aace diabetes guidelines 2011 american academy of clinical endocrinology guidelines 2011
TRANSCRIPT
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AACE Guidelines
Yehuda Handelsman, MD, FACP, FACE, FNLA; Jeffrey I. Mechanick, MD, FACP, FACE, FACN, ECNU;
Lawrence Blonde, MD, FACP, FACE; George Grunberger, MD, FACP, FACE;
Zachary T. Bloomgarden, MD, FACE; George A. Bray, MD, MACP, MACE;
Samuel Dagogo-Jack, MD, FACE; Jaime A. Davidson, MD, FACP, MACE
Daniel Einhorn, MD, FACP, FACE; Om Ganda, MD, FACE;
Alan J. Garber, MD, PhD, FACE; Irl B. Hirsch, MD; Edward S. Horton, MD, FACE;
Faramarz Ismail-Beigi, MD, PhD; Paul S. Jellinger, MD, MACE; Kenneth L. Jones, MD;
Lois Jovanovi, MD, MACE; Harold Lebovitz, MD, FACE; Philip Levy, MD, MACE;
Etie S. Moghissi, MD, FACP, FACE; Eric A. Orzeck, MD, FACP, FACE;
Aaron I. Vinik, MD, PhD, FACP, MACP; Kathleen L. Wyne, MD, PhD, FACE
American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice are systematically
of the content herein is based on literature reviews. In areas of uncertainty, professional judgment was applied.
rapid changes in this area are expected, periodic revisions are inevitable. We encourage medical professionals to use
this information in conjunction with their best clinical judgment. The presented recommendations may not be appropri-
ate in all situations. Any decision by practitioners to apply these guidelines must be made in light of local resources and
individual patient circumstances.
Copyright AACE 2011
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AACE Task Force for Developing a Diabetes Comprehensive Care Plan
Writing Committee
Cochairpersons
Yehuda Handelsman, MD, FACP, FACE, FNLA
Jeffrey I. Mechanick, MD, FACP, FACE, FACN, ECNU
Lawrence Blonde, MD, FACP, FACE
George Grunberger, MD, FACP, FACE
Task Force Members
Zachary T. Bloomgarden, MD, FACE
George A. Bray, MD, MACP, MACE
Samuel Dagogo-Jack, MD, FACE
Jaime A. Davidson, MD, FACP, MACEDaniel Einhorn, MD, FACP, FACE
Om Ganda, MD, FACE
Alan J. Garber, MD, PhD, FACE
Irl B. Hirsch, MD
Edward S. Horton, MD, FACE
Faramarz Ismail-Beigi, MD, PhD
Paul S. Jellinger, MD, MACE
Kenneth L. Jones, MD
Lois Jovanovi, MD, MACE
Harold Lebovitz, MD, FACE
Philip Levy, MD, MACE
Etie S. Moghissi, MD, FACP, FACEEric A. Orzeck, MD, FACP, FACE
Aaron I. Vinik, MD, PhD, FACP, MACP
Kathleen L. Wyne, MD, PhD, FACE
Reviewers
Alan J. Garber, MD, PhD, FACE
Daniel L. Hurley, MD
Farhad Zangeneh, MD, FACP, FACE
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Abbreviations:
AACE = American Association of Clinical
Endocrinologists; BEL = best evidence level; CDE =
CGM
monitoring; CPGCSII =
CVD = car-
DM DPP-4
inhibitor = dipeptidyl-peptidase 4 inhibitor; EL = evi-
dence level; FDA
FPG GDM = gestational
GFR
GLP-1A1C = hemoglobin
A1c
; HDL-C = high-density lipoprotein cholesterol;
LDL-C = low-density lipoprotein cholesterol; MDI
NPH
Hagedorn; PPG Q = clinical
R = recommendation; RCT = randomized
controlled trial; SMBG-
cose; T1DMT2DM = typeTZD = thiazolidinedione
1. INTRODUCTION
-
glycemic control.
-lished American Association of Clinical Endocrinologists
-
control. This comprehensive approach is based on the evi-
-
globin A1c
-
-
recommendations.
following:
-
prehensive care plan for clinical endocrinologists and
-
tronically in clinical practices to assist with decision-
-
cal implementation strategies in a more concise format than
-
-
2. METHODS
-
-
-
review byEndocrine Practice.
Comments may be appended to the recommendation grade
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regarding -
clinical management is based on what is in the best interest
Fig. 1.
