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Diabetes Management Guidelines: 2011USPHS Scientific and Training Symposium – Pharmacy Category
June 21st, 2011
CDR Ryan Schupbach, Pharm.D., BCPS, CACP, NCPSClinical Pharmacy Director, PHS Claremore Indian Hospital
Clinical Assistant Professor, University of Oklahoma College of Pharmacy
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Objectives
• Generalize contemporary changes in guidelines relating to the diagnosis, treatment and medication management of diabetes
• Explore diabetes outcome measures where pharmacist practitioners can have significant impact
• Systematize preferred medications from evidence-based literature in the treatment of diabetes
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Overview
• Impact of Diabetes Mellitus (DM)
• Diabetes Practice Guidelines– Focus: 2011 ADA Standards of Medical Care
• Treatment Algorithms for Glycemic Control– 2009 ADA/EASD guidelines for T2DM– AACE December 2009 Update
T2DM= Type 2 Diabetes Mellitus
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Diabetes Epidemiology - 2010
• Diabetes affects 25.8 million in U.S.– 8.3% of population (>90% have T2DM)– 19 million diagnosed; 7 million undiagnosed
• 1.9 million adults diagnosed in 2010
• 79 million people have pre-diabetes in U.S.– 35% of adults aged 20 and older– 50% of adults aged 65 and older
Center for Disease Control and Prevention. National Diabetes Fact Sheet, 2011.
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Impact of Diabetes in the U.S.
• Diabetes is the leading cause of:– Kidney failure– Non-traumatic limb amputation– New cases of blindness
• Diabetes in the 7th leading cause for death in U.S.
• Diabetes is a major cause of heart disease and stroke
Center for Disease Control and Prevention. National Diabetes Fact Sheet, 2011.
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Financial Impact of Diabetes (2007)
Total (Indirect & Direct costs) $174 billion
Direct medical costs $116 billion
Indirect costs $58 billion (disability, work loss, premature mortality)
“Medical expenses for patients with diabetes are more than two times higher than for people without diabetes”
Center for Disease Control and Prevention. National Diabetes Fact Sheet, 2011.
“Overall, the risk for death among people with diabetes is about twice that of people of similar age but without diabetes. “
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• 2 main sets of guidelines utilized in U.S.– American Diabetes Association (ADA)– American Association of Clinical Endocrinology
(AACE)
• Lots of overlap, but AACE generally considered “more intense”
• Evidence based, well accepted, clinically relevant and can be easily incorporated into clinical practice
Diabetes Guideline Management
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• ADA publishes guideline update every January in Diabetes Care journal – Clinical Practice Recommendations – http://professional.diabetes.org/CPR_Search.aspx
• AACE updates guidelines periodically in Endocrine Practice journal– April 2011– Medical Guidelines for Clinical Practice for the
Management of Diabetes Mellitus– www.aace.com/publications/guidelines
Diabetes Guideline Management
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STANDARDS OF MEDICAL CAREIN DIABETES—2011
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Level of Evidence Description
A Clear or supportive evidence from adequately powered well-conducted, generalizable, randomized controlled trials
Compelling nonexperimental evidence B Supportive evidence from well-conducted cohort studies or
case-control studyC Supportive evidence from poorly controlled or uncontrolled
studies Conflicting evidence with the weight of evidence supporting the recommendation
E Expert consensus or clinical experience
ADA Evidence Grading System for Clinical Recommendations
ADA. Diabetes Care 2011;34(suppl 1):S12. Table 1.
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CLASSIFICATION AND DIAGNOSIS OF DIABETES
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• Type 1 diabetes– β-cell destruction
• Type 2 diabetes– Progressive insulin secretory defect
• Gestational diabetes mellitus
• Other specific types of diabetes– Genetic defects in β-cell function, insulin action
– Diseases of the exocrine pancreas
– Drug- or chemical-induced
Classification of Diabetes
ADA. I. Classification and Diagnosis. Diabetes Care 2011;34(suppl 1):S12.
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Fasting plasma glucose (FPG)≥126 mg/dl (7.0 mmol/l)
ORTwo-hour plasma glucose ≥200 mg/dl
(11.1 mmol/l) during an OGTTOR
A random plasma glucose ≥200 mg/dl (11.1 mmol/l)
ORA1C ≥6.5%
Criteria for the Diagnosis of Diabetes
ADA. I. Classification and Diagnosis. Diabetes Care 2011;34(suppl 1):S13. Table 2.
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A1C ≥6.5%
The test should be performed in a laboratory using an NGSP-certified method standardized to the
DCCT assay*
Criteria for the Diagnosis of Diabetes
*In the absence of unequivocal hyperglycemia, result should be confirmed by repeat testing.
ADA. I. Classification and Diagnosis. Diabetes Care 2011;34(suppl 1):S13. Table 2.
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Categories of increased risk for diabetes (Prediabetes)*
IFG: FPG 100-125 mg/dl (5.6-6.9 mmol/l)or
IGT: 2-h plasma glucose in the 75-g OGTT140-199 mg/dl (7.8-11.0 mmol/l)
orA1C 5.7-6.4%
Prediabetes: IFG, IGT, Increased A1C
*IFG = Impaired Fasting Glucose
*IGT = Impaired Glucose Tolerance
ADA. I. Classification and Diagnosis. Diabetes Care 2011;34(suppl 1):S13. Table 3.
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TESTING FOR DIABETES IN ASYMPTOMATIC PATIENTS
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• Consider testing overweight adults with one or more additional risk factors:
• In those without risk factors, begin testing at age 45 years
• If tests are normal: Repeat testing at 3-year intervals (E)
Recommendations: Testing for Diabetes in Asymptomatic Patients
ADA. II. Testing in Asymptomatic Patients. Diabetes Care 2011;34(suppl 1):S13-S14.
Physical Inactivity HDL <35mg/dL and/or TGY >250mg/dL
1st degree relative with DM Polycystic Ovarian Syndrome
High risk race/ethnicity (e.g., African American, Native American)
A1C ≥5.7%, IGT, or IFG on previous testing
Women with baby >9 lbs or GDM Conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans)
HTN or treatment for HTN History of CVD
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DETECTION AND DIAGNOSIS OF GESTATIONAL DIABETES MELLITUS
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• Screen for undiagnosed type 2 diabetes at the first prenatal visit in those with risk factors, using standard diagnostic criteria (B)
• In pregnant women not previously known to have diabetes, screen for GDM at 24-28 weeks gestation, using a 75-g OGTT and the diagnostic cutpoints below (B)
• GDM diagnosis: when any of the following plasma glucose values are exceeded:– Fasting ≥92 mg/dl – 1 h ≥180 mg/dl – 2 h ≥153 mg/dl
Recommendations:Detection and Diagnosis of GDM
ADA. III. Detection and Diagnosis of GDM. Diabetes Care 2011;34(suppl 1):S15.
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PREVENTION AND/OR DELAY OF TYPE 2 DIABETES
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• Refer patients with IGT (A), IFG (E), or A1C 5.7-6.4% (E) to support program– Weight loss 7% of body weight– At least 150 min/week moderate activity
• Consider metformin if multiple risk factors, especially if hyperglycemia (e.g., A1C>6%) progresses despite lifestyle interventions (B)
• In those with prediabetes, monitor for development of diabetes annually (E)
Recommendations:Prevention/Delay of Type 2 Diabetes
ADA. IV. Prevention/Delay of Type 2 Diabetes. Diabetes Care 2011;34(suppl 1):S16.
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DIABETES CARE
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• Initial Medical Evaluation
• Medical History
• Review of current treatment plan (if any)
• Physical Examination
• Laboratory Examination
• Referrals
Components of the Comprehensive Diabetes Evaluation
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• A complete medical evaluation should be performed to:– Classify the diabetes– Detect presence of diabetes complications– Review previous treatment, glycemic control in patients
with established diabetes– Assist in formulating a management plan– Provide a basis for continuing care
Diabetes Care: Initial Evaluation
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S16.
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Physical examination
•Height, weight, BMI
• Blood pressure determination, including orthostatic measurements when indicated
•Fundoscopic examination*
•Thyroid palpation
• Skin examination (for acanthosis nigricans and insulin injection sites)
Components of the Comprehensive Diabetes Evaluation
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S17. Table 8.
*See appropriate referrals for these categories.
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Physical examination
• Comprehensive foot examination
–Inspection
– Palpation of dorsalis pedis and posterior tibial pulses
– Presence/absence of patellar and Achilles reflexes
– Determination of proprioception, vibration, and monofilament sensation
Components of the Comprehensive Diabetes Evaluation
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S17. Table 8.
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Laboratory evaluation
• A1C, if results not available within past 2–3 months
• If not performed/available within past year:– Fasting lipid profile, including total, LDL, HDL and triglycerides– Liver function tests– Test for urine albumin excretion with spot urine albumin/creatinine
ratio– Serum creatinine and calculated GFR– TSH in type 1 diabetes, dyslipidemia, or women >50 years of age
Components of the Comprehensive Diabetes Evaluation
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S17. Table 8.
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Referrals•Annual dilated eye exam
•Family planning for women of reproductive age
•Registered dietitian for MNT
•Diabetes self-management education
• Dental examination
• Mental health professional, if needed
Components of the Comprehensive Diabetes Evaluation
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S17. Table 8.
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• Self-monitoring of blood glucose should be carried out 3+ times daily for patients using multiple insulin injections or insulin pump therapy (A)
• For patients using less frequent insulin injections, noninsulin therapy, or medical nutrition therapy alone– SMBG may be useful as a guide to success of therapy (E)– However, several recent trials have called into question
clinical utility, cost-effectiveness, of routine SMBG in non–insulin-treated patients
Recommendations: Glucose Monitoring
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S17.
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• Perform A1C test at least twice yearly in patients meeting treatment goals (and have stable glycemic control) (E)
• Perform A1C test quarterly in patients whose therapy has changed or who are not meeting glycemic goals (E)
• Use of point-of-care testing for A1C allows for timely decisions on therapy changes, when needed (E)
Recommendations: A1C
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S18.
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Mean plasma glucoseA1C (%) mg/dl mmol/l
6 126 7.07 154 8.68 183 10.29 212 11.8
10 240 13.411 269 14.912 298 16.5
Correlation of A1C with Estimated Average Glucose (eAG)
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S18. Table 9.
These estimates are based on ADAG data of ~2,700 glucose measurements over 3 months per A1C measurement in 507 adults with type 1, type 2, and no diabetes. The correlation between A1C and average glucose was 0.92. A calculator for converting A1C results into estimated average glucose (eAG) is available at http//professional.diabetes.org/GlucoseCalculator.aspx.
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Recommendations:Glycemic Goals in Adults
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S19.
• Lowering A1C to below or around 7%– Shown to reduce microvascular and neuropathic
complications of diabetes– If implemented soon after diagnosis of diabetes, associated
with long-term reduction in macrovascular disease
• Therefore, a reasonable A1C goal for many non-pregnant adults is <7% (B)
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Recommendations:Glycemic Goals in Adults
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S19.
• Conversely, less stringent A1C goals may be appropriate for patients with:
– History of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, extensive comorbid conditions
– Those with longstanding diabetes in whom the general goal is difficult to attain despite diabetes self-management education, appropriate glucose monitoring, and effective doses of multiple glucose lowering agents including insulin (C)
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Intensive Glycemic Control and Cardiovascular Outcomes: ACCORD
Gerstein HC, et al, for the Action to Control Cardiovascular Risk in Diabetes Study Group.N Engl J Med 2008;358:2545-2559.
©2008 New England Journal of Medicine. Used with permission.
Primary Outcome: Nonfatal MI, nonfatal stroke, CVD death
HR=0.90 (0.78-1.04)
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A1C <7.0%*
Preprandial capillary plasma glucose 70–130 mg/dl*
Peak postprandial capillary plasma glucose†
<180 mg/dl*
Glycemic Recommendations for Non-Pregnant Adults with Diabetes
*Postprandial glucose measurements should be made 1–2 h after the beginning of the meal, generally peak levels in patients with diabetes.
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S21. Table 10.
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• Consider bariatric surgery for adults with BMI >35 kg/m2 and type 2 diabetes (B)
• After surgery, life-long lifestyle support and medical monitoring is necessary (E)
• Insufficient evidence to recommend surgery in patients with BMI <35 kg/m2 outside of a research protocol (E)
Recommendations: Bariatric Surgery
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S26.
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• Provide an influenza vaccine annually to all diabetic patients ≥6 months of age (C)
• Administer pneumococcal polysaccharide vaccine to all diabetic patients ≥2 years
• One-time revaccination recommended for those >64 years previously immunized at <65 years if administered >5 years ago
Recommendations: Immunization
ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S27.
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PREVENTION AND MANAGEMENT OFDIABETES COMPLICATIONS
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• Measure blood pressure at every diabetes visit
• A goal systolic blood pressure <130 mmHg is appropriate for most patients with diabetes (C)
• Patients with diabetes should be treated to a diastolic blood pressure <80 mmHg (B)
• Patients with more severe hypertension (≥140/≥90 mmHg) at diagnosis or follow-up– Should receive pharmacologic therapy in addition to
lifestyle therapy (A)
Recommendations: Hypertension/Blood Pressure Control
ADA. VI. Prevention, Management of Complications. Diabetes Care 2011;34(suppl 1):S27.
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Treatment• Pharmacotherapy for DM patients with hypertension
– Pair with a regimen that includes either an ACE inhibitor or angiotensin II receptor blocker
– If one class is not tolerated, the other should be substituted
• If needed to achieve blood pressure targets– Thiazide diuretic should be added to those with estimated
GFR ≥30 ml x min/1.73 m2
– Loop diuretic for those with an estimated GFR <30 ml x min/1.73 m2 (C)
Recommendations: Hypertension/Blood Pressure Control
ADA. VI. Prevention, Management of Complications. Diabetes Care 2011;34(suppl 1):S27.
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• In most adult patients– Measure fasting lipid profile at least annually
• In adults with low-risk lipid values (LDL <100 mg/dl, HDL >50 mg/dl, and triglycerides <150 mg/dl)– Lipid assessments may be repeated every 2 years (E)
• To improve lipid profile in patients with diabetes, recommend lifestyle modification (A), focusing on– Reduction of saturated fat, trans fat, cholesterol intake– Increased n-3 fatty acids, viscous fiber, plant
stanols/sterols– Weight loss (if indicated)– Increased physical activity
Recommendations:Dyslipidemia/Lipid Management
ADA. VI. Prevention, Management of Complications. Diabetes Care 2011;34(suppl 1):S29.
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• Statin therapy should be added to lifestyle therapy, regardless of baseline lipid levels, for diabetics:– with overt CVD (A)– without CVD who are >40 years of age and have one or
more other CVD risk factors (A)
• In individuals without overt CVD– Primary goal is an LDL <100 mg/dl (2.6 mmol/l) (A)
• In individuals with overt CVD– Lower LDL goal of <70 mg/dl, using a high dose of a statin
is an option (B)
Recommendations:Dyslipidemia/Lipid Management
ADA. VI. Prevention, Management of Complications. Diabetes Care 2011;34(suppl 1):S29.
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A1C <7.0%*
Blood pressure <130/80 mmHg†
Lipids:LDL cholesterol <100 mg/dl‡
Recommendations: Glycemic, Blood Pressure, Lipid Control in Adults
*More or less stringent glycemic goals may be appropriate for individual patients. Goals should be individualized based on: duration of diabetes, age/life expectancy, comorbid conditions, known CVD or advanced microvascular complications, hypoglycemia unawareness, and individual patient considerations.
†Based on patient characteristics and response to therapy, higher or lower systolic blood pressure targets may be appropriate.‡In individuals with overt CVD, a lower LDL cholesterol goal of <70 mg/dl (1.8 mmol/l), using a high dose of statin, is an option .
ADA. VI. Prevention, Management of Complications. Diabetes Care 2011;34(suppl 1):S31. Table 12.
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• Consider aspirin therapy (75–162 mg/day) (C)– As primary prevention in type 1 or type 2 diabetics at
increased cardiovascular risk (10-year risk >10%)– Includes most men >50 years of age or women >60 years
of age who have at least one additional major risk factor• Family history of CVD, HTN, Smoking, Dyslipidemia, Albuminuria
• Aspirin should not be recommended for CVD prevention for diabetic adults at low CVD risk, since potential bleeding likely offset potential benefits (C)• 10-year CVD risk <5%: men <50 and women <60 years of age
with no major additional CVD risk factors
Recommendations: Antiplatelet Agents
ADA. VI. Prevention, Management of Complications. Diabetes Care 2011;34(suppl 1):S31.
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• Use aspirin therapy (75–162 mg/day)– Secondary prevention strategy in those with diabetes with a
history of CVD (A)
• For patients with CVD, documented aspirin allergy– Clopidogrel (75 mg/day) should be used (B)
• Combination therapy with ASA (75–162 mg/day) and clopidogrel (75 mg/day)– Reasonable for up to 1 year after acute coronary syndrome (B)
Recommendations: Antiplatelet Agents
ADA. VI. Prevention, Management of Complications. Diabetes Care 2011;34(suppl 1):S31.
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Recommendations: Smoking Cessation
ADA. VI. Prevention, Management of Complications. Diabetes Care 2011;34(suppl 1):S32.
*If not contraindicated.
• Advise all patients not to smoke (A)
• Include smoking cessation counseling and other forms of treatment as a routine component of diabetes care (B)
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• In patients with type 1 diabetes, hypertension, and any degree of albuminuria– ACE inhibitors shown to delay progression of nephropathy (A)
• In type 2 diabetes, hypertension, and microalbuminuria– Both ACE inhibitors and ARBs shown to delay progression to
macroalbuminuria (A)
• In type 2 diabetes, hypertension, macroalbuminuria, and renal insