Transcript Rating: Fair, Imperative

Evidence-Based Diabetes Nutrition Therapy Practice
Guidelines for Adults: Effectiveness and Recommendations
October 17, 2016
Speakers & Disclosures
• Marion Franz, MS, RDN, CDE
• Nothing to disclose
• Catherine Brown, MS, RDN, CDE
• Nothing to disclose
Authors: Nutrition Therapy Practice
Guideline for T1D and T2D in Adults
• Janice Macleod, MA, RDN, CDE
• Alison Evert, MS, RDN, CDE
• Catherine Brown, MS, RDN, CDE
• Adam Reppert, MS, RDN, CDE
• Megan Robinson, MS, RDN, CDE
• Erica Gradwell, MS, RDN (Academy Lead Analyst)
• Deepa Handu, PhD, RDN (Academy Project
Manager EAL)
• Marion J Franz, MS, RDN, CDE (Chair)
Learning Outcomes
• State the effectiveness, and factors contributing to
effectiveness, of evidence-based diabetes nutrition
therapy interventions provided by RDNs.
• Identify evidence-based nutrition therapy
recommendations for adults with diabetes.
• Integrate evidence-based diabetes nutrition
therapy recommendations into the nutrition care
process.
An Overview
of Evidence-Based
Practice (EBP)
Academy’s Evidence-Based Nutrition
Practice Guidelines
• Systematic review: systematically
reviewed evidence summaries &
conclusion statements = what the
evidence says
• Guideline recommendations: based
on systematic reviews = course of
action for the practitioner
• Published in the Evidence Analysis
Library: www.andeal.org
Evidence Analysis Library
Systematic
Review
Evidence Based
Practice
Guidelines
Implementation
Toolkits
Data Synthesis and Grade
Systematic review conclusion statement
grades
• I: good/strong
• II: fair
• III: limited/weak
• IV: expert opinion only
• V: grade not assignable
Data Synthesis and Ratings
• Recommendation ratings
• Strong: quality of evidence is grade I or II
• Fair: quality of evidence is II or III
• Weak: quality of evidence is either suspect or welldone studies show little clear advantage of one
approach versus another
• Consensus: expert opinion or grade IV
• Insufficient evidence: lack of evidence, grade V, or
unclear balance between benefits and harms
• Recommendation ratings
• Imperative: applies to all members of the guideline
population
• Conditional: applies only under certain circumstance
Bottom Line
Evidence-based practice leads to:
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•
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Improved quality of care
Increased patient safety
Decreased variation in practice
Efficient use of resources
Increased likelihood of achieving desired patient
outcomes
• Improved client, provider & payer satisfaction
• Increased credibility of the RDN within the
healthcare team
Your Turn: EBPG Based on Systemic
Reviews—Any Potential Problems?
What are potential problems with
systematic reviews ?
A.
B.
C.
D.
Search criteria not specific enough
Inappropriate study inclusion criteria
Study duration not reported
Requiring low drop-out rates
eliminates studies in which the
intervention is difficult to maintain
long-term
Example: Study Inclusion Criteria
Cochrane Review (2009): Low-GI or low-GL for diabetes, study review
criteria:
• … “diabetes not already optimally controlled”
• Excluded Wolever 2008: n=162 T2D; 1-yr; high-CHO/high-GI, highCHO/low-GI, low CHO/high MUFA diets; A1C between groups NS at
1-year
• Conclusion based on 11 studies: 1988-2004; 4 wks or longer
• “A1C decreased by 0.5% with low GI diet, statistically and clinically
significant.”
Thomas & Elliott. Cochrane Database of Systematic Reviews 2009. Issue 1. Art. No.
CD006296; Wolever et al. Am J Clin Nutr 87:114, 2008
Academy’s Review Study Criteria and
Conclusion on GI
… relationship of differing levels of GI intake,
independent of weight loss on glycemia, insulin and
CVD risk factors?
• Study inclusion criteria: adults with db; …≥10
subjects in study groups; >80% completion rate;
study trial 12 wks or longer in duration; search
back to 1980
• 4 studies:
• no significant effect of GI on A1C in adults with
T2D; no studies in T1D
Academy of Nutrition and Dietetics Evidence Analysis Library
Example: Requiring Low Drop-Out Rates
Question: could low-CHO diets achieved in short-term (6-12
mo) high-intensity interventions be achieved long-term (24
mo) with lower intensity interventions (what is feasible in
outpatient practice)?
