLP-1 and SGLT-2), and then also give him a low dose of pioglitazone. I would also emphasize lifestyle intervention, and target an A1c level of 7%.”

    • Dr. Devan Kansagara (ACP): “Largely agree with what has been said in terms of medication choices and target. I would use a sulfonylurea here.”

    • Dr. Rita Kalyani (Endocrine Society): “For this relatively young patient who has a long-life expectancy, I would target an A1c of 6.5% or 7%. Sulfonylureas would be a good choice, but we should also remember that once daily insulin could also be considered here. The Endocrine Society put forward an insulin affordability position paper in November 2018, which considers cases like this. Once daily NPH could be something to consider with this patient.” We concede that he would not unfortunately qualify for many insurance programs – if he had insurance of any kind, we’d recommend Sanofi’s ValYOU program where he could get Toujeo.

2. New ADA 2019 Standards of Care Discussion Emphasizes Patient-Centricity, GLP-1 as First-Line Injectable; “Living Document” Changes Will Be Communicated to ADA Community as Changes Are Made

Washington University’s Dr. Joshua Neumiller overviewed the new 2019 ADA Standards of Care, focusing on its patient-centric focus, its recommendation of GLP-1s as the first-line injectable, and emphasizing the new “living document” format of the guidelines.

  • Consideration of patient-centered glycemic management is a major focus of ADA’s 2019 guidelines. Dr. Neumiller underscored the need when using the treatment algorithm to assess key patient characteristics, including current lifestyle, comorbidities (i.e. ACSVD, HF, CKD), clinical characteristics such as A1c, weight, and age, mental health considerations such as motivation and depression, and the cultural and socioeconomic context of the patient. Notably, these considerations are especially apparent when considering second-line medication after metformin for patients without established ASCVD or CKD. Here, the guidelines separate patient considerations into three main categories: compelling need to minimize hypoglycemia risk, compelling need to minimize weight gain or promote weight loss, and where cost is a major issue. Of course, all of these considerations are surely important to most patients, which can make it hard to definitively tease out which path to take – which patient doesn’t want to avoid hypoglycemia, lose weight, and do so at the lowest possible cost?

    • Notably, regarding issues of cost, sulfonylureas remain prominently featured on the guidelines, and we’re curious to see how results from the CAROLINA study – which showed that sulfonylurea glimepiride did not lead to elevated CV risk when compared to Tradjenta – might be incorporated into guidelines. We certainly hope they are not seen as the final word on SFUs! As a reminder, Lilly/BI had recently announced that DPP-4 inhibitor Tradjenta met its primary endpoint in the CAROLINA trial, demonstrating non-inferiority to sulfonylurea glimepiride on three-point MACE. No numbers were provided and, while not explicitly stated, it seems Tradjenta did not show superiority to glimepiride. Full results will be presented on June 10 at ADA 2019 in San Francisco. To be sure, concerns with sulfonylureas in regard to weight gain and hypoglycemia risk are certainly real, and we’re eager to see data on these outcomes when full results are presented from CAROLINA in June.

  • Dr. Neumiller provided additional context on the new recommendation of GLP-1s as the “first-line injectable” over insulin. This recommendation for GLP-1s was definitely one of the most notable changes to the 2019 Standards of Care. As a reminder, the consensus recommendations note that “in patients who need greater glucose-lowering effect of an injectable medication, GLP-1 receptor agonists are the preferred choice to insulin. For patients with extreme and symptomatic hyperglycemia, insulin is still recommended.” Dr. Neumiller reviewed meta-analysis data showing that GLP-1s are associated with similar A1c lowering effects to insulin while also providing superior weight loss effects. We remain thrilled to see GLP-1s promoted over basal insulin, given preferable effects on weight, the option of once-weekly dosing, little to no hypoglycemia risk, and long-term beta cell preservation; we’ve seen this recommendation received with impressive enthusiasm among thought leaders.

  • Dr. Neumiller emphasized that the ADA Standards of Care are now a “living document” that will continuously incorporate notable changes into the document. This change first began with the 2018 ADA Standards of Care and helps to reflect the fast pace of movement and innovation within the diabetes field right now. What constitutes a “notable change” that would be incorporated into the living document? Dr. Neumiller outlined that updates will be made in response to important events that include approval of new treatments (medications or devices), publications of new findings that support a change to a recommendation and/or evidence level of a recommendation, or publication of consensus document endorsed by ADA that would necessitate an update of the Standards of Care. Generally, we’re thrilled to see the ADA take this approach to updating its consensus documents, especially with the recent torrent of CVOT updates for diabetes pharmacotherapies – see our CVOT landscape to see what’s to come in the near future as well!

