Guideline:
Diabetes type 1 and 2 evidence-based nutrition practice guideline for adults
Bibliographic Source(s)
- American Dietetic Association (ADA). Diabetes type 1 and 2 evidence-based nutrition practice guideline for adults. Chicago (IL): American Dietetic Association (ADA); 2008. Various p. [206 references]
Guideline Status
This is the current release of the guideline.
This guideline updates a previous version: American Dietetic Association. Nutrition practice guidelines for type 1 and type 2 diabetes mellitus. Chicago (IL): American Dietetic Association; 2001 Dec. Various p.
The guideline will undergo a complete revision every three to five years.
Guideline Category
Assessment of Therapeutic Effectiveness
Counseling
Evaluation
Management
Treatment
Intended Users
Advanced Practice Nurses
Dietitians
Health Care Providers
Nurses
Pharmacists
Physician Assistants
Physicians
Students
Guideline Objective(s)
Overall Objectives
- To help dietetic practitioners patients and consumers make shared decisions about health care choices in specific clinical circumstances
- To provide evidence-based recommendations for effective medical nutrition therapy (MNT) in the management of type 1 and type 2 diabetes in adults that assist in the normalization and maintenance of glycemia lipid profiles and blood pressure
Specific Objectives
- To define evidence-based diabetes nutrition recommendations for registered dieticians (RDs) that are carried out in collaboration with other health care providers
- To guide practice decisions that integrate medical nutritional and behavioral strategies
- To reduce variations in practice among RDs
- To promote self-management strategies that empower the adult with diabetes to take responsibility for day-to-day management
- To provide the RD with data to make recommendations to adjust MNT or recommend other therapies to achieve desired outcomes
- To enhance the quality of life for the adult with diabetes utilizing customized strategies based on the individual's preferences lifestyle and goals
- To develop guidelines for interventions that have measurable clinical outcomes
- To define the highest quality of care within cost constraints of the current health care environment
Target Population
Adults (>19 years) with type 1 or type 2 diabetes mellitus
Interventions and Practices Considered
Diagnosis/Evaluation
- Referral to a registered dietitian
- Nutritional assessment
- Medical/health history
- Medication and supplement history
- Social history
- Personal history
- Biochemical data
- Anthropometric measurements
- Height weight body mass index (BMI) waist circumference
- Weight change rate
- Food and nutrition history
- Food intake
- Nutrition and health awareness
- Physical activity and exercise
- Food availability
- Psychosocial and economic issues impacting nutrition therapy
- Consideration of comorbid conditions and need for additional modifications in nutrition care plan
Management/Treatment
- Individualized prescription for medical nutrition therapy based on:
- Food/nutrition intervention
- Physical activity interventions
- Behavioral interventions
- Pharmacotherapy when indicated
Major Outcomes Considered
- Morbidity
- Mortality
- Quality of life
- Lipid and lipoprotein levels
- Serum blood glucose level
- Hemoglobin A1C level
- Blood pressure
- Weight loss
- Incidence of cardiovascular disease
- Cost of medical care
Methods Used to Collect/Select Evidence
Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
Searches of PubMed and CENTRAL databases and hand searches of other relevant literature were performed on the following topics:
- Process for providing medical nutrition therapy (MNT) for adults with diabetes
- Carbohydrate -- distribution/amount sucrose glycemic index fiber
- Protein
- Blood glucose monitoring
- Prevention and treatment of cardiovascular disease
- Weight management
- Physical activity
General Exclusion Criteria
As a general rule studies are excluded if the:
- Study sample size is less than 10 in each treatment group
- Drop-out rate was >20%
Inclusion Criteria
- Study design preferences: randomised controlled trials or clinical controlled studies large nonrandomized observational studies and cohort case-control studies
- Limited to articles in English
The American Dietetic Association (ADA) has determined that for narrowly focused questions dealing with therapy or treatment six well designed randomized controlled trials that demonstrate similar results is sufficient to draw a conclusion.
No one study design was preferred for all questions. The preferred study design depended on the type of question. The ADA uses the following principles in the table below for identifying preferred study design.
