Memorandum

ADA 2019 Nutrition Therapy Consensus Report released, adding more positivity around low-carb patterns – April 19, 2019

Diabetes Care article – No one-size-fits-all approach, given many eating approaches show benefit; focus on vegetables (non-starchy), minimize sugar, refined grains, eat whole foods

Today, ADA released a very important document: Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report. The 15-page article surveys the nutrition science landscape in diabetes (345 citations), providing consensus recommendations on eating patterns, macronutrients (carbs, fat, protein), CVD risk, diabetes prevention, and more. This is the first update to this influential document in five years, and it’s a big deal – the 2014 edition has been cited 994 times.

For those wishing to hear one nutrition answer, there isn’t one – similar to the 2014 edition, ADA emphasizes there is no one-size-fits-all eating plan for diabetes. This is sensible, given that Mediterranean, low carb, vegan/vegetarian, and other approaches can all reduce A1c, drop weight, and improve cardiovascular risk. (Table 3 is the key one; see below).

Our big takeaway from reading this edition, however, is more positivity on low-carb approaches – there is at least as much enthusiasm for this eating pattern as for Mediterranean diets, a very big change from 2014. For instance, the “Eating Patterns” consensus recommendations read as follows:

  • “Until the evidence surrounding comparative benefits of different eating patterns in specific individuals strengthens, health care providers should focus on the key factors that are common among the patterns: Emphasize nonstarchy vegetables. Minimize added sugars and refined grains. Choose whole foods over highly processed foods to the extent possible.

  • Reducing overall carbohydrate intake for individuals with diabetes has demonstrated the most evidence for improving glycemia and may be applied in a variety of eating patterns that meet individual needs and preferences.

  • For select adults with type 2 diabetes not meeting glycemic targets or where reducing anti-glycemic medications is a priority, reducing overall carbohydrate intake with low- or very low- carbohydrate eating plans is a viable approach.”

This 2019 update adds 99 citations, a section on prediabetes, and deletes the evidence grades from the prior version – all positive changes, given the research nuance in this area. This also presents a challenge for healthcare providers and industry: what should they specifically tell people to eat? We think the first statement above is a great start, and hopefully broader use of CGM can help inform personalized nutrition.

Overall, we see this update as positive progress from ADA, who has been criticized in the past as being anti-low-carb; that is clearly not the case after reading this document. This is a complicated area, and we salute ADA for nicely balancing strong, oppositional views (low-carb vs. low-fat) in an area without much comparative, long-term evidence. While providers and companies will still have to make decisions on what to advise people, at least there are some evidence-based patterns to choose from. And hopefully, more use of CGM in nutrition trials will allow for fine-tuned assessment of time-in-range on different diets.

See below for interviews with some of the authors.

Table 3: Eating Patterns Summary

  • There is also a short section on intermittent fasting, an area with exploding research and public interest and some positive early data in diabetes and prediabetes. We expect this section to receive big updates over the next few years, given the research trends. Adam has tried 16:8 time-restricted feeding for over 215 days (first meal at 12pm, last food by 8pm), and just crunched his CGM data: a median 85% time-in-tight-range of 70-140 mg/dl, a median glucose of 114 mg/dl, and 1% <70 mg/dl. On 30% of days, he has seen >90% of readings in 70-140 mg/dl. He’ll be sharing more on this soon, but we see potential for intermittent fasting to provide useful clarity on another variable in nutrition: when to eat.

Interviews with the Co-Authors and Collaborators

Dr. Tim Garvey (University of Alabama at Birmingham)

“Working on the ADA Nutrition Update was a collegial process – fun, actually. I was impressed by the data-driven nature and the desire of all participants to generate a scientifically valid product. I think there are two themes that emerged compared with the prior recommendations. First, there is a greater emphasis on potential benefits of a low-carb diet. While there was discussion and disagreement regarding how to define different intensities of the diet (i.e., how many carbs), there was agreement that reasonable data has emerged to suggest it as a viable and important option in diabetes.

The second theme was a greater attention to obesity and weight loss. Desirable weight loss minimums were specified (7%-10%) for patients with type 2 diabetes and obesity. Also, the figure of 10% weight loss for prevention, which appears to be maximally effective. The recommendations that cultural and personal preferences should be taken into account – and many meal plans can be used – stays the same.

I have never been comfortable with the term “healthy eating” since I think that depends on long-term outcomes regarding mortality and CVD. The only data we have along those lines is for the Mediterranean diet. For the rest, we have short-term data showing safety and utility in diabetes. One measure of a healthy diet (just my opinion) is the avoidance of processed foods, and the ADA recommendations make this a point of recommendation.

Just my opinion – we need to be less wishy-washy about the beneficial effects of weight loss in diabetes treatment and prevention, but these new nutrition recommendations are a step forward.”

Dr. Will Cefalu (Chief Scientific, Medical, and Mission Officer, ADA)

“We are incredibly proud to publish the new Nutrition Consensus Report, and I want to applaud the painstaking dedication and efforts of the entire committee. This nutrition update has been a top priority for me since I joined the ADA more than two years ago. The Consensus Report reflects the recommendations based on the latest scientific evidence and provides the most up-to-date nutritional guidance for people living with diabetes.

It’s important to note that the evidence confirms there is not one eating pattern that can be endorsed for all individuals with diabetes, thus, the Consensus Report informs on a variety of eating patterns. This is why it is so important for individuals to have regular access to a nutrition specialist (RDN) so that their preferences, needs and goals are discussed and understood in developing a personalized nutrition plan that supports their diabetes care plan and adjusts throughout their life.”

Janice MacLeod (Companion Medical, Columbia, MD)

Can you tell us a little about developing the guidelines? How was the process? “A strength of this particular consensus group was the inclusion of clinicians with years of clinical practice working directly with patients (but who do not necessarily have extensive research experience) as well as nutrition researchers who are highly skilled in research but who do not have the patient experience. Along with this we had our very strong patient advocate, Kelly Rawlings. Also valuable was considering technology-enabled approaches and calling out the necessity of integrating nutrition therapy with the overall treatment plan. Increasingly we are seeing dietitians and diabetes educators embedded at the point of care and a trend towards bundling diabetes counseling as part of value-based care and payment models vs. traditional fee-for-service. Along with technology-enabled solutions, this will be critical to expand access and reach and enable the pivot from time-bound, episodic care to data-driven, on-demand, as-needed care directly addressing therapeutic inertia.

The consensus report is ultimately a compilation of the latest research specific to people with diabetes and prediabetes. It should be noted that research evidence in this publication was limited to studies with direct outcomes in people with diabetes or prediabetes. Research studies focused on nutrition get a lot of media attention, but not all studies are created equal and can be confusing for clinicians and the public to determine how they impact actual clinical care. This publication aims to summarize the highest quality evidence to allow clinicians to individualize nutrition guidance.

It is not evidence, but people that decide what foods to eat. When I speak about nutrition, I like to use a Venn diagram to illustrate this. We as clinicians bring our clinical expertise and our knowledge of the evidence, and our clients bring their expertise in themselves and their lives; it is where all of this intersects that the magic happens (shared decision making). As diabetes clinicians we collaborate with our patients to help them make decisions about their own care plan including food choices based on facts, not myths or hype but good choices that fit with their lives. 

Though it would be simpler, a “one-size-fits-all” approach just does not fit. This is not surprising considering the broad spectrum of people with diabetes, their cultural backgrounds, personal preferences, co-occurring conditions, and socioeconomic settings. This has always been the case.”

How is ADA thinking about HCP training for these new guidelines? “We will be presenting the Consensus Report at the ADA Scientific Sessions. Important updates from the Consensus Report were incorporated in the “Living” ADA Standards of Care simultaneous to the release of this Consensus Report. We will also be presenting this Consensus Report in a three-part, 4.5-hour presentation at AADE 2019 in Houston. A series of translation tools and resources are being developed by the ADA. The biggest piece of advice I can share with my colleagues is to listen to your patients – truly listen. They have the answers within them, and we are only there to guide from the sidelines. In addition, I encourage educators and dietitians to embrace technology-enabled solutions. This will include digital health tools as well as diabetes devices such as CGM, insulin pumps, and smart insulin pens. Being able to see real-time the effect of various food choices and/or eating patterns on glycemia can be incredibly empowering, much more so than the dietitian prescribing a particular eating approach. Going Beyond A1c to include time-in-range, quality of glycemia, variability, etc. would be highly valuable. Strategic, paired-meal SMBG checks can be another powerful teaching tool many of us have used for years. We ask our patients to notice what happens when they eat certain foods or eating patterns vs. others. It is also important to regularly assess and monitor the achievement of other metabolic goals (blood pressure, lipids, weight) and collaborate with the patient in adjusting the care plan accordingly.” 