• 144 T2D: low-CHO diet (<30 g/d) or a low-fat diet
• 53% returned at 12-mo and 47% at 24-mo
• Low-CHO results: 24% CHO at 3-mo; 40% CHO at 5-mo;
back to baseline at 12- mo; 48% CHO (↑ 8% from baseline)
at 24-mo
• Researchers’ comments:
• “…suggests that low-carb diets may be difficult to
sustain.” .
Iqbal et al. Obesity 2010;18:1733
Systemic Reviews: Today’s Best Option!
• Potential problems with research studies
• Small number of usually motivated subjects with
frequent counseling and support provided
• Short-term—diabetes a life-long disease
• Baseline food intake often not reported
• Compare equal caloric intakes but do not compare
study caloric intake to usual caloric intake
• Can outcomes be implemented long-term with “realworld” eating rarely asked
• However, systematic reviews (and metaanalyses) are today’s best option!
• Academy: reputable systematic reviews!
Nutrition Practice Guideline for T1D and
T2D in Adults: Studies Included
• 60 studies met inclusion criteria
• 22 primary studies related to effectiveness
provided by RDNs
• 18 RCTs, 1 non-randomized clinical study, 3
cohort studies; no systematic reviews or metaanalyses
• 38 primary studies on diabetes nutrition
therapy interventions
• 33 RCTs, 4 observational, 1 systematic review
Study Inclusion Criteria:
• Adults over 18-yrs
• Subjects with T1D or T2D
• Outpatient and ambulatory care
• RCTs, cohort studies, non-randomized clinical
studies, observational/non-controlled trials
• Study duration of at least 12-wks (3-mos)
• 10 more subjects per study group
• 80% completion rate
Effectiveness of EvidenceBased Diabetes Nutrition
Therapy Interventions
Provided by RDNs
Effectiveness: Primary Questions
• How effective is MNT provided by an RDN on
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•
•
•
Glycemia (A1C and/or glucose);
CVD risk factors (lipids and blood pressure);
Weight management (weight, WC, BMI);
Medication usage (insulin and/or other glucoselowering medications);
• Quality of life?
• Additional study inclusion criteria:
• Individualized MNT provided by an RDN over more
than one visit
• Definition of nutrition intervention provided by RDN
Effectiveness: Secondary Questions
• How many encounters with an RDN are
needed for implementation of effective
MNT?
• What types of MNT interventions
implemented by RDNs (in clinical practice)
are effective?
MNT and Glycemia (A1C)
T2D
• 21 study arms (18 studies), n=4,181
• 0.3% to 2.0% ↓ A1C at 3 mo
• O.3% to 1.8% ↓ A1C at 6 mo
• O.3% to 1.6% ↓ A1C, with ongoing MNT support, at
12 mo
• 0.6% to 1.8% ↓ A1C at >12 mo
• Although MNT effective throughout the disease
process, ↓ largest in newly diagnosed persons
and/or persons with baseline A1C >8.0%; ↓
0.5% to 2.0%
MNT and Glycemia (A1C)
T1D
• 3 studies, n=808, MNT contributed to:
• 1.0% and 1.9% ↓ A1C during first 6 mo
• Maintained to 1-yr
• Continued for up to 6.5 yrs (DCCT)
Usual Care (when reported)
• 0 to +0.2% A1C change
MNT provided by RDNs effectiveness on glycemia:
Grade: Level I/Strong
MNT and CVD Risk Factors
16 studies:
• Mixed effects on total cholesterol, LDL-C, HDL-C, TG
• Normal or mildly elevated lipid levels (TC. LDL, TG);
normal to mildly low TG
• ~50 to 75% of participants on lipid-lowering medications
• Mixed effects on blood pressure
• Near-normal BP
• ~50% to 75% on anti-hypertensive medications
MNT provided by RDNs effectiveness on CVD risk
factors:
Grade: Level II/Fair
MNT and Weight Management
18 studies:
• Body weight: T2D and T1D outcomes mixed
• BMI: T2D and T1D outcomes mixed
• WC: T2D outcomes mixed
MNT provided by RDNs effectiveness on weight
management:
Grade: Level II/Fair
MNT and Impact on Medication Usage
T2D
• 11 studies
• Decreases in doses or number of glucose- lowering meds
in 12 study arms
• Weight gain with initiation of insulin therapy prevented
T1D
• 2 studies
• CHO counting implemented; although number of insulin
injections increased, A1C improved without an increases
in total insulin dose
• Weight gain with insulin pump therapy prevented
MNT provided by RDNs effectiveness on medication
usage:
Grade: Level I/Strong
MNT and Quality of Life
6 studies
T1D
• 3 studies SS improvements in QOL despite
increases in number of insulin injections and/or
MNT requirements
T2D
• 3 studies QOL SS improvements
MNT provided by RDNs effectiveness on quality of
life:
Grade: Level I/Strong
RDN MNT Encounters: Effectiveness
Studies
T2D
• Initial series (first 3-6 mo)
• Minimum of 3; ranging from 3 to 12 encounters
• Minimum of 2 hrs; ranging from 2 to 16 hrs
• Follow-up visits (next 6-15 mo)
• Minimum of 1; ranging from 1 to 6 encounters
• Minimum of 1-hr; ranging from 1 to 6 hrs
T1D
• Initial series (first 6 mo)
• Ranged from 4 to 6
• One long-term study, monthly visits
Nutrition Therapy Interventions by
RDNs in Effectiveness Studies
T2D
• Individualized nutrition therapy, energy
restriction, portion control, sample menus, CHO
counting, exchange lists, simple meal plans lowfat vegan—implemented and effective
• All resulted in a reduced energy intake
T1D
• Carbohydrate counting used to determine
mealtime insulin doses
Your Turn!
What is a primary goal of MNT for T2D?
To assist the client:
A. Achieve a minimum weight loss of ~ 5 kg
B. Improve lipid profile
C. Decrease use of glucose-lowering medications
D. Improve blood glucose control management
What is a primary goal of MNT for T1D?
Evidence-Based Nutrition
Therapy Recommendations
for Adults with Diabetes
Nutrition Therapy Recommendations
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Nutrition prescription
Energy intake
Macronutrient composition
Carbohydrate management strategies
Fiber intake
Glycemic index/load
Nutritive sweeteners
Non-nutritive sweeteners
Protein intake and protein intake for diabetic kidney disease
Cardioprotective eating patterns
Nutrient adequacy
Alcohol consumption
Physical activity
Blood glucose monitoring
andeal.org
Reminders!
• Recommendations for non-pregnant adults with
type 1 or type 2 diabetes
• Not all recommendations carry the same weight
• Strong, Fair, Weak, Consensus, Insufficient Evidence
• Not all recommendations apply to all people
with diabetes.
• Imperative or Conditional
• Implement in collaboration with the patient and
based on patient’s ability (literacy, numeracy),
preferences, and management goals
Nutrition Prescription
• No Concentrated Sweets
• No Sugar Added
• 1800 kcal ADA Diet
NONE OF THE ABOVE!
Nutrition Prescription
• Individualize the nutrition prescription and
implement evidence-based guidelines in
collaboration with the adult with diabetes.
Rating: Fair, Imperative
• A variety of eating patterns are acceptable
• Personal preferences and metabolic goals should be
considered
• Treatment decisions should be founded on evidencebased guidelines
On a personal note…
So what can we
recommend?
Energy Intake
For BMI >25, the RDN should encourage:
• A reduced-energy, healthful eating plan, with a goal
of weight loss, weight maintenance, and/or
prevention of weight gain. Rating: Strong,
Conditional
• Studies based on reduced energy interventions report
significant reduction in HbA1c of 0.3% to 2.0% in adults
with type 2 diabetes, as well as improvements in
medication adjustments and quality of life.
For BMI <25, the RDN should encourage:
• Consumption of a healthful eating plan, with a goal
of weight maintenance and/or prevention of weight
gain. A variety of eating patterns are acceptable.
Rating: Consensus, Conditional
Macronutrient Composition
Low Fat!
Low Carb!
Macronutrient Composition
• Individualize the macronutrient composition of
the healthful eating plan within the appropriate
energy intake. Rating: Fair, Imperative
• Limited research regarding differing amounts of
carbohydrates (39% to 57% of energy) and fat (27%
to 40% of energy), reported no significant effects on
A1C or insulin levels in adults with diabetes,
independent of weight loss.
