VLTO FNTIINLTHERAPY NUTRITIONAL OF EVOLUTION Diabetes Care 1

Nutrition Therapy for Adults With Alison B. Evert,1 Michelle Dennison,2 Christopher D. Gardner,3 Diabetes or Prediabetes: W. Timothy Garvey,4,5 Ka Hei Karen Lau,6 Janice MacLeod,7 Joanna Mitri,8 A Consensus Report Raquel F. Pereira,9 Kelly Rawlings,10 Shamera Robinson,11 Laura Saslow,12 11 13 https://doi.org/10.2337/dci19-0014 Sacha Uelmen, Patricia B. Urbanski, and William S. Yancy Jr.14,15 This Consensus Report is intended to provide clinical professionals with evidence- based guidance about individualizing nutrition therapy for adults with diabetes or prediabetes. Strong evidence supports the efficacy and cost-effectiveness of nutrition therapy as a component of quality diabetes care, including its integration into the medical management of diabetes; therefore, it is important that all members of the health care team know and champion the benefits of nutrition therapy and key nutrition messages. Nutrition counseling that works toward improving or maintaining glycemic targets, achieving weight management goals, and improving cardiovascular risk factors (e.g., blood pressure, lipids, etc.) within individualized treatment goals is 1UW Neighborhood Clinics, UW Medicine, Uni- versity of Washington, Seattle, WA recommended for all adults with diabetes and prediabetes. 2 “ fi ” Oklahoma City Indian Clinic, Oklahoma City, OK Though it might simplify messaging, a one-size- ts-all eating plan is not evident 3Stanford Diabetes Research Center and Stanford for the prevention or management of diabetes, and it is an unrealistic expectation PreventionResearch Center, Department of Med- given the broad spectrum of people affected by diabetes and prediabetes, their icine, Stanford University, Stanford, CA cultural backgrounds, personal preferences, co-occurring conditions (often referred 4Diabetes Research Center, Department of Nu- to as comorbidities), and socioeconomic settings in which they live. Research provides trition Sciences, University of Alabama at Bir- mingham, Birmingham, AL clarity on many food choices and eating patterns that can help people achieve health 5Birmingham Veterans Affairs Medical Center, goals and quality of life. The American Diabetes Association (ADA) emphasizes that Birmingham, AL medical nutrition therapy (MNT) is fundamental in the overall diabetes management 6Joslin Diabetes Center, Boston, MA 7 plan, and the need for MNT should be reassessed frequently by health care providers Companion Medical, Inc., Columbia, MD 8 in collaboration with people with diabetes across the life span, with special attention Section on Clinical, Behavioral and Outcomes – Research Lipid Clinic, Adult Diabetes Section, during times of changing health status and life stages (1 3). Joslin Diabetes Center, Harvard Medical School, This Consensus Report now includes information on prediabetes, and previous Boston, MA ADA nutrition position statements, the last of which was published in 2014 (4), did 9Simple Concepts Consulting, Bellevue, WA 10Vida Health, San Francisco, CA not. Unless otherwise noted, the research reviewed was limited to those studies 11 conducted in adults diagnosed with prediabetes, type 1 diabetes, and/or type 2 American Diabetes Association, Arlington, VA 12Department of Health Behavior and Biological diabetes. Nutrition therapy for children with diabetes or women with gestational Sciences, University of Michigan School of Nurs- diabetes mellitus is not addressed in this review but is covered in other ADA ing, Ann Arbor, MI publications, specifically Standards of Medical Care in Diabetes (5,6). 13St. Luke’s Health Care System, Duluth, MN 14Duke Diet and Fitness Center, Department of Medicine, Duke University Health System, Dur- DATA SOURCES, SEARCHES, AND STUDY SELECTION ham, NC The authors of this report were chosen following a national call for experts to ensure 15Durham Veterans Affairs Medical Center, Dur- diversity of the members both in professional interest and cultural background, ham, NC including a person living with diabetes who served as a patient advocate. An outside Corresponding author: William S. Yancy Jr., market research company was used to conduct the literature search and was paid [email protected] using ADA funds. The authors convened in person for one group meeting and actively This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/ participated in monthly teleconference calls between February and November 2018. doi:10.2337/dci19-0014/-/DC1. Focused teleconference calls, email, and web-based collaboration were also used to This article is part of a special article collection reach consensus on final recommendations between November 2018 and January available at http://care.diabetesjournals. 2019. The 2014 position statement (4) was used as a starting point, and a search was org/evolution-nutritional-therapy. conducted on PubMed for studies published in English between 1 January 2014 and This article is featured in a podcast available at 28 February 2018 to provide the updated evidence of nutrition therapy interventions http://www.diabetesjournals.org/content/diabetes- in nonhospitalized adults with prediabetes and type 1 and type 2 diabetes. Details on core-update-podcasts. the keywords and the search strategy are reported in the Supplementary Data, © 2019 by the American Diabetes Association. emphasizing randomized controlled trials (RCTs), systematic reviews, and meta- Readers may use this article as long as the work is properly cited, the use is educational and not analyses of RCTs. An exception was made to the inclusion criteria for the use of meal for profit, and the work is not altered. More infor- studies for the insulin dosing section. In addition to the search results, in select cases mation is available at http://www.diabetesjournals the authors identified relevant research to include in reaching consensus. The .org/content/license. Diabetes Care Publish Ahead of Print, published online April 18, 2019 2 Consensus Report Diabetes Care

consensus report was peer reviewed (see treatment of a disease or condition to obtain the expert knowledge and ex- ACKNOWLEDGMENTS) and suggestions incor- through the modification of nutrient or perience can be found in the Academy of porated as deemed appropriate by the whole-food intake (7). To complement Nutrition and Dietetics Standards of Prac- authors. Though evidence-based, the diabetes nutrition therapy, members of tice and Standards of Professional Perfor- recommendations presented are the in- the health care team can and should mance (12). Health care professionals can formed, expert opinions of the authors after provide evidence-based guidance that use the education algorithm suggested consensus was reached through presen- allows people with diabetes to make by ADA, the American Association of Dia- tation and discussion of the evidence. healthy food choices that meet their in- betes Educators, and the Academy of Nu- dividual needs and optimize their overall trition and Dietetics (1) that defines and health. The Dietary Guidelines for Amer- describes the four critical times to as- EFFECTIVENESS OF DIABETES icans (DGA) 2015–2020 provide a basis for sess, provide, and adjust care. The NUTRITION THERAPY healthy eating for all Americans and rec- algorithm is intended for use by the Consensus recommendations ommend that people consume a healthy RDN and the interprofessional team for c Refer adults living with type 1 or eating pattern that accounts for all foods determining how and when to deliver type 2 diabetes to individualized, and beverages within an appropriate cal- diabetes education and nutrition ser- diabetes-focused MNT at diagnosis orie level (8). For people with diabetes, vices. The number of encounters the and as needed throughout the life recommendations that differ from the person with diabetes might have with span and during times of changing DGA are highlighted in this report. the RDN is described in Table 2 (9). health status to achieve treatment MNT is an evidence-based application In addition to diabetes MNT, DSMES is goals. Coordinate and align the of the nutrition care process provided by important for people with diabetes to fi MNT plan with the overall manage- an RDN and is the legal de nition of improve cardiometabolic and microvas- ment strategy, including use of nutrition counseling by an RDN in the U.S. cular outcomes in a disease that is largely – – medications, physical activity, etc., (9 12). Essential components of MNT self-managed (1,19 23). DSMES includes on an ongoing basis. are assessment, nutrition diagnosis, in- the ongoing process that facilitates the c Refer adults with diabetes to terventions (e.g., education and coun- knowledge, skills, and abilities necessary comprehensive diabetes self- seling), and monitoring with ongoing for diabetes self-care throughout the life management education and sup- follow-up to support long-term lifestyle span, with nutrition as one of the core port (DSMES) services according to changes, evaluate outcomes, and modify curriculum topics taught in comprehen- national standards. interventions as needed (9,10). The goals sive programs (21). c Diabetes-focused MNT isprovided by of nutrition therapy are described in a registered dietitian nutritionist/ Table 1. Is MNT effective in improving registered dietitian (RDN), prefera- The unique academic preparation, outcomes? bly one who has comprehensive training, skills, and expertise make the Reported hemoglobin A1c (A1C) reduc- knowledge and experience in di- RDN the preferred member of the health tions from MNT can be similar to or abetes care. care team to provide diabetes MNT and greater than what would be expected c Refer people with prediabetes and leadership in interprofessional team-based with treatment using currently available – overweight/obesity to an intensive nutrition and diabetes care (1,9,13 18). medication for type 2diabetes (9). Strong fi fi lifestyle intervention program that Although certi cation (such as Certi ed evidence supports the effectiveness of fi includes individualized goal-setting Diabetes Educator, Board Certi ed- MNT interventions provided by RDNs for components, such as the Diabetes Advanced Diabetes Management) is improving A1C, with absolute decreases Prevention Program (DPP) and/or not required, ideally the RDN will have up to 2.0% (in type 2 diabetes) and up to – to individualized MNT. comprehensive knowledge and experi- 1.9% (in type 1 diabetes) at 3 6 months. c Diabetes MNT is a covered Medi- ence in diabetes care and prevention Ongoing MNT support is helpful in main- care benefit and should be ade- (9,17). Detailed guidance for the RDN taining glycemic improvements (9). quately reimbursed by insurance and other payers or bundled in Table 1—Goals of nutrition therapy evolving value-based care and pay- c To promote and support healthful eating patterns, emphasizing a variety of nutrient-dense ment models. foods in appropriate portion sizes, in order to improve overall health and specifically to: c DPP-modeled intensive lifestyle ○ Improve A1C, blood pressure, and cholesterol levels (goals differ for individuals based on interventions and individualized age, duration of diabetes, health history, and other present health conditions. Further recommendations for individualization of goals can be found in the ADA Standards of MNT for prediabetes should be Medical Care in Diabetes [345]) covered by third-party payers or ○ Achieve and maintain body weight goals bundled in evolving value-based ○ Delay or prevent complications of diabetes care and payment models. c To address individual nutrition needs based on personal and cultural preferences, health literacy and numeracy, access to healthful food choices, willingness and ability to make How is diabetes nutrition therapy behavioral changes, as well as barriers to change defined and provided? c To maintain the pleasure of eating by providing positive messages about food choices, while The National Academy of Medicine limiting food choices only when indicated by scientific evidence (formerly the Institute of Medicine) c To provide the individual with diabetes with practical tools for day-to-day meal planning broadly defines nutrition therapy as the care.diabetesjournals.org Evert and Associates 3