| Type of Question | Preferred Study Designs (in order of preference) |
|---|---|
| Diagnosis questions | Sensitivity & specificity of diagnostic test Cross-sectional study |
| Etiology causation or harm questions | Prospective Cohort Case Control Study Cross-sectional study |
| Therapy and prevention questions | Randomized controlled trial Nonrandomized trial |
| Natural history and prognosis questions | Cohort study |
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Grading the Strength of the Evidence for a Conclusion Statement or Recommendation Conclusion Grading Table
| Strength of Evidence Elements | Grade I Good/Strong |
Grade II Fair |
Grade III Limited/Weak |
Grade IV Expert Opinion Only |
Grade V Grade Not Assignable |
|---|---|---|---|---|---|
Quality
|
Studies of strong design for question Free from design flaws bias and execution problems |
Studies of strong design for question with minor methodological concerns OR Only studies of weaker study design for question |
Studies of weak design for answering the question OR Inconclusive findings due to design flaws bias or execution problems |
No studies available Conclusion based on usual practice expert consensus clinical experience opinion or extrapolation from basic research |
No evidence that pertains to question being addressed |
| Consistency Of findings across studies |
Findings generally consistent in direction and size of effect or degree of association and statistical significance with minor exceptions at most | Inconsistency among results of studies with strong design OR Consistency with minor exceptions across studies of weaker designs |
Unexplained inconsistency among results from different studies OR Single study unconfirmed by other studies |
Conclusion supported solely by statements of informed nutrition or medical commentators | NA |
Quantity
|
One to several good quality studies Large number of subjects studies Studies with negative results having sufficiently large sample size for adequate statistical power |
Several studies by independent investigators Doubts about adequacy of sample size to avoid Type I and Type II error |
Limited number of studies Low number of subjects studies and/or inadequate sample size within studies |
Unsubstantiated by published studies | Relevant studies have not been done |
Clinical Impact
|
Studied outcome relates directly to the question Size of effect is clinically meaningful Significant (statistical) difference is large |
Some doubt about the statistical or clinical significance of effect | Studies outcome is an intermediate outcome or surrogate for the true outcome of interest OR Size of effect is small or lacks statistical and/or clinical significance |
Objective data unavailable | Indicates area for future research |
| Generalizability To population of interest |
Studied population intervention and outcomes are free from serious doubts about generalizability | Minor doubts about generalizability | Serious doubts about generalizability due to narrow or different study population intervention or outcomes studied | Generalizability limited to scope of experience | NA |
This grading system was based on the grading system from: Greer N Mosser G Logan G Wagstrom Halaas G. A practical approach to evidence grading. Jt Comm. J Qual Improv. 2000; 26:700-712. In September 2004 The ADA Research Committee modified the grading system to this current version.
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Step 1: Formulate the question
Specify a question in a defined area of practice; or state a tentative conclusion or recommendation that is being considered. Include the patient type and special needs of the target population involved the alternatives under consideration and the outcomes of interest.
Step 2: Gather and classify evidence reports
Conduct a systematic search of the literature to find evidence related to the question gather studies and reports and classify them by type of evidence. Classes differentiate primary reports of new data according to study design and distinguish them from reports that are a systematic review and synthesis of primary reports.
Step 3: Critically appraise each report
Review each report for relevance to the question and critique for scientific validity. Abstract key information from the report and assign a code to indicate the quality of the study by completing quality criteria checklist.
Step 4: Summarize evidence in a narrative and an overview table
Combine findings from all reports in a table that pulls out the important information from the article worksheets. Write a brief narrative that summarizes and synthesizes the information abstracted from the articles that is related to the question asked.
Step 5: Develop a conclusion statement and grade the strength of evidence supporting the conclusion
Develop a concise conclusion statement (the answer to the question) taking into account the synthesis of all relevant studies and reports their class and their quality ratings. Assign a grade to indicate the overall strength or weakness of evidence informing the conclusion statement.
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
The expert workgroup which includes practitioners and researchers with a depth of experience in the specific field of interest develops the disease-specific guideline. The guideline development involves the following steps.
Review Evidence Based Conclusions
The workgroup meets to review the materials resulting from the evidence analysis which may include review of the conclusion statements evidence summaries and evidence worksheets.
Formulate Recommendations for the Guideline Integrating Conclusions from Evidence Analysis
The work group uses an expert consensus method to formulate recommendations taking into account the following:
- Recommendations for what the dietitian should do and why
- Rating of recommendations based on strength of supporting evidence
- Label of Conditional (clearly define a specific situation) or Imperative (broadly applicable to the target population without restraints on the pertinence)
- Risks and Harms of Implementing the Recommendations including potential risks harms or adverse consequences
- Conditions of Application including organizational barriers or conditions that may limit application
- Potential Costs Associated with Application
- Recommendation Narrative
- Recommendation Strength Rationale evidence strength and methodological issues
- Minority Opinions when the expert working group cannot reach consensus on a recommendation
- Supporting Evidence
Rating Scheme for the Strength of the Recommendations
Criteria for Recommendation Rating
| Statement Rating | Definition | Implication for Practice |
|---|---|---|
| Strong | A Strong recommendation means that the workgroup believes that the benefits of the recommended approach clearly exceed the harms (or that the harms clearly exceed the benefits in the case of a strong negative recommendation) and that the quality of the supporting evidence is excellent/good (grade I or II)*. In some clearly identified circumstances strong recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms. | Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. |
| Fair | A Fair recommendation means that the workgroup believes that the benefits exceed the harms (or that the harms clearly exceed the benefits in the case of a negative recommendation) but the quality of evidence is not as strong (grade II or III)*. In some clearly identified circumstances recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits outweigh the harms. | Practitioners should generally follow a Fair recommendation but remain alert to new information and be sensitive to patient preferences. |
| Weak | A Weak recommendation means that the quality of evidence that exists is suspect or that well-done studies (grade I II or III)* show little clear advantage to one approach versus another. | Practitioners should be cautious in deciding whether to follow a recommendation classified as Weak and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. |
| Consensus | A Consensus recommendation means that Expert opinion (grade IV)* supports the guideline recommendation even though the available scientific evidence did not present consistent results or controlled trials were lacking. | Practitioners should be flexible in deciding whether to follow a recommendation classified Consensus although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. |
| Insufficient Evidence | An Insufficient Evidence recommendation means that there is both a lack of pertinent evidence (grade V)* and/or an unclear balance between benefits and harms. | Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Insufficient Evidence and should exercise judgment and be alert to emerging publications that report evidence that clarifies the balance of benefit versus harm. Patient preference should have a substantial influencing role. |
*Conclusion statements are assigned a grade based on the strength of the evidence. Grade I is good; grade II fair; grade III limited; grade IV signifies expert opinion only and grade V indicates that a grade is not assignable because there is no evidence to support or refute the conclusion. The evidence and these grades are considered when assigning a rating (Strong Fair Weak Consensus Insufficient Evidence - see chart above) to a recommendation.