    • Notably, not too many audience members were actually aware of this development of ADA updating its Standards of Cares to be a “living document.” When asked by Dr. Neumiller if they were aware, only a few audience members raised their hands and murmured in agreement – completely understandable, seeing as these updates were just made very recently. Dr. Cefalu noted that when updates are made to the living document, updates will be announced to all ADA members as soon as possible. We’re definitely pleased to see this commitment to better communicating updates to the Standards of Care.

  • For further commentary on ADA’s 2019 Standard of Care guidelines, see our full report here.

3. Dr. Mary Julius on Risk Stratification for Hypoglycemia Management and Importance of Shared Decision Models

Dr. Mary Julius (Northeast Ohio VA Healthcare System) explained that targeting high risk patients for population management is an effective tool when combatting an expensive complication such as hypoglycemia. Notably, the Veterans Health Administration runs a “Choosing Wisely Hypoglycemia Safety Initiative (CW-HSI)” for managing hypoglycemia risk, which recently ran a pilot program using EMRs to identify hypoglycemia risk in its population. In total, 9,300 patients were screened, and 25% of those screened had a reported hypoglycemic event. A high-risk cohort was stratified based on three criteria: (i) A1c <7%, (ii) use of a sulfonylurea or insulin, and (iii) age 75 or greater, or dementia/cognitive impairment. The CW-HSI website notes that “patients at greatest risk for hypoglycemia include those with A1C <6% (4x risk), <6.5% (2.25x risk), or <7.0 (2x risk); treatment with insulin (5x risk) or a sulfonylurea (2x risk); age >75; and/or cognitive impairment or dementia.”

  • Shared decision making between patient and provider is a key framework for mitigating hypoglycemia. Dr. Julius highlighted the AHRQ SHARE model for providers looking to use shared decision making. The SHARE model is composed of five steps: (i) seeking patient participation, (ii) helping patients explore and compare treatment options, (iii) assessing patient values and preferences, (iv) reaching a decision with the patient, and (v) evaluating the patient’s decision. She also emphasized that informed consent and preference-sensitive care should be at the center of the shared decision making process.

    • Despite the theoretical benefits of shared decision making models, however, several barriers currently exist that prevent their full and effective implementation. Time, expense, and resource constraints can limit implementation, especially seeing as there is still a dearth of adequate decision aids describing hypoglycemic risk. Moreover, providers may feel that they are “already doing” the SHARE model and not fully incorporate all of its aspects into their care. Communication challenges with patients who have low health literacy, along with patients of different cultural backgrounds, are also present.

4. Therapeutic Inertia Panel: Solutions Proposed Include Value-Based Care Models, Improved Screening, and Investments in Earlier Combo Therapy

A panel focusing on therapeutic inertia led the second day of ADA Postgrad 2019, featuring stakeholders from across the diabetes landscape. Panelists included Dr. John Cuddeback (American Medical Group Association, Alexandria, Virginia), Ms. Jennifer Trujillo (PharmD, University of Colorado, Aurora, Colorado), Ms. Gretchen Youssef (MedStar Health, Washington, D.C.), and our very own Ms. Kelly Close (The diaTribe Foundation, San Francisco, California). ADA’s Dr. Will Cefalu kicked off the session by highlighting the ever-growing cost of diabetes – $327 billion for diagnosed diabetes in 2017, equal to 1 out of every 4 healthcare dollars – and emphasized that “we can’t afford this disease moving forward.” Despite more efficacious therapies, patient progression to targets is not improving: Achievement of individualized targets has decreased from 70% to 64% between 2003 and 2014, while the percentage of patients with an A1c >9% has increased from 13% to 16% between 2007 and 2014. Dr. Cefalu described ADA efforts to address “therapeutic inertia”, including the ADA Summit on Therapeutic Inertia held last November. The Summit (along with the soon-to-be-published white paper detailing its consensus recommendations) will be “Phase 1” of ADA’s Campaign for Overcoming Therapeutic Inertia. Phase 2 will focus on “recognizing results and expanding reach,” while Phase 3 will focus on accelerating diabetes care globally through the practice of ADA Standards of Care. See Dr. Cefalu’s slides from the presentation here – we highly recommend taking a look! Following this overview, Dr. Cefalu led the panel through several questions to showcase broad perspectives on therapeutic inertia. We’ve compiled the most valuable quotes from throughout the panel below:

  • At the PCP level, what do we need to do to arm the provider to address therapeutic inertia?