Table 2—Academy of Nutrition and Dietetics evidence-based nutrition practice hydrate intake to optimize meal guidelines–recommended structure for the implementation of MNT for adults timing and food choices and to with diabetes (9) guide medication and physical ac- Initial series of MNT encounters: The RDN should implement three to six MNT encounters during the first 6 months following diagnosis and determine if additional MNT encounters tivity recommendations. are needed based on an individualized assessment. c People with diabetes and those at MNT follow-up encounters: The RDN should implement a minimum of one annual MNT risk for diabetes are encouraged to follow-up encounter. consume at least the amount of dietary fiber recommended for the general public; increasing fiber in- take, preferably through food (veg- Cost-effectiveness of lifestyle inter- the DPP and/or to individualized MNT etables, pulses [beans, peas, and ventions and MNT for the prevention typically provided by an RDN with the lentils], fruits, and whole intact grains) and management of diabetes has been goals of improving eating habits, in- or through dietary supplement, may documented in multiple studies (12,17, creasing moderate-intensity physical help in modestly lowering A1C. 24,25). The National Academy of Med- activity to at least 150 min per week, icine recommends individualized MNT, and achieving and maintaining 7–10% Do macronutrient needs differ for provided by an RDN upon physician re- loss of initial body weight if needed people with diabetes compared with ferral, as part of the multidisciplinary (14,17,33,34). More intensive interven- the general population? approach to diabetes care (7). Diabetes tion programs are the most effective in Although numerous studies have at- MNT is a covered Medicare benefit and decreasing diabetes incidence and im- tempted to identify the optimal mix of should also be adequately reimbursed by proving cardiovascular disease (CVD) risk macronutrients for the eating plans of insurance and other payers, or bundled in factors (35). people with diabetes, a systematic re- evolving value-based care and payment Both DPP-modeled intensive lifestyle view (45) found that there is no ideal mix models, because it can result in improved interventions and individualized MNT that applies broadly and that macronu- outcomes such as reduced A1C and cost for prediabetes have demonstrated cost- trient proportions should be individual- savings (12,17,25). effectiveness (17,36) and therefore should ized. It has been observed that people be covered by third-party payers or bun- with diabetes, on average, eat about the What nutrition therapy interventions dled in evolving value-based care and same proportions of macronutrients as best help people with prediabetes payment models (25). the general public: ;45% of their calories prevent or delay the development of To make diabetes prevention pro- from carbohydrate (see Table 3), ;36– type 2 diabetes? grams more accessible, digital health 40% of calories from fat, and the re- The strongest evidence for type 2 di- tools are an area of increasing interest mainder (;16–18%) from protein abetes prevention comes from several in the public and private sectors. Pre- (46–48). Regardless of the macronutrient studies, including the DPP (26–28). The liminary research studies support that mix, total energy intake should be ap- DPP demonstrated that an intensive life- the delivery of diabetes prevention life- propriate to attain weight management style intervention resulting in weight loss style interventions through technology- goals. Further, individualization of the could reduce the incidence of type 2 enabled platforms and digital health macronutrient composition will depend diabetes for adults with overweight/ tools can result in weight loss, improved on the status of the individual, including obesity and impaired glucose tolerance glycemia, and reduced risk for diabetes metabolic goals (glycemia, lipid profile, by 58% over 3 years (26). Follow-up of and CVD, although more rigorous studies etc.), physical activity, food preferences, three large studies of lifestyle interven- are needed (37–44). and availability. tion for diabetes prevention has shown sustained reduction in the rate of con- MACRONUTRIENTS Do carbohydrate needs differ for version to type 2 diabetes: 43% reduction Consensus recommendations people with diabetes compared with at 20 years in the Da Qing Diabetes the general population? c Evidence suggests that there is not Prevention Study (29); 43% reduction Carbohydrate is a readily used source of an ideal percentage of calories at 7 years in the Finnish Diabetes Pre- energy and the primary dietary influence from carbohydrate, protein, and vention Study (DPS) (30); and 34% re- on postprandial blood glucose (8,49). fat for all people with or at risk duction at 10 years (28) and 27% Foods containing carbohydratedwith for diabetes; therefore, macronu- reduction at 15 years extended follow- various proportions of sugars, starches, trient distribution should be based up of the DPP (31) in the U.S. Diabetes and fiberdhave a wide range of effects on individualized assessment of Prevention Program Outcomes Study on the glycemic response. Some result in current eating patterns, preferen- (DPPOS). The follow-up of the Da Qing an extended rise and slow fall of blood ces, and metabolic goals. study also demonstrated a reduction glucose concentrations, while others re- c When counseling people with dia- in cardiovascular and all-cause mor- sult in a rapid rise followed by a rapid betes, a key strategy to achieve tality (32). fall (50). The quality of carbohydrate glycemic targets should include Substantial evidence indicates that foods selecteddideally rich in dietary an assessment of current dietary individuals with prediabetes should be fiber, vitamins, and minerals and low intake followed by individualized referred to an intensive behavioral life- in added sugars, fats, and sodiumd guidance on self-monitoring carbo- style intervention program modeled on should be addressed as part of an 4 Consensus Report Diabetes Care

individualized eating plan that includes curve.” Two systematic reviews of the DGA concluded that available evidence all components necessary for optimal literature regarding GI and GL in individ- doesnot supportthe recommendationto nutrition (4,9). uals with diabetes and at risk for diabetes limit dietary cholesterol for the general The amount of carbohydrate intake reported no significant impact on A1C population, exact recommendations for required for optimal health in humans is and mixed results on fasting glucose dietary cholesterol for other populations, unknown. Although the recommended (9,50). Further, studies have used varying such as people with diabetes, are not as dietary allowance for carbohydrate for definitions of low and high GI foods, clear (8). Whereas cholesterol intake has adults without diabetes (19 years and leading to uncertainty in the utility of correlated with serum cholesterol levels, older) is 130 g/day and is determined in GI and GL in clinical care (45). it has not correlated well with CVD events part by the brain’s requirement for glu- (65,66). More research is needed regard- cose, this energy requirement can be What are the total protein needs of ing the relationship among dietary cho- fulfilled by the body’s metabolic pro- people with diabetes? lesterol, blood cholesterol, and CVD cesses, which include glycogenolysis, glu- There is limited research in people with events in people with diabetes. coneogenesis (via metabolism of the diabetes or prediabetes without kidney glycerol component of fat or gluconeo- disease on the impact of various amounts What is the role of fat in the prevention genic amino acids in protein), and/or of protein consumed. Some comparisons of type 2 diabetes? ketogenesis in the setting of very low of protein amounts have not demon- Large epidemiologic studies have found dietary carbohydrate intake (49). strated differences in diabetes-related that consumption of polyunsaturated fat outcomes(57–60). A12-weekstudy com- or biomarkers of polyunsaturated fatty What are the dietary fiber needs of paring 30% vs. 15% energy from protein acids are associated with lower risk of people with diabetes? noted improvements in weight, fasting type 2 diabetes (67). Supplementation The regular intake of sufficient dietary glucose, and insulin requirements in the with omega-3 fatty acids in prediabetes fiber is associated with lower all-cause group that consumed 30% energy from has demonstrated some efficacy in sur- mortality in people with diabetes (51,52). protein (61). A meta-analysis from rogate outcomes beyond serum triglyc- Therefore, people with diabetes should 2013 of studies ranging from 4–24 weeks eride levels. In a single-blinded RCT consume at least the amount of fiber in duration reported that high-protein design in Asia, 107 subjects with newly recommended by the DGA 2015–2020 eating plans (25–32% of total energy diagnosed impaired glucose metabolism (minimum of 14 g of fiber per 1,000 kcal) vs. 15–20%) resulted in 2 kg greater and coronary heart disease (CHD) sup- with at least half of grain consumption weight loss and 0.5% greater improve- plemented with 1,800 mg/day of eico- being whole intact grains (8). Other ment in A1C but no statistically signifi- sapentaenoic acid (EPA) experienced sources of dietary fiber include non- cant improvements in fasting serum improved postprandial triglycerides, gly- starchy vegetables, avocados, fruits, glucose, serum lipid profiles, or blood cemia, insulin secretion ability, and en- and berries, as well as pulses such as pressure (62). dothelial function over a 6-month period beans, peas, and lentils. (68). Further, in a recent multisite RCT that A few studies have shown modest What are the dietary fat and cholesterol included 57% of participants with diabetes, A1C reduction (20.2% to 20.3%) (53, goals for people with diabetes? age 50 years or older, and with at least one 54) with intake in excess of 50 g of fiber The National Academy of Medicine has additional CVD risk factor, plus elevated per day. However, such very high intake defined an acceptable macronutrient fasting triglycerides and low HDL-C, bene- of fiber may cause flatulence, bloating, distribution for total fat for all adults fits were seen from adding 2 g of icosapent and diarrhea. Meeting the recommen- to be 20–35% of total calorie intake (49). ethyl twice daily to statin therapy in terms ded fiber intake through foods that are Eating patterns that replace certain car- of lower rates of a composite CVD outcome naturally high in dietary fiber, as com- bohydrate foods with those higher in and CVD mortality, but there were also pared with supplementation, is encour- total fat, however, have demonstrated slightly higher rates of hospitalization for aged for the additional benefits of greater improvements in glycemia and atrial fibrillation and serious bleeding (68a). coexisting micronutrients and phyto- certain CVD risk factors (serum HDL cho- The intervention in the PREvencion´ chemicals (55). lesterol [HDL-C] and triglycerides) com- con DIeta MEDiterranea´ (PREDIMED) pared with lower fat diets. The types or study, comparing a Mediterranean-style Does the use of glycemic index and quality of fats in the eating plans may eating pattern supplemented either with glycemic load impact glycemia? influence CVD outcomes beyond the total extra-virgin olive oil or with nuts versus The use of the glycemic index (GI) and amount of fat (63). Foods containing syn- a control diet, reduced incidence of glycemic load (GL) to rank carbohydrate thetic sources of trans fats should be min- type 2 diabetes among people without foods according to their effects on gly- imized to the greatest extent possible (8). diabetes at high cardiovascular risk at cemia continues to be of interest for Ruminant trans fats, occurring naturally baseline (69). The Malmo¨ Diet and Can- people with diabetes and those at risk in meat and dairy products, do not need cer cohort study examined specific food for diabetes. As defined by Brand-Miller to be eliminated because they are present sources of saturated fat and found that et al. (56), “the GI provides a good in such small quantities (64). intake of saturated fat from dairy prod- summary of postprandial glycemia. It The body makes enough cholesterol ucts, coconut oil, and palm kernel oil predicts the peak (or near peak) re- for physiological and structural functions were associated with lower diabetes risk sponse, the maximum glucose fluctua- such that people do not need to obtain (70), whereas saturated fat intake was tion, and other attributes of the response cholesterol through foods. Although the associated with higher risk of diabetes in care.diabetesjournals.org Evert and Associates 5

Table 3—Eating patterns reviewed for this report Type of eating pattern Description Potential benefits reported* USDA Dietary Guidelines For Americans Emphasizes a variety of vegetables from all of the DGA added to the table for (DGA) (8) subgroups; fruits, especially whole fruits; grains, at reference; not reviewed as part least half of which are whole intact grains; lower- of this Consensus Report fat dairy; a variety of protein foods; and oils. This eating pattern limits saturated fats and trans fats, added sugars, and sodium. Mediterranean-style (69,76,85–91) Emphasizes plant-based food (vegetables, beans, c Reduced risk of diabetes nuts and seeds, fruits, and whole intact grains); fish c A1C reduction and other seafood; olive oil as the principal source c Lowered triglycerides of dietary fat; dairy products (mainly yogurt and c Reduced risk of major cheese) in low to moderate amounts; typically cardiovascular events fewer than 4 eggs/week;red meat in low frequency and amounts; wine in low to moderate amounts; and concentrated sugars or honey rarely. Vegetarian or vegan (77–80,92–99) The two most common approaches found in the c Reduced risk of diabetes literature emphasize plant-based vegetarian c A1C reduction eating devoid of all flesh foods but including egg c Weight loss (ovo) and/or dairy (lacto) products, or vegan eating c Lowered LDL-C and non–HDL-C devoid of all flesh foods and animal-derived products. Low-fat (26,45,80,83,100–106) Emphasizes vegetables, fruits, starches (e.g., breads/ c Reduced risk of diabetes crackers, pasta, whole intact grains, starchy c Weight loss vegetables), lean protein sources (including beans), and low-fat dairy products. In this review, defined as total fat intake #30% of total calories and saturated fat intake #10%. Very low-fat (107–109) Emphasizes fiber-rich vegetables, beans, fruits, whole c Weight loss intact grains, nonfat dairy, fish, and egg whites and c Lowered blood pressure comprises 70–77% carbohydrate (including 30– 60 g fiber), 10% fat, 13–20% protein. Low-carbohydrate (110–112) Emphasizes vegetables low in carbohydrate (such as c A1C reduction salad greens, broccoli, cauliflower, cucumber, c Weight loss cabbage, and others); fat from animal foods, oils, c Lowered blood pressure butter, and avocado; and protein in the form of c Increased HDL-C and lowered meat, poultry, fish, shellfish, eggs, cheese, nuts, triglycerides and seeds. Some plans include fruit (e.g., berries) and a greater array of nonstarchy vegetables. Avoids starchy and sugary foods such as pasta, rice, potatoes, bread, and sweets. There is no consistent definition of “low” carbohydrate. In this review, a low-carbohydrate eating pattern is defined as reducing carbohydrates to 26–45% of total calories. Very low-carbohydrate (VLC) (110–112) Similar to low-carbohydrate pattern but further limits c A1C reduction carbohydrate-containing foods, and meals c Weight loss typically derive more than half of calories from fat. c Lowered blood pressure Often has a goal of 20–50 g of nonfiber c Increased HDL-C and lowered carbohydrate per day to induce nutritional ketosis. triglycerides In this review a VLC eating pattern is defined as reducing carbohydrate to ,26% of total calories. Dietary Approaches to Stop Hypertension Emphasizes vegetables, fruits, and low-fat dairy c Reduced risk of diabetes (DASH) (81,118,119) products; includes whole intact grains, poultry, c Weight loss fish, and nuts; reduced in saturated fat, red meat, c Lowered blood pressure sweets, and sugar-containing beverages. May also be reduced in sodium. Paleo (120–122) Emphasizes foodstheoreticallyeatenregularlyduring c Mixed results early human evolution, such as lean meat, fish, c Inconclusive evidence shellfish, vegetables, eggs, nuts, and berries. Avoids grains, dairy, salt, refined fats, and sugar. *Source: RCTs, meta-analyses, observational studies, nonrandomized single-arm studies, cohort studies. USDA, U.S. Department of Agriculture. 6 Consensus Report Diabetes Care

the PREDIMED study (71). Other meta- This section emphasizes evidence One of the largest and longest analyses of observational studies have from randomized trials of eating pat- RCTs, the PREDIMED trial, compared not shown an inverse relationship with terns in people with type 1 diabetes, a Mediterranean-style eating pattern full-fat dairy intake and diabetes risk type 2 diabetes, and prediabetes and with a low-fat eating pattern. After (72,73). The inconsistent results in the was limited to those trials with at least 4 years, glycemic management improved above studies may be due to variations in 10 people in each dietary group and a and the need for glucose-lowering med- food sources of fat (70) or the fact that retention rate of .50%. Overall, few ications was lower in the Mediterranean some analyses have relied on self- long-term (2 years or longer) random- eating pattern group (89). In addition, reported dietary information, which can ized trials have been conducted of any the PREDIMED trial showed that a Med- be limited by inaccuracy. of the dietary patterns in any of the iterranean-style eating pattern inter- For more information on fat intake and conditions examined. vention enriched with olive oil or nuts CVD risk, see the section ROLE OF NUTRITION significantly reduced CVD incidence in both THERAPY IN THE PREVENTION AND MANAGEMENT OF What is the evidence for specific eating people with and without diabetes (91). DIABETES COMPLICATIONS (CVD, DIABETIC KIDNEY DIS- patterns to manage prediabetes and Vegetarian or Vegan Eating Patterns EASE, AND GASTROPARESIS). prevent type 2 diabetes? Studies of vegetarian or vegan eating The most robust research available re- plans ranged in duration from 12 to lated to eating patterns for prediabe- 74 weeks and showed mixed results EATING PATTERNS tes or type 2 diabetes prevention are on glycemia and CVD risk factors. These Mediterranean-style, low-fat, or low- Consensus recommendations eating plans often resulted in weight loss carbohydrate eating plans (26,69,74,75). c (92–97). Two meta-analyses of con- A variety of eating patterns (com- The PREDIMED trial, a large RCT, com- trolled trials (98,99) concluded that veg- binations of different foods or food pared a Mediterranean-style to a low-fat etarian and vegan eating plans can groups) are acceptable for the eating pattern for prevention of type 2 reduce A1C by an average of 0.3–0.4% management of diabetes. diabetes onset, with the Mediterranean- c in people with type 2 diabetes, and the Until the evidence surrounding style eating pattern resulting in a 30% fi larger meta-analysis (99) also reported comparative bene ts of different lower relative risk (69). Epidemiologic stud- fi that plant-based eating patterns reduced eating patterns in speci c individ- ies correlate Mediterranean-style (76), veg- weight (weight reduction of 2 kg), waist uals strengthens, health care pro- etarian (77–80), and Dietary Approaches to circumference, LDL cholesterol (LDL-C), viders should focus on the key Stop Hypertension (DASH) (76,81) eating and non–HDL-C with no significant effect factors that are common among patterns with a lower risk of developing on fasting insulin, HDL-C, triglycerides, the patterns: type 2 diabetes, with no effect for low- ○ and blood pressure. Emphasize nonstarchy vegetables. carbohydrate eating patterns (82). ○ Minimize added sugars and Several large type 2 diabetes preven- Low-Fat Eating Pattern fi re ned grains. tion RCTs (26,74,83,84) used low-fat eat- In the Look AHEAD (Action for Health in ○ Choose whole foods over highly ing plans to achieve weight loss and Diabetes) trial (100), individuals follow- processed foods to the extent improve glucose tolerance, and some ing a calorie-restricted low-fat eating possible. demonstrated decreased incidence of pattern, in the context of a structured c Reducing overall carbohydrate in- diabetes (26,74,83). Given the limited weight loss program using meal replace- take for individuals with diabetes evidence, it is unclear which of the eating ments, achieved moderate success com- has demonstrated the most evi- patterns are optimal. pared with the control condition eating dence for improving glycemia plan (101). However, lowering total fat and may be applied in a variety What is the evidence for specific eating intake did not consistently improve gly- of eating patterns that meet in- patterns to manage type 2 diabetes? cemia or CVD risk factors in people with dividual needs and preferences. Mediterranean-Style Eating Pattern type 2 diabetes based on a systematic c For select adults with type 2 di- – The Mediterranean-style pattern has review (45), several studies (102 105), abetes not meeting glycemic fi demonstrated a mixed effect on A1C, and a meta-analysis (106). Bene t from a targets or where reducing anti- weight, and lipids in a number of RCTs low-fat eating pattern appears to be glycemicmedicationsisapriority, (85–90). In the Dietary Intervention mostly related to weight loss as opposed reducing overall carbohydrate Randomized Controlled Trial (DIRECT), to the eating pattern itself (100,101). intake with low- or very low- obese adults with type 2 diabetes Additionally, low-fat eating patterns carbohydrate eating plans is a “ were randomized to a calorie-restricted have commonly been used as the con- viable approach. ” Mediterranean-style, a calorie-restricted trol intervention compared with other An eating pattern represents the to- lower-fat, or a low-carbohydrate eating eating patterns. tality of all foods and beverages con- pattern (28% of calories from carbo- Very Low-Fat: Ornish or Pritikin Eating sumed (8) (Table 3). An eating plan is a hydrate) without emphasis on calorie Patterns guide to help individuals plan when, restriction. A1C was lowest in the low- The Ornish and Pritikin lifestyle programs what, and how much to eat on a daily carbohydrate group after 2 years, whereas are two of the best known multicompo- basis and applies to the foods empha- fasting plasma glucose was lower in the nent very low-fat eating patterns. The sized in the individual’s selected eating Mediterranean-style group than in the Ornish program emphasizes a very low- pattern. lower-fat group (90). fat, whole-foods, plant-based eating care.diabetesjournals.org Evert and Associates 7

plan (about 70% of calories from carbo- Table 4—Quick reference conversion of percent calories from carbohydrate shown hydrate, 10% from fat, 20% from protein, in grams per day as reported in the research reviewed for this report and 60 g of fiber), predominantly from Calories 10% 20% 30% 40% 50% 60% 70% vegetables, beans, fruits, grains, nonfat 1,200 30 g 60 g 90 g 120 g 150 g 180 g 210 g dairy, and egg whites. The Pritikin in- 1,500 38 g 75 g 113 g 150 g 188 g 225 g 263 g tervention advises that people consume 77%of calories fromcarbohydrate, about 2,000 50 g 100 g 150 g 200 g 250 g 300 g 350 g 10% from fat, 13% from protein, and 30– 2,500 63 g 125 g 188 g 250 g 313 g 375 g 438 g 40 g of fiber per 1,000 calories, with no calorie restriction during a 26-day stay carbohydrate based on number of calo- 13–29participants, lastingnolongerthan in an in-patient treatment center. Three ries consumed per day. 3 months, and finding mixed effects on nonrandomized single-arm studies with Because of theoretical concerns re- A1C, weight, and lipids (120–122). 69 to 652 participants lasting between garding use of VLC eating plans in people 3 weeks and 2–3 years show that these Intermittent Fasting with chronic kidney disease, disordered multicomponent lifestyle intervention While intermittent fasting is not an eating patterns, and women who are programs may improve glucose levels, eating pattern by definition, it has pregnant, further research is needed be- weight, blood pressure, and HDL-C, been included in this discussion be- fore recommendations can be made with a mixed effect on triglycerides cause of increased interest from the for these subgroups. Adopting a VLC (107–109). diabetes community. Fasting means to eating plan can cause diuresis and swiftly go without food, drink, or both for a Low-Carbohydrate or Very Low- reduce blood glucose; therefore, consul- period of time. People fast for reasons Carbohydrate Eating Patterns tation with a knowledgeable practitioner ranging from weight management to Low-carbohydrate eating patterns, es- at the onset is necessary to prevent upcoming medical visits to religious pecially very low-carbohydrate (VLC) dehydration and reduce insulin and and spiritual practice. Intermittent eating patterns, have been shown to hypoglycemic medications to prevent fastingisawayofeatingthatfocuses reduce A1C and the need for antihyper- hypoglycemia. more on when you eat (i.e., consuming glycemic medications. These eating pat- No randomized trials were found in all daily calories in set hours during the terns are among the most studied eating people with type 2 diabetes that varied day) than what you eat. While it usually patterns for type 2 diabetes. One meta- the saturated fat content of the low- or involves set times for eating and set analysis of RCTs that compared low- very low-carbohydrate eating patterns times for fasting, people can approach carbohydrate eating patterns (defined to examine effects on glycemia, CVD risk intermittent fasting in many different # as 45% of calories from carbohydrate) factors, or clinical events. Most of the ways. to high-carbohydrate eating patterns trials using a carbohydrate-restricted Published intermittent fasting studies fi . (de ned as 45% of calories from car- eating pattern did not restrict saturated involving diabetes and diabetes pre- fi bohydrate) found that A1C bene ts fat;fromthe currentevidence, thiseating vention demonstrate a variety of ap- were more pronounced in the VLC inter- pattern does not appear to increase proaches, including restricting food , ventions (where 26% of calories came overall cardiovascular risk, but long- intake for 18 to 20 h per day, alternate- from carbohydrate) at 3 and 6 months term studies with clinical event out- day fasting, and severe calorie restric- but not at 12 and 24 months (110). comes are needed (113–117). tion for up to 8 consecutive days or Another meta-analysis of RCTs longer (123). Four fasting studies of compared a low-carbohydrate eating DASH Eating Pattern One small, 8-week study comparing participants with type 2 diabetes were pattern (defined as ,40% of calories # the DASH eating pattern with a control small ( 63 participants) and of short from carbohydrate) to a low-fat eating # group in people with type 2 diabetes duration ( 20 weeks). Three of the stud- pattern (defined as ,30% of calories – indicated improved A1C, blood pres- ies (124 126) demonstrated that inter- from fat). In trials up to 6 months long, mittent fasting, either in consecutive days sure, and cholesterol levels and weight the low-carbohydrate eating pattern of restrictionor by fasting 16 hper dayor loss with the DASH eating pattern, with improved A1C more, and in trials of more, may result in weight loss; how- no difference in triglycerides (118). An- varying lengths, lowered triglycerides, ever, there was no improvement in A1C other RCT compared the DASH eating raised HDL-C, lowered blood pressure, compared with a nonfasting eating plan. pattern incorporating increased physical and resulted in greater reductions in One of the studies (127) showed similar activity with a standard eating pattern diabetes medication (111). Finally, in reductions in A1C, weight, and medica- without increased physical activity and another meta-analysis comparing low- tion doses when 2 days of severe energy found blood pressure was lower in the carbohydrate to high-carbohydrate eat- restriction were compared with chronic DASH and physical activity group, but ing patterns, the larger the carbohydrate energy restriction. Another study looked A1C, weight, and lipids did not differ restriction, the greater the reduction in at men with prediabetes and timing of (119). A1C, though A1C was similar at durations food intake over a 24-h period, with the of 1 year and longer for both eating Paleo Eating Pattern intervention group restricted to a 6-h patterns (112). Table 4 provides a quick Research studies focused on a paleo schedule of eating (with final meal before reference conversion of percentage of eating pattern in adults with type 2 di- 3 P.M.) compared with a control schedule calories from carbohydrate to grams of abetes are small and few, ranging from where eating occurred over a 12-h period; 8 Consensus Report Diabetes Care

improved insulin sensitivity, b-cell re- over highly processed foods to the extent is 7–10% for preventing progression sponsiveness, blood pressure, oxidative possible (132). to type 2 diabetes. stress, and appetite were shown in the Multiple trials and meta-analyses have c In select individuals with type 2 intervention group (128). The safety of been published addressing the compar- diabetes, an overall healthy eating intermittent fasting in people with spe- ative effects of specific eating patterns plan that results in energy deficit in cial health situations, including preg- for diabetes. Whereas no single eating conjunction with weight loss med- nancy and disordered eating, has not pattern has emerged as being clearly ications and/or metabolic surgery been studied. superior to all others for all diabetes- should be considered to help related outcomes, evidence suggests achieve weight loss and mainte- certain eating patterns are better for nance goals, lower A1C, and reduce What is the evidence to support specific outcomes. All eating patterns fi CVD risk. speci c eating patterns in the include a range of more-healthy versus c In conjunction with lifestyle ther- management of type 1 diabetes? less-healthy options: lentils and sugar- For adults with type 1 diabetes, no trials apy, medication-assisted weight sweetened beverages are both consid- met the inclusion criteria for this Consen- loss can be considered for people ered part of a vegan eating pattern; fish sus Report related to Mediterranean- at risk for type 2 diabetes when andprocessedredmeatsarebothcon- style, vegetarian or vegan, low-fat, needed to achieve and sustain sidered part of a low-carbohydrate eat- low-carbohydrate, DASH, paleo, Or- 7–10% weight loss. ing pattern; and removing the bun nish, or Pritikin eating patterns. We found c People with prediabetes at a healthy from a fast food burger might make it limited evidence about the safety and/or weight should be considered for part of a paleo eating pattern but does effects of fasting on type 1 diabetes (129). lifestyle intervention involving both not necessarily make it healthier. Fur- A few studies have examined the aerobic and resistance exercise and ther, studies comparing the same two or impact of a VLC eating pattern for adults a healthy eating plan such as a Med- more eating patterns could easily dif- with type 1 diabetes. One randomized iterranean-style eating plan. fer in the investigators’ definition of crossover trial with 10 participants c People with diabetes and predia- the patterns, the effectiveness of the examined a VLC eating pattern aiming betes should be screened and eval- research team in fostering pattern adher- for 47 g carbohydrate per day without a uated during DSMES and MNT ence among study participants, the ac- focus on calorie restriction compared encounters for disordered eating, curacy of assessing pattern adherence, with a higher carbohydrate eating pat- and nutrition therapy should ac- study duration, and participant popula- tern aiming for 225 g carbohydrate per commodate these disorders. tion characteristics. day for 1 week each. Participants follow- ing the VLC eating pattern had less ENERGY BALANCE AND WEIGHT What is the role of weight loss therapy glycemic variability, spent more time MANAGEMENT in euglycemia and less time in hypogly- in people with prediabetes or diabetes cemia, and required less insulin (130). A Consensus recommendations with overweight or obesity? There is substantial evidence indicating single-arm 48-person trial of a VLC eating c To support weight loss and improve that weight loss is highly effective in pattern aimed at a goal of 75 g of A1C, CVD risk factors, and quality preventing progression from prediabe- carbohydrate or less per day found of life in adults with overweight/ tes to type 2 diabetes and in managing that weight, A1C, and triglycerides obesity and prediabetes or diabe- cardiometabolic health in type 2 di- were reduced and HDL-C increased after tes, MNT and DSMES services abetes. Overweight and obesity are 3 months, and after 4 years A1C was still should include an individualized also increasingly prevalent in people lower and HDL-C was still higher than at eating plan in a format that results with type 1 diabetes and present clin- baseline (131). This evidence suggests in an energy deficit in combination ical challenges regarding diabetes that a VLC eating pattern may have with enhanced physical activity. treatment and CVD risk factors potential benefits for adults with c For adults with type 2 diabetes who (133,134). Therefore, MNT and DSMES type 1 diabetes, but clinical trials of are not taking insulin and who have that include an overall healthy eating sufficient size and duration are needed limited health literacy or numer- plan in a format that results in an to confirm prior findings. acy, or who are older and prone to energy deficit, as well as a collaborative hypoglycemia, a simple and effec- effort to achieve weight loss in people tive approach to glycemia and with type 1 diabetes, type 2 diabetes, or Does the current evidence support weight management emphasizing fi prediabetes and overweight/obesity, are speci c eating patterns for the appropriate portion sizes and recommended. management of diabetes? healthy eating may be considered. Until the evidence surrounding compar- Eating plans that create an energy c In type 2 diabetes, 5% weight loss ative benefits of different eating patterns deficit and are customized to fit the is recommended to achieve clinical in specific individuals strengthens, health person’s preferences and resources benefit, and the benefits are pro- care providers should focus on the key can help with long-term sustainment gressive. The goal for optimal out- factors that are common among the and are the cornerstone of weight loss comes is 15% or more when needed patterns: 1) emphasize nonstarchy veg- therapy. Regular physical activity, which and can be feasibly and safely ac- etables, 2) minimize added sugars and can contribute to both weight loss complished.Inprediabetes,thegoal refined grains, and 3)choose whole foods and prevention of weight regain, and care.diabetesjournals.org Evert and Associates 9