Adapted by the American Dietetic Association from the American Academy of Pediatrics Classifying Recommendations for Clinical Practice Guideline Pediatrics. 2004;114;874-877.
Cost Analysis
An analysis was performed of potential costs associated with application of the recommendations in the guideline.
Although costs of medical nutrition therapy (MNT) sessions and reimbursement vary MNT sessions are essential for improved outcomes. MNT education can be considered cost effective when considering the benefits of nutrition interventions on the onset and progression of comorbidities versus the cost of the intervention. Furthermore MNT can be considered cost effective as interventions for prevention or delay of type 2 diabetes saves the cost of the intervention.
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation
Each guideline is reviewed internally and externally using the AGREE (Appraisal of Guidelines for Research and Evaluation) instrument as the evaluation tool. The external reviewers consist of a multidisciplinary group of individuals (may include dietitians doctors psychologists pharmacists nurses etc.). The review is done electronically. The guideline is adjusted by consensus of the expert panel and approved by American Dietetic Association's Evidence-Based Practice Committee prior to publication on the Evidence Analysis Library (EAL).
Major Recommendations
Ratings for the strength of the recommendations (Strong Fair Weak Consensus Insufficient Evidence) conclusion grades (I-V) and statement labels (Conditional versus Imperative) are defined at the end of "Major Recommendations."
Diabetes Mellitus (DM): Medical Nutrition Therapy (MNT)
DM: MNT and Number/Length of Initial Series of Encounters
MNT provided by a registered dietitian (RD) is recommended for individuals with type 1 and type 2 diabetes. An initial series of three to four encounters each lasting from 45 to 90 minutes is recommended. This series beginning at diagnosis of diabetes or at first referral to an RD for MNT for diabetes should be completed within three to six months. The RD should determine if additional MNT encounters are needed after the initial series based on the nutrition assessment of learning needs and progress towards desired outcomes. Studies based on a range in the number (1 to 5 individual sessions or a series of 6 to 12 group sessions) and length (45 to 90 minutes) report sustained positive outcomes at one year and longer. Studies implementing a variety of nutrition interventions report a reduction in A1C levels and some studies also report improved lipid profiles improved weight management adjustments in medications and reduction in the risk for onset and progression of comorbidities.
Strong Imperative
DM: MNT Long-Term Follow-up Encounters
At least one follow-up encounter is recommended annually to reinforce lifestyle changes and to evaluate and monitor outcomes that impact the need for changes in MNT or medication. The RD should determine if additional MNT encounters are needed. Studies involving regular lifestyle intervention sessions (up to 1 per month) report sustained positive outcomes at one year and longer.
Strong Imperative
Recommendations Strength Rationale
- Conclusion statement was Grade I
DM: Assessment and Diabetes
DM: Nutrition Assessment
The RD should assess food intake (focusing on carbohydrate) medication metabolic control (glycemia lipids and blood pressure) anthropometric measurements and physical activity to serve as the basis for implementation of the nutrition prescription goals and intervention. Individuals who have diabetes should receive MNT tailored by the RD.
Strong Imperative
Recommendations Strength Rationale
- Conclusion statement was Grade I
DM: Assessment of Glycemic Control
Assessment of Glycemic Control
The RD should assess glycemic control and focus medical nutrition therapy to achieve and maintain blood glucose levels in the target range (target glucose levels noted in the American Diabetes Association Standards of Medical Care in Diabetes). Studies evaluating the effectiveness of diabetes MNT at three to six months reported reductions in A1C ranging from 0.25% to 2.9%.
Strong Imperative
Recommendation Strength Rationale
- Conclusion statement was Grade I
DM: Assess Relative Importance of Weight Management
Assess Relative Importance of Weight Management
The RD should assess the relative importance of weight management for persons with diabetes who are overweight or obese. While modest weight loss has been shown to improve insulin resistance in overweight and obese insulin-resistant individuals research on sustained weight loss interventions lasting 1 year or longer reported inconsistent effects on A1C.