-level review mechanism.
Table 1
2010 American Association of Clinical Endocrinologists Protocol for
Production of Clinical Practice GuidelinesStep I: Evidence Ratinga
Numerical
descriptor
(evidence level)b Semantic descriptor (reference methodology)
1
1
2
2
2 2
4
a Adapted from reference 1:Endocr Practb
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Table 2
2010 American Association of Clinical Endocrinologists Protocol for
Production of Clinical Practice GuidelinesStep II:
Evidence Analysis and Subjective Factorsa
Study design Data analysis Interpretation of results
Intent-to-treat
Appropriate statistics
Selection bias Incompleteness
Appropriate blinding
aEndocr Pract
Table 3
2010 American Association of Clinical Endocrinologists Protocol for
Production of Clinical Practice GuidelinesStep III:
Grading of Recommendations; How Different Evidence Levels
Can Be Mapped to the Same Recommendation Gradea,b
Bestevidence
level
Subjectivefactorimpact
Two-thirdsconsensus Mapping
Recommendationgrade
1 Yes Direct A
2 Yes A
2 Yes Direct B1 Yes B
Yes B
Yes Direct C
2 Yes C
4 Yes C
4 Yes Direct D
Yes D
D
a - -bEndocr Pract
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-
3. EXECUTIVE SUMMARY
3.Q1.1. Diagnosis of DM
Grade A; BEL 1
or
load in the morning after an overnight fast of at
or
or
-
Grade D; BEL 4
Grade D; BEL 4
--
Grade D; BEL
4
Grade D; BEL 4
Grade D; BEL
4
Grade
D; BEL 4
Grade
C; BEL 3
Grade C; BEL 3
-
-ance test.
- -
Grade A; BEL 1
-
-
creatic islet
Grade A; BEL 1
Grade A; BEL 1
- -
Grade C; BEL 3
Table 4
2010 American Association of
Clinical Endocrinologists Protocol
for Production of Clinical Practice Guidelines
a
Cost-effectiveness
Evidence gaps
aEndocr Pract
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-
-
Grade A; BEL 1
-
-
Grade D; BEL 4
Grade D; BEL 4
Grade
D; BEL 4
-
body weight if overweight or obese and participation
Grade D; BEL 4-
Grade A; BEL 1
-
Grade A;
BEL 1
-
Grade A; BEL 1
weight loss may be considered when lifestyle modi-
m2Grade D; BEL 4
laparoscopic-assisted gastric banding in patients with
2
2 to achieve at
Grade A; BEL 1
Grade D; BEL 4
3.Q3. What is the Role of a DM Comprehensive Care
Glucose Testing and Interpretation
Test Result Diagnosis
126
test on a different day
200
test on a different day
Hemoglobin A1c
test on a different day
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-
Grade A; BEL 4
-
-
Grade D; BEL 4
-
Grade D; BEL 4
[See Appendix for Q4: What is the Imperative for
-
-
Grade A; BEL 1
Grade D, BEL 4
-
Grade B,
BEL 2
Grade A;
BEL 1
Grade
A; BEL 1
Grade A; BEL 1
-
Grade A;
BEL 1
For most hospitalized persons with hyperglyce- -
Grade D; BEL 4
-
Grade D; BEL 4
Grade D; BEL 4
-
(Grade A; BEL 1)-
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Grade D; BEL 4
Treatment targets for dyslipidemia are based on
-
-
Grade A; BEL 1
-
Grade C; BEL 3
-
-
Grade D; BEL 4-
in weight loss and weight maintenance programs.
-
-
-
Grade D; BEL 4
Grade D; BEL 4
-
Grade A; BEL 1
Antihyperglycemic agents may be broadly cat-
-
glargine and detemir are preferred over intermediate-
Grade A;
BEL 1
-
Grade A; BEL 1
-
have a more rapid onset and offset of action and are
Grade A; BEL
1
Grade A; BEL 1
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be considered for patients in whom adherence to a
Grade D; BEL 4
Grade B; BEL 3
- -
priate intervals when treatment goals are not achieved
Grade D; BEL 4
-
Grade D; BEL 4
Grade D; BEL 4
Grade A; BEL 1
-
Grade A; BEL 1
-
-
Grade D; BEL4
Grade B;
BEL 2
Grade D;
BEL 4 -
Grade D; BEL
4
-
Grade
D; BEL 4
-
sidered when glycemic targets are not achievable
Grade C; BEL 3). An
-
-
Grade B; BEL 2
treatment for postprandial hyperglycemia in pregnant
Grade B; BEL 2
-
women.
Grade D; BEL 4
-
Grade D; BEL 4-
Grade D; BEL 4
Grade D; BEL 4 -
Grade D;
BEL 4
preferred for critically ill patients.
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Grade D; BEL 4
Grade D; BEL 4
-
Grade D; BEL 4
the effects of their lifestyle and pharmacologic ther-
Grade
D; BEL 4
Grade D; BEL 4
-
Grade D; BEL4 -
cagon may be given by a trained family member or by
Grade D; BEL 4
Grade
D; BEL 4
Grade D; BEL
4
-
Grade A; BEL 1
become hypoglycemic and have been treated with
an
-
Grade D; BEL 4
3.Q10. How Should Microvascular and Neuropathic
Disease Be Prevented, Diagnosed, and Treated
improving glycemic control.
Grade
D; BEL 4
-
Grade A; BEL
1
-
Grade A; BEL 1
Being overweight or obese
Sedentary lifestyle
Hypertension
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ComprehensiveDiabetesCareTreatmentGoals
Parameter
TreatmentGoal
Reference(evidenceleveland
studydesign)
HemoglobinA1c
110
140
140-180
40inmen;
80
Aspirin
a
-
a
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-
-
Grade D; BEL 4
Grade B; BEL 2
Grade C; BEL 3
-
Grade D; BEL 4
implemented to slow the progression of retinopathy
Grade D; BEL 4
-
Grade D; BEL 4
Grade
A; BEL 1
Grade C; BEL 3-
-
Grade
A; BEL 1
-
ment; orthotics to treat and prevent foot deformities;-
Grade A; BEL 1
-
-
Grade A; BEL 1
3.Q11. How Should Macrovascular Disease Be
Prevented, Diagnosed, and Treated in Patients
Grade A; BEL 1
Grade D; BEL 4
Grade A; BEL 1
-
agents are selected on the basis of their ability to
-
gression of nephropathy and retinopathy; angiotensin-
converting enzyme inhibitors or angiotensin II recep-
Grade D; BEL 4-
-
and newer-generation -
Grade A; BEL 1
-Grade A; BEL 1-
Grade A; BEL 1-
-
target for therapy. Statins are the treatment of choicein the absence of contraindications. Combinations of
Grade A; BEL 1
-
cases of statin-related adverse events or intolerance
Grade A; BEL 2
-
-
Grade A;
BEL 1
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Grade
C; BEL 3
Grade D; BEL 4
3.Q12. How Should Other Common Comorbidities of
Grade D; BEL 4
Grade
A; BEL 1
-
-
Grade D; BEL 4
3.Q12.2. Depression
Grade A; BEL 1
4. APPENDIX: EVIDENCE BASE
4.Q1.1. Diagnosis of DM
-
-
-
-
-
-
the pancreatic
-
-
-
-
-
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-
cations are approved by the FDA for the management of
-
P
-
Obesity
The cornerstone for controlling obesity in prediabe-
-
-
-
-
perioperative complications were more common with gas-
percentage of reversal is related to the degree of weight
-
-
-
4.Q3. What is the Role of a DM Comprehensive
A.
4.Q4. What is the Imperative for Education and
different health care providers allows the patient to learn
-
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-
tion to foot care. They often have more time than physi-
their physician. Having a CDE credential indicates the
in this area.
to especially follow their prescribed meal plan and physi-
cal activity program as an integral part of their therapy.
-
-
tion administration is another important area that can be
-
-
treatment plans and set goals that other team members will
It is important that a patient has a primary care physi-cian. It is critical that a primary care physician addresses
-
patients might not be seen on a timely basis for medical
-
the appropriate specialist as part of their care.
-
-
-
-
-
-
-
-
-
trials achieving improved A1C levels and epidemiologic
-
target A1C-
-
-
terminal illness.
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-
-
-
-
therapy glycemic targets that were associated with a higher
-
-
-
-
-
-
-
-
recommended.
-
-
-
-
-
-
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-
-
-
port when appropriate. The last category applies to those
-
-
-
vs foods that may promote disease or complications from
-
-
American Association of Clinical Endocrinologists Healthful Eating Recommendations for
Patients With Diabetes Mellitus
Topic RecommendationReference (evidence level and
study design)
habits
Carbohydrate
negative health effects
Fat trans
Avoid or limit processed meats
controlled trial.
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-
the physician or a registered dietician in all patients with
-
ommendations aimed at optimizing glycemic control and
2
adopting the principles given in Tables 7 and 8 are to per-
-
-
Key recommendations address the need for consistency in
-
-
physician.
-
ing the effects of increased physical activity alone from
-
a main component in weight loss and maintenance pro-
-
-
-
is to achieve clinical and biochemical targets with as few
statement has important implications for the choice of
-
-
-
-
-
be associated with the development of vitamin B12
-
-
effect not widely appreciated.
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-
-
Colesevelam and -
-
systemic adverse effects.
-
-
-
-
Bromocriptine is a potent agonist at dopamine D2
receptors
-
-
impairment.
-
-
-
Several years of clinical trials and treatment with -
-
postprandial hyperglycemia and is associated with minimal
do not increase satiety. The administration of pharmaco-
-
-
-
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-
-
-
has stated that patients on therapy do not need to be moni-
-
-
prolonged lifestyle and oral agent efforts to achieve glyce-
mic control has been revised in the last decade to incorpo-
-
-
glargine and detemir are preferred over intermediate-
-
-
control has been achieved in the absence of hypoglyce-
-
-
-
-
-
-
-
-
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are consistently modest and mild weight loss is common.
-
resistance.
-
-
-
the largest meal once daily or at the 2 largest meals twice
-
-
meal patternsAnother advantage
-
lin doses at each meal depending on the size of the meal
-
may vary considerably on the basis of body weight and
-
-
-
4.Q7.1.
-
-
4.Q7.2.
-
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Table10
Summ
aryDataFromCost-effectivenessAnalysesComparingContinuousSubcutaneousInsulinInfusionWith
MultipleDailyInjectionsinAdultsandChildrenWithType1D
iabetesMellitus
Reference
Studyobjective,perspective,datasource
QALYsgained
Costper
QALY(ICER)
USthird-partypayerperspective
CSII:$16
ImprovedglycemiccontrolfromCSIIled
Canadianpayerperspective
CSII:Can$27
inpregnancy
CS
II:80
104
Improvementsinglyc
emiccontrolwith
ofdiabetes-related
complications
standards
-
-
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-
combination with metformin.
-
-
By the time these offspring themselves reach childbearing
is not simply a genetic predisposition is inferred from the
-
-
not able to maintain normoglycemia with a carbohydrate-
-
-
-
-
are not the only factors at play in the early stages of child-
hood that can have lasting adverse effects on the offspring.
-
-
4.Q7.5.
-
American Diabetes Association standards of medical care
The management of hyperglycemia in the hospital
-
-
-
may be appropriate in terminally ill patients or in patients
-
-
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-
-
-
-sition to oral agents in the day or two before discharge is
often necessary.
When and How Should Glucose
-
term assessment is most often by A1C.
chain of hemoglobin.
-
-
-
-
-
-
of A1C
-
hypoglycemia is typically recognized in association with
-
-
Hypoglycemia is associated with more short-term disabil-
ity and higher health care costs. Hypoglycemia manifests
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awareness and response to hypoglycemia. Severe and pro-
longed hypoglycemia may be associated with severe con-
arrhythmia.
-
lin reserve and perhaps the drive for strict glycemic con-
-
-
-
by a period of intensive therapy that dampens glyce-
-
Hypoglycemia is an important consideration in the
achievement of glycemic goals.
-
-
4.Q10. How Should Microvascular and
Neuropathic Disease Be Prevented,
-
after the onset of
clinical manifestation of diabetic nephropathy in persons
-
-
-
-
-
-vention for diabetic nephropathy.
-
-
2
Stage Description
Stage 1 Kidney damage with normal or
Stage 2 Kidney damage with mildly
-
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-
-
-
-
This property hasbeen demonstrated for the angiotensin-converting enzyme
-
demonstrated after renin-angiotensin-aldosterone sys-
-
-
-
-
-
-
-
nephrologist is cost-effective and delays the time to dialy-
-
-
-
-
-
-
-
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by an ophthalmologist. This 2-step approach can be an
-
-
-
-
strategies for primary prevention of diabetic retinopathy
-
-
-
-
-
-
-
-
-
-
ther progression. It is vitally important to improve strength
-
density correlates inversely with
-
-
with treatment.