behavioral strategies are also impor- as an adjunct to lifestyle interventions, account dietary preferences together tant components of lifestyle therapy for resulting in greater weight loss that is with the individual’s health literacy, weight management (26,74,83,135–137). maintained for a longer period of time. resources, food availability, meal prep- Structured weight loss programs with The data also support the position aration skills, and physical activity to regular visits and use of meal replace- that weight loss therapy is effective at maximize the ability to attain and main- ments have been shown to enhance all phases of type 2 diabetes, both in tain the eating plan (173,174). Individu- weight loss in people with diabetes individuals with recent-onset disease alized eating plans should support calorie (138–140). (1,149) and in people with longer dura- reduction (e.g., employing use of appro- The combined data do not point to a tions of diabetes treated with multiple priate portion sizes, meal replacements, threshold of weight loss for maximal clin- diabetes medications (136,149). and/or behavioral interventions) in the ical benefits in people with diabetes; In the DPP, maximal prevention of context of a lifestyle program, with rather, the greater the weight loss, the diabetes over 4 years was observed at appropriate modifications in the med- greater the benefits. Previous recommen- about 7–10% weight loss (151). This is ication plan to minimize associated dations of weight loss of 5% or $7% for consistent with the study using phenter- adverse effects such as weight gain, people with overweight or obesity are mine/topiramate ER, where weight loss hypoglycemia, and hypotension. based on the threshold needed for ther- of 10% reduced incident diabetes by 79% Weight loss interventions can be apeutic advantages; however, weight loss over 2 years and any further weight implemented in usual care settings targeted at $15%, when such can feasibly loss to $15% did not lead to additional and alternately in telehealth programs andsafelybeaccomplished,isassociated prevention (152). For this reason, nutri- (175,176). In general, the intervention with even better outcomes in type 2 di- tion therapy to support a 7–10% weight intensity and degree of individual par- abetes (138,141). loss is the appropriate goal in treating ticipation in the program are important The UK Prospective Diabetes Study people with prediabetes, unless addi- factors for successful weight loss (161– (UKPDS) demonstrated that decreases tional weight loss is desired for other 163,175). in fasting glucose were correlated with purposes. Nutrition therapy can be a degree of weight loss (142). A meta- component of a lifestyle intervention What is the role of weight loss on analysis conducted by Franz et al. (137) program or used in conjunction with potential for type 2 diabetes remission? found that lifestyle interventions pro- antiobesity medications and/or meta- The Look AHEAD trial (177) and the ducing ,5% weight loss had less effect bolic surgery (153,154) in people with DiabetesRemission ClinicalTrial(DiRECT) on A1C, lipids, or blood pressure com- prediabetes. (138) highlight the potential for type 2 pared with studies achieving weight loss Regular physical activity by itself diabetes remissionddefined as the of $5%. Other meta-analyses focusing (155,156) or as part of a comprehensive maintenance of euglycemia (complete on nonmedicine or medicine-assisted lifestyle plan (26,74,83,151) can prevent remission) or prediabetes level of glyce- weight loss interventions in type 2 di- progression to type 2 diabetes in high- mia (partial remission) with no diabe- abetes support this finding (143–145). risk individuals. Studies have demon- tes medication for at least 1 year More recently, the Look AHEAD trial strated beneficial effects of both aerobic (177,178)din people undergoing weight (139,141) compared standard DSMES and resistance exercise and additive loss treatment. In the Look AHEAD trial, to a more intensive lifestyle interven- benefits when both forms of exercise when compared with the control group, tion and reduced-calorie eating plan. are combined (157–159). the intensive lifestyle arm resulted in at The intensive lifestyle intervention re- least partial diabetes remission in 11.5% sulted in 8.6% weight loss at 1 year, and What is the best weight loss plan for of participants as compared with 2% in the downstream therapeutic benefits individuals with diabetes? the control group (177). The DiRECT trial were far-ranging even though benefits For purposes of weight loss, the ability showed that at 1 year, weight loss were not seen for the primary cardio- to sustain and maintain an eating plan associated with the lifestyle interven- vascular outcomes (100). that results in an energy deficit, irre- tion resulted in diabetes remission in A systematic review of the effective- spective of macronutrient composition 46% of participants (138). Remission ness of MNT revealed mixed weight loss or eating pattern, is critical for success rates were related to magnitude of outcomes in participants with type 1 and (160–163). Studies investigating spe- weight loss, rising progressively from 2 diabetes (9). Similarly, while DSMES is cific weight loss eating plans using a 7% to 86% as weight loss at 1 year a fundamental component of diabetes broad range of macronutrient compo- increased from ,5% to $15% (138). care (1), it does not consistently produce sition in people with diabetes have Diet composition may also play a role; in sufficient weight loss to achieve optimal shown mixed results regarding effects an RCT by Esposito et al. (179), despite therapeutic benefits in people with di- on weight, A1C, serum lipids, and blood only a 2-kg difference in weight loss, the abetes (136,146,147). For these reasons, pressure (102,103,106,164–171). As a group following a low-carbohydrate diabetes MNT and DSMES should result, the evidence does not identify Mediterranean-style eating pattern emphasize a targeted and concerted one eating plan that is clearly superior (see Table 3) experienced greater rates plan for weight management. to others and that can be gener- of at least partial diabetes remission, The addition of metabolic surgery ally recommended for weight loss for with rates of 14.7% at year 1 and 5% (148), weight loss medications (149), people with diabetes (172). Thus, an at year 6 compared with 4.7% and 0%, and glucose-lowering agents that pro- individualized plan for diabetes nutri- respectively, in the group following a mote weight loss (150) can also be used tion therapy is warranted, taking into low-fat eating plan. 10 Consensus Report Diabetes Care

What is the role of eating plans that Health care professionals should consider consumption of beverages containing result in energy deficits and weight loss screening for disordered eating, refer to a sugar substitutes that was supported in type 1 diabetes? mental health professional, and individu- by the ADA concluded there is not Obesity prevalence among people with alize nutrition therapy accordingly (206). enough evidence to determine whether type 1 diabetes has been significantly sugar substitute use definitively leads to increasing (180–182). Currently, over SWEETENERS long-term reduction in body weight or 50% of people with type 1 diabetes cardiometabolic risk factors, including Consensus recommendations have overweight or obesity (180–182). glycemia (212). Using sugar substitutes c A recent study suggested obesity may Replace sugar-sweetened bever- does not make an unhealthy choice promote progression to overt type 1 ages (SSBs) with water as often healthy; rather, it makes such a choice diabetes in at-risk individuals (183), as possible. less unhealthy. If sugar substitutes are c but further confirmatory studies are When sugar substitutes are used to used to replace caloric sweeteners, with- needed. In addition, in people with es- reduce overall calorie and carbo- out caloric compensation, they may be tablished type 1 diabetes, presence of hydrate intake, people should be useful in reducing caloric and carbohy- obesity can worsen insulin resistance, counseled to avoid compensating drate intake (213), although further re- glycemic variability, microvascular dis- with intake of additional calories search is needed to confirm these ease complications, and cardiovascular from other food sources. concepts (214). Multiple mechanisms risk factors (184–188). Therefore, weight have been proposed for potential ad- management has been recommended as Does the consumption of SSBs impact verse effects of sugar substitutes, e.g., an essential component of care for peo- risk of diabetes? adversely altering feelings of hunger and ple with type 1 diabetes who have over- SSB consumption in the general popula- fullness, substituting for healthier foods, weight or obesity (189–192). tion contributes to a significantly in- or reducing awareness of calorie intake There is a scarcity of evidence from creased risk of type 2 diabetes, weight (215). As people aim to reduce their RCTs evaluating weight loss interven- gain, heart disease, kidney disease, non- intake of SSBs, the use of other alter- tions in type 1 diabetes. A retrospective alcoholic liver disease, and tooth decay natives, with a focus on water, is en- nested-control study indicated that life- (207). For example, a meta-analysis re- couraged (212). style-induced weight loss improved gly- ported that consumption of at least one Sugar alcohols represent a separate cemia with a reduction in insulin doses serving of SSB per day increased risk of category of sweeteners. Like sugar sub- compared with controls (193). Individu- type 2 diabetes in adults with prediabe- stitutes, sugar alcohols have been ap- als with type 1 diabetes and obesity may tes by 26% (208). In a separate meta- proved by the FDA for consumption by benefit from eating plans that result in an analysis, consumption of regular soda the general public and people with di- energy deficit and that are lower in total increased type 2 diabetes risk by 13%, abetes. Whereas sugar alcohols have carbohydrate and GI and higher in fiber while consumption of diet soda in- fewer calories per gram than sugars, and lean protein (194). Currently, ad- creased type 2 diabetes risk by 8% they are not as sweet. Therefore, a higher junctive pharmacotherapy is not in- (209). Conversely, the replacement of amount is required to match the degree dicated for individuals with type 1 SSBs with an equal amount of water of sweetness of sugars, generally bring- diabetes. However, there is preliminary reduced the risk of type 2 diabetes by ing the calorie content to a level similar to evidence that in select individuals with 7–8% (210). that of sugars (216). Use of sugar alcohols type 1 diabetes and excess adiposity, needs to be balanced with their potential newer pharmacotherapy (i.e., glucagon- What is the impact of sugar to cause gastrointestinal effects in sen- like peptide 1 receptor agonists or substitutes? sitive individuals. Currently, there is little sodium–glucose cotransporter 2 inhibi- The U.S. Food and Drug Administration research on the potential benefits of tors) (195,196) can decrease body weight (FDA) has reviewed several types of sugar sugar alcohols for people with diabetes and improve glycemia, though they are substitutes for safety and approved them (217). currently not indicated. In addition, met- for consumption by the general public, abolic surgery in appropriate candidates including people with diabetes (211). In can decrease body weight and improve this report, the term sugar substitutes ALCOHOL CONSUMPTION glycemia (197,198). refers to high-intensity sweeteners, ar- Consensus recommendations tificial sweeteners, nonnutritive sweet- c It is recommended that adults with eners, and low-calorie sweeteners. These How does disordered eating factor into diabetes or prediabetes who drink include saccharin, neotame, acesulfame- weight management? alcohol do so in moderation (one When counseling individuals with diabe- K, aspartame, sucralose, advantame, drink or less per day for adult tes and prediabetes about weight man- stevia, and luo han guo (or monk fruit). women and two drinks or less agement, special attention also must Replacing added sugars with sugar sub- per day for adult men). be given to prevent, diagnose, and treat stitutes could decrease daily intake of c Educating people with diabetes disordered eating. Disordered eating can carbohydrates and calories. These die- about the signs, symptoms, and make following an eating plan chal- tary changes could beneficially affect self-management of delayed hypo- lenging (199). The prevalence of disor- glycemic, weight, and cardiometabolic glycemia after drinking alcohol, dered eating varies, affecting 18% to 40% control. However, an American Heart especially when using insulin of people with diabetes (199–205). Association science advisory on the care.diabetesjournals.org Evert and Associates 11