Macronutrient Composition
• Usual intake:
• 44-46% carb
• 36-40% fat
• 16-18% protein
• Even intensive efforts to modify macronutrient
intake result in tendency to return to usual
intake
Delahanty et al. Am J Clin Nutr 2009;89:518; Eeley et al. Diabetic Med
1995;13:656; Vitolins et al. J Am Diet Assoc 2009;109;1367; Oza-Frank et
al. J Am Diet Assoc 2009;109:1173.
Carbohydrate Management Strategies
• To successfully manage diabetes, my patients
must be taught
•
•
•
•
Exchanges
Carb choices
Carb counting
Maybe none of the above
• Your first question might be, “What diabetes
medications do you take?”
Carbohydrate Management Strategies
For those on multiple daily injections (MDI) or
insulin pump therapy, the RDN should educate
on:
• Carbohydrate counting using insulin-tocarbohydrate ratios. Rating: Fair, Imperative
• Results in significant decreases in A1C of 0.4% to
1.6% and increases in quality of life for up to 44
months without significant change in weight.
Carbohydrate Management Strategies
For those on fixed insulin doses or insulin
secretagogues, the RDN should educate on:
• Carbohydrate consistency (timing and amount)
using one of the following strategies:
• Carbohydrate counting alone
• Plate Method, portion control and simplified meal
plan
• Food lists (such as Choose Your Foods. Food Lists for
Diabetes) and carbohydrate choices
• Consistent carbohydrate intake can improve
glycemic control and reduce risk for
hypoglycemia. Rating: Strong, Conditional
Carbohydrate Management Strategies
For those on MNT or other diabetes medications,
the RDN should educate on:
• Carbohydrate counting alone
• Plate Method, portion control and simplified meal
plan
• Food lists (such as Choose Your Foods. Food Lists for
Diabetes) and carbohydrate choices
• Monitoring carbohydrate intake, whether by
carbohydrate counting or experience-based
estimation, remains a key strategy in achieving
glycemic control. Rating: Fair, Conditional
Your Turn!
• Mr. Gorman is a 59 y.o. who presents
with A1C 8%, BMI 26, and HTN. He is
married and works full time as an
engineer. He takes metformin,
glimepiride, and lisinopril. What meal
planning approach might you use
with him?
A. Carb Counting
B. Calorie Counting
C. Food Lists/Carb Choices
D. Plate Method
Fiber Intake
• Consume dietary fiber from foods at the levels
recommended by the Dietary Reference Intakes
(DRI) (21-25 g/d for women and 30-38 g/d for
men, depending on age) or USDA (14 g/1,000
kcal) due to the overall health benefits of dietary
fiber. Rating: Fair, Conditional
• Limited research regarding differing amounts of fiber
intake from foods, independent of weight loss,
reported mixed results on A1C
Fiber Intake
• Oatmeal instead of grits
• Whole wheat bread instead of white bread
• Fresh fruit instead of juice
• Beans instead of croutons in a salad
Glycemic Index/Load
• Lowering glycemic index or glycemic load may or
may not have a significant effect on glycemic
control. Rating: Fair, Imperative
• Studies longer than 12 weeks report no significant
impact of glycemic index or glycemic load,
independent of weight loss, on A1C.
You don’t have to teach this!
Nutritive Sweeteners
• Intake of nutritive sweeteners, when substituted
isocalorically for other carbohydrates, will not
have a significant effect on A1C or insulin levels.
Rating: Fair, Imperative
• Avoid excessive intake of nutritive sweeteners to
avoid displacing nutrient-dense foods and to
avoid excessive calorie and carbohydrate intake.
Rating: Fair, Imperative
Non-Nutritive Sweeteners (NNS)
• Intake of NNS (such as aspartame, sucralose,
and stevia) will not have a significant effect on
glycemic control. Rating: Weak, Imperative
• Substituting foods and beverages containing
NNS can potentially reduce overall calorie and
carb intake if substituted for caloric sweeteners
without compensation by intake of additional
calories from other food sources. Rating: Fair,
Imperative
Protein Intake
• Adding protein to meals and/or snacks does not
prevent or assist in the treatment of
hypoglycemia. Rating: Fair, Imperative
• Carbohydrates prevent hypoglycemia!
• Carbohydrates treat hypoglycemia!
Protein Intake/Diabetic Kidney Disease
• For adults with diabetes and DKD, there is no
need to prescribe a protein restriction. Rating:
Strong, Conditional
• There is no significant impact of protein intake
(ranging from 0.7 to 2.0 g/kg/day) on GFR.