Strong Conditional
Recommendation Strength Rationale
- Conclusion statement was Grade II
DM: Intervention Options
Intervention Options
The RD should implement MNT selecting from a variety of interventions (reduced energy and fat intake carbohydrate counting simplified meal plans healthy food choices individualized meal planning strategies exchange lists insulin-to-carbohydrate ratios physical activity and behavioral strategies). Nutrition education and counseling should be sensitive to the personal needs willingness to change and ability to make changes of the individual with diabetes. Studies reporting on effectiveness of MNT report a variety in the number and type of MNT sessions that lead to improved outcomes.
Strong Imperative
Recommendation Strength Rationale
- Conclusion statement was Grade I
DM: Macronutrients
Macronutrient Percentages
The RD should encourage consumption of macronutrients based on the Dietary Reference Intakes (DRI) for healthy adults. Research does not support any ideal percentage of energy from macronutrients for persons with diabetes.
Strong Imperative
Recommendation Strength Rationale
- Conclusion statement for Carbohydrate was Grade I
- Conclusion statement for Protein was Grade II
DM: Carbohydrate
DM: Carbohydrate Intake Consistency
In persons on either MNT alone glucose-lowering medications or fixed insulin doses meal and snack carbohydrate intake should be kept consistent on a day-to-day basis. Consistency in carbohydrate intake results in improved glycemic control.
Strong Conditional
Carbohydrate Intake and Insulin Dose Adjustment
In persons with type 1 or type 2 diabetes who adjust their mealtime insulin doses or who are on insulin pump therapy insulin doses should be adjusted to match carbohydrate intake (insulin-to-carbohydrate ratio). This can be accomplished by comprehensive nutrition education and counseling on interpretation of blood glucose patterns nutrition-related medication management and collaboration with the healthcare team. Adjusting insulin dose based on planned carbohydrate intake improves glycemic control and quality of life without any adverse effects.
Strong Conditional
Recommendation Strength Rationale
- Conclusion statement was Grade I
DM: Sucrose and Diabetes
DM: Sucrose Intake
If persons with diabetes choose to eat foods containing sucrose the sucrose-containing foods should be substituted for other carbohydrate foods. Sucrose intakes of 10 to 35 percent of total energy intake do not have a negative effect on glycemic or lipid responses when substituted for isocaloric amounts of starch.
Strong Conditional
Recommendation Strength Rationale
- Conclusion statement was Grade I
DM: Non-nutritive Sweeteners and Diabetes
DM: Non-nutritive Sweeteners
If persons with diabetes choose to consume products containing U.S. Food and Drug Administration (FDA)-approved non-nutritive sweeteners at levels that do not exceed the acceptable daily intakes (ADIs) the RD should advise that some of these products may contain energy and carbohydrate from other sources that needs to be accounted for. Research on non-nutritive sweeteners reports no effect on changes in glycemic response.
Fair Conditional
Recommendation Strength Rationale
- Conclusion statements were Grade III
DM: Glycemic Index and Diabetes
DM: Glycemic Index
If the use of glycemic index (GI) is proposed as a method of meal planning the RD should advise on the conflicting evidence of effectiveness of this strategy. Studies comparing high versus low GI diets report mixed effects on A1C.
Fair Conditional
Recommendation Strength Rationale
- Conclusion statement was Grade II
DM: Fiber and Diabetes
DM: Fiber Intake and Glycemia
Recommendations for fiber intake for people with diabetes are similar to the recommendations for the general public (daily reference intake [DRI]: 14 grams per 1000 kilocalories [kcal]). While diets containing 44 to 50 grams of fiber daily are reported to improve glycemia more usual fiber intakes (up to 24 grams daily) have not shown beneficial effects on glycemia. It is unknown if free-living individuals can daily consume the amount of fiber needed to improve glycemia.
Strong Imperative
DM: Fiber Intake and Cholesterol
Include foods containing 25 to 30 grams of fiber per day with special emphasis on soluble fiber sources (7 to 13 grams). Diets high in total and soluble fiber as part of cardioprotective nutrition therapy can further reduce total cholesterol by 2% to 3% and low-density lipoprotein (LDL) cholesterol up to 7%.
Strong Imperative
Recommendation Strength Rationale
- Conclusion statement for Fiber and Diabetes was Grade I
- Conclusion statement for Fiber and Coronary Heart Disease (CHD) were Grades I II and III
DM: Protein and Diabetes
DM: Protein Intake and Normal Renal Function
In persons with type 1 or type 2 diabetes with normal renal function the RD should advise that usual protein intake of approximately 15% to 20% of daily energy intake does not need to be changed. Although protein has an acute effect on insulin secretion usual protein intake in long-term studies has minimal effects on glucose lipids and insulin concentrations.
Fair Conditional
Protein Intake and Nephropathy
In persons with diabetic nephropathy a protein intake of one gram or less per kg body weight per day is recommended. Diets with less than one gram protein per kg body weight per day have been shown to improve albuminuria in persons with nephropathy; however they have not been shown to have significant effects on glomerular filtration rates (GFR).
Fair Conditional
DM: Protein Intake and Late Stage Nephropathy
For persons with late stage diabetic nephropathy (Chronic Kidney Disease [CKD] Stages 3-5) hypoalbuminemia (an indicator of malnutrition) and energy intake must be monitored and changes in protein and energy intake made to correct deficits. A protein intake of approximately 0.7 grams per kg body weight per day has been associated with hypoalbuminemia whereas a protein intake of approximately 0.9 grams per kg body weight per day has not.
Fair Conditional
Recommendation Strength Rationale
- Conclusion statement is Grade II
DM: Glucose Monitoring
DM: Blood Glucose Monitoring
For individuals on nutrition therapy alone or nutrition therapy in combination with glucose-lowering medications self-monitoring of blood glucose (SMBG) is recommended. Frequency and timing is dependent on diabetes management goals and therapies (i.e. MNT diabetes medications and physical activity). When SMBG is incorporated into diabetes education programs and the information from SMBG is used to make changes in diabetes management SMBG is associated with improved glycemic control.
Fair Conditional
DM: Frequency of Blood Glucose Monitoring
For persons with type 1 or type 2 diabetes on insulin therapy at least three to eight blood glucose tests per day are recommended to determine the adequacy of the insulin dose(s) and guide adjustments in insulin dose(s) food intake and physical activity. Some insulin regimens require more testing to establish the best integrated therapy (insulin food and activity). Once established some insulin regimens will require less frequent self-monitoring of blood glucose (SMBG). Intervention studies that include self-management training and adjustment of insulin doses based on SMBG result in improved glycemic control.
Strong Conditional
DM: Possible Need for Continuous Glucose Monitoring or More Frequent SMBG
Persons experiencing unexplained elevations in A1C or unexplained hypoglycemia and hyperglycemia may benefit from use of continuous glucose monitoring (CGM) or more frequent SMBG. It is essential that persons with diabetes receive education as to how to calibrate CGM and how to interpret CGM results. Studies have proven the accuracy of CGM and most show that using the trend/pattern data from CGM can result in less glucose variability and improved glucose control.
Fair Conditional
Recommendation Strength Rationale
- Conclusion statements were Grades I and II
DM: Prevention and Treatment of CVD
DM: CVD and Cardioprotective Nutrition Therapy
Cardioprotective nutrition interventions for the prevention and treatment of CVD should be implemented in the initial series of encounters. Diabetes is associated with an increased risk for CVD and glycemic control may improve the lipid profile.
Strong Imperative
CVD and Cardioprotective Nutrition Interventions
Cardioprotective nutrition interventions for prevention and treatment of CVD include reduction in saturated and trans fats and dietary cholesterol and interventions to improve blood pressure. Studies in persons with diabetes utilizing these interventions report a reduction in cardiovascular risk and improved cardiovascular outcomes.
Strong Imperative
Recommendation Strength Rationale
- Conclusion statement was Grade I
DM: Weight Management
DM: Diabetes and Weight Management
The RD should advise that glycemic control is the primary focus for diabetes management. While decreasing energy intake may improve glycemic control it is unclear whether weight loss alone will improve glycemic control. Sustained weight loss interventions lasting 1 year or longer reported inconsistent effects on hemoglobin A1C.
Fair Conditional
Recommendation Strength Rationale
- Conclusion statement was Grade II
DM: Physical Activity
DM: Type 2 Diabetes and Physical Activity
In persons with type 2 diabetes 90 to 150 minutes of accumulated moderate-intensity aerobic physical activity per week as well as resistance/strength training three times per week is recommended. Both aerobic and resistance training improve glycemic control independent of weight loss. Physical activity also improves insulin sensitivity and decreases risk for cardiovascular disease and all-cause mortality.
Strong Conditional
DM: Type 1 Diabetes and Physical Activity
Individuals with type 1 diabetes should be encouraged to engage in regular physical activity. Although exercise is not reported to improve glycemic control in persons with type 1 diabetes individuals may receive the same benefits from exercise as the general public—decreased risk for cardiovascular disease and improved sense of well-being.
Fair Conditional
DM: Physical Activity and Insulin/Insulin Secretagogue Use
The RD should instruct individuals on insulin or insulin secretagogues on the safety guidelines to prevent hypoglycemia (frequent blood glucose monitoring and possible adjustment in insulin dose or carbohydrate intake). Research indicates that the incidence of hypoglycemia during exercise may depend on baseline glucose levels.
Fair Conditional
Recommendation Strength Rationale
- Conclusion statements were Grades I and II
DM: Coordination of Care and Diabetes
DM: Coordination of Care
The RD should implement MNT and coordinate care with an interdisciplinary team. An interdisciplinary team approach is necessary to integrate MNT for patients with diabetes into overall management.
Consensus Imperative
Recommendation Strength Rationale
- Conclusion statement was Grade I
DM: Monitor & Evaluate and Diabetes
DM: Monitoring and Evaluation
The RD should monitor and evaluate food intake medication metabolic control (glycemia lipids and blood pressure) anthropometric measurements and physical activity. Research reports sustained improvements in A1C at 12 months and longer with long-term follow-up encounters with an RD.