and the potential need for more frequent or insulin secretagogues, is rec- with diabetes or prediabetes have glucose monitoring after consuming alco- ommended. The importance of not been supported by evidence, hol (227,229). glucose monitoring after drink- and therefore routine use is not ing alcohol beverages to reduce recommended. How does alcoholconsumption impact hypoglycemia risk should be c It is recommended that MNT for emphasized. risk of developing type 2 diabetes? people taking metformin include Comprehensive reviews and meta- an annual assessment of vitamin analyses suggest a protective effect of What are the effects of alcohol B12 status with guidance on sup- moderate alcohol intake on the risk of consumption on diabetes-related plementation options if deficiency developing type 2 diabetes, with a higher outcomes? is present. rate of diabetes in alcohol abstainers and It is important that health care providers c The routine use of chromium or heavy consumers (222,230–232). Mod- counsel people with diabetes about al- vitamin D micronutrient supple- erate alcohol intake ranging from 6–48 cohol consumption and encourage mod- ments or any herbal supplements, g/day (0.5–3.4 drinks) was associated erate and sensible use for people including cinnamon, curcumin, or with a 30–56% lower incidence of choosing to consume alcohol. Moderate aloe vera, for improving glycemia type 2 diabetes (9,222,230–232). Knott alcohol consumption has minimal acute in people with diabetes is not sup- et al. (232) reported reduced risk of and/or long-term detrimental effects on ported by evidence and is therefore type 2 diabetes at all levels of alcohol glycemia in people with type 1 or type 2 not recommended. , diabetes (218–221), with some epidemi- intake 63 g per day with peak reduction – ologic data showing improved glycemia at a daily alcohol intake of 10 14 g and improved insulin sensitivity with (approximately 1 drink) per day in women and non-Asian populations. moderate intake. One alcohol-containing What is the effectiveness of A meta-analysis and systematic review beverage is defined as 12-oz beer, 5-oz micronutrients on diabetes-related (233) that examined the effects of spe- wine, or 1.5-oz distilled spirits, each outcomes? cific types of alcohol beverage consump- Scientific evidence does not support containing approximately 15 g of alcohol tion and the incidence of type 2 diabetes the use of dietary supplements in the (8). Excessive amounts of alcohol (.3 form of vitamins or minerals to meet drinks per day or 21 drinks per week for found that wine consumption was asso- fi glycemic targets or improve CVD risk men and .2 drinks per day or 14 drinks ciated with signi cantly lower diabetes factors in people with diabetes or pre- per week for women) consumed on a risk, as compared with a smaller reduc- diabetes, in the absence of an under- consistent basis may contribute to hy- tion in risk with beer and spirits. A lying deficiency(234–236).Peoplewith perglycemia (222). Starting with one U-shaped relationship between alcohol diabetes not achieving glucose targets drink per day, risk for reduced adherence dose and diabetes risk was found among may have an increased risk of micro- to self-care and healthy lifestyle behav- all three types of alcohol, with lowest diabetes risk at 20–30 g of alcohol per day nutrient deficiencies (237), so maintaining iors has been reported with increasing from wine and beer and 7–15 g of alcohol a balanced intake of food sources that alcohol consumption (223). per day from spirits; the decrease in provide at least the recommended daily diabetes incidence was 20% for wine, allowance for nutrients and micronu- What are the effects of alcohol 9% for beer, and 5% for spirits. trients is essential (234). For special consumption on hypoglycemia risk in While epidemiologic evidence shows populations, including women planning people with diabetes? a correlation between alcohol consump- pregnancy, people with celiac disease, Despite the potential glycemic and car- tion and risk of diabetes, the evidence older adults, vegetarians, and people diovascular benefits of moderate alcohol does not suggest that providers should following an eating plan that restricts consumption, alcohol intake may place advise abstainers to start consuming overall calories or one or more people with diabetes at increased risk for alcohol. Ultimately, alcohol consumption macronutrients, a multivitamin supple- delayed hypoglycemia (221,224–226). is an individual’s choice, but additional ment may be justified (238). This effect may be a result of inhibition factors such as history of alcohol use, A systematic review on the effect of of gluconeogenesis, reduced hypoglyce- religion, genetic factors, and mental chromium supplementation on glu- mia awareness due to the cerebral effects health, as well as medication interac- cose and lipid metabolism concluded of alcohol, and/or impaired counterregu- tions, should be considered when coun- that evidence is limited by poor study latory responses to hypoglycemia (227). seling on alcohol use. quality and heterogeneity in method- This is particularly relevant for those using ology and results (239,240). Evidence insulin or insulin secretagogues who can MICRONUTRIENTS, HERBAL from clinical studies that evaluated experience delayed nocturnal or fasting SUPPLEMENTS, AND RISK OF magnesium (241,242) and vitamin D hypoglycemia after evening alcohol con- MEDICATION-ASSOCIATED (243–253) supplementation to im- sumption. Consuming alcohol with food DEFICIENCY prove glycemia in people with diabetes fl can minimize the risk of nocturnal Consensus recommendations is likewise con icting. However, evi- hypoglycemia (227,228). It is essential dence is emerging that suggests that c Without underlying deficiency, the that people with diabetes receive magnesium status may be related to benefits of multivitamins or mineral education regarding the recognition and diabetes risk in people with prediabe- supplementsonglycemiaforpeople management of delayed hypoglycemia tes (254). 12 Consensus Report Diabetes Care

What is the role of herbal with respect to time and amount per c For individuals with type 1 diabe- supplementation in the management meal (9,275,276). tes, intensive insulin therapy using of diabetes? Results from recent high-fat and/or the carbohydrate counting ap- It is important to consider that nutritional high-protein mixed meal studies con- proach can result in improved gly- supplements and herbal products are tinue to support previous findings that cemia and is recommended. not standardized or regulated (255,256). glucose response to mixed meals high c For adults using fixed daily insulin Health care providers should ask about in protein and/or fat along with car- doses, consistent carbohydrate in- the use of supplements and herbal prod- bohydrate differ among individuals; take with respect to time and ucts, and providers and people with or at therefore, a cautious approach to in- amount, while considering the in- risk for diabetes should discuss the po- creasing insulin doses for high-fat sulin action time, can result in tential benefit of these products weighed and/or high-protein mixed meals is improved glycemia and reduce against the cost and possible adverse recommended to address delayed hy- the risk for hypoglycemia. effects and drug interactions. The vari- perglycemia that may occur 3 h or more c When consuming a mixed meal ability of herbal and micronutrient sup- after eating (277–290). If using an insulin that contains carbohydrate and is plements makes research in this area pump, a split bolus feature (part of the high in fat and/or protein, insulin challenging and makes it difficult to bolus delivered immediately, the re- dosing should not be based solely conclude effectiveness. To date, there is mainder over a programmed duration on carbohydrate counting. A cau- limited evidence supporting the addition of time) may provide better insulin cov- tious approach to increasing meal- of herbal supplements to manage glyce- erage for high-fat and/or high-protein time insulin doses is suggested; mia. Because of public interest and the mixed meals (278,281). Checking glucose continuous glucose monitoring lack of conclusive data, the National 3 h after eating may help to determine if (CGM) or self-monitoring of blood Center for Complementary and Integra- additional insulin adjustments (i.e., in- glucose (SMBG) should guide tive Health at the National Institutes of creasing or stopping bolus) are required decision-making for administration Health aims to answer important public (278,290). Because these insulin dosing of additional insulin. health and scientific questions by fund- algorithms require determination of an- ing and conducting research on comple- ticipated nutrient intake to calculate the What is the role of the RDN in mentary medicine. mealtime dose, health literacy and nu- medication adjustment? meracy should be evaluated. The ef- RDNs providing MNT in diabetes care fectiveness of insulin dosing decisions Does the use of metformin affect should assess and monitor medication should be confirmed with a structured vitamin B12 status? changes in relation to the nutrition care approach to SMBG or CGM to evaluate Metformin is associated with vitamin B12 plan. Along with other diabetes care fi individual responses and guide insulin de ciency, with a recentsystematic review providers, RDNs who possess advanced dose adjustments. recommending that annual blood testing practice training and clinical expertise of vitamin B12 levels be considered in should take an active role in facilitating metformin-treated people, especially in and maintaining organization-approved ROLE OF NUTRITION THERAPY IN those with anemia or peripheral neurop- diabetes medication protocols. Use of THE PREVENTION AND athy (257). This study found that even in organization-approved protocols for in- MANAGEMENT OF DIABETES fi the absence of anemia, B12 de ciency was sulin and other glucose-lowering medica- COMPLICATIONS (CVD, DIABETIC fi prevalent. The exact cause of B12 de - tions can help reduce therapeutic inertia KIDNEY DISEASE, AND ciency in people taking metformin is not and/or reduce the risk of hypoglycemia GASTROPARESIS) known, but some research points to mal- and hyperglycemia (12,16–18,262,263). absorption caused by metformin, with CVD other studies suggesting improvements Consensus recommendations How should nutrition therapy vary in B12 status with calcium supplementa- c In general, replacing saturated fat – tion (258 261). The standard of treatment based on type and intensity of insulin with unsaturated fats reduces both has been B12 injections, but new research plan? total cholesterol and LDL-C and also For people with type 1 diabetes using suggest that high-dose oral supplementa- benefits CVD risk. basal-bolus insulin therapy, a primary tion may be as effective (258,259). More c In type 2 diabetes, counseling peo- focus for MNT should include guidance research is needed in this area. ple on eating patterns that replace on adjusting insulin based on anticipated foods high in carbohydrate with dietary intake, particularly carbohydrate foods lower in carbohydrate and MNT AND ANTIHYPERGLYCEMIC intake (9,264–270); recent or expected higher in fat may improve glycemia, MEDICATIONS (INCLUDING physical activity; and glucose data. In- triglycerides, and HDL-C; empha- INSULIN) tensive insulin management education sizing foods higher in unsaturated programs that include nutrition therapy Consensus recommendations fat instead of saturated fat may have been shown to improve A1C c All RDNs providing MNT in diabetes additionally improve LDL-C. (9,264,268,271–273) and quality of life care should assess and monitor c People with diabetes and prediabe- (9,274). For people using fixed daily in- medication changes in relation to tes are encouraged to consume less sulin doses, carbohydrate intake on a the nutrition care plan. than 2,300 mg/day of sodium, the day-to-day basis should be consistent care.diabetesjournals.org Evert and Associates 13

