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Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report Diabetes Care 2019;42:731754 | https://doi.org/10.2337/dci19-0014 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 efcacy 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 benets 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 recommended for all adults with diabetes and prediabetes. Though it might simplify messaging, a one-size-ts-alleating plan is not evident for the prevention or management of diabetes, and it is an unrealistic expectation given the broad spectrum of people affected by diabetes and prediabetes, their cultural backgrounds, personal preferences, co-occurring conditions (often referred to as comorbidities), and socioeconomic settings in which they live. Research provides clarity on many food choices and eating patterns that can help people achieve health goals and quality of life. The American Diabetes Association (ADA) emphasizes that medical nutrition therapy (MNT) is fundamental in the overall diabetes management plan, and the need for MNT should be reassessed frequently by health care providers in collaboration with people with diabetes across the life span, with special attention during times of changing health status and life stages (13). This Consensus Report now includes information on prediabetes, and previous ADA nutrition position statements, the last of which was published in 2014 (4), did not. Unless otherwise noted, the research reviewed was limited to those studies conducted in adults diagnosed with prediabetes, type 1 diabetes, and/or type 2 diabetes. Nutrition therapy for children with diabetes or women with gestational diabetes mellitus is not addressed in this review but is covered in other ADA publications, specically Standards of Medical Care in Diabetes (5,6). DATA SOURCES, SEARCHES, AND STUDY SELECTION The authors of this report were chosen following a national call for experts to ensure diversity of the members both in professional interest and cultural background, including a person living with diabetes who served as a patient advocate. An outside market research company was used to conduct the literature search and was paid using ADA funds. The authors convened in person for one group meeting and actively participated in monthly teleconference calls between February and November 2018. Focused teleconference calls, email, and web-based collaboration were also used to reach consensus on nal recommendations between November 2018 and January 2019. The 2014 position statement (4) was used as a starting point, and a search was conducted on PubMed for studies published in English between 1 January 2014 and 28 February 2018 to provide the updated evidence of nutrition therapy interventions in nonhospitalized adults with prediabetes and type 1 and type 2 diabetes. Details on the keywords and the search strategy are reported in the Supplementary Data, emphasizing randomized controlled trials (RCTs), systematic reviews, and meta- analyses of RCTs. An exception was made to the inclusion criteria for the use of meal studies for the insulin dosing section. In addition to the search results, in select cases the authors identied relevant research to include in reaching consensus. The 1 UW Neighborhood Clinics, UW Medicine, Uni- versity of Washington, Seattle, WA 2 Oklahoma City Indian Clinic, Oklahoma City, OK 3 Stanford Diabetes Research Center and Stanford Prevention Research Center, Department of Med- icine, Stanford University, Stanford, CA 4 Diabetes Research Center, Department of Nu- trition Sciences, University of Alabama at Bir- mingham, Birmingham, AL 5 Birmingham Veterans Affairs Medical Center, Birmingham, AL 6 Joslin Diabetes Center, Boston, MA 7 Companion Medical, Inc., Columbia, MD 8 Section on Clinical, Behavioral and Outcomes Research Lipid Clinic, Adult Diabetes Section, Joslin Diabetes Center, Harvard Medical School, Boston, MA 9 Simple Concepts Consulting, Bellevue, WA 10 Vida Health, San Francisco, CA 11 American Diabetes Association, Arlington, VA 12 Department of Health Behavior and Biological Sciences, University of Michigan School of Nurs- ing, Ann Arbor, MI 13 St. Lukes Health Care System, Duluth, MN 14 Duke Diet and Fitness Center, Department of Medicine, Duke University Health System, Dur- ham, NC 15 Durham Veterans Affairs Medical Center, Dur- ham, NC Corresponding author: William S. Yancy Jr., [email protected] This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/ doi:10.2337/dci19-0014/-/DC1. This article is part of a special article collection available at http://care.diabetesjournals. org/evolution-nutritional-therapy. This article is featured in a podcast available at http://www.diabetesjournals.org/content/diabetes- core-update-podcasts. © 2019 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for prot, and the work is not altered. More infor- mation is available at http://www.diabetesjournals .org/content/license. Alison B. Evert, 1 Michelle Dennison, 2 Christopher D. Gardner, 3 W. Timothy Garvey, 4,5 Ka Hei Karen Lau, 6 Janice MacLeod, 7 Joanna Mitri, 8 Raquel F. Pereira, 9 Kelly Rawlings, 10 Shamera Robinson, 11 Laura Saslow, 12 Sacha Uelmen, 11 Patricia B. Urbanski, 13 and William S. Yancy Jr. 14,15 Diabetes Care Volume 42, May 2019 731 EVOLUTION OF NUTRITIONAL THERAPY

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Nutrition Therapy for AdultsWithDiabetes or Prediabetes:A Consensus ReportDiabetes Care 2019;42:731–754 | https://doi.org/10.2337/dci19-0014

This Consensus Report is intended to provide clinical professionals with evidence-based guidance about individualizing nutrition therapy for adults with diabetes orprediabetes. Strong evidence supports the efficacy and cost-effectiveness of nutritiontherapy as a component of quality diabetes care, including its integration into themedical management of diabetes; therefore, it is important that all members of thehealth care team know and champion the benefits of nutrition therapy and keynutritionmessages. Nutrition counseling thatworks toward improving ormaintainingglycemic targets, achieving weight management goals, and improving cardiovascularrisk factors (e.g., blood pressure, lipids, etc.) within individualized treatment goals isrecommended for all adults with diabetes and prediabetes.Though it might simplify messaging, a “one-size-fits-all” eating plan is not evident

for the prevention or management of diabetes, and it is an unrealistic expectationgiven the broad spectrum of people affected by diabetes and prediabetes, theircultural backgrounds, personal preferences, co-occurring conditions (often referredto as comorbidities), and socioeconomic settings inwhich they live. Researchprovidesclarity on many food choices and eating patterns that can help people achieve healthgoals and quality of life. The American Diabetes Association (ADA) emphasizes thatmedical nutrition therapy (MNT) is fundamental in the overall diabetes managementplan, and the need for MNT should be reassessed frequently by health care providersin collaboration with people with diabetes across the life span, with special attentionduring times of changing health status and life stages (1–3).This Consensus Report now includes information on prediabetes, and previous

ADA nutrition position statements, the last of which was published in 2014 (4), didnot. Unless otherwise noted, the research reviewed was limited to those studiesconducted in adults diagnosed with prediabetes, type 1 diabetes, and/or type 2diabetes. Nutrition therapy for children with diabetes or women with gestationaldiabetes mellitus is not addressed in this review but is covered in other ADApublications, specifically Standards of Medical Care in Diabetes (5,6).

DATA SOURCES, SEARCHES, AND STUDY SELECTION

The authors of this report were chosen following a national call for experts to ensurediversity of the members both in professional interest and cultural background,including a person living with diabetes who served as a patient advocate. An outsidemarket research company was used to conduct the literature search and was paidusing ADA funds. The authors convened in person for one groupmeeting and activelyparticipated in monthly teleconference calls between February and November 2018.Focused teleconference calls, email, and web-based collaboration were also used toreach consensus on final recommendations between November 2018 and January2019. The 2014 position statement (4) was used as a starting point, and a search wasconducted on PubMed for studies published in English between 1 January 2014 and28 February 2018 to provide the updated evidence of nutrition therapy interventionsin nonhospitalized adults with prediabetes and type 1 and type 2 diabetes. Details onthe keywords and the search strategy are reported in the Supplementary Data,emphasizing randomized controlled trials (RCTs), systematic reviews, and meta-analyses of RCTs. An exception was made to the inclusion criteria for the use of mealstudies for the insulin dosing section. In addition to the search results, in select casesthe authors identified relevant research to include in reaching consensus. The

1UW Neighborhood Clinics, UW Medicine, Uni-versity of Washington, Seattle, WA2Oklahoma City Indian Clinic, Oklahoma City, OK3StanfordDiabetesResearchCenter andStanfordPreventionResearchCenter,DepartmentofMed-icine, Stanford University, Stanford, CA4Diabetes Research Center, Department of Nu-trition Sciences, University of Alabama at Bir-mingham, Birmingham, AL5Birmingham Veterans Affairs Medical Center,Birmingham, AL6Joslin Diabetes Center, Boston, MA7Companion Medical, Inc., Columbia, MD8Section on Clinical, Behavioral and OutcomesResearch Lipid Clinic, Adult Diabetes Section,Joslin Diabetes Center, Harvard Medical School,Boston, MA9Simple Concepts Consulting, Bellevue, WA10Vida Health, San Francisco, CA11American Diabetes Association, Arlington, VA12Department of Health Behavior and BiologicalSciences, University of Michigan School of Nurs-ing, Ann Arbor, MI13St. Luke’s Health Care System, Duluth, MN14Duke Diet and Fitness Center, Department ofMedicine, Duke University Health System, Dur-ham, NC15Durham Veterans Affairs Medical Center, Dur-ham, NC

Corresponding author: William S. Yancy Jr.,[email protected]

This article contains Supplementary Data onlineat http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dci19-0014/-/DC1.

This article is part of a special article collectionavailable at http://care.diabetesjournals.org/evolution-nutritional-therapy.

This article is featured in a podcast available athttp://www.diabetesjournals.org/content/diabetes-core-update-podcasts.

© 2019 by the American Diabetes Association.Readers may use this article as long as the workis properly cited, the use is educational and notfor profit, and the work is not altered. More infor-mation is available at http://www.diabetesjournals.org/content/license.

Alison B. Evert,1 Michelle Dennison,2

Christopher D. Gardner,3

W. Timothy Garvey,4,5 Ka Hei Karen Lau,6

Janice MacLeod,7 Joanna Mitri,8

Raquel F. Pereira,9 Kelly Rawlings,10

Shamera Robinson,11 Laura Saslow,12

SachaUelmen,11 Patricia B.Urbanski,13 and

William S. Yancy Jr.14,15

Diabetes Care Volume 42, May 2019 731

EVOLU

TIONOFNUTR

ITIONALTH

ERAPY

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consensus reportwas peer reviewed (seeACKNOWLEDGMENTS) and suggestions incor-porated as deemed appropriate by theauthors. Though evidence-based, therecommendations presented are the in-formed,expertopinionsof theauthorsafterconsensus was reached through presen-tation and discussion of the evidence.

EFFECTIVENESS OF DIABETESNUTRITION THERAPY

Consensus recommendations

c Refer adults living with type 1 ortype 2 diabetes to individualized,diabetes-focusedMNT at diagnosisand as needed throughout the lifespan and during times of changinghealth status to achieve treatmentgoals. Coordinate and align theMNT planwith the overall manage-ment strategy, including use ofmedications, physical activity, etc.,on an ongoing basis.

c Refer adults with diabetes tocomprehensive diabetes self-management education and sup-port (DSMES) services according tonational standards.

c Diabetes-focusedMNTisprovidedbya registered dietitian nutritionist/registered dietitian (RDN), prefera-bly one who has comprehensiveknowledge and experience in di-abetes care.

c Refer people with prediabetes andoverweight/obesity to an intensivelifestyle intervention program thatincludes individualized goal-settingcomponents, such as the DiabetesPrevention Program (DPP) and/orto individualized MNT.

c Diabetes MNT is a covered Medi-care benefit and should be ade-quately reimbursed by insuranceand other payers or bundled inevolving value-based care and pay-ment models.

c DPP-modeled intensive lifestyleinterventions and individualizedMNT for prediabetes should becovered by third-party payers orbundled in evolving value-basedcare and payment models.

How is diabetes nutrition therapydefined and provided?The National Academy of Medicine(formerly the Institute of Medicine)broadly defines nutrition therapy as the

treatment of a disease or conditionthrough the modification of nutrient orwhole-food intake (7). To complementdiabetes nutrition therapy, members ofthe health care team can and shouldprovide evidence-based guidance thatallows people with diabetes to makehealthy food choices that meet their in-dividual needs and optimize their overallhealth. The Dietary Guidelines for Amer-icans (DGA)2015–2020provide a basis forhealthy eating for all Americans and rec-ommend that people consume a healthyeating pattern that accounts for all foodsand beverages within an appropriate cal-orie level (8). For people with diabetes,recommendations that differ from theDGA are highlighted in this report.

MNT is an evidence-based applicationof the nutrition care process provided byan RDN and is the legal definition ofnutritioncounselingbyanRDN in theU.S.(9–12). Essential components of MNTare assessment, nutrition diagnosis, in-terventions (e.g., education and coun-seling), and monitoring with ongoingfollow-up to support long-term lifestylechanges, evaluate outcomes, andmodifyinterventions as needed (9,10). The goalsof nutrition therapy are described inTable 1.

The unique academic preparation,training, skills, and expertise make theRDN the preferredmember of the healthcare team to provide diabetes MNT andleadership in interprofessional team-basednutrition and diabetes care (1,9,13–18).Although certification (such as CertifiedDiabetes Educator, Board Certified-Advanced Diabetes Management) isnot required, ideally the RDN will havecomprehensive knowledge and experi-ence in diabetes care and prevention(9,17). Detailed guidance for the RDN

to obtain the expert knowledge and ex-perience can be found in the Academy ofNutrition and Dietetics Standards of Prac-tice and Standards of Professional Perfor-mance (12). Health care professionals canuse the education algorithm suggestedby ADA, the American Association of Dia-betes Educators, and the Academy of Nu-trition and Dietetics (1) that defines anddescribes the four critical times to as-sess, provide, and adjust care. Thealgorithm is intended for use by theRDN and the interprofessional team fordetermining how and when to deliverdiabetes education and nutrition ser-vices. The number of encounters theperson with diabetes might have withthe RDN is described in Table 2 (9).

In addition to diabetesMNT, DSMES isimportant for people with diabetes toimprove cardiometabolic and microvas-cular outcomes in a disease that is largelyself-managed (1,19–23). DSMES includesthe ongoing process that facilitates theknowledge, skills, and abilities necessaryfor diabetes self-care throughout the lifespan, with nutrition as one of the corecurriculum topics taught in comprehen-sive programs (21).

Is MNT effective in improvingoutcomes?Reported hemoglobin A1c (A1C) reduc-tions from MNT can be similar to orgreater than what would be expectedwith treatment using currently availablemedication for type2diabetes (9). Strongevidence supports the effectiveness ofMNT interventions provided by RDNs forimproving A1C, with absolute decreasesup to 2.0% (in type 2 diabetes) and up to1.9% (in type 1 diabetes) at 3–6 months.Ongoing MNT support is helpful in main-taining glycemic improvements (9).

Table 1—Goals of nutrition therapyc To promote and support healthful eating patterns, emphasizing a variety of nutrient-densefoods in appropriate portion sizes, in order to improve overall health and specifically to:○ Improve A1C, blood pressure, and cholesterol levels (goals differ for individuals based onage, duration of diabetes, health history, and other present health conditions. Furtherrecommendations for individualization of goals can be found in the ADA Standards ofMedical Care in Diabetes [345])

○ Achieve and maintain body weight goals○ Delay or prevent complications of diabetes

c To address individual nutrition needs based on personal and cultural preferences, healthliteracy and numeracy, access to healthful food choices, willingness and ability to makebehavioral changes, as well as barriers to change

c To maintain the pleasure of eating by providing positive messages about food choices, whilelimiting food choices only when indicated by scientific evidence

c To provide the individual with diabetes with practical tools for day-to-day meal planning

732 Consensus Report Diabetes Care Volume 42, May 2019

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Cost-effectiveness of lifestyle inter-ventions and MNT for the preventionand management of diabetes has beendocumented in multiple studies (12,17,24,25). The National Academy of Med-icine recommends individualized MNT,provided by an RDN upon physician re-ferral, as part of the multidisciplinaryapproach to diabetes care (7). DiabetesMNT is a covered Medicare benefit andshould also be adequately reimbursed byinsurance and other payers, or bundled inevolving value-based care and paymentmodels, because it can result in improvedoutcomes such as reduced A1C and costsavings (12,17,25).

What nutrition therapy interventionsbest help people with prediabetesprevent or delay the development oftype 2 diabetes?The strongest evidence for type 2 di-abetes prevention comes from severalstudies, including the DPP (26–28). TheDPP demonstrated that an intensive life-style intervention resulting inweight losscould reduce the incidence of type 2diabetes for adults with overweight/obesity and impaired glucose toleranceby 58% over 3 years (26). Follow-up ofthree large studies of lifestyle interven-tion for diabetes prevention has shownsustained reduction in the rate of con-version to type2diabetes: 43% reductionat 20 years in the Da Qing DiabetesPrevention Study (29); 43% reductionat 7 years in the Finnish Diabetes Pre-vention Study (DPS) (30); and 34% re-duction at 10 years (28) and 27%reduction at 15 years extended follow-up of the DPP (31) in the U.S. DiabetesPrevention Program Outcomes Study(DPPOS). The follow-up of the Da Qingstudy also demonstrated a reductionin cardiovascular and all-cause mor-tality (32).Substantial evidence indicates that

individuals with prediabetes should bereferred to an intensive behavioral life-style intervention program modeled on

the DPP and/or to individualized MNTtypically provided by an RDN with thegoals of improving eating habits, in-creasing moderate-intensity physicalactivity to at least 150 min per week,and achieving and maintaining 7–10%loss of initial body weight if needed(14,17,33,34). More intensive interven-tion programs are the most effective indecreasing diabetes incidence and im-proving cardiovascular disease (CVD) riskfactors (35).

Both DPP-modeled intensive lifestyleinterventions and individualized MNTfor prediabetes have demonstrated cost-effectiveness (17,36) and therefore shouldbe covered by third-party payers or bun-dled in evolving value-based care andpayment models (25).

To make diabetes prevention pro-grams more accessible, digital healthtools are an area of increasing interestin the public and private sectors. Pre-liminary research studies support thatthe delivery of diabetes prevention life-style interventions through technology-enabled platforms and digital healthtools can result in weight loss, improvedglycemia, and reduced risk for diabetesand CVD, althoughmore rigorous studiesare needed (37–44).

MACRONUTRIENTS

Consensus recommendations

c Evidence suggests that there is notan ideal percentage of caloriesfrom carbohydrate, protein, andfat for all people with or at riskfor diabetes; therefore, macronu-trient distribution should be basedon individualized assessment ofcurrent eating patterns, preferen-ces, and metabolic goals.

c When counseling people with dia-betes, a key strategy to achieveglycemic targets should includean assessment of current dietaryintake followed by individualizedguidance on self-monitoring carbo-

hydrate intake to optimize mealtiming and food choices and toguide medication and physical ac-tivity recommendations.

c People with diabetes and those atrisk for diabetes are encouraged toconsume at least the amount ofdietary fiber recommended for thegeneral public; increasing fiber in-take, preferably through food (veg-etables, pulses [beans, peas, andlentils], fruits, and whole intact grains)or through dietary supplement, mayhelp in modestly lowering A1C.

Do macronutrient needs differ forpeople with diabetes compared withthe general population?Although numerous studies have at-tempted to identify the optimal mix ofmacronutrients for the eating plans ofpeople with diabetes, a systematic re-view (45) found that there is no ideal mixthat applies broadly and that macronu-trient proportions should be individual-ized. It has been observed that peoplewith diabetes, on average, eat about thesame proportions of macronutrients asthegeneral public:;45%of their caloriesfrom carbohydrate (see Table 3), ;36–40% of calories from fat, and the re-mainder (;16–18%) from protein(46–48). Regardless of themacronutrientmix, total energy intake should be ap-propriate to attain weight managementgoals. Further, individualization of themacronutrient composition will dependon the status of the individual, includingmetabolic goals (glycemia, lipid profile,etc.), physical activity, food preferences,and availability.

Do carbohydrate needs differ forpeople with diabetes compared withthe general population?Carbohydrate is a readily used source ofenergy and the primary dietary influenceon postprandial blood glucose (8,49).Foods containing carbohydratedwithvarious proportions of sugars, starches,and fiberdhave a wide range of effectson the glycemic response. Some result inan extended rise and slow fall of bloodglucose concentrations, while others re-sult in a rapid rise followed by a rapidfall (50). The quality of carbohydratefoods selecteddideally rich in dietaryfiber, vitamins, and minerals and lowin added sugars, fats, and sodiumdshould be addressed as part of an

Table 2—Academy of Nutrition and Dietetics evidence-based nutrition practiceguidelines–recommended structure for the implementation of MNT for adultswith diabetes (9)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 encountersare needed based on an individualized assessment.

MNT follow-up encounters: The RDN should implement a minimum of one annual MNTfollow-up encounter.

care.diabetesjournals.org Evert and Associates 733

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individualized eating plan that includesall components necessary for optimalnutrition (4,9).The amount of carbohydrate intake

required for optimal health in humans isunknown. Although the recommendeddietary allowance for carbohydrate foradults without diabetes (19 years andolder) is 130 g/day and is determined inpart by the brain’s requirement for glu-cose, this energy requirement can befulfilled by the body’s metabolic pro-cesses,which include glycogenolysis, glu-coneogenesis (via metabolism of theglycerol component of fat or gluconeo-genic amino acids in protein), and/orketogenesis in the setting of very lowdietary carbohydrate intake (49).

What are the dietary fiber needs ofpeople with diabetes?The regular intake of sufficient dietaryfiber is associated with lower all-causemortality inpeoplewithdiabetes (51,52).Therefore, people with diabetes shouldconsume at least the amount of fiberrecommended by the DGA 2015–2020(minimum of 14 g of fiber per 1,000 kcal)with at least half of grain consumptionbeing whole intact grains (8). Othersources of dietary fiber include non-starchy vegetables, avocados, fruits,and berries, as well as pulses such asbeans, peas, and lentils.A few studies have shown modest

A1C reduction (20.2% to 20.3%) (53,54) with intake in excess of 50 g of fiberper day. However, such very high intakeof fiber may cause flatulence, bloating,and diarrhea. Meeting the recommen-ded fiber intake through foods that arenaturally high in dietary fiber, as com-pared with supplementation, is encour-aged for the additional benefits ofcoexisting micronutrients and phyto-chemicals (55).

Does the use of glycemic index andglycemic load impact glycemia?The use of the glycemic index (GI) andglycemic load (GL) to rank carbohydratefoods according to their effects on gly-cemia continues to be of interest forpeople with diabetes and those at riskfor diabetes. As defined by Brand-Milleret al. (56), “the GI provides a goodsummary of postprandial glycemia. Itpredicts the peak (or near peak) re-sponse, the maximum glucose fluctua-tion, andother attributes of the response

curve.” Two systematic reviews of theliterature regarding GI and GL in individ-ualswith diabetes and at risk for diabetesreported no significant impact on A1Cand mixed results on fasting glucose(9,50). Further, studies haveused varyingdefinitions of low and high GI foods,leading to uncertainty in the utility ofGI and GL in clinical care (45).

What are the total protein needs ofpeople with diabetes?There is limited research in people withdiabetes or prediabetes without kidneydiseaseon the impactof various amountsof protein consumed. Some comparisonsof protein amounts have not demon-strated differences in diabetes-relatedoutcomes (57–60).A12-weekstudycom-paring 30% vs. 15% energy from proteinnoted improvements in weight, fastingglucose, and insulin requirements in thegroup that consumed 30% energy fromprotein (61). A meta-analysis from2013 of studies ranging from 4–24weeksin duration reported that high-proteineating plans (25–32% of total energyvs. 15–20%) resulted in 2 kg greaterweight loss and 0.5% greater improve-ment in A1C but no statistically signifi-cant improvements in fasting serumglucose, serum lipid profiles, or bloodpressure (62).

What are the dietary fat and cholesterolgoals for people with diabetes?The National Academy of Medicine hasdefined an acceptable macronutrientdistribution for total fat for all adultsto be 20–35% of total calorie intake (49).Eating patterns that replace certain car-bohydrate foods with those higher intotal fat, however, have demonstratedgreater improvements in glycemia andcertain CVD risk factors (serum HDL cho-lesterol [HDL-C] and triglycerides) com-pared with lower fat diets. The types orquality of fats in the eating plans mayinfluence CVD outcomes beyond the totalamount of fat (63). Foods containing syn-thetic sources of trans fats should be min-imized to the greatest extent possible (8).Ruminant trans fats, occurring naturallyin meat and dairy products, do not needto be eliminated because they are presentin such small quantities (64).

The body makes enough cholesterolfor physiological and structural functionssuch that people do not need to obtaincholesterol through foods. Although the

DGA concluded that available evidencedoesnot support the recommendation tolimit dietary cholesterol for the generalpopulation, exact recommendations fordietary cholesterol forotherpopulations,such as people with diabetes, are not asclear (8). Whereas cholesterol intake hascorrelated with serum cholesterol levels,it hasnot correlatedwellwithCVDevents(65,66).More research is needed regard-ing the relationship among dietary cho-lesterol, blood cholesterol, and CVDevents in people with diabetes.

What is the role of fat in the preventionof type 2 diabetes?Large epidemiologic studies have foundthat consumption of polyunsaturated fator biomarkers of polyunsaturated fattyacids are associated with lower risk oftype 2 diabetes (67). Supplementationwith omega-3 fatty acids in prediabeteshas demonstrated some efficacy in sur-rogate outcomes beyond serum triglyc-eride levels. In a single-blinded RCTdesign in Asia, 107 subjects with newlydiagnosed impaired glucose metabolismand coronary heart disease (CHD) sup-plemented with 1,800 mg/day of eico-sapentaenoic acid (EPA) experiencedimproved postprandial triglycerides, gly-cemia, insulin secretion ability, and en-dothelial function over a 6-month period(68). Further, in a recentmultisite RCT thatincluded57%ofparticipantswithdiabetes,age 50 years or older, andwith at least oneadditional CVD risk factor, plus elevatedfasting triglycerides and low HDL-C, bene-fitswere seen fromadding 2 gof icosapentethyl twice daily to statin therapy in termsof lower ratesofacompositeCVDoutcomeand CVD mortality, but there were alsoslightly higher rates of hospitalization foratrial fibrillation and serious bleeding (68a).

The intervention in the PREvencioncon DIeta MEDiterranea (PREDIMED)study, comparing a Mediterranean-styleeating pattern supplemented either withextra-virgin olive oil or with nuts versusa control diet, reduced incidence oftype 2 diabetes among people withoutdiabetes at high cardiovascular risk atbaseline (69). The Malmo Diet and Can-cer cohort study examined specific foodsources of saturated fat and found thatintake of saturated fat from dairy prod-ucts, coconut oil, and palm kernel oilwere associated with lower diabetes risk(70), whereas saturated fat intake wasassociated with higher risk of diabetes in

734 Consensus Report Diabetes Care Volume 42, May 2019

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Table 3—Eating patterns reviewed for this report

Type of eating pattern Description Potential benefits reported*

USDA Dietary Guidelines For Americans(DGA) (8)

Emphasizes a variety of vegetables from all of thesubgroups; fruits, especially whole fruits; grains, atleast half of which are whole intact grains; lower-fat dairy; a variety of protein foods; and oils. Thiseating pattern limits saturated fats and trans fats,added sugars, and sodium.

DGA added to the table forreference; not reviewed as partof this Consensus Report

Mediterranean-style (69,76,85–91) Emphasizes plant-based food (vegetables, beans,nuts and seeds, fruits, andwhole intact grains);fishand other seafood; olive oil as the principal sourceof dietary fat; dairy products (mainly yogurt andcheese) in low to moderate amounts; typicallyfewer than4eggs/week; redmeat in low frequencyand amounts; wine in low to moderate amounts;and concentrated sugars or honey rarely.

c Reduced risk of diabetesc A1C reductionc Lowered triglyceridesc Reduced risk of majorcardiovascular events

Vegetarian or vegan (77–80,92–99) The two most common approaches found in theliterature emphasize plant-based vegetarianeating devoid of all flesh foods but including egg(ovo) and/or dairy (lacto) products, or vegan eatingdevoid of all flesh foods and animal-derivedproducts.

c Reduced risk of diabetesc A1C reductionc Weight lossc Lowered LDL-C and non–HDL-C

Low-fat (26,45,80,83,100–106) Emphasizes vegetables, fruits, starches (e.g., breads/crackers, pasta, whole intact grains, starchyvegetables), lean protein sources (includingbeans), and low-fat dairy products. In this review,defined as total fat intake #30% of total caloriesand saturated fat intake #10%.

c Reduced risk of diabetesc Weight loss

Very low-fat (107–109) Emphasizesfiber-rich vegetables, beans, fruits,wholeintact grains, nonfat dairy, fish, and eggwhites andcomprises 70–77% carbohydrate (including 30–60 g fiber), 10% fat, 13–20% protein.

c Weight lossc Lowered blood pressure

Low-carbohydrate (110–112) Emphasizes vegetables low in carbohydrate (such assalad greens, broccoli, cauliflower, cucumber,cabbage, and others); fat from animal foods, oils,butter, and avocado; and protein in the form ofmeat, poultry, fish, shellfish, eggs, cheese, nuts,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 consistentdefinition of “low” carbohydrate. In this review,a low-carbohydrate eating pattern is defined asreducing carbohydrates to 26–45% of totalcalories.

c A1C reductionc Weight lossc Lowered blood pressurec Increased HDL-C and loweredtriglycerides

Very low-carbohydrate (VLC) (110–112) Similar to low-carbohydrate patternbut further limitscarbohydrate-containing foods, and mealstypically derivemore than half of calories from fat.Often has a goal of 20–50 g of nonfibercarbohydrate per day to induce nutritional ketosis.In this review a VLC eating pattern is defined asreducing carbohydrate to ,26% of total calories.

c A1C reductionc Weight lossc Lowered blood pressurec Increased HDL-C and loweredtriglycerides

Dietary Approaches to Stop Hypertension(DASH) (81,118,119)

Emphasizes vegetables, fruits, and low-fat dairyproducts; includes whole intact grains, poultry,fish, and nuts; reduced in saturated fat, red meat,sweets, and sugar-containing beverages. May alsobe reduced in sodium.

c Reduced risk of diabetesc Weight lossc Lowered blood pressure

Paleo (120–122) Emphasizes foods theoreticallyeaten regularlyduringearly human evolution, such as lean meat, fish,shellfish, vegetables, eggs, nuts, and berries.Avoids grains, dairy, salt, refined fats, and sugar.

c Mixed resultsc Inconclusive evidence

*Source: RCTs, meta-analyses, observational studies, nonrandomized single-arm studies, cohort studies. USDA, U.S. Department of Agriculture.

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the PREDIMED study (71). Other meta-analyses of observational studies havenot shown an inverse relationship withfull-fat dairy intake and diabetes risk(72,73). The inconsistent results in theabove studiesmay be due to variations infood sources of fat (70) or the fact thatsome analyses have relied on self-reported dietary information, which canbe limited by inaccuracy.Formore informationon fat intake and

CVD risk, see the section ROLE OF NUTRITION

THERAPY IN THE PREVENTION AND MANAGEMENT OF

DIABETES COMPLICATIONS (CVD, DIABETIC KIDNEY DIS-

EASE, AND GASTROPARESIS).

EATING PATTERNS

Consensus recommendations

c A variety of eating patterns (com-binations of different foods or foodgroups) are acceptable for themanagement of diabetes.

c Until the evidence surroundingcomparative benefits of differenteating patterns in specific individ-uals strengthens, health care pro-viders should focus on the keyfactors that are common amongthe patterns:

○ Emphasize nonstarchy vegetables.○ Minimize added sugars and

refined grains.○ Choose whole foods over highly

processed foods to the extentpossible.

c Reducing overall carbohydrate in-take for individuals with diabeteshas demonstrated the most evi-dence for improving glycemiaand may be applied in a varietyof eating patterns that meet in-dividual needs and preferences.

c For select adults with type 2 di-abetes not meeting glycemictargets or where reducing anti-glycemic medications is a priority,reducing overall carbohydrateintake with low- or very low-carbohydrate eating plans is aviable approach.

An eating pattern represents the to-tality of all foods and beverages con-sumed (8) (Table 3). An eating plan is aguide to help individuals plan when,what, and how much to eat on a dailybasis and applies to the foods empha-sized in the individual’s selected eatingpattern.

This section emphasizes evidencefrom randomized trials of eating pat-terns in people with type 1 diabetes,type 2 diabetes, and prediabetes andwas limited to those trials with at least10 people in each dietary group and aretention rate of .50%. Overall, fewlong-term (2 years or longer) random-ized trials have been conducted of anyof the dietary patterns in any of theconditions examined.

What is the evidence for specific eatingpatterns to manage prediabetes andprevent type 2 diabetes?The most robust research available re-lated to eating patterns for prediabe-tes or type 2 diabetes prevention areMediterranean-style, low-fat, or low-carbohydrate eating plans (26,69,74,75).The PREDIMED trial, a large RCT, com-pared a Mediterranean-style to a low-fateating pattern for prevention of type 2diabetes onset, with the Mediterranean-style eating pattern resulting in a 30%lower relative risk (69). Epidemiologic stud-ies correlate Mediterranean-style (76), veg-etarian (77–80), and Dietary Approaches toStop Hypertension (DASH) (76,81) eatingpatterns with a lower risk of developingtype 2 diabetes, with no effect for low-carbohydrate eating patterns (82).