-
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-
daily basis.
adapted from one recently proposed by the International
-
ities in the peripheral somatosensory system in people with
-
-
-
-
-
-
-
-
-
-
-
-
-
-
other physiological stresses; and as an indicator for more
-
-
-
-
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a relationship between hyperglycemia and the develop-
-
a greater
-
-
4.Q11. How Should Macrovascular DiseaseBe Prevented, Diagnosed, and Treated in
-
-
myocardial infarction at baseline and was almost 6-fold
greater than the incidence of myocardial infarction in non-
-
-
Fig. 2.
-
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Table11
Symptoms
Tests
Treatments
Cardiac
intolerance
Gastrointestinal
electrogastrogram
Constipation
Endoscop
y
Sexualdysfunction
Bladderdysfunction
sonograph
y
Sudomotordysfunction
hyperhidrosis
Pupillomotorandvisceraldysfunction
Carewithdrivingatn
ight
Impairedvisceralsensation:silent
-
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-
-
as well as in those with hyperglycemia. Early epidemio-
-
-
in patients referred to a cardiologist for coronary artery
-
-
-
-
als investigated the effect of intensive glycemic control
vs ordinary glycemic control on the development of new
-
glycemic control.
-
-
to correlate very well with the development of clinical car-
-
-
controversial owing to recent data showing little to no
-
The data from the many clinical trials and observa-
-
reported that low-dosage aspirin was associated with a
-
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-
-
-
-
4.Q11.3.
-
-
with either an angiotensin-converting enzyme inhibitor
-
-
strated a decrease in the progression of nephropathy and
-
-
-
-
-
--
lowering has the greatest and most immediate impact on
-
-
-
and the average recorded.
-
-
-
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-
-
ciated with increased long-term morbidity and mortality.
-
-
-
-
-
treatment regimen and avoid overtreatment.
-
-
aged as aggressively and with the same agents as in overt
-
as vasodilating
-
-
4.Q11.4.
-
hyperglycemia. -
ized by increased levels of triglyceride-rich lipoproteins
Table 12
Suggested Priority of Initiating Blood PressureLowering Agents
Therapy
Reference (evidence level and
study design)
Evidence based
Additional therapy
Direct renin inhibitor
Selective 1
Central 2
agonists
Direct vasodilators
-
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-
the latter being responsible for transfer of triglycerides and
cholesterol esters from very low-density lipoprotein and
-
level.
associated phospholipase A2
-
if the
-
-
-
hypertriglyceridemia.
In patients with fasting triglyceride concentrations of
-
-
-
-
-
-
-
erides with proliferator-activated receptor-
-
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necessary to prevent pancreatitis. Use of gemfibrozil is
-
no randomized interventional trials of prediabetes with
4.Q11.5.
-
-cation of glycemic control.
The impression in the past was that diagnosing asymp-
-
-
to identify those patients who will receive the most ben-
4.Q12. How Should Other Common Comorbidities of
DM Be Addressed
4.Q12.1. S
-
-
to a sleep specialist who may choose to do an overnight
and physical.
-
-
-
-
-
appropriate.
4.Q12.2. Depression
recommended. Untreated comorbid depression can have
-
pressant medication is associated with an increased relative
ACKNOWLEDGMENT
-
-
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FACE.
DISCLOSURE
Cochairpersons
reports that he has received
-
reports that he has received
reports that he has received
for his role as investigator from Boehinger Ingelheim
Dr. George Grunberger reports that he has
-
Inc.
Task Force Members
reports that he has
reports that he does not have
interests.
Dr. Samuel Dagogo-Jackreports that he has received
reports that he has received
Company.
reports that he has received shares
-
reports that he has received
-
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reports that he has received con-
reports that he has received
-
-
reports that he has
reports that he has received
reports that he does not have
interests.
reports that she has received
reports that he has received
reports that she has received
reports that he has received
-
and the American Diabetes Association.
reports that she has received
Reviewers
reports that he has received
reports that he does not have
interests.
reports that he has received
Medical Writer reports that she does not have any
interests.
REFERENCES
Note: All reference sources are followed by an evidence
level (EL) rating of 1, 2, 3, or 4 and the study design. The
strongest evidence levels ( and) appear in red
for easier recognition.
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