    • Dr. Cuddeback: “An important idea is moving knowledge, not patients. Video conferencing for primary care teams and building relationships with diabetes experts are huge needs. We need to remember that time constraints are one of the most important drivers of therapeutic inertia. Also, engaging with PCPs is more than just education on guidelines. We need to emphasize cultural humility as well. Help in this area is also a big part of providing support to primary care teams.”

    • Ms. Close: “Society can be a bit oblivious to how hard primary care teams are working. From a patient perspective, there is also much obliviousness about science – the science is transformative in diabetes, and there extensive benefits emerging from diabetes therapies with cardio- and renal-protective effects (e.g., GLP-1, SGLT-2 inhibitors). We must invest in these therapies. Finally, there is also an obliviousness about who diabetes is affecting, especially amongst the most marginalized communities.”

  • On issues of access, reimbursement, and cost:

    • Dr. Cuddeback: “I think the payment system must be the focus. Moving toward value-based payment instead of an individual fee for service model will be key.”

    • Ms. Youssef: “I am also optimistic about the push toward value-based care. With this, we will see better care and better outcomes. The current fee-for-service model is just crazy, and people don’t get what they want or what they need in this model.”

    • Ms. Close: “Patients are really interested in time in range as a metric ... every patient on insulin and on a sulfonylurea should have access to a CGM [applause from the room]. Having an improved time in range makes me feel better as a patient, and there are so many areas where patients can feel less shame and be more motivated. On this point, we’d like to see more investment on emotional well-being and mental health as well.

    • Dr. Cefalu: “We’ve been very interested in prevention for years. But there is a lot of pushback from other stakeholders saying that we shouldn’t invest in these resources. I do think that there are some positive things happening with translation. Looking ahead, we need to define better methodologies to overcome systemic barriers. Clearly, if we are going to stem the tide of diabetes, we need to invest in prevention.”

  • What are some tools that can assist you at your level in overcoming therapeutic inertia?

    • Ms. Trujillo: “There are lots of opportunities with improvement for decision support. We are not using EHR or decision support tools as well as we could right now. Translating these better so that they are user-friendly and easy to use is a must. We also need to think about how to get resources to PCPs to better manage diabetes – this is really challenging and complex.”

    • Dr. Cuddeback: “One of the big investments is screening – identifying people with diabetes at an early stage. Only about 60% of people who should be screened are being screened. Looking at the data, the patients where you are more likely to find a diagnosis of diabetes – they are actually being screened at a lower rate than the general population. There are some very straightforward opportunities to invest in with screening: people on Medicaid, BMI >40, people from zip codes with lower education levels. These are all populations that we can look at specifically to improve diagnosis and screening.”

    • Ms. Youssef: “In terms of technology, we are using cell-enabled meters for our high-risk patients, and it transformed their management. But, there are all these other meters out there that use Bluetooth technologies. How do we look at these large swaths of data on our screens? There needs to be ways to easily manage data for clinicians.”

  • Closing remarks:

    • Ms. Close: “I would love to have everyone think about getting the healthcare systems more involved in this. We also need to look at where there may be biases in the system, and really address these as well in order to truly address therapeutic inertia. We really need to think about investments in combination therapy (for example, GLP-1 and SGLT-2s) and earlier intensification.

    • Ms. Trujillo: “One piece of advice – approach every single patient knowing that there is some barrier to adherence. Don’t assume good adherence. Assume that there are barriers, and go in with the questions necessary to get to these underlying issues.”

    • Ms. Youssef: “We need to look at systems and supporting the primary care teams. Oftentimes they are marginalized and looked down upon. We need to support them.”

    • Dr. Cuddeback: “If on Monday we can get to a value-based payment system, that would be great. A quick win would be improving screening strategies. We should focus on the portions of the population where we are able to do the most good.”