Several large type 2 diabetes preven-tion RCTs (26,74,83,84) used low-fat eat-ing plans to achieve weight loss andimprove glucose tolerance, and somedemonstrated decreased incidence ofdiabetes (26,74,83). Given the limitedevidence, it is unclearwhich of the eatingpatterns are optimal.

What is the evidence for specific eatingpatterns to manage type 2 diabetes?

Mediterranean-Style Eating Pattern

The Mediterranean-style pattern hasdemonstrated a mixed effect on A1C,weight, and lipids in a number of RCTs(85–90). In the Dietary InterventionRandomized Controlled Trial (DIRECT),obese adults with type 2 diabeteswere randomized to a calorie-restrictedMediterranean-style, a calorie-restrictedlower-fat, or a low-carbohydrate eatingpattern (28% of calories from carbo-hydrate) without emphasis on calorierestriction. A1C was lowest in the low-carbohydrate group after 2 years, whereasfasting plasma glucose was lower in theMediterranean-style group than in thelower-fat group (90).

One of the largest and longestRCTs, the PREDIMED trial, compareda Mediterranean-style eating patternwith a low-fat eating pattern. After4 years, glycemicmanagement improvedand the need for glucose-lowering med-ications was lower in the Mediterraneaneating pattern group (89). In addition,the PREDIMED trial showed that a Med-iterranean-style eating pattern inter-vention enriched with olive oil or nutssignificantly reduced CVD incidence in bothpeople with and without diabetes (91).

Vegetarian or Vegan Eating Patterns

Studies of vegetarian or vegan eatingplans ranged in duration from 12 to74 weeks and showed mixed resultson glycemia and CVD risk factors. Theseeating plans often resulted in weight loss(92–97). Two meta-analyses of con-trolled trials (98,99) concluded that veg-etarian and vegan eating plans canreduce A1C by an average of 0.3–0.4%in people with type 2 diabetes, and thelarger meta-analysis (99) also reportedthat plant-based eating patterns reducedweight (weight reduction of 2 kg), waistcircumference, LDL cholesterol (LDL-C),and non–HDL-C with no significant effecton fasting insulin, HDL-C, triglycerides,and blood pressure.

Low-Fat Eating Pattern

In the Look AHEAD (Action for Health inDiabetes) trial (100), individuals follow-ing a calorie-restricted low-fat eatingpattern, in the context of a structuredweight loss program using meal replace-ments, achieved moderate success com-pared with the control condition eatingplan (101). However, lowering total fatintake did not consistently improve gly-cemia or CVD risk factors in people withtype 2 diabetes based on a systematicreview (45), several studies (102–105),and ameta-analysis (106). Benefit from alow-fat eating pattern appears to bemostly related to weight loss as opposedto the eating pattern itself (100,101).Additionally, low-fat eating patternshave commonly been used as the “con-trol” intervention compared with othereating patterns.

Very Low-Fat: Ornish or Pritikin Eating

Patterns

TheOrnish andPritikin lifestyle programsare two of the best known multicompo-nent very low-fat eating patterns. TheOrnish program emphasizes a very low-fat, whole-foods, plant-based eating

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plan (about 70% of calories from carbo-hydrate, 10% from fat, 20% fromprotein,and 60 g of fiber), predominantly fromvegetables, beans, fruits, grains, nonfatdairy, and egg whites. The Pritikin in-tervention advises that people consume77%of calories fromcarbohydrate, about10% from fat, 13% from protein, and 30–40 g of fiber per 1,000 calories, with nocalorie restriction during a 26-day stayin an in-patient treatment center. Threenonrandomized single-arm studies with69 to 652 participants lasting between3 weeks and 2–3 years show that thesemulticomponent lifestyle interventionprograms may improve glucose levels,weight, blood pressure, and HDL-C,with a mixed effect on triglycerides(107–109).

Low-Carbohydrate or Very Low-

Carbohydrate Eating Patterns

Low-carbohydrate eating patterns, es-pecially very low-carbohydrate (VLC)eating patterns, have been shown toreduce A1C and the need for antihyper-glycemic medications. These eating pat-terns are among the most studied eatingpatterns for type 2 diabetes. One meta-analysis of RCTs that compared low-carbohydrate eating patterns (definedas#45% of calories from carbohydrate)to high-carbohydrate eating patterns(defined as .45% of calories from car-bohydrate) found that A1C benefitswere more pronounced in the VLC inter-ventions (where ,26% of calories camefrom carbohydrate) at 3 and 6 monthsbut not at 12 and 24 months (110).Another meta-analysis of RCTs

compared a low-carbohydrate eatingpattern (defined as ,40% of caloriesfrom carbohydrate) to a low-fat eatingpattern (defined as ,30% of caloriesfrom fat). In trials up to 6 months long,the low-carbohydrate eating patternimproved A1C more, and in trials ofvarying lengths, lowered triglycerides,raised HDL-C, lowered blood pressure,and resulted in greater reductions indiabetes medication (111). Finally, inanother meta-analysis comparing low-carbohydrate to high-carbohydrate eat-ing patterns, the larger the carbohydraterestriction, the greater the reduction inA1C, though A1Cwas similar at durationsof 1 year and longer for both eatingpatterns (112). Table 4 provides a quickreference conversion of percentage ofcalories from carbohydrate to grams of

carbohydrate based on number of calo-ries consumed per day.

Because of theoretical concerns re-garding use of VLC eating plans in peoplewith chronic kidney disease, disorderedeating patterns, and women who arepregnant, further research is needed be-fore recommendations can be madefor these subgroups. Adopting a VLCeating plan can cause diuresis and swiftlyreduce blood glucose; therefore, consul-tationwith a knowledgeable practitionerat the onset is necessary to preventdehydration and reduce insulin andhypoglycemic medications to preventhypoglycemia.

No randomized trials were found inpeople with type 2 diabetes that variedthe saturated fat content of the low- orvery low-carbohydrate eating patternsto examine effects on glycemia, CVD riskfactors, or clinical events. Most of thetrials using a carbohydrate-restrictedeating pattern did not restrict saturatedfat; fromthecurrentevidence, thiseatingpattern does not appear to increaseoverall cardiovascular risk, but long-term studies with clinical event out-comes are needed (113–117).

DASH Eating Pattern

One small, 8-week study comparingthe DASH eating pattern with a controlgroup in people with type 2 diabetesindicated improved A1C, blood pres-sure, and cholesterol levels and weightloss with the DASH eating pattern, withno difference in triglycerides (118). An-other RCT compared the DASH eatingpattern incorporating increased physicalactivity with a standard eating patternwithout increased physical activity andfound blood pressure was lower in theDASH and physical activity group, butA1C, weight, and lipids did not differ(119).

Paleo Eating Pattern

Research studies focused on a paleoeating pattern in adults with type 2 di-abetes are small and few, ranging from

13–29participants, lastingno longer than3 months, and finding mixed effects onA1C, weight, and lipids (120–122).

Intermittent Fasting

While intermittent fasting is not aneating pattern by definition, it hasbeen included in this discussion be-cause of increased interest from thediabetes community. Fasting means togo without food, drink, or both for aperiod of time. People fast for reasonsranging from weight management toupcoming medical visits to religiousand spiritual practice. Intermittentfasting is a way of eating that focusesmore on when you eat (i.e., consumingall daily calories in set hours during theday) than what you eat. While it usuallyinvolves set times for eating and settimes for fasting, people can approachintermittent fasting in many differentways.

Published intermittent fasting studiesinvolving diabetes and diabetes pre-vention demonstrate a variety of ap-proaches, including restricting foodintake for 18 to 20 h per day, alternate-day fasting, and severe calorie restric-tion for up to 8 consecutive days orlonger (123). Four fasting studies ofparticipants with type 2 diabetes weresmall (#63 participants) and of shortduration (#20 weeks). Three of the stud-ies (124–126) demonstrated that inter-mittent fasting, either in consecutive daysof restrictionor by fasting 16hper dayormore, may result in weight loss; how-ever, there was no improvement in A1Ccomparedwith a nonfasting eating plan.One of the studies (127) showed similarreductions in A1C, weight, and medica-tion doses when 2 days of severe energyrestriction were compared with chronicenergy restriction. Another study lookedat men with prediabetes and timing offood intake over a 24-h period, with theintervention group restricted to a 6-hscheduleof eating (withfinalmeal before3 P.M.) compared with a control schedulewhere eating occurred over a 12-h period;

Table 4—Quick reference conversion of percent calories from carbohydrate shownin grams per day as reported in the research reviewed for this report

Calories 10% 20% 30% 40% 50% 60% 70%

1,200 30 g 60 g 90 g 120 g 150 g 180 g 210 g

1,500 38 g 75 g 113 g 150 g 188 g 225 g 263 g

2,000 50 g 100 g 150 g 200 g 250 g 300 g 350 g

2,500 63 g 125 g 188 g 250 g 313 g 375 g 438 g

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improved insulin sensitivity, b-cell re-sponsiveness, blood pressure, oxidativestress, and appetite were shown in theintervention group (128). The safety ofintermittent fasting in people with spe-cial health situations, including preg-nancy and disordered eating, has notbeen studied.

What is the evidence to supportspecific eating patterns in themanagement of type 1 diabetes?For adults with type 1 diabetes, no trialsmet the inclusion criteria for this Consen-sus Report related to Mediterranean-style, vegetarian or vegan, low-fat,low-carbohydrate, DASH, paleo, Or-nish, or Pritikin eating patterns.We foundlimited evidence about the safety and/oreffects of fasting on type 1 diabetes (129).A few studies have examined the

impact of a VLC eating pattern for adultswith type 1 diabetes. One randomizedcrossover trial with 10 participantsexamined a VLC eating pattern aimingfor 47 g carbohydrate per day without afocus on calorie restriction comparedwith a higher carbohydrate eating pat-tern aiming for 225 g carbohydrate perday for 1 week each. Participants follow-ing the VLC eating pattern had lessglycemic variability, spent more timein euglycemia and less time in hypogly-cemia, and required less insulin (130). Asingle-arm 48-person trial of a VLC eatingpattern aimed at a goal of 75 g ofcarbohydrate or less per day foundthat weight, A1C, and triglycerideswere reduced and HDL-C increased after3 months, and after 4 years A1C was stilllower and HDL-C was still higher than atbaseline (131). This evidence suggeststhat a VLC eating pattern may havepotential benefits for adults withtype 1 diabetes, but clinical trials ofsufficient size and duration are neededto confirm prior findings.

Does the current evidence supportspecific eating patterns for themanagement of diabetes?Until the evidence surrounding compar-ativebenefits of different eating patternsin specific individuals strengthens, healthcare providers should focus on the keyfactors that are common among thepatterns: 1) emphasize nonstarchy veg-etables, 2) minimize added sugars andrefinedgrains, and3) choosewhole foods

over highly processed foods to the extentpossible (132).