What research would you most like to see in nutrition? “This is well summarized near the end of the report:

  • the impact of different eating patterns compared with one another, controlling for supplementary advice (such as stress reduction, physical activity, or smoking cessation);

  • the impact of weight loss on other outcomes (which eating plans are beneficial only with weight loss, which can show benefit regardless of weight loss);

  • how cultural or personal preferences, psychological support, co-occurring conditions, socioeconomic status, food insecurity, and other factors impact being consistent with an eating plan and its effectiveness;

  • the need for increased length and size of studies, to better understand the long-term impact on clinically relevant outcomes;

  • tailoring nutrition therapy and diabetes education to different racial/ethnic groups and socioeconomic groups;

  • comparisons of different delivery methods aided by technology (e.g., mobile technology, apps, social media, technology-enabled and internet-based tools); and

  • ongoing cost-effectiveness studies that will further support coverage by third-party payers or bundling services into evolving value-based care and payment models.

  • In addition, standardizing what is meant by low-carbohydrate, very low carbohydrate, etc. so research studies can be compared. Also, the use of CGM in research comparison of different patterns.” 

How does ADA think various coaches (Vida, Livongo, One Drop, Virta, etc.) should learn about the new guidelines? “For the various diabetes companies I have had the privilege of working with over the past few years (LifeScan, Welldoc, and currently Companion Medical) all have been dedicated to assuring their products and any associated guidance align with the current standards of care and have a process of regular review to assure ongoing alignment. In many ways I believe industries dedicated to developing a rigorous science journey potentially play a big role in driving adoption of standards of care.”

Kelly Rawlings (Vida Health)

Can you tell us a little about developing the guidelines? How was the process? “Based on literature search criteria you can read about in the report and its supplementary data, the panel had 629 diabetes-related (and prediabetes-related) nutrition therapy research articles to examine. Those articles were new evidence, published since the 2014 nutrition guidelines. We broke into small teams by topic to create evidence tables. Then we examined articles to see which met our inclusion criteria and which did not. In some cases, our reviews uncovered additional articles, and those that met inclusion criteria were also considered. We created evidence summary tables, discussed those as small teams, then shared our summaries and preliminary recommendations with panel members during a series of conference calls. The small groups drafted sections, shared those out for comments and discussion, made revisions, etc. We repeated this several times after we assembled the sections into a report. The process was not a meta-analysis or systematic review; the recommendations were crafted based on discussion and consensus. The collaborative work and consensus process allowed us to bring individual expertise to the table (and wow, what a dedicated, knowledgeable group of clinicians and researchers were at the table), manage the scope (and word count!) of the report, and home in on clinically significant and actionable recommendations. The goal was to create an evidence-based, usable resource for clinicians to aid their treatment and care of people living with diabetes in the context of everyday life.”

Can you talk a little about your goals for being part of the process? “I was invited to be on the panel in the role of patient advocate. The American Diabetes Association has consistently included people living with diabetes on its committees, writing groups, and panels – and did so for this panel. Typically, however, such individuals serve first as clinicians or researchers. The role of patient advocate allows a full focus on participating as a person, an expert, in the lived experience. I appreciated that the ADA included this role – and that the co-chairs and fellow panel members were so welcoming – from the very beginning. This was not a "Hey, we wrote this thing, please read it and make a few minor suggestions so that we can say a patient was involved," situation. How cool is that?!”

How do you think the new guidelines can help change recommendations on diet for the ADA website? "The audience for the report is first, clinicians, and second, researchers. There will be many opportunities for the ADA – as well as many other organizations – to translate the recommendations for people affected by diabetes. Speaking as an individual who has trained and worked as a journalist, it's important to confirm information found on websites, by checking primary sources.”

There is a bigger focus on low-carb eating patterns in this document. How do you feel about the increasing visibility and evidence? “The “no one size fits all” guidance was also included in the 2014 paper. I'm glad that it seems to be resonating for people who have read the new report. I've seen some social media commentary (looking at you, Adam Brown) that called the report a “win” for the low-carb diabetes community. I think the last descriptor – diabetes – is the most important. Because the “no-one-size-fits-all” guidance means flexibility and multiple ways to find and adjust – and live with – personal nutrition solutions for those affected by diabetes. Diabetes changes over a lifetime. An at-risk individual's health status, situation, and needs change, too. Medical nutrition therapy, and of course diabetes and prediabetes care and self-care as a whole, should not be a Crock-Pot – set it and forget it.”

What research would you most like to see in nutrition? “Research that will influence better access to and uptake of medical nutrition therapy as needed through the lifespan. Also, less focus on macros and more focus on eating patterns and foods, and practical applications in daily life.”