Diabetes Technology

5. IDC’s Ms. Mary Johnson Highlights Emerging Diabetes Technologies: ACE Pump Approval, MiniMed 780G, Dexcom G7

IDC’s Ms. Mary Johnson provided a stellar overview of current and emerging diabetes technology, highlighting several new advances with the potential to majorly impact patient care on the horizon:

  • Ms. Johnson emphasized the very exciting recent news that FDA cleared Tandem’s t:slim X2 as the first-ever interoperable pump. In the decision, FDA created a new category called “alternate controller enabled (ACE)” infusion pumps. These pumps will be regulated at class II (510(k)) with special controls and are cleared with interoperability in mind, meaning that they can be used as part of an AID system or as a standalone pump (with/without CGM).

    • Ms. Johnson also expressed excitement over the soon-to-come t:slim X2 mobile app. The app will allow users to view pump status and alerts without pulling out their pump, and will also allow for automatic upload of data to t:connect (Tandem’s web-based data application). Excitingly, remote monitoring by caregivers will also be newly enabled – a huge step forward. Looking ahead, Ms. Johnson noted that future features may include integration with data on diet, sleep, and exercise, as well as insulin dosing advice and smartwatch integration.

  • Medtronic MiniMed 780G: Ms. Johnson highlighted several exciting new updates expected in the next-gen advanced hybrid closed loop system: automatic correction boluses, goals of >80% time in range and 100% time in closed-loop, remote monitoring, Bluetooth software updates, and an improved Guardian sensor. Launch of the 780G is expected in April 2020. See our ATTD 2019 coverage for more in-depth updates on the 780G, including Dr. Richard Bergenstal explaining the new optional set points (100 mg/dl vs. 120 mg/dl) and Dr. Bruce Bode on the NIH FLAIR studying comparing the 670G to the 780G, set to start in the coming months.

  • Dexcom G7: Ms. Johnson noted that launch of the G7 is anticipated in 2020, consistent with timing of a “late 2020 launch” given by Dexcom management in the past. Broader rollout is expected in 2021. As a reminder, the G7 will include a new, fully disposable applicator and boast 14-15 day wear plus a reduced cost.

NASH and Obesity

6. Dr. Kenneth Cusi Bullish on Pioglitazone for NASH Treatment; Calls Liver Biopsies “Suboptimal” Gold Standard for Diagnosis; Hopes Future ADA SOC Will Include NASH in Treatment Algorithm

Dr. Kenneth Cusi (University of Florida) advocated for the broadened use of TZD pioglitazone as a NASH treatment. Per Dr. Cusi, pioglitazone has shown impressive efficacy in NASH resolution, achieving this endpoint in ~2 out of 3 patients. Moreover – and perhaps more importantly – he also touted its ability to prevent liver fibrosis, considered the more important of these two endpoints. Pioglitazone’s effects extend outside the liver as well: It drives reversal of insulin resistance, systemic inflammation, ectopic fat deposition, and lipotoxicity. However, there are considerable drawbacks to pioglitazone treatment: weight gain (although Dr. Cusi contends that this is “metabolically healthy fat”), edema, osteoporosis (what Dr. Cusi sees as the biggest concern), and a small signal for bladder cancer. Generally speaking, Dr. Cusi was quite bullish on the use of pioglitazone in NASH, which aligns with what we’ve heard from other thought leaders – at CMHC 2017, we heard Drs. Jay Skyler and Robert Eckel both endorse the use of pioglitazone in NASH. As a reminder, pioglitazone is already somewhat often prescribed off-label because of the absence of an FDA-approved therapy for NASH.

  • Pioglitazone faces several barriers preventing its widespread penetration into NASH treatment, namely that many providers are unaware of its efficacy in NASH, or they feel uncomfortable prescribing what they assume to be exclusively a diabetes drug (“let’s leave that to the endocrinologists”). For what’s to come in NASH, see our competitive landscape here.

  • Dr. Cusi explained that liver biopsies remain the “suboptimal” gold standard for characterizing histology in NASH. On the bright side, liver biopsies can confirm the diagnosis and staging of the disease, and can effectively determine the severity of liver injury and fibrosis. However, the practice is very expensive, involves potential complications, and is often impacted by sampling/reading error. These drawbacks not only limit the effectiveness of the test, but also dissuade at-risk patients from pursuing a diagnosis. It’s clear that better diagnostic methodologies may represent the next big breakthrough in the NASH field; indeed, we’ve heard some thought leaders comment that there’s as much competition in developing noninvasive biomarkers for NASH as there is to bring the first approved NASH therapy to market. On this front, FDA’s recently released draft guidance for the clinical development of NASH drugs specifically prompts sponsors to invest in pursuing such diagnostic advances.