events in studies that reduced saturated in monounsaturated fat showed signif- sameamountthatisrecommended fat intake from about 17% to about 9% of icant reductions in fasting glucose, tri- for the general population. energy, but reductions in stroke, cardio- glycerides, body weight, and systolic blood c The recommendation for the gen- vascular mortality, or overall mortality pressure along with significant increases in eral public to eat a serving of fish were not found. Subgrouping of the HDL-C. The systematic review and meta- (particularly fatty fish) at least two studies suggested that benefit occurred analysis also reviewed four studies with a times per week is also appropriate by replacing saturated fat with polyun- total of 44 participants comparing eating for people with diabetes. saturated fat but not with carbohydrate plans high in monounsaturated fat with or protein (296). In a systematic review of those high in polyunsaturated fat. The Does comprehensive diabetes observational studies, saturated fats eating plans high in monounsaturated fat nutrition therapy support were not associated with all-cause mor- led to a significant reduction in fasting cardiovascular risk factor reduction? tality, CVD, CHD, ischemic stroke, or plasma glucose (63). Nutrition therapy that includes the de- type 2 diabetes, but limitations common velopment of an eating plan designed to Polyunsaturated Fats to observational studies were noted optimize blood glucose trends, blood As is recommended for the general (297). Further, in a more recent large, pressure, and lipid profiles is important public, an increase in foods containing prospective study including 7% of par- in the management of diabetes and can the long-chain omega-3 fatty acids EPA ticipants with self-reported diabetes, lowerthe riskofCVD, CHD,andstroke (9). and docosahexaenoic acid (DHA), such higher intake of saturated fat was asso- Findings from clinical trials support the as are found in fatty fish, is recommen- ciated with lower risk of total mortality role of nutrition therapy for achieving ded for individuals with diabetes be- (hazard ratio 0.86 [0.76–0.99], P for glycemic targets and decreasing various cause of their beneficial effects on trend = 0.0088) (298). In the PREDIMED markers of cardiovascular and hyper- lipoproteins, prevention of heart dis- study, which included close to 50% of tension risk (9,24,291–293). ease, and associations with positive people with diabetes, intakes of mono- health outcomes in observational stud- unsaturated and polyunsaturated fats ies (302,303). For people following a were associated with a lower risk of What are considerations for fat intake vegetarian or vegan eating pattern, CVD and death, whereas intakes of sat- for people who are at risk for or have omega-3 a-linoleic acid (ALA) found urated fat and trans fat were associated CVD and diabetes? in plant foods such as flax, walnuts, with a higher risk of CVD. The replace- Total Fat and soy are reasonable replacements ment of saturated fat with monounsat- There has been increasing research for foods high in saturated fat and may urated or polyunsaturated fat in food or examining the effects of high-fat, provide some CVD benefits, though the replacement of trans fat with monoun- low-carbohydrate eating patterns on car- evidence is inconclusive. saturated fat in food was inversely as- diometabolic risk factors, with two sys- Evidence does not conclusively sup- fi sociated with CVD (299). tematic reviews showing bene ts of port recommending omega-3 (EPA and In general, replacing saturated fat with low-carbohydrateeatingplanscompared DHA) supplements for all people with with low-fat eating plans on glycemic and unsaturated fats, especially polyunsatu- rated fat, significantly reduces both total diabetes for the prevention or treatment CVD risk parameters in the treatment of of cardiovascular events. In the most type 2 diabetes (see the section LOW- cholesterol and LDL-C, and replacement with monounsaturated fat from plant recent ASCEND (A Study of Cardiovascu- CARBOHYDRATE OR VERY LOW-CARBOHYDRATE EATING lar Events iN Diabetes) trial, when com- PATTERNS) (106,111). sources, such as olive oil and nuts, re- duces CVD risk. Replacing saturated fat pared with placebo, supplementation of Saturated Fat with carbohydrate also reduces total omega-3 fatty acids at the dose of 1 g/day fi The 2015–2020 DGA recommend con- cholesterol and LDL-C, but significantly did not lead to cardiovascular bene tin suming less than 10% of calories from increases triglycerides and reduces peoplewithdiabeteswithoutevidence of – saturated fat by replacing it with mono- HDL-C (299,300). CVD (68a, 304 305). Omega-3 fatty acid unsaturated and polyunsaturated fatty supplements have not reduced CVD acids (8). The scientific rationale for de- Monounsaturated Fats events or mortality in randomized trials creasing saturated fat in the diet is based A recent meta-analysis of nine RCTs but may have utility in people who re- on the effect of saturated fat in raising showed that, compared with control, quire triglyceride reduction (304,306). LDL-C, a contributing factor in athero- the Mediterranean-style eating pattern, The Vitamin D and Omega-3 Trial (VITAL), sclerosis (294). which is high in monounsaturated fats in which 13% of the participants had In a Presidential Advisory ondietary fat from plant sources such as olive oil and type 2 diabetes, supplementation with and CVD, the American Heart Association nuts, improved outcomes of glycemia, 1 g of omega-3 fatty acids did not result concluded that lowering intake of satu- body weight, and cardiovascular risk in a lower incidence of major cardiovas- rated fat and replacing it with unsatu- factors in participants with type 2 di- cular events (305). However, in the Re- rated fats, especially polyunsaturated abetes (301). A systematic review and duction of Cardiovascular Events With fats, will lower the incidence of CVD meta-analysis of 24 studies and including Icosapent Ethyl–Intervention Trial (295). A meta-analysis of randomized 1,460 participants compared the effect (REDUCE-IT), in which 57% of 823 partic- trials not focused on people with diabe- of eating plans high in monounsaturated ipants had diabetes, 2 g of prescrip- tes showed a 17% reduction (hazard ratio fat with that of eating plans high in tion icosapent ethyl twice daily (total 0.83 [95% CI 0.72–0.96]) in risk of CVD carbohydrates. The eating plans high daily dose, 4 g) significantly reduced 14 Consensus Report Diabetes Care

cardiovascular events by 25% when com- imbalances; and addressing the precip- the amount of dietary protein be- pared with placebo (68a). itating cause(s) with appropriate drug low the recommended daily allow- therapy (227). Correcting hyperglycemia Trans Fat ance (0.8 g/kg body weight/day) is one strategy for the management of A meta-analysis of seven RCTs showed that does not meaningfully alter glyce- gastroparesis, as acute hyperglycemia increased trans fat intake did not result in mic measures, cardiovascular risk delays gastric emptying (325,326). Mod- changes in glucose, insulin, or triglyceride measures, or the course of glomer- ification of food and beverage intake is concentrations but led to an increase in ular filtration rate decline and may the primary management strategy, es- total and LDL-C and a decrease in HDL-C increase risk for malnutrition. concentrations (307). Trans fats also have pecially among individuals with mild been associated with all-cause mortality, symptoms. Are protein needs different for people fi total CHD, and CHD mortality (297). People with gastroparesis may nd it with diabetes and kidney disease? helpful to eat small, frequent meals. Historically, low-protein eating plans Replacing solid food with a greater pro- Can lowering sodium intake reduce were advised to reduce albuminuria portion of liquid calories to meet indi- blood pressure and other and progression of chronic kidney dis- vidualized nutrition requirements may cardiovascular risk factors in people ease in people with DKD, typically with be helpful because consuming solid with diabetes? improvements in albuminuria but no Many health groups acknowledge the food in large volumes is associated clear effect on estimated glomerular with longer gastric emptying times current average intake of sodium, which filtration rate. In addition, there is . (327,328). Large meals can also decrease is 3,500 mg daily (308), should be some indication that a low-protein eating reduced (8,309–312) to prevent and the lower esophageal sphincter pressure, plan may lead to malnutrition in individ- which may cause gastric reflux, providing manage hypertension. While reducing – uals with DKD (317 321). The average further aggravation (327). sodium to the general recommendation daily level of protein intake for people of ,2,300 mg/day demonstrates bene- Results from an RCT demonstrated eat- with diabetes without kidney disease is ing plans that emphasize small-particle- ficial effects on blood pressure (118), – typically 1 1.5 g/kg body weight/day or size (,2 mm) foods may reduce further reduction warrants caution. 15–20% of total calories (45,146). Evi- Some studies measuring urine sodium severity of gastrointestinal symptoms dence does not suggest that people with fi excretion in people with type 1 (313) and (329). Small-particle-size food is de ned DKD need to restrict protein intake to “ type 2 (314) diabetes have shown in- as food easy to mash with a fork into less than the average protein intake. small particle size.” High-fiber foods, creased mortality associated with the For people with DKD and macroalbu- lowest sodium intakes. A secondary anal- such as whole intact grains and foods minuria, changing to a more soy-based with seeds, husks, stringy fibers, and ysis of data from the Ongoing Telmisartan source of protein may improve CVD risk Alone and in Combination With Ramipril membranes, should be excluded from factors but does not appear to alter the eating plan. Many of the foods Global Endpoint Trial (ONTARGET) sug- proteinuria (322,323). gests sodium excretions ,3 g/day and typically recommended for people with .7 g/day were both associated with diabetes, such as leafy green salads, raw increased mortality in people with Gastroparesis vegetables, beans, and fresh fruits, and other food like fatty or tough meat, can type 2 diabetes (315), leading to contin- Consensus recommendations be some of the most difficult foods for ued controversy over the potential ben- c Selection of small-particle-size foods efits versus harms of lowering sodium the gastroparetic stomach to grind and may improve symptoms of diabetes- empty (324,329). Notably, the majority intake below the general recommenda- related gastroparesis. fi of nutrition therapy interventions for tion. In the absence of clear scienti c c Correcting hyperglycemia is one fi gastroparesis are based on the knowl- evidence for bene tinpeoplewith strategy for the management of combined diabetes and hypertension edge of the pathophysiology and clin- gastroparesis, as acute hyperglyce- ical judgment rather than empirical (313,314), sodium intake goals that mia delays gastric emptying. fi research (227). are signi cantly lower than 2,300 mg/day c Use of CGM and/or insulin pump should be considered only on an indi- The use of an insulin pump is another therapy may aid the dosing and option for individuals with type 1 di- vidual basis. When individualizing so- timing of insulin administration in dium intake recommendations, careful abetes and insulin-requiring type 2 di- people with type 1 or type 2 di- abetes with gastroparesis (330). A small consideration must be given to issues abetes with gastroparesis. such as food preference, palatability, but positive 12-month trial reported a availability, and additional cost of fresh 1.8% reduction in A1C and decreased or specialty low-sodium products (316). How is diabetic gastroparesis best hospitalizations with insulin pump use managed? (331). An insulin pump can be used to Consultation by an RDN knowledgeable provide consistent basal insulin infusion, Diabetic Kidney Disease in the management of gastroparesis is as well as the ability to modify mealtime Consensus recommendation helpful in setting and maintaining treat- insulin delivery doses as needed. The ment goals (324). Treatment goals in- variable bolus feature allows the user c In individuals with diabetes and clude managing and reducing symptoms; to administer a portion of the meal bolus non–dialysis-dependent diabetic correcting fluid, electrolyte, and nu- in an extended fashion over a longer kidney disease (DKD), reducing tritional deficiencies and glycemic period of time (227). Use of this feature care.diabetesjournals.org Evert and Associates 15