What “big picture” advice would you tell HCPs about the new guidelines, if they only have a couple of minutes to focus on this? “1. At every office visit, please discuss and counsel on weight loss with people with diabetes or prediabetes who live with overweight or obesity. Then refer to nutrition therapy and diabetes education. 2. Consider shared decision making and referring to nutrition therapy and diabetes education at times beyond diagnosis. We need nutrition therapy “boosters” and it’s great to receive those from practitioners who can focus on our personal nutrition and new recommendations. Patients? If you don't have or it has been a long time since your provider reviewed your medical nutrition therapy plan, consider getting a tune-up. This new report says that many eating patterns can help you manage diabetes, and that your health status, any risk factors for diabetes-related complications, and your preferences are key. So yes, you CAN eat that. Let the “food police” talk among themselves. Instead, consider pausing to ask yourself: Does this food/drink choice I’m about to make support my health goals?”

Sacha Uelmen (Managing Director, Diabetes Education and Nutrition, ADA)

Can you tell us a little about developing the guidelines? How was the process? “We approached this Consensus Report with particular care given the daily impact on people living with diabetes. As with most processes, we fine-tuned along the way. One of our goals was to make the process as simple and streamlined as possible for our dedicated volunteers. The in-person meeting in 2018 actually occurred about halfway through the overall process, and the entire writing group was in attendance. By the time of the in-person meeting, the members had begun reviewing the literature to inform discussions around scope and recommendations as well as pulling together details for the roadmap to publication. I, Sacha, personally advocated for inclusion of a person with diabetes on the writing group, and this was a first for ADA; however, it is not the last. Also, it was important to have a diversity of interests and expertise in different eating plans in order to make this statement more comprehensive and relevant.”

What was different about this update process relative to previous updates? “I can’t speak to the previous process as this is not only my first time doing this with ADA, but my first experience leading an endeavor like this. I am super grateful for Dr. Cefalu and Mindy Saraco’s guidance through this process, as well as our experienced chairs and the members of the writing group. As an RDN, CDE, and someone who actively utilized the 2014 paper in my clinical practice prior to joining the ADA, I definitely had some opinions about what I thought would be important in a revision. One of the most important aspects was to ensure that we were both true to the science and that the interpretation was clear and concise for our diverse audience. We also emphasized diversity of writing group members both professionally and culturally. Finally, my role allows me the privilege to access the most common questions received from people with diabetes to our Center for Information (1-800-DIABETES), as well as the thousands of ADA professional members (HCPs), and a network of dietitians and nutrition providers across the country. This unique view of the differing concerns from across the country in a wide variety of care settings really helped us challenge the writing group to be sure we were answering the right questions, with the research available and most relevant to both our professional and consumer audiences.”

There is a bigger focus on low-carb eating patterns in this document. How do you feel about the increasing visibility and evidence? “Personally, based on years of clinical experience and more than a year of biweekly teleconference discussions with the writing group and peer reviewers and a deep dive into the literature, I believe there is a need for clarity around what “low carb” really means and more defined guidance around personalizing individual nutrition goals. There is still a big disparity and fair bit of confusion between how low-carbohydrate eating patterns are actually implemented in research and the outcomes that show benefit versus the interpretation by the public and many influencers for whom “low carb” actually means “no carbs.” It’s important that we begin to change the conversation, and, more importantly, change our conversation based on scientific evidence. Many influencers are creating an environment of shame and confusion for people who may not be able or prepared to eliminate carbohydrates completely from their eating plans. There is no evidence to date that suggests that “no carb” is necessary.

Finally, the term “keto” has added more confusion in the healthcare community because it is different from and confused with the ketogenic diet, a dietary intervention intended to cause ketosis in the setting of epilepsy and some other disease states. The current use of “keto” in the diabetes setting refers to varying levels of carbohydrate reduction shown in the low- and very-low carb research reviewed for this report, defined on the low end as <26% of calories from carbohydrate. Managing diabetes is tough, and food and glycemia are not the only factors people have to consider when making food choices. I do also worry about the psychological impact in this environment of public food shaming that occurs regularly in consumer (broadcast and magazines) and social media channels. Again, it is vitally important our message regarding any eating plan is based on scientific evidence, and when we compare one eating plan to another, we make that case based on head-to-head scientific studies. I believe throughout the entire process to produce this Consensus Report, we were careful to do just that.”