  • Dr. Cusi expressed enthusiasm that the ADA 2019 Standards of Care now include a mention of NASH. Notably, recommendation 4.14 in the 2019 Standards of Care states that “patients with type 2 diabetes or prediabetes and elevated liver enzymes or fatty liver on ultrasound should be evaluated for presence of NASH.” This is the first time that the Standards of Care have mentioned NASH. Looking ahead, Dr. Cusi hopes that future versions will incorporate NASH and its treatment options in the official treatment algorithm.

7. Obesity Panel Highlights Need for Pharmacotherapy to Address Underlying Biological Mechanisms Driving Weight Regain; Diet-Wise, No “Ideal Mix” of Macronutrients for Weight Loss

  • Dr. Timothy Garvey (University of Alabama) explained that obesity pharmacotherapy is necessary to fight the body’s natural predilection towards weight regain after weight loss. Dr. Garvey described how after a patient initially loses weight, their body viciously aims to regain that lost weight through a series of hormonal changes: hormones that make the patient eat more go up (ghrelin), hormones that makes the patient eat less go down (leptin, PYY), the patient becomes hungrier and even develops a psychological preference for foods with higher caloric amounts. Weight regain is also irrespective of the macronutrient content of the diet the patient may be on (see figure below). Essentially, all biological mechanisms drive the patient toward weight gain. In this context, pharmacotherapy is truly needed, and help to fight the biological mechanisms that catalyze weight regain.

  • Dr. Garvey also stressed the myriad benefits of weight loss, which spans several different other conditions. Dr. Garvey noted that therapeutic weight loss can reduce complications in a number of other conditions, including diabetes, hypertension, dyslipidemia, NAFLD, sleep apnea, osteoarthritis, and others. We’re glad to see this reminder of just how comprehensive addressing obesity can be in improving the overall health of patients.

  • In discussing lifestyle management of obesity, Ms. Raquel Pereira (Simple Concepts Consulting, Redmond, Washington) argued that there is no “ideal mix” of macronutrient intake when it comes to specific diets. She emphasized that different individuals will react differently to various macronutrient compositions in their diet – individualization and personalization of recommendations is key here. Nonetheless, total energy intake should be appropriate to attain weight management goals. Ideal individualized macronutrient compositions for each client is influenced by a number of factors, including metabolic goals, food preferences, and satiety regulation.

    • Ms. Pereira also emphasized that weight is the consequence of a multitude of different factors. These include culture, food preferences, relationship with food, self-management, physical activity, schedule, sleep habits, stress management, skills levels, time management, food accessibility, family, friends, and neighbors support, past weight management status, and psychological status. We appreciated this reminder of just how holistic weight management must be – so many different variables must be considered! On this front, Dr. Pereira noted that it’s the goal of the practitioner to tie all of these factors together – they must tie together cause and consequence, resources, and alternative paths the patient can take.

Social Determinants and Mental Health

8. Dr. Felicia Hill-Briggs Advocates for Bold Macro-Level Solutions to Remove Systemic Barriers that Drive Health Inequities

In our opinion, this was one of the best talks of the meeting, and it elicited a passionately positive reaction from attendees. We’re glad to see ADA promote discussion of social determinants of health and give a platform to these important ideas that are often difficult to discuss. Dr. Hill-Briggs underscored this point in her talk, noting that “We don’t have these conversations [about social determinants and inequality] often at professional meetings. It’s uncomfortable here in the US to confront the policy and the history that have directly resulted in patterns of health inequities, but ultimately we cannot solve problems that we are not willing to identify or name.”

  • Dr. Hill-Briggs overviewed the many persistent inequalities between blacks and whites in the US. Specifically regarding diabetes, the statistics are frightening: When compared to whites, blacks have a 1.8 times higher prevalence of diabetes, 2.1 times higher rate of mortality due to diabetes, 3.5 times higher rate of lower extremity amputation, and 4.2 times higher rate of ESRD from diabetes. Years of systemic barriers and oppressive policies have driven this disparity, as reflected in the inequalities listed in the table below from Dr. Hill-Briggs:




Median Household Income



Median Wealth



Population Living Below Poverty Line



Home Ownership Rate



Unemployment Rate



Proficient Literacy



  • For context, the WHO’s definition of “social determinants of health” is as follows: “The social determinants of health are the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life. These forces and systems include economic policies and systems, development agendas, social norms, social policies and political systems.” It’s clear how the inequalities listed above – ranging from income to housing to literacy rates – represent systemic and unyielding forces that can drive affected individuals toward poor health outcomes.