Multiple trials andmeta-analyses havebeen published addressing the compar-ative effects of specific eating patternsfor diabetes. Whereas no single eatingpattern has emerged as being clearlysuperior to all others for all diabetes-related outcomes, evidence suggestscertain eating patterns are better forspecific outcomes. All eating patternsinclude a range of more-healthy versusless-healthy options: lentils and sugar-sweetened beverages are both consid-ered part of a vegan eating pattern; fishand processed red meats are both con-sidered part of a low-carbohydrate eat-ing pattern; and removing the bunfrom a fast food burger might make itpart of a paleo eating pattern but doesnot necessarily make it healthier. Fur-ther, studies comparing the same two ormore eating patterns could easily dif-fer in the investigators’ definition ofthe patterns, the effectiveness of theresearch team in fostering pattern adher-ence among study participants, the ac-curacy of assessing pattern adherence,study duration, and participant popula-tion characteristics.

ENERGY BALANCE AND WEIGHTMANAGEMENT

Consensus recommendations

c To support weight loss and improveA1C, CVD risk factors, and qualityof life in adults with overweight/obesity and prediabetes or diabe-tes, MNT and DSMES servicesshould include an individualizedeating plan in a format that resultsin an energy deficit in combinationwith enhanced physical activity.

c For adultswith type 2diabeteswhoare not taking insulin andwho havelimited health literacy or numer-acy, or who are older and prone tohypoglycemia, a simple and effec-tive approach to glycemia andweight management emphasizingappropriate portion sizes andhealthy eating may be considered.

c In type 2 diabetes, 5% weight lossis recommended to achieve clinicalbenefit, and the benefits are pro-gressive. The goal for optimal out-comes is 15%ormorewhenneededand can be feasibly and safely ac-complished. Inprediabetes, thegoal

is 7–10% for preventing progressionto type 2 diabetes.

c In select individuals with type 2diabetes, an overall healthy eatingplan that results in energy deficit inconjunction with weight loss med-ications and/or metabolic surgeryshould be considered to helpachieve weight loss and mainte-nance goals, lower A1C, and reduceCVD risk.

c In conjunction with lifestyle ther-apy, medication-assisted weightloss can be considered for peopleat risk for type 2 diabetes whenneeded to achieve and sustain7–10% weight loss.

c People with prediabetes at a healthyweight should be considered forlifestyle intervention involving bothaerobic and resistance exercise anda healthy eatingplan such as aMed-iterranean-style eating plan.

c People with diabetes and predia-betes should be screened and eval-uated during DSMES and MNTencounters for disordered eating,and nutrition therapy should ac-commodate these disorders.

What is the role of weight loss therapyin people with prediabetes or diabeteswith overweight or obesity?There is substantial evidence indicatingthat weight loss is highly effective inpreventing progression from prediabe-tes to type 2 diabetes and in managingcardiometabolic health in type 2 di-abetes. Overweight and obesity arealso increasingly prevalent in peoplewith type 1 diabetes and present clin-ical challenges regarding diabetestreatment and CVD risk factors(133,134). Therefore, MNT and DSMESthat include an overall healthy eatingplan in a format that results in anenergy deficit, as well as a collaborativeeffort to achieve weight loss in peoplewith type 1 diabetes, type 2 diabetes, orprediabetes and overweight/obesity, arerecommended.

Eating plans that create an energydeficit and are customized to fit theperson’s preferences and resourcescan help with long-term sustainmentand are the cornerstone of weight losstherapy. Regular physical activity, whichcan contribute to both weight lossand prevention of weight regain, and

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behavioral strategies are also impor-tant components of lifestyle therapy forweight management (26,74,83,135–137).Structured weight loss programs withregular visits and use of meal replace-ments have been shown to enhanceweight loss in people with diabetes(138–140).The combined data do not point to a

threshold of weight loss for maximal clin-ical benefits in people with diabetes;rather, the greater the weight loss, thegreater the benefits. Previous recommen-dations of weight loss of 5% or $7% forpeople with overweight or obesity arebased on the threshold needed for ther-apeutic advantages; however, weight losstargeted at$15%, when such can feasiblyand safely be accomplished, is associatedwith even better outcomes in type 2 di-abetes (138,141).The UK Prospective Diabetes Study

(UKPDS) demonstrated that decreasesin fasting glucose were correlated withdegree of weight loss (142). A meta-analysis conducted by Franz et al. (137)found that lifestyle interventions pro-ducing ,5% weight loss had less effecton A1C, lipids, or blood pressure com-paredwith studies achievingweight lossof $5%. Other meta-analyses focusingon nonmedicine or medicine-assistedweight loss interventions in type 2 di-abetes support this finding (143–145).More recently, the Look AHEAD trial(139,141) compared standard DSMESto a more intensive lifestyle interven-tion and reduced-calorie eating plan.The intensive lifestyle intervention re-sulted in 8.6% weight loss at 1 year, andthe downstream therapeutic benefitswere far-ranging even though benefitswere not seen for the primary cardio-vascular outcomes (100).A systematic review of the effective-

ness of MNT revealed mixed weight lossoutcomes in participants with type 1 and2 diabetes (9). Similarly, while DSMES isa fundamental component of diabetescare (1), it does not consistently producesufficient weight loss to achieve optimaltherapeutic benefits in people with di-abetes (136,146,147). For these reasons,diabetes MNT and DSMES shouldemphasize a targeted and concertedplan for weight management.The addition of metabolic surgery

(148), weight loss medications (149),and glucose-lowering agents that pro-mote weight loss (150) can also be used

as an adjunct to lifestyle interventions,resulting in greater weight loss that ismaintained for a longer period of time.The data also support the positionthat weight loss therapy is effective atall phases of type 2 diabetes, both inindividuals with recent-onset disease(1,149) and in people with longer dura-tions of diabetes treated with multiplediabetes medications (136,149).

In the DPP, maximal prevention ofdiabetes over 4 years was observed atabout 7–10% weight loss (151). This isconsistent with the study using phenter-mine/topiramate ER, where weight lossof 10% reduced incident diabetes by 79%over 2 years and any further weightloss to $15% did not lead to additionalprevention (152). For this reason, nutri-tion therapy to support a 7–10% weightloss is the appropriate goal in treatingpeople with prediabetes, unless addi-tional weight loss is desired for otherpurposes. Nutrition therapy can be acomponent of a lifestyle interventionprogram or used in conjunction withantiobesity medications and/or meta-bolic surgery (153,154) in people withprediabetes.

Regular physical activity by itself(155,156) or as part of a comprehensivelifestyle plan (26,74,83,151) can preventprogression to type 2 diabetes in high-risk individuals. Studies have demon-strated beneficial effects of both aerobicand resistance exercise and additivebenefits when both forms of exerciseare combined (157–159).

What is the best weight loss plan forindividuals with diabetes?For purposes of weight loss, the abilityto sustain and maintain an eating planthat results in an energy deficit, irre-spective of macronutrient compositionor eating pattern, is critical for success(160–163). Studies investigating spe-cific weight loss eating plans using abroad range of macronutrient compo-sition in people with diabetes haveshown mixed results regarding effectson weight, A1C, serum lipids, and bloodpressure (102,103,106,164–171). As aresult, the evidence does not identifyone eating plan that is clearly superiorto others and that can be gener-ally recommended for weight loss forpeople with diabetes (172). Thus, anindividualized plan for diabetes nutri-tion therapy is warranted, taking into

account dietary preferences togetherwith the individual’s health literacy,resources, food availability, meal prep-aration skills, and physical activity tomaximize the ability to attain and main-tain the eating plan (173,174). Individu-alizedeating plans should support caloriereduction (e.g., employing use of appro-priate portion sizes, meal replacements,and/or behavioral interventions) in thecontext of a lifestyle program, withappropriate modifications in the med-ication plan to minimize associatedadverse effects such as weight gain,hypoglycemia, and hypotension.

Weight loss interventions can beimplemented in usual care settingsand alternately in telehealth programs(175,176). In general, the interventionintensity and degree of individual par-ticipation in the program are importantfactors for successful weight loss (161–163,175).

What is the role of weight loss onpotential for type2diabetes remission?The Look AHEAD trial (177) and theDiabetesRemissionClinical Trial (DiRECT)(138) highlight the potential for type 2diabetes remissionddefined as themaintenance of euglycemia (completeremission) or prediabetes level of glyce-mia (partial remission) with no diabe-tes medication for at least 1 year(177,178)din people undergoingweightloss treatment. In the Look AHEAD trial,when compared with the control group,the intensive lifestyle arm resulted in atleast partial diabetes remission in 11.5%of participants as compared with 2% inthe control group (177). The DiRECT trialshowed that at 1 year, weight lossassociated with the lifestyle interven-tion resulted in diabetes remission in46% of participants (138). Remissionrates were related to magnitude ofweight loss, rising progressively from7% to 86% as weight loss at 1 yearincreased from ,5% to $15% (138).Diet compositionmay also play a role; inan RCT by Esposito et al. (179), despiteonly a 2-kg difference in weight loss, thegroup following a low-carbohydrateMediterranean-style eating pattern(see Table 3) experienced greater ratesof at least partial diabetes remission,with rates of 14.7% at year 1 and 5%at year 6 compared with 4.7% and 0%,respectively, in the group following alow-fat eating plan.

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What is the role of eating plans thatresult inenergydeficitsandweight lossin type 1 diabetes?Obesity prevalence among people withtype 1 diabetes has been significantlyincreasing (180–182). Currently, over50% of people with type 1 diabeteshave overweight or obesity (180–182).A recent study suggested obesity maypromote progression to overt type 1diabetes in at-risk individuals (183),but further confirmatory studies areneeded. In addition, in people with es-tablished type 1 diabetes, presence ofobesity can worsen insulin resistance,glycemic variability, microvascular dis-ease complications, and cardiovascularrisk factors (184–188). Therefore, weightmanagement has been recommended asan essential component of care for peo-ple with type 1 diabetes who have over-weight or obesity (189–192).There is a scarcity of evidence from

RCTs evaluating weight loss interven-tions in type 1 diabetes. A retrospectivenested-control study indicated that life-style-induced weight loss improved gly-cemia with a reduction in insulin dosescompared with controls (193). Individu-als with type 1 diabetes and obesity maybenefit fromeating plans that result in anenergy deficit and that are lower in totalcarbohydrate and GI and higher in fiberand lean protein (194). Currently, ad-junctive pharmacotherapy is not in-dicated for individuals with type 1diabetes. However, there is preliminaryevidence that in select individuals withtype 1 diabetes and excess adiposity,newer pharmacotherapy (i.e., glucagon-like peptide 1 receptor agonists orsodium–glucose cotransporter 2 inhibi-tors) (195,196) candecreasebodyweightand improve glycemia, though they arecurrently not indicated. In addition, met-abolic surgery in appropriate candidatescan decrease body weight and improveglycemia (197,198).

How does disordered eating factor intoweight management?When counseling individuals with diabe-tes and prediabetes about weight man-agement, special attention also mustbe given to prevent, diagnose, and treatdisordered eating. Disordered eating canmake following an eating plan chal-lenging (199). The prevalence of disor-dered eating varies, affecting 18% to 40%of people with diabetes (199–205).

Health care professionals should considerscreening for disordered eating, refer to amental health professional, and individu-alize nutrition therapy accordingly (206).

SWEETENERS

Consensus recommendations

c Replace sugar-sweetened bever-ages (SSBs) with water as oftenas possible.

c When sugar substitutes are used toreduce overall calorie and carbo-hydrate intake, people should becounseled to avoid compensatingwith intake of additional caloriesfrom other food sources.

Does the consumption of SSBs impactrisk of diabetes?SSB consumption in the general popula-tion contributes to a significantly in-creased risk of type 2 diabetes, weightgain, heart disease, kidney disease, non-alcoholic liver disease, and tooth decay(207). For example, a meta-analysis re-ported that consumption of at least oneserving of SSB per day increased risk oftype 2 diabetes in adults with prediabe-tes by 26% (208). In a separate meta-analysis, consumption of regular sodaincreased type 2 diabetes risk by 13%,while consumption of diet soda in-creased type 2 diabetes risk by 8%(209). Conversely, the replacement ofSSBs with an equal amount of waterreduced the risk of type 2 diabetes by7–8% (210).

What is the impact of sugarsubstitutes?The U.S. Food and Drug Administration(FDA)has reviewed several typesof sugarsubstitutes for safety andapproved themfor consumption by the general public,including people with diabetes (211). Inthis report, the term sugar substitutesrefers to high-intensity sweeteners, ar-tificial sweeteners, nonnutritive sweet-eners, and low-calorie sweeteners. Theseinclude saccharin, neotame, acesulfame-K, aspartame, sucralose, advantame,stevia, and luo han guo (or monk fruit).Replacing added sugars with sugar sub-stitutes could decrease daily intake ofcarbohydrates and calories. These die-tary changes could beneficially affectglycemic, weight, and cardiometaboliccontrol. However, an American HeartAssociation science advisory on the

consumption of beverages containingsugar substitutes that was supportedby the ADA concluded there is notenough evidence to determine whethersugar substitute use definitively leads tolong-term reduction in body weight orcardiometabolic risk factors, includingglycemia (212). Using sugar substitutesdoes not make an unhealthy choicehealthy; rather, it makes such a choiceless unhealthy. If sugar substitutes areused to replace caloric sweeteners, with-out caloric compensation, they may beuseful in reducing caloric and carbohy-drate intake (213), although further re-search is needed to confirm theseconcepts (214). Multiple mechanismshave been proposed for potential ad-verse effects of sugar substitutes, e.g.,adversely altering feelings of hunger andfullness, substituting for healthier foods,or reducing awareness of calorie intake(215). As people aim to reduce theirintake of SSBs, the use of other alter-natives, with a focus on water, is en-couraged (212).

Sugar alcohols represent a separatecategory of sweeteners. Like sugar sub-stitutes, sugar alcohols have been ap-proved by the FDA for consumption bythe general public and people with di-abetes. Whereas sugar alcohols havefewer calories per gram than sugars,they arenot as sweet. Therefore, a higheramount is required to match the degreeof sweetness of sugars, generally bring-ing the calorie content toa level similar tothat of sugars (216). Useof sugar alcoholsneeds to be balancedwith their potentialto cause gastrointestinal effects in sen-sitive individuals. Currently, there is littleresearch on the potential benefits ofsugar alcohols for people with diabetes(217).

ALCOHOL CONSUMPTION

Consensus recommendations

c It is recommended that adults withdiabetes or prediabetes who drinkalcohol do so in moderation (onedrink or less per day for adultwomen and two drinks or lessper day for adult men).

c Educating people with diabetesabout the signs, symptoms, andself-management of delayed hypo-glycemia after drinking alcohol,especially when using insulin

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or insulin secretagogues, is rec-ommended. The importance ofglucose monitoring after drink-ing alcohol beverages to reducehypoglycemia risk should beemphasized.

What are the effects of alcoholconsumption on diabetes-relatedoutcomes?It is important that health care providerscounsel people with diabetes about al-cohol consumption and encourage mod-erate and sensible use for peoplechoosing to consume alcohol. Moderatealcohol consumption has minimal acuteand/or long-term detrimental effects onglycemia in people with type 1 or type 2diabetes (218–221), with some epidemi-ologic data showing improved glycemiaand improved insulin sensitivity withmoderate intake.Onealcohol-containingbeverage is defined as 12-oz beer, 5-ozwine, or 1.5-oz distilled spirits, eachcontaining approximately 15 g of alcohol(8). Excessive amounts of alcohol (.3drinks per day or 21 drinks per week formen and .2 drinks per day or 14 drinksper week for women) consumed on aconsistent basis may contribute to hy-perglycemia (222). Starting with onedrink per day, risk for reduced adherenceto self-care and healthy lifestyle behav-iors has been reported with increasingalcohol consumption (223).

What are the effects of alcoholconsumption on hypoglycemia risk inpeople with diabetes?Despite the potential glycemic and car-diovascular benefits of moderate alcoholconsumption, alcohol intake may placepeople with diabetes at increased risk fordelayed hypoglycemia (221,224–226).This effect may be a result of inhibitionof gluconeogenesis, reduced hypoglyce-mia awareness due to the cerebral effectsof alcohol, and/or impaired counterregu-latory responses to hypoglycemia (227).This is particularly relevant for those usinginsulin or insulin secretagogues who canexperience delayed nocturnal or fastinghypoglycemia after evening alcohol con-sumption. Consuming alcohol with foodcan minimize the risk of nocturnalhypoglycemia (227,228). It is essentialthat people with diabetes receiveeducation regarding the recognition andmanagement of delayed hypoglycemia

and the potential need for more frequentglucose monitoring after consuming alco-hol (227,229).

Howdoesalcoholconsumption impactrisk of developing type 2 diabetes?Comprehensive reviews and meta-analyses suggest a protective effect ofmoderate alcohol intake on the risk ofdeveloping type 2 diabetes, with a higherrate of diabetes in alcohol abstainers andheavy consumers (222,230–232). Mod-erate alcohol intake ranging from 6–48g/day (0.5–3.4 drinks) was associatedwith a 30–56% lower incidence oftype 2 diabetes (9,222,230–232). Knottet al. (232) reported reduced risk oftype 2 diabetes at all levels of alcoholintake,63 gper daywith peak reductionat a daily alcohol intake of 10–14 g(approximately 1 drink) per day inwomen and non-Asian populations.

Ameta-analysis and systematic review(233) that examined the effects of spe-cific types of alcohol beverage consump-tion and the incidence of type 2 diabetesfound that wine consumption was asso-ciated with significantly lower diabetesrisk, as compared with a smaller reduc-tion in risk with beer and spirits. AU-shaped relationship between alcoholdose and diabetes risk was found amongall three types of alcohol, with lowestdiabetes risk at 20–30gof alcohol per dayfrom wine and beer and 7–15 g of alcoholper day from spirits; the decrease indiabetes incidence was 20% for wine,9% for beer, and 5% for spirits.

While epidemiologic evidence showsa correlation between alcohol consump-tion and risk of diabetes, the evidencedoes not suggest that providers shouldadvise abstainers to start consumingalcohol. Ultimately, alcohol consumptionis an individual’s choice, but additionalfactors such as history of alcohol use,religion, genetic factors, and mentalhealth, as well as medication interac-tions, should be considered when coun-seling on alcohol use.

MICRONUTRIENTS, HERBALSUPPLEMENTS, AND RISK OFMEDICATION-ASSOCIATEDDEFICIENCY

Consensus recommendations

c Without underlying deficiency, thebenefits ofmultivitamins ormineralsupplementsonglycemia forpeople

with diabetes or prediabetes havenot been supported by evidence,and therefore routine use is notrecommended.

c It is recommended that MNT forpeople taking metformin includean annual assessment of vitaminB12 status with guidance on sup-plementation options if deficiencyis present.

c The routine use of chromium orvitamin D micronutrient supple-ments or any herbal supplements,including cinnamon, curcumin, oraloe vera, for improving glycemiain people with diabetes is not sup-portedbyevidenceand is thereforenot recommended.

What is the effectiveness ofmicronutrients on diabetes-relatedoutcomes?Scientific evidence does not supportthe use of dietary supplements in theform of vitamins or minerals to meetglycemic targets or improve CVD riskfactors in people with diabetes or pre-diabetes, in the absence of an under-lying deficiency (234–236). Peoplewithdiabetes not achieving glucose targetsmay have an increased risk of micro-nutrient deficiencies (237), so maintaininga balanced intake of food sources thatprovide at least the recommended dailyallowance for nutrients and micronu-trients is essential (234). For specialpopulations, including women planningpregnancy, people with celiac disease,older adults, vegetarians, and peoplefollowing an eating plan that restrictsoverall calories or one or moremacronutrients, a multivitamin supple-ment may be justified (238).

A systematic review on the effect ofchromium supplementation on glu-cose and lipid metabolism concludedthat evidence is limited by poor studyquality and heterogeneity in method-ology and results (239,240). Evidencefrom clinical studies that evaluatedmagnesium (241,242) and vitamin D(243–253) supplementation to im-prove glycemia in people with diabetesis likewise conflicting. However, evi-dence is emerging that suggests thatmagnesium status may be related todiabetes risk in people with prediabe-tes (254).

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What is the role of herbalsupplementation in the managementof diabetes?It is important to consider that nutritionalsupplements and herbal products arenot standardized or regulated (255,256).Health care providers should ask aboutthe use of supplements and herbal prod-ucts, and providers and people with or atrisk for diabetes should discuss the po-tential benefit of theseproductsweighedagainst the cost and possible adverseeffects and drug interactions. The vari-ability of herbal and micronutrient sup-plements makes research in this areachallenging and makes it difficult toconclude effectiveness. To date, there islimited evidence supporting the additionof herbal supplements to manage glyce-mia. Because of public interest and thelack of conclusive data, the NationalCenter for Complementary and Integra-tive Health at the National Institutes ofHealth aims to answer important publichealth and scientific questions by fund-ing and conducting research on comple-mentary medicine.

Does the use of metformin affectvitamin B12 status?Metformin is associated with vitamin B12deficiency,witharecentsystematic reviewrecommending that annual blood testingof vitamin B12 levels be considered inmetformin-treated people, especially inthose with anemia or peripheral neurop-athy (257). This study found that even intheabsenceof anemia, B12deficiencywasprevalent. The exact cause of B12 defi-ciency in people taking metformin is notknown, but some research points to mal-absorption caused by metformin, withother studies suggesting improvementsin B12 status with calcium supplementa-tion (258–261). The standard of treatmenthas been B12 injections, but new researchsuggest that high-dose oral supplementa-tion may be as effective (258,259). Moreresearch is needed in this area.

MNT AND ANTIHYPERGLYCEMICMEDICATIONS (INCLUDINGINSULIN)

Consensus recommendations

c All RDNsprovidingMNT in diabetescare should assess and monitormedication changes in relation tothe nutrition care plan.

c For individuals with type 1 diabe-tes, intensive insulin therapy usingthe carbohydrate counting ap-proach can result in improved gly-cemia and is recommended.

c For adults using fixed daily insulindoses, consistent carbohydrate in-take with respect to time andamount, while considering the in-sulin action time, can result inimproved glycemia and reducethe risk for hypoglycemia.

c When consuming a mixed mealthat contains carbohydrate and ishigh in fat and/or protein, insulindosing should not be based solelyon carbohydrate counting. A cau-tious approach to increasing meal-time insulin doses is suggested;continuous glucose monitoring(CGM) or self-monitoring of bloodglucose (SMBG) should guidedecision-making for administrationof additional insulin.

What is the role of the RDN inmedication adjustment?RDNs providing MNT in diabetes careshould assess and monitor medicationchanges in relation to the nutrition careplan. Along with other diabetes careproviders, RDNs who possess advancedpractice training and clinical expertiseshould take an active role in facilitatingand maintaining organization-approveddiabetes medication protocols. Use oforganization-approved protocols for in-sulin and other glucose-lowering medica-tions can help reduce therapeutic inertiaand/or reduce the risk of hypoglycemiaand hyperglycemia (12,16–18,262,263).

How should nutrition therapy varybased on type and intensity of insulinplan?For people with type 1 diabetes usingbasal-bolus insulin therapy, a primaryfocus for MNT should include guidanceon adjusting insulin based on anticipateddietary intake, particularly carbohydrateintake (9,264–270); recent or expectedphysical activity; and glucose data. In-tensive insulin management educationprograms that include nutrition therapyhave been shown to improve A1C(9,264,268,271–273) and quality of life(9,274). For people using fixed daily in-sulin doses, carbohydrate intake on aday-to-day basis should be consistent

with respect to time and amount permeal (9,275,276).

Results from recent high-fat and/orhigh-protein mixed meal studies con-tinue to support previous findings thatglucose response to mixed meals highin protein and/or fat along with car-bohydrate differ among individuals;therefore, a cautious approach to in-creasing insulin doses for high-fatand/or high-protein mixed meals isrecommended to address delayed hy-perglycemia that may occur 3 h or moreafter eating (277–290). If using an insulinpump, a split bolus feature (part of thebolus delivered immediately, the re-mainder over a programmed durationof time) may provide better insulin cov-erage for high-fat and/or high-proteinmixed meals (278,281). Checking glucose3 h after eating may help to determine ifadditional insulin adjustments (i.e., in-creasing or stopping bolus) are required(278,290). Because these insulin dosingalgorithms require determination of an-ticipated nutrient intake to calculate themealtime dose, health literacy and nu-meracy should be evaluated. The ef-fectiveness of insulin dosing decisionsshould be confirmed with a structuredapproach to SMBG or CGM to evaluateindividual responses and guide insulindose adjustments.

ROLE OF NUTRITION THERAPY INTHE PREVENTION ANDMANAGEMENT OF DIABETESCOMPLICATIONS (CVD, DIABETICKIDNEY DISEASE, ANDGASTROPARESIS)

CVD

Consensus recommendations

c In general, replacing saturated fatwith unsaturated fats reduces bothtotal cholesterol andLDL-Candalsobenefits CVD risk.

c In type 2 diabetes, counseling peo-ple on eating patterns that replacefoods high in carbohydrate withfoods lower in carbohydrate andhigher in fatmay improveglycemia,triglycerides, and HDL-C; empha-sizing foods higher in unsaturatedfat instead of saturated fat mayadditionally improve LDL-C.

c People with diabetes and prediabe-tes are encouraged to consume lessthan 2,300 mg/day of sodium, the

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sameamountthat isrecommendedfor the general population.

c The recommendation for the gen-eral public to eat a serving of fish(particularly fatty fish) at least twotimes per week is also appropriatefor people with diabetes.

Does comprehensive diabetesnutrition therapy supportcardiovascular risk factor reduction?Nutrition therapy that includes the de-velopment of an eating plan designed tooptimize blood glucose trends, bloodpressure, and lipid profiles is importantin the management of diabetes and canlower the riskofCVD,CHD,andstroke (9).Findings from clinical trials support therole of nutrition therapy for achievingglycemic targets and decreasing variousmarkers of cardiovascular and hyper-tension risk (9,24,291–293).

What are considerations for fat intakefor people who are at risk for or haveCVD and diabetes?

Total Fat

There has been increasing researchexamining the effects of high-fat,low-carbohydrate eating patterns on car-diometabolic risk factors, with two sys-tematic reviews showing benefits oflow-carbohydrateeatingplanscomparedwith low-fat eating plans on glycemic andCVD risk parameters in the treatment oftype 2 diabetes (see the section LOW-CARBOHYDRATE OR VERY LOW-CARBOHYDRATE EATING

PATTERNS) (106,111).

Saturated Fat

The 2015–2020 DGA recommend con-suming less than 10% of calories fromsaturated fat by replacing it with mono-unsaturated and polyunsaturated fattyacids (8). The scientific rationale for de-creasing saturated fat in the diet is basedon the effect of saturated fat in raisingLDL-C, a contributing factor in athero-sclerosis (294).In aPresidentialAdvisoryondietary fat

andCVD, theAmericanHeart Associationconcluded that lowering intake of satu-rated fat and replacing it with unsatu-rated fats, especially polyunsaturatedfats, will lower the incidence of CVD(295). A meta-analysis of randomizedtrials not focused on people with diabe-tes showeda17% reduction (hazard ratio0.83 [95% CI 0.72–0.96]) in risk of CVD

events in studies that reduced saturatedfat intake from about 17% to about 9% ofenergy, but reductions in stroke, cardio-vascular mortality, or overall mortalitywere not found. Subgrouping of thestudies suggested that benefit occurredby replacing saturated fat with polyun-saturated fat but not with carbohydrateorprotein (296). In a systematic reviewofobservational studies, saturated fatswere not associated with all-cause mor-tality, CVD, CHD, ischemic stroke, ortype 2 diabetes, but limitations commonto observational studies were noted(297). Further, in a more recent large,prospective study including 7% of par-ticipants with self-reported diabetes,higher intake of saturated fat was asso-ciated with lower risk of total mortality(hazard ratio 0.86 [0.76–0.99], P fortrend = 0.0088) (298). In the PREDIMEDstudy, which included close to 50% ofpeople with diabetes, intakes of mono-unsaturated and polyunsaturated fatswere associated with a lower risk ofCVD and death, whereas intakes of sat-urated fat and trans fat were associatedwith a higher risk of CVD. The replace-ment of saturated fat with monounsat-urated or polyunsaturated fat in food orreplacement of trans fat with monoun-saturated fat in food was inversely as-sociated with CVD (299).

In general, replacing saturated fatwithunsaturated fats, especially polyunsatu-rated fat, significantly reduces both totalcholesterol and LDL-C, and replacementwith monounsaturated fat from plantsources, such as olive oil and nuts, re-duces CVD risk. Replacing saturated fatwith carbohydrate also reduces totalcholesterol and LDL-C, but significantlyincreases triglycerides and reducesHDL-C (299,300).

Monounsaturated Fats

A recent meta-analysis of nine RCTsshowed that, compared with control,the Mediterranean-style eating pattern,which is high in monounsaturated fatsfrom plant sources such as olive oil andnuts, improved outcomes of glycemia,body weight, and cardiovascular riskfactors in participants with type 2 di-abetes (301). A systematic review andmeta-analysis of 24 studies and including1,460 participants compared the effectof eating plans high in monounsaturatedfat with that of eating plans high incarbohydrates. The eating plans high

in monounsaturated fat showed signif-icant reductions in fasting glucose, tri-glycerides, bodyweight, and systolic bloodpressurealongwith significant increases inHDL-C. The systematic review and meta-analysis also reviewed four studies with atotal of 44 participants comparing eatingplans high in monounsaturated fat withthose high in polyunsaturated fat. Theeating plans high inmonounsaturated fatled to a significant reduction in fastingplasma glucose (63).

Polyunsaturated Fats

As is recommended for the generalpublic, an increase in foods containingthe long-chain omega-3 fatty acids EPAand docosahexaenoic acid (DHA), suchas are found in fatty fish, is recommen-ded for individuals with diabetes be-cause of their beneficial effects onlipoproteins, prevention of heart dis-ease, and associations with positivehealth outcomes in observational stud-ies (302,303). For people following avegetarian or vegan eating pattern,omega-3 a-linoleic acid (ALA) foundin plant foods such as flax, walnuts,and soy are reasonable replacementsfor foods high in saturated fat and mayprovide some CVD benefits, though theevidence is inconclusive.

Evidence does not conclusively sup-port recommending omega-3 (EPA andDHA) supplements for all people withdiabetes for the prevention or treatmentof cardiovascular events. In the mostrecent ASCEND (A Study of Cardiovascu-lar Events iN Diabetes) trial, when com-pared with placebo, supplementation ofomega-3 fatty acids at thedoseof 1 g/daydid not lead to cardiovascular benefit inpeoplewithdiabeteswithoutevidenceofCVD (68a, 304–305). Omega-3 fatty acidsupplements have not reduced CVDevents or mortality in randomized trialsbut may have utility in people who re-quire triglyceride reduction (304,306).TheVitaminD andOmega-3 Trial (VITAL),in which 13% of the participants hadtype 2 diabetes, supplementation with1 g of omega-3 fatty acids did not resultin a lower incidence of major cardiovas-cular events (305). However, in the Re-duction of Cardiovascular Events WithIcosapent Ethyl–Intervention Trial(REDUCE-IT), in which 57% of 823 partic-ipants had diabetes, 2 g of prescrip-tion icosapent ethyl twice daily (totaldaily dose, 4 g) significantly reduced

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cardiovascular events by 25%when com-pared with placebo (68a).

Trans Fat

Ameta-analysis of seven RCTs showed thatincreased trans fat intake did not result inchanges in glucose, insulin, or triglycerideconcentrations but led to an increase intotal and LDL-C and a decrease in HDL-Cconcentrations (307). Trans fats also havebeen associated with all-cause mortality,total CHD, and CHD mortality (297).

Can lowering sodium intake reduceblood pressure and othercardiovascular risk factors in peoplewith diabetes?Many health groups acknowledge thecurrent average intake of sodium, whichis .3,500 mg daily (308), should bereduced (8,309–312) to prevent andmanage hypertension. While reducingsodium to the general recommendationof ,2,300 mg/day demonstrates bene-ficial effects on blood pressure (118),further reduction warrants caution.Some studies measuring urine sodiumexcretion in people with type 1 (313) andtype 2 (314) diabetes have shown in-creased mortality associated with thelowest sodium intakes. A secondary anal-ysis of data from theOngoing TelmisartanAlone and in Combination With RamiprilGlobal Endpoint Trial (ONTARGET) sug-gests sodium excretions ,3 g/day and.7 g/day were both associated withincreased mortality in people withtype 2 diabetes (315), leading to contin-ued controversy over the potential ben-efits versus harms of lowering sodiumintake below the general recommenda-tion. In the absence of clear scientificevidence for benefit in people withcombined diabetes and hypertension(313,314), sodium intake goals thatare significantly lower than 2,300 mg/dayshould be considered only on an indi-vidual basis. When individualizing so-dium intake recommendations, carefulconsideration must be given to issuessuch as food preference, palatability,availability, and additional cost of freshor specialty low-sodium products (316).

Diabetic Kidney Disease

Consensus recommendation

c In individuals with diabetes andnon–dialysis-dependent diabetickidney disease (DKD), reducing

the amount of dietary protein be-low the recommended daily allow-ance (0.8 g/kg body weight/day)does not meaningfully alter glyce-mic measures, cardiovascular riskmeasures, or the course of glomer-ular filtration rate decline and mayincrease risk for malnutrition.

Are protein needs different for peoplewith diabetes and kidney disease?Historically, low-protein eating planswere advised to reduce albuminuriaand progression of chronic kidney dis-ease in people with DKD, typically withimprovements in albuminuria but noclear effect on estimated glomerularfiltration rate. In addition, there issome indication that a low-protein eatingplan may lead to malnutrition in individ-uals with DKD (317–321). The averagedaily level of protein intake for peoplewith diabetes without kidney disease istypically 1–1.5 g/kg body weight/day or15–20% of total calories (45,146). Evi-dence does not suggest that people withDKD need to restrict protein intake toless than the average protein intake.

For people with DKD and macroalbu-minuria, changing to a more soy-basedsource of protein may improve CVD riskfactors but does not appear to alterproteinuria (322,323).

Gastroparesis

Consensus recommendations

c Selection of small-particle-size foodsmay improve symptoms of diabetes-related gastroparesis.

c Correcting hyperglycemia is onestrategy for the management ofgastroparesis, as acute hyperglyce-mia delays gastric emptying.

c Use of CGM and/or insulin pumptherapy may aid the dosing andtiming of insulin administration inpeople with type 1 or type 2 di-abetes with gastroparesis.

How is diabetic gastroparesis bestmanaged?Consultation by an RDN knowledgeablein the management of gastroparesis ishelpful in setting and maintaining treat-ment goals (324). Treatment goals in-cludemanaging and reducing symptoms;correcting fluid, electrolyte, and nu-tritional deficiencies and glycemic

imbalances; and addressing the precip-itating cause(s) with appropriate drugtherapy (227). Correcting hyperglycemiais one strategy for the management ofgastroparesis, as acute hyperglycemiadelays gastric emptying (325,326). Mod-ification of food and beverage intake isthe primary management strategy, es-pecially among individuals with mildsymptoms.

People with gastroparesis may find ithelpful to eat small, frequent meals.Replacing solid food with a greater pro-portion of liquid calories to meet indi-vidualized nutrition requirements maybe helpful because consuming solidfood in large volumes is associatedwith longer gastric emptying times(327,328). Large meals can also decreasethe loweresophageal sphincter pressure,whichmay cause gastric reflux, providingfurther aggravation (327).

Results from an RCT demonstrated eat-ing plans that emphasize small-particle-size (,2 mm) foods may reduceseverity of gastrointestinal symptoms(329). Small-particle-size food is definedas “food easy to mash with a fork intosmall particle size.” High-fiber foods,such as whole intact grains and foodswith seeds, husks, stringy fibers, andmembranes, should be excluded fromthe eating plan. Many of the foodstypically recommended for people withdiabetes, such as leafy green salads, rawvegetables, beans, and fresh fruits, andother food like fatty or tough meat, canbe some of the most difficult foods forthe gastroparetic stomach to grind andempty (324,329). Notably, the majorityof nutrition therapy interventions forgastroparesis are based on the knowl-edge of the pathophysiology and clin-ical judgment rather than empiricalresearch (227).

The use of an insulin pump is anotheroption for individuals with type 1 di-abetes and insulin-requiring type 2 di-abetes with gastroparesis (330). A smallbut positive 12-month trial reported a1.8% reduction in A1C and decreasedhospitalizations with insulin pump use(331). An insulin pump can be used toprovide consistent basal insulin infusion,as well as the ability to modify mealtimeinsulin delivery doses as needed. Thevariable bolus feature allows the userto administer a portion of themeal bolusin an extended fashion over a longerperiod of time (227). Use of this feature

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may help to decrease the risk of post-prandial hyperglycemia as well as hypo-glycemia.

How is the risk of malnutrition indiabetic gastroparesis managed?When an individual with gastroparesisfalls below target weight, nutrition sup-port in the form of oral (for acute exac-erbation of symptoms), enteral, orparenteral nutrition should be consid-ered (327). A 5% unintentional loss ofusual body weight over 3 months or 10%loss over 6 months is indicative of se-vere malnutrition. Other nutritional riskparameters include weight ,80% ofideal weight, BMI ,20 kg/m2, or aloss of 5 lb or 2.5% of baseline weightin 1 month.

PERSONALIZED NUTRITION

Consensus recommendation

c Studies using personalized nutri-tion approaches to examinegenetic, metabolomic, and micro-biome variations have not yetidentified specific factors that con-sistently improve outcomes intype 1 diabetes, type 2 diabetes, orprediabetes.

Do genetic, metabolomic, ormicrobiome variants, or other types ofpersonalized nutrition prescriptions,influence glycemic or other diabetes-related outcomes?Currently, use of nutrition counselingapproaches aimed at personalizing guid-ancebasedongenetic,metabolomic, andmicrobiome information is an area ofintense research. Testing has becomeavailable commercially, with direct-to-consumer advertising. Some intriguingresearch has shown, for example, thewide interpersonal variability in bloodglucose response to standardized mealsthat could be predicted by clinical andmicrobiome profiles (332). At this point,however, no clear conclusions can bedrawn regarding their utility owing towide variations in the markers used forpredicting outcomes, in the populationsand nutrients studied, and in the asso-ciations found.Further, overall findings tend to sup-

port evidence from existing clinical trialsand observational studies showing thatpeople with markers indicating higher

risk for diabetes, prediabetes, or insulinresistance have lower risk when theyreduce calorie, carbohydrate, or satu-rated fat intake and/or increase fiberor protein intake compared with theirpeers (333–337).

CONCLUSIONS

Ideally, aneatingplan shouldbedevelopedin collaboration with the person with pre-diabetes or diabetes and an RDN throughparticipation in diabetes self-managementeducation when the diagnosis of pre-diabetes or diabetes is made. Nutritiontherapy recommendations need to beadjusted regularly based on changes inan individual’s life circumstances, prefer-ences, and disease course (1). Regularfollow-up with a diabetes health careprovider is also critical to adjust otheraspectsofthetreatmentplanas indicated.

One of the most commonly askedquestions upon receiving a diagnosisof diabetes is “What can I eat?” Despitewidespread interest in evidence-baseddiabetes nutrition therapy interventions,large, well-conducted nutrition trialscontinue to lag far behind other areasof diabetes research. Unfortunately, na-tional data indicate that most peoplewith diabetes do not receive any nutri-tion therapy or formal diabetes educa-tion (4,9,16,20).

Strategies to improve access, clinicaloutcomes, and cost effectiveness includethe following

c reducing barriers to referrals and al-lowing self-referrals to MNT andDSMES;

c providing in-person or technology-enabled diabetes nutrition therapyandeducation integratedwithmedicalmanagement (9,12,13,15,16,19,22,291–293,338–342);

c engineering solutions that includetwo-way communication betweenthe individual and his or her healthcare team to provide individualizedfeedback and tailored education basedon the analyzed patient-generatedhealth data (38,264,343);

c increasing the use of communityhealth workers and peer coaches toprovide culturally appropriate, ongo-ing support and clinically linked carecoordination and improve the reachof MNT and DSMES (15,19,23,38,343,344).

Evaluating nutrition evidence is com-plex given that multiple dietary factorsinfluence glycemic management andCVD risk factors, and the influenceof a combination of factors can be sub-stantial. Based on a review of the evi-dence, it is clear that knowledge gapscontinue to exist and further research onnutrition and eating patterns is neededin individuals with type 1 diabetes, type 2diabetes, and prediabetes. Future stud-ies should address

c the impact of different eating pat-terns compared with one another,controlling for supplementary advice(such as stress reduction, physicalactivity, or smoking cessation);

c the impact of weight loss on otheroutcomes (which eating plans arebeneficial only with weight loss, whichcan show benefit regardless of weightloss);

c how cultural or personal preferences,psychological supports, co-occurringconditions, socioeconomic status, foodinsecurity, and other factors impactbeing consistent with an eating planand its effectiveness;

c the need for increased length and sizeof studies, to better understand long-term impacts on clinically relevantoutcomes;

c tailoring MNT and DSMES to differentracial/ethnic groups and socioeco-nomic groups;

c comparisons of different deliverymethods aided by technology (e.g.,mobile technology, apps, social me-dia, technology-enabled and internet-based tools); and

c ongoing cost-effectiveness studiesthat will further support coverageby third-party payers or bundlingservices into evolving value-basedcare and payment models.

Acknowledgments. The authors acknowledgeMindy Saraco (Managing Director, Medical Af-fairs, ADA) for her help with the developmentof the Consensus Report. The authors thankMargaret Powers for providing her expertisein reviewing and/or consulting with the authors,Melinda Maryniuk for serving as a liaison to theADA Professional Practice Committee (PPC), andthe PPC for providing valuable review and feed-back. The authors acknowledge the invited peerreviewers who provided comments on an earlierdraft of this report: Kelli Begay (Indian Health

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Service, Rockville,MD), Guoxun Chen (Universityof Tennessee, Knoxville, TN), Frank Hu (HarvardT.H. Chan School of Public Health, Boston, MA),Melinda Maryniuk (Maryniuk & Associates Di-abetes and Nutrition Consultants, Jamaica Plain,MA),Margaret Powers (HealthPartners Institute,Minneapolis, MN), Judith Wylie-Rosett (AlbertEinstein College of Medicine, Bronx, NY), AlyceThomas (St. Joseph’s Health, Paterson, NJ), EmilyWeatherup (Michigan Medicine, University ofMichigan, Ann Arbor, MI), and Gretchen Youssef(MedStar Health, Washington, DC).Duality of Interest. The authors disclosed allpotential financial conflicts of interest withindustry. These disclosures were discussed atthe onset of the consensus statement devel-opment process. The ADA uses general rev-enues to fund development of its consensusreports and does not rely on industry supportfor these purposes. A.B.E. reports honorariumfrom the Academy of Nutrition and Dieteticsand the ADA outside of the submitted work.W.T.G. reports personal fees from Novo Nor-disk, Merck, Amgen, Gilead, BOYDSense, theAmerican Medical Group Association, and Jans-sen and grants from Sanofi, Pfizer, Merck, andNovo Nordisk outside of the submitted work.K.H.K.L. reports personal fees from SunstarFoundation outside of the submitted work.J.Mi. reports speaking fees from New EnglandDairy and Dairy Farmer, research support andconsulting/speaking fees from the National DairyCouncil, and research support from Kowa Com-pany and the National Institutes of Health out-side of the submitted work. K.R. was previouslyemployed by the ADA. L.S. reports grants fromthe National Institutes of Health and internalUniversity ofMichigan grants.W.S.Y. reports a con-sulting relationship with dietdoctor.com, whichbegan after the Consensus Report was sub-mitted to Diabetes Care. No other potentialconflicts of interest relevant to this articlewere reported.Author Contributions. All authors were re-sponsible for drafting the Consensus Report andrevising it critically for important intellectualcontent. All authors approved the version tobe published.

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