How is ADA thinking about HCP training for these new guidelines? “In addition to three sessions at our Scientific Sessions in June, the Consensus Report will be presented at AADE and FNCE in 2019. Regionally, Sacha will present to the Virginia AADE Coordinating Body. We are working with key volunteers to develop a specific presentation for inclusion at other professional education meetings such as Diabetes Is Primary, and a Consumer Article by Kelly Rawlings will be published in the May/June issue of Diabetes Forecast, available online and at newsstands on May 1. This report, and the recommendations found within, were a priority for Dr. Cefalu, as Chief Scientific, Medical and Mission Officer as soon as he arrived at ADA. He had a great interest in nutritional interventions prior to joining ADA and vowed to make sure that ADA reviewed the latest scientific evidence on nutrition so all patients with diabetes would benefit.”

Ultimately, what “big picture” advice would you tell HCPs about the new guidelines, if they only have a couple of minutes to focus on this? “There are many factors to consider when it comes to developing a personalized eating plan for diabetes. It’s important to help the individual to prioritize goals based on their unique circumstances and health needs. Refer to a dietitian annually and at critical times in life. A1c reductions achieved through nutritional adjustments are similar – if not better than – those achieved by prescribing a pill.

For something concrete and tangible, encourage consumption of non-starchy vegetables and drink water. Did I mention non-starchy vegetables and water? Once you’re drinking water most of the time and half your plate is consistently filled with non-starchy vegetables, fine-tune from there. If those two things seem completely unrealistic, figure out if there are added sugars that can be reduced or eliminated in the diet. Determine your baseline: What are you eating and how many carbs are you eating now each day, each meal, each snack, each drink. Figure it out by tracking for a few days, then start by cutting back on the easy stuff. All too often, people decide that they are going to eliminate their favorite food and wonder why it’s so hard to do; instead, look at your carb intake and pick things that you won’t miss … or that you’ll miss less.”

How would ADA advise patients to be thinking about nutrition as they consider multiple approaches that were listed? “We know that changing behaviors and especially eating patterns can be tough, and we see that those changes are often difficult to maintain long-term, especially for individuals with diabetes. I would encourage people to use the chart with the overview of eating patterns and consider which one most closely matches their personal preferences and health goals. We encourage they meet with a dietitian to discuss their goals, their preferences and their individual situation. There is also a helpful chart that shows the breakdown of carbs per day in relation to percentage of calories. For many people, it will be helpful to understand how many grams of carbohydrates they are eating each day and how those are distributed across the day. From there, pick one thing to get you closer to your goals, and ask your doctor for a referral to a Registered Dietitian Nutritionist.”

What research would you most like to see in nutrition? “I’d like to see more research on the impact of meal timing on blood glucose. I’m very interested in intermittent fasting, but we see in CGM data that timing of meals can make a big difference, and there is not a lot of research on that. However, I’d also like to see more research that translates eating pattern research to real world implementation to determine if the results withstand the realities of day to day lives in diverse individuals. In many of the studies noted in this report, the level of support provided to participants was much more intense than would occur outside of the research setting. If we’re really going to bend the curve, we need to know what works at community and population levels. In addition, Dr. Cefalu has identified the need for more head-to-head nutrition studies that examine efficacy, outcomes, and more clearly define the levels of macronutrients (i.e., carbs) to achieve specific treatment goals – particularly among individuals with type 1 diabetes.”

How do you feel the guidelines can contribute to discussion/action on prevention of complications, prevention of type 2 diabetes, and prevention of prediabetes? “I think these guidelines provide a more whole-person view of managing diabetes, prediabetes and complications to consider all aspects of an individual’s health. It’s too easy to focus only on the glycemic aspects of diabetes care, and people with diabetes are more at risk for a number of complications and co-occurring conditions. We need to consider the whole person, not just their blood sugar when discussing dietary needs and changes. Also, the ADA and Dr. Cefalu are very interested in diabetes prevention in general, and diabetes reversal in particular. We are currently working with a group of international experts to redefine what remission means and working toward a definition that is agnostic of treatment. This includes reversal achieved through nutritional intervention.”

How does ADA think various coaches (Vida, Livongo, mySugr, One Drop, Virta, etc.) should learn about the new guidelines? “Read it. Our writing group worked very hard to ensure that the research was translated at a level that a majority of health care providers could digest. I personally challenged the writing group throughout the process to write to a diverse audience. We made every effort to design the paper in a way that is more accessible to a wider audience given that nutrition information is consumed by the media and public regardless of the intent.”

 

--by Adam Brown and Kelly Close