• The type of protein (vegetable-based versus
animal-based) will not have a significant effect
on GFR. Rating: Weak, Conditional
Cardioprotective Eating Patterns
• Consume a cardioprotective dietary pattern,
within the recommended energy intake. Rating:
Strong, Imperative
• Modifications to decrease saturated fat intake and
increase unsaturated fat intake
• Individualize reduction in sodium intake. Rating:
Fair, Imperative
• <2,300 mg per day; for adults with both diabetes and
hypertension, further reduction in sodium intake
should be individualized
Nutrient Adequacy
• No clear evidence of benefit from
supplementation in people who do not have
underlying deficiencies. Rating: Fair, Conditional
• Not advised due to lack of evidence of efficacy
or long term safety:
• Antioxidants, such as vitamin E and C and carotene
• Micronutrients, such as chromium, magnesium and
vitamin D
• Herbal supplements, such as cinnamon
Alcohol consumption
• For people who chose to drink alcohol, do so in
moderation:
• 1 drink/day for women; up to 2 drinks/day for men
• Alcohol consumption may increase risk for
delayed hypoglycemia, if using insulin or insulin
secretagogues.
• Rating: Weak, Conditional
Physical Activity
• Encourage an individualized physical activity
plan unless medically contraindicated, to
gradually achieve the following:
• >150 minutes or more of physical activity per week
• Moderate-intensity aerobic exercise (50% to 70% of
maximum heart rate) spread over >3days/week with
no more than 2 consecutive days without exercise
• Resistance training >2 days/week
• Reduce sedentary time by breaking up extended
amounts of time (more than 90 minutes) spent
sitting
• Rating: Strong, Imperative
Physical Activity
• Educate adults with diabetes who take insulin or
insulin secretagogues that physical activity may
cause hypoglycemia if medication doses or
carbohydrate consumption is not altered.
Rating: Consensus, Conditional
Blood Glucose Monitoring
• Ensure that adults with type 1 diabetes and type
2 diabetes are educated about glucose
monitoring and using data to adjust therapy.
• When prescribed as part of a broader
educational context, results may help guide
treatment decisions and self-management.
• Rating: Fair, Imperative
Integrating
Recommendations into the
Nutrition Care Process
Nutrition Care Process
• Based on effectiveness research reviewed,
recommendations for the Nutrition Care
Process are written
• Screening and Referral
• Nutrition assessment
• Nutrition interventions
• Nutrition monitoring and evaluation
Screening and Referral
The RDN in collaboration with other health care team
member should ensure that all overweight/obese adults at
risk are screened for T2D.
Rating: Fair/Imperative
The RDN in collaboration with other health care team
members should ensure that all adults with T1D and T2D are
referred for MNT
Rating: Strong/Imperative
Screening and Referral cont.
The RDN should implement 3 to 6 MNT encounters during the
first 6 mos, and determine if additional MNT encounters are
needed
Rating: Strong/Imperative
The RDN should implement a minimum of one annual MNT
follow-up encounter.
Rating: Strong/Imperative
Nutrition Assessment
The RDN should assess the following to formulate the
nutrition care plan:
• Biochemical data, medical tests and medication usage
• Nutrition-focused physical findings
• Client history
• Food and nutrition-related history
• Client’s psychological and social history
Rating: Fair/Imperative
Nutrition Intervention
As reviewed
Coordination of Care
• Implement MNT and coordinate care with an
interdisciplinary health care team, the adult with
diabetes, and important others (e.g., family,
friends, and colleagues)
Rating: Strong/Imperative
Nutrition Monitoring and Evaluation
The RDN should monitor and evaluate the factors
listed in Nutrition Assessment including the client’s
psychological and social situation.
Rating: Fair/Imperative
Practice Applications: In an “Ideal” World
All people with T2D should:
• Lose 5% to 10% of baseline weight
• Eat a reduced-energy nutrient-dense eating pattern
in appropriate portion sizes
• Participate in 150 min/wk of regular physical activity
All people with T1D should:
• Count carbohydrates
• Adjust insulin based on insulin-to-carbohydrate ratios
• Use insulin correction factors
Practice Applications: In the “Real” World
• Facilitate behavior changes that individuals with
diabetes are willing and able to make and that
are based on proven lifestyle interventions
• A variety of nutrition therapy and physical
activity interventions can be implemented
• Integrate recommendations into the nutrition
care process—
• However, nutrition therapy for diabetes is
effective!
What is important?
Individualization