Strong Imperative
DM: Evaluation of Glycemic Control
The RD should primarily use blood glucose monitoring results in evaluating the achievement of goals and effectiveness of MNT. Glucose monitoring results can be used to determine whether adjustments in foods and meals will be sufficient to achieve blood glucose goals or if medication additions or adjustments need to be combined with MNT.
Consensus Imperative
Recommendation Strength Rationale
- Conclusion statement for MNT was Grade I
Definitions:
Conditional versus Imperative Recommendations
Recommendations can be worded as conditional or imperative statements. Conditional statements clearly define a specific situation while imperative statements are broadly applicable to the target population without restraints on their pertinence. More specifically a conditional recommendation can be stated in if/then terminology (e.g. If an individual does not eat food sources of omega-3 fatty acids then 1g of EPA and DHA omega-3 fatty acid supplements may be recommended for secondary prevention).
In contrast imperative recommendations "require" or "must" or "should achieve certain goals" but do not contain conditional text that would limit their applicability to specified circumstances. (e.g. Portion control should be included as part of a comprehensive weight management program. Portion control at meals and snacks results in reduced energy intake and weight loss).
Levels of Evidence
| Strength of Evidence Elements | Grade I Good/Strong |
Grade II Fair |
Grade III Limited/Weak |
Grade IV Expert Opinion Only |
Grade V Grade Not Assignable |
|---|---|---|---|---|---|
Quality
|
Studies of strong design for question Free from design flaws bias and execution problems |
Studies of strong design for question with minor methodological concerns OR Only studies of weaker study design for question |
Studies of weak design for answering the question OR Inconclusive findings due to design flaws bias or execution problems |
No studies available Conclusion based on usual practice expert consensus clinical experience opinion or extrapolation from basic research |
No evidence that pertains to question being addressed |
| Consistency Of findings across studies |
Findings generally consistent in direction and size of effect or degree of association and statistical significance with minor exceptions at most | Inconsistency among results of studies with strong design OR Consistency with minor exceptions across studies of weaker designs |
Unexplained inconsistency among results from different studies OR Single study unconfirmed by other studies |
Conclusion supported solely by statements of informed nutrition or medical commentators | NA |
Quantity
|
One to several good quality studies Large number of subjects studies Studies with negative results having sufficiently large sample size for adequate statistical power |
Several studies by independent investigators Doubts about adequacy of sample size to avoid Type I and Type II error |
Limited number of studies Low number of subjects studies and/or inadequate sample size within studies |
Unsubstantiated by published studies | Relevant studies have not been done |
Clinical Impact
|
Studied outcome relates directly to the question Size of effect is clinically meaningful Significant (statistical) difference is large |
Some doubt about the statistical or clinical significance of effect | Studies outcome is an intermediate outcome or surrogate for the true outcome of interest OR Size of effect is small or lacks statistical and/or clinical significance |
Objective data unavailable | Indicates area for future research |
| Generalizability To population of interest |
Studied population intervention and outcomes are free from serious doubts about generalizability | Minor doubts about generalizability | Serious doubts about generalizability due to narrow or different study population intervention or outcomes studied | Generalizability limited to scope of experience | NA |
This grading system was based on the grading system from: Greer N Mosser G Logan G Wagstrom Halaas G. A practical approach to evidence grading. Jt Comm. J Qual Improv. 2000; 26:700-712. In September 2004 The ADA Research Committee modified the grading system to this current version.
Criteria for Recommendation Rating
| Statement Rating | Definition | Implication for Practice |
|---|---|---|
| Strong | A Strong recommendation means that the workgroup believes that the benefits of the recommended approach clearly exceed the harms (or that the harms clearly exceed the benefits in the case of a strong negative recommendation) and that the quality of the supporting evidence is excellent/good (grade I or II)*. In some clearly identified circumstances strong recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms. | Practitioners should follow a Strong recommendation unless a clear and compelling rationale for an alternative approach is present. |
| Fair | A Fair recommendation means that the workgroup believes that the benefits exceed the harms (or that the harms clearly exceed the benefits in the case of a negative recommendation) but the quality of evidence is not as strong (grade II or III)*. In some clearly identified circumstances recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits outweigh the harms. | Practitioners should generally follow a Fair recommendation but remain alert to new information and be sensitive to patient preferences. |
| Weak | A Weak recommendation means that the quality of evidence that exists is suspect or that well-done studies (grade I II or III)* show little clear advantage to one approach versus another. | Practitioners should be cautious in deciding whether to follow a recommendation classified as Weak and should exercise judgment and be alert to emerging publications that report evidence. Patient preference should have a substantial influencing role. |
| Consensus | A Consensus recommendation means that Expert opinion (grade IV)* supports the guideline recommendation even though the available scientific evidence did not present consistent results or controlled trials were lacking. | Practitioners should be flexible in deciding whether to follow a recommendation classified Consensus although they may set boundaries on alternatives. Patient preference should have a substantial influencing role. |
| Insufficient Evidence | An Insufficient Evidence recommendation means that there is both a lack of pertinent evidence (grade V)* and/or an unclear balance between benefits and harms. | Practitioners should feel little constraint in deciding whether to follow a recommendation labeled as Insufficient Evidence and should exercise judgment and be alert to emerging publications that report evidence that clarifies the balance of benefit versus harm. Patient preference should have a substantial influencing role. |
*Conclusion statements are assigned a grade based on the strength of the evidence. Grade I is good; grade II fair; grade III limited; grade IV signifies expert opinion only and grade V indicates that a grade is not assignable because there is no evidence to support or refute the conclusion. The evidence and these grades are considered when assigning a rating (Strong Fair Weak Consensus Insufficient Evidence - see chart above) to a recommendation.