  • Dr. Hill-Briggs reviewed WHO recommendations for addressing the seemingly insurmountable problem presented by social inequities. Notably, these international recommendations are focused on macro-level solutions, whereas US recommendations have largely focused on steps within healthcare that can be taken – Dr. Hill-Briggs believes that these steps, while useful, need to be supplemented by larger-scale initiatives to truly address this problem. Specifically, WHO has three recommendations:

    • Improve daily living conditions: putting major emphasis on early child development and education; improving living and working conditions; and create social protection policy that is supportive of all

    • Tackle the inequitable distribution of power, money, and resources: create a strong public sector that is committed, capable, and adequately financed. Ensure legitimacy, space, and support for civil society, for an accountable private sector, and for the public to agree in reinvestment in collective action.

    • Measure and understand the problem and assess the impact of action: acknowledge that there is a problem, and then ensure that health inequity is measured. Develop national and global health equity surveillance systems and evaluate the health equity impact of policy and action.

  • Dr. Hill-Briggs emphasized the need to move toward solutions that address systemic barriers and the root cause of social determinants of health. She noted the three stages that have defined the evolving intervention framework for social determinants over time. First, intervention focused on equality, where it was assumed that everyone would benefit from the same supports, and therefore they were treated equally. Then, the current practice focus evolved to more heavily consider equity. In this strategy, individuals are given different supports to make it possible for them to have equal access. Dr. Hill-Briggs then posited that the future should focus on solutions that remove systemic barriers. In this system, the cause of inequity is addressed, making other approaches unnecessary – an ideal solution, to be sure. Importantly, Dr. Hill-Briggs pointed toward multi-sector partnerships as a key methodology for this type of action. We’re glad to see this advocacy for a more aggressive interventional approach – this type of bold action will be necessary to meet the challenge of our largest public health problem.

9. Dr. Mary de Groot Promotes Behavioral Medicine for Non-Mental Healthcare Providers in Diabetes Care

Indiana University’s Dr. Mary de Groot explained how non-mental healthcare providers can use behavior medicine approaches in diabetes care. We’re always highly impressed by Dr. de Groot’s presentations (see our coverage of a similar presentation at AADE 2017). She reviewed the importance of patient-centered care, recommendations and rationale for screening and evaluating psychological outcomes, and discussed the process for psychological screening and referrals in clinical practice.

  • Dr. de Groot deftly picked apart common barriers to psychological screening and evaluation, providing succinct counterpoints for each possible concern:

Common Concerns


“It takes time”

Can be done within the patient flow

“It’s complicated”

Can take many simple forms

“It’s too academic”

Good evaluation is clinically useful

“I might learn something I don’t want to know”

Response relies on established clinical procedures

“I might create a problem just by asking”

Asking may reveal a problem, but not create it

“This is somebody else’s idea, not mine”

Externally imposed standards create opportunities to enhance clinical care

  • Dr. de Groot provided an interesting graphical definition of diabetes distress as being driven by the difference between the ideal level of diabetes self-management and the actual level the patient is at. When these two curves diverge, the diabetes distress the patient experiences correspondingly grows in magnitude. Patients feel as if they are losing control of their diabetes and experience mounting distress as this chasm widens.

10. ADA Touts Training Program for Mental Health Provider Directory

ADA emphasized a concurrent full-day mental health training session happening during ADA Postgrad, where over 100 psychologists and social workers became certified as part of ADA’s new mental health provider directory. The announcement drew hearty applause from a room filled with those who understand the significant impact this move can have. Indeed, ADA underscored the major impact this broad scale training would have for providers, who are often saddled by the knowledge that a patient needs mental health support but may be unsure about to whom they can refer the patient. Last year, ADA launched a diabetes-specific mental health provider directory (see it here), and we’re thrilled to see that ADA’s efforts to expand providers eligible for listing in this database are having an impact.

  • This training was part of a larger partnership between the ADA and the American Psychological Association (APA) to offer continuing education for mental health professionals interested in providing mental health care to people with diabetes. Individuals must first complete a 7-hour in person program, followed by a 5-hour online course. Future in-person programs will be offered at ADA 2019 in June in San Francisco and at APA’s Annual Convention in August 2019 in Chicago.


--by Martin Kurian, Ann Carracher, and Kelly Close