may help to decrease the risk of post- risk for diabetes, prediabetes, or insulin Evaluating nutrition evidence is com- prandial hyperglycemia as well as hypo- resistance have lower risk when they plex given that multiple dietary factors glycemia. reduce calorie, carbohydrate, or satu- influence glycemic management and rated fat intake and/or increase fiber CVD risk factors, and the influence How is the risk of malnutrition in or protein intake compared with their of a combination of factors can be sub- – diabetic gastroparesis managed? peers (333 337). stantial. Based on a review of the evi- When an individual with gastroparesis dence, it is clear that knowledge gaps falls below target weight, nutrition sup- continue to exist and further research on port in the form of oral (for acute exac- CONCLUSIONS nutrition and eating patterns is needed erbation of symptoms), enteral, or Ideally, an eating plan should be developed in individuals with type 1 diabetes, type 2 parenteral nutrition should be consid- in collaboration with the person with pre- diabetes, and prediabetes. Future stud- ered (327). A 5% unintentional loss of diabetes or diabetes and an RDN through ies should address usual body weight over 3 months or 10% participation in diabetes self-management loss over 6 months is indicative of se- education when the diagnosis of pre- c the impact of different eating pat- vere malnutrition. Other nutritional risk diabetes or diabetes is made. Nutrition terns compared with one another, parameters include weight ,80% of therapy recommendations need to be controlling for supplementary advice ideal weight, BMI ,20 kg/m2,ora adjusted regularly based on changes in (such as stress reduction, physical loss of 5 lb or 2.5% of baseline weight an individual’s life circumstances, prefer- activity, or smoking cessation); in 1 month. ences, and disease course (1). Regular c the impact of weight loss on other follow-up with a diabetes health care outcomes (which eating plans are provider is also critical to adjust other beneficial only with weight loss, which PERSONALIZED NUTRITION aspectsofthetreatmentplanasindicated. can show benefit regardless of weight Consensus recommendation One of the most commonly asked loss); c how cultural or personal preferences, c Studies using personalized nutri- questions upon receiving a diagnosis “ ” psychological supports, co-occurring tion approaches to examine of diabetes is What can I eat? Despite conditions, socioeconomic status, food genetic, metabolomic, and micro- widespread interest in evidence-based insecurity, and other factors impact biome variations have not yet diabetes nutrition therapy interventions, being consistent with an eating plan identified specific factors that con- large, well-conducted nutrition trials and its effectiveness; sistently improve outcomes in continue to lag far behind other areas c the need for increased length and size type 1 diabetes, type 2 diabetes, or of diabetes research. Unfortunately, na- of studies, to better understand long- prediabetes. tional data indicate that most people with diabetes do not receive any nutri- term impacts on clinically relevant tion therapy or formal diabetes educa- outcomes; Do genetic, metabolomic, or tion (4,9,16,20). c tailoring MNT and DSMES to different microbiome variants, or other types of Strategies to improve access, clinical racial/ethnic groups and socioeco- personalized nutrition prescriptions, outcomes, and cost effectiveness include nomic groups; influence glycemic or other diabetes- the following c comparisons of different delivery related outcomes? methods aided by technology (e.g., Currently, use of nutrition counseling c reducing barriers to referrals and al- mobile technology, apps, social me- approaches aimed at personalizing guid- lowing self-referrals to MNT and dia, technology-enabled and internet- ancebased ongenetic, metabolomic, and DSMES; based tools); and microbiome information is an area of c providing in-person or technology- c ongoing cost-effectiveness studies intense research. Testing has become enabled diabetes nutrition therapy that will further support coverage available commercially, with direct-to- and education integrated with medical by third-party payers or bundling consumer advertising. Some intriguing management (9,12,13,15,16,19,22, services into evolving value-based research has shown, for example, the 291–293,338–342); care and payment models. wide interpersonal variability in blood c engineering solutions that include glucose response to standardized meals two-way communication between that could be predicted by clinical and the individual and his or her health microbiome profiles (332). At this point, care team to provide individualized however, no clear conclusions can be feedback and tailored education based Acknowledgments. The authors acknowledge drawn regarding their utility owing to on the analyzed patient-generated Mindy Saraco (Managing Director, Medical Af- wide variations in the markers used for health data (38,264,343); fairs, ADA) for her help with the development of the Consensus Report. The authors thank predicting outcomes, in the populations c increasing the use of community Margaret Powers for providing her expertise and nutrients studied, and in the asso- health workers and peer coaches to in reviewing and/or consulting with the authors, ciations found. provide culturally appropriate, ongo- Melinda Maryniuk for serving as a liaison to the Further, overall findings tend to sup- ing support and clinically linked care ADA Professional Practice Committee (PPC), and the PPC for providing valuable review and feed- port evidence from existing clinical trials coordination and improve the reach back. The authors acknowledge the invited peer and observational studies showing that of MNT and DSMES (15,19,23,38, reviewers who provided comments on an earlier people with markers indicating higher 343,344). draft of this report: Kelli Begay (Indian Health 16 Consensus Report Diabetes Care

Service, Rockville, MD), Guoxun Chen (University 5. American Diabetes Association. 13. Children therapy compared with dietary advice in patients of Tennessee, Knoxville, TN), Frank Hu (Harvard and adolescents: Standards of Medical Care in with type 2 diabetes. Am J Clin Nutr 2017;106: T.H. Chan School of Public Health, Boston, MA), Diabetesd2019.DiabetesCare2019;42(Suppl.1): 1394–1400 Melinda Maryniuk (Maryniuk & Associates Di- S148–S164 19. Ferguson S, Swan M, Smaldone A. Does abetes and Nutrition Consultants, Jamaica Plain, 6. American Diabetes Association. 14. Manage- diabetes self-management education in conjunc- MA), Margaret Powers (HealthPartners Institute, ment of diabetes in pregnancy: Standards of tion with primary care improve glycemic control Minneapolis, MN), Judith Wylie-Rosett (Albert Medical Care in Diabetesd2019. Diabetes Care in Hispanic patients? A systematic review and Einstein College of Medicine, Bronx, NY), Alyce 2019;42(Suppl. 1):S165–S172 meta-analysis. Diabetes Educ 2015;41:472–484 Thomas (St. Joseph’s Health, Paterson, NJ), Emily 7. Institute of Medicine. The Role of Nutrition in 20. Lynch EB, Liebman R, Ventrelle J, Avery EF, Weatherup (Michigan Medicine, University of Maintaining Health in the Nation’s Elderly: Eval- Richardson D. A self-management intervention Michigan, Ann Arbor, MI), and Gretchen Youssef uating Coverage of Nutrition Services for the for African Americans with comorbid diabetes (MedStar Health, Washington, DC). Medicare Population [Internet], 1999. Available and hypertension: a pilot randomized controlled Duality of Interest. The authors disclosed all from https://www.nap.edu/catalog/9741/the- trial. Prev Chronic Dis 2014;11:130349 potential financial conflicts of interest with role-of-nutrition-in-maintaining-health-in-the- 21. Beck J, Greenwood DA, Blanton L, et al.; 2017 industry. These disclosures were discussed at nations-elderly. Accessed 2 October 2018 Standards Revision Task Force. 2017 National the onset of the consensus statement devel- 8. U.S. Department of Health and Human Ser- Standards for Diabetes Self-Management Edu- opment process. The ADA uses general rev- vice; U.S. Department of Agriculture. 2015–2020 cation and Support. Diabetes Care 2017;40: enues to fund development of its consensus Dietary Guidelines for Americans, 8th edition 1409–1419 reports and does not rely on industry support [Internet], 2015. Available from https://health. 22. Chrvala CA, Sherr D, Lipman RD. Diabetes for these purposes. A.B.E. reports honorarium gov/dietaryguidelines/2015/guidelines/. Ac- self-management education for adults with from the Academy of Nutrition and Dietetics cessed 18 January 2019 type 2 diabetes mellitus: a systematic review and the ADA outside of the submitted work. 9. Franz MJ, MacLeod J, Evert A, et al. Academy of the effect on glycemic control. Patient Educ W.T.G. reports personal fees from Novo Nor- of Nutrition and Dietetics Nutrition practice Couns 2016;99:926–943 disk, Merck, Amgen, Gilead, BOYDSense, the guideline for type 1 and type 2 diabetes in adults: 23. Ku GMV, Kegels G. Effects of the First Line American Medical Group Association, and Jans- systematic review of evidence for medical nu- Diabetes Care (FiLDCare) self-management ed- sen and grants from Sanofi,Pfizer, Merck, and trition therapy effectiveness and recommenda- ucation and support project on knowledge, Novo Nordisk outside of the submitted work. tions for integration into the nutrition care attitudes, perceptions, self-management practi- K.H.K.L. reports personal fees from Sunstar process. J Acad Nutr Diet 2017;117:1659–1679 ces and glycaemic control: a quasi-experimental Foundation outside of the submitted work. 10. Lacey K, Pritchett E. Nutrition Care Process study conducted in the Northern Philippines. J.Mi. reports speaking fees from New England and Model: ADA adopts road map to quality care BMJ Open 2014;4:e005317 Dairy and Dairy Farmer, research support and and outcomes management. J Am Diet Assoc 24. Sun Y, You W, Almeida F, Estabrooks P, Davy consulting/speaking fees from the National Dairy 2003;103:1061–1072 B. The effectiveness and cost of lifestyle inter- Council, and research support from Kowa Com- 11. LegalInformationInstitute.42CFR§410.132– ventions including nutrition education for di- pany and the National Institutes of Health out- Medical nutrition therapy [Internet]. Available abetes prevention: a systematic review and side of the submitted work. K.R. was previously from https://www.law.cornell.edu/cfr/text/42/ meta-analysis. J Acad Nutr Diet 2017;117:404– employed by the ADA. L.S. reports grants from 410.132. Accessed 2 October 2018 421.e36 the National Institutes of Health and internal 12. Davidson P, Ross T, Castor C. Academy 25. Academy of Nutrition and Dietetics Evidence University of Michigan grants. W.S.Y. reports a con- of Nutrition and Dietetics: Revised 2017 Stand- Analysis Library. MNT: cost effectiveness, cost- sulting relationship with dietdoctor.com, which ards of Practice and Standards of Professional benefit, or economic savings of MNT (2009) began after the Consensus Report was sub- Performance for Registered Dietitian Nutrition- [Internet]. Available from https://www.andeal. mitted to Diabetes Care. No other potential ists (Competent, Proficient, and Expert) in Di- org/topic.cfm?cat=4085&conclusion_statement_ fl con icts of interest relevant to this article abetes Care. J Acad Nutr Diet 2018;118:932–946. id=251001. Accessed 2 October 2018 were reported. e48 26. Knowler WC, Barrett-Connor E, Fowler SE, Author Contributions. All authors were re- 13. Andrews RC, Cooper AR, Montgomery AA, et al.; Diabetes Prevention Program Research sponsible for drafting the Consensus Report and et al. 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