Adapted by the American Dietetic Association from the American Academy of Pediatrics Classifying Recommendations for Clinical Practice Guideline Pediatrics. 2004;114;874-877.
Clinical Algorithm(s)
Algorithms are provided in the original guideline document for:
- Diabetes type 1 and 2 evidence-based nutrition practice guideline for adults
- Diabetes nutrition assessment
- Diabetes nutrition diagnosis
- Diabetes nutrition intervention: nutrition prescription
- Diabetes nutrition monitoring and evaluation
Type of Evidence supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").
The guideline contains conclusion statements that are supported by evidence summaries and evidence worksheets. These resources summarize the important studies (randomized controlled trials (RCTs) clinical studies observational studies cohort and case-control studies) pertaining to the conclusion statement and provide the study details.
Potential Benefits
A primary goal of implementing these recommendations includes improving an adult's ability to achieve optimal nutrition through healthful food choices and a physically active lifestyle. Medical nutrition therapy employing either a series of individual or group sessions and employing a variety of nutrition interventions also report improvements in glycemia lipid profiles and blood pressure improved weight management decreased need for medications and reduction in the risk for onset and progression of comorbidities.
Potential Harms
Overall Risk/Harm Considerations
When using these recommendations:
- Review the patient's age socioeconomic status cultural issues and other health conditions.
- Consider a referral to a behavioral specialist if psychosocial issues are a concern.
- Consider a referral to social services to assist patients with financial arrangements if economic issues are a concern.
- Use clinical judgment when evaluating patients with long-standing diabetes and comorbid conditions.
Recommendation Specific Risks/Harms
Macronutrients
Carbohydrate
- Although total carbohydrate content of meals and snacks is the first priority macronutrient content and total energy intake cannot be ignored as excessive energy intake may lead to weight gain even if glycemic control is maintained.
- Diets too low in carbohydrates eliminate many foods that are important sources of vitamins minerals fiber and energy.
Sucrose
- Excessive substitution of sucrose for starches could potentially contribute to inadequate intake of foods contributing other essential nutrients. If sucrose-containing foods are habitually added to usual intake excessive energy intake is a concern.
Protein
- Diets too low in protein and energy intake can lead to hypoalbuminemia (malnutrition) and unintentional weight loss. This needs to be monitored in persons with diabetic neuropathy who are restricting protein intake and may have a diminished appetite.
Self-Monitoring of Blood Glucose
- Frequent glucose self-monitoring may cause pain and discomfort
- Individuals should know of proper disposal of hazardous waste.
Physical Activity
- Before beginning a program of physical activity more vigorous than brisk walking people with diabetes should be assessed for conditions that might be associated with an increased risk of cardiovascular disease. Of concern are uncontrolled hypertension severe autonomic or peripheral neuropathy and preproliferative or proliferative retinopathy or macular edema.
- In previously sedentary individuals whose 10-year risk of a coronary event is likely to be equal to or greater than 10% a graded exercise test with electrocardiogram monitoring is recommended.
- In individuals taking insulin or insulin secretagogues physical activity can cause hypoglycemia if medication dose or carbohydrate intake is not adjusted. Carbohydrate should be ingested if pre-exercise levels are less than 100 mg/dL.
Contraindications
Clinical judgment is crucial in application of these guidelines. Careful consideration should be given to the application of these guidelines for patients with significant medical comorbidities.
Qualifying Statements
- This American Dietetic Association Evidence-Based Nutrition Practice Guideline is meant to serve as a general framework for handling clients with particular health problems. It may not always be appropriate to use these nutrition practice guidelines to manage clients because individual circumstances may vary. For example different treatments may be appropriate for clients who are severely ill or who have co-morbid socioeconomic or other complicating conditions. The independent skill and judgment of the health care provider must always dictate treatment decisions. These nutrition practice guidelines are provided with the express understanding that they do not establish or specify particular standards of care whether legal medical or other.
- While the guideline represents a statement of best practice based on the latest available evidence at the time of publishing they are not intended to overrule professional judgment. Rather they may be viewed as a relative constraint on individual clinician discretion in a particular clinical circumstance.
- This guideline recognizes the role of patient preferences for possible outcomes of care when the appropriateness of a clinical intervention involves a substantial element of personal choice or values.
Description of Implementation Strategy
The publication of this guideline is an integral part of the plans for getting the American Dietetic Association Medical Nutrition Therapy (ADA MNT) evidence-based recommendations on diabetes to all dietetics practitioners engaged in teaching about or researching diabetes as quickly as possible. National implementation workshops at various sites around the country and during the ADA Food Nutrition Conference Expo (FNCE) are planned. Additionally there are recommended dissemination and adoption strategies for local use of the ADA Diabetes Type 1 and 2 Evidence-Based Nutrition Practice Guideline for Adults.
The guideline development team recommended multi-faceted strategies to disseminate the guideline and encourage its implementation. Management support and learning through social influence are likely to be effective in implementing guidelines in dietetic practice. However additional interventions may be needed to achieve real change in practice routines.
Implementation of the Diabetes Type 1 and 2 guideline will be achieved by announcement at professional events presentations and training. Some strategies include:
- National and Local Events – State dietetic association meetings and media coverage will help promote the guideline
- Local Feedback Adaptation – Presentation by members of the work group at peer review meetings and opportunities for continuing education unites (CEUs) for courses completed
- Education Initiatives – The guideline and supplementary resources are freely available for use in the education and training of dietetic interns and students in approved Commission on Accreditation of Dietetics Education (CADE) programs
- Champions – Local champions have been identified and expert members of the guideline team will prepare articles for publications. Resources are provided that include PowerPoint presentations full guidelines and pre-prepared case studies.
- Practical Tools – Some of the tools that will be developed to help implement the guideline include specially designed resources such as clinical algorithms slide presentations training and toolkits.
Specific distribution strategies include:
Publication in Full – The guideline is available electronically at the ADA Evidence Analysis Library website (www.adaevidencelibrary.com) and has been announced to all the ADA dietetic practice groups. The ADA Evidence Analysis Library will also provide downloadable supporting information and links to relevant position papers.
Implementation Tools
Clinical Algorithm
For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.
IOM Care Need
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness
Bibliographic Source(s)
- American Dietetic Association (ADA). Diabetes type 1 and 2 evidence-based nutrition practice guideline for adults. Chicago (IL): American Dietetic Association (ADA); 2008. Various p. [206 references]
Adaptation
The levels of evidence was based on the grading system from: Greer N Mosser G Logan G Wagstrom Halaas G. A practical approach to evidence grading. Jt Comm. J Qual Improv. 2000; 26:700-712. In September 2004 The American Dietetic Association (ADA) Research Committee modified the grading system to this current version.
The grades of recommendation were adapted by the American Dietetic Association (ADA) from the American Academy of Pediatrics Classifying Recommendations for Clinical Practice Guideline Pediatrics. 2004;114;874-877.
Source(s) of Funding
American Dietetic Association
Guideline Committee
Diabetes Type 1 and 2 Evidence-Based Guideline Workgroup
Composition of Group that Authored the Guideline
Workgroup Members: Carolyn J. Leontos MS RD CDE Chair; Marion J. Franz MS RD CDE; Lea Ann Holzmeister RD CDE; Karmeen Kulkarni MS RD CDE; Arlene M. Monk RD LD CDE; Margaret A. Powers MS. RD; Naomi Wedel MS RD
Financial Disclosures/Conflicts of Interest
In the interest of full disclosure American Dietetic Association (ADA) has adopted the policy of revealing relationships workgroup members have with companies that sell products or services that are relevant to this topic. Workgroup members are required to disclose potential conflicts of interest by completing the ADA Conflict of Interest Form. It should not be assumed that these financial interests will have an adverse impact on the content but they are noted here to fully inform readers. Users of the evidence analysis library may assume that only work group members listed below have potential conflicts of interest to disclose.
Carolyn Leontos: Received honorariums from Takeda Roche Diagnostics Aventis Novartis; shareholder in Johnson & Johnson and Abbott Laboratories Inc. stock.
Marion Franz: Employed with Nutrition Concept by Franz Inc. consulted for General Mills and Nestle and has received honorariums for General Mills Nestle and Kraft.
Karmeen Kulkarni: Employed by Abbott Diabetes care.
Guideline Status
This is the current release of the guideline.
This guideline updates a previous version: American Dietetic Association. Nutrition practice guidelines for type 1 and type 2 diabetes mellitus. Chicago (IL): American Dietetic Association; 2001 Dec. Various p.
The guideline will undergo a complete revision every three to five years.
Guideline Availability
Electronic copies: Available from the American Dietetic Association Web site.
Availability of Companion Documents
The following is available:
- Executive summary of recommendations. Chicago (IL): American Dietetic Association; March 2008. Available from the American Dietetic Association Web site.
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI on April 29 2003. The information was verified by the guideline developer on August 6 2003. This summary was updated by ECRI Institute on November 5 2008. The updated information was verified by the guideline developer on December 9 2008.
COPYRIGHT STATEMENT
The American Dietetic Association encourages the free exchange of evidence in nutrition practice guidelines and promotes the adaptation of the guidelines for local conditions. However please note that guidelines are subject to copyright provisions. To replicate or reproduce this guideline in part or in full please obtain agreement from the American Dietetic Association. Please contact Kari Kren at kkren@eatright.org for copyright permission.
When modifying the guidelines for local circumstances significant departures from these comprehensive guidelines should be fully documented and the reasons for the differences explicitly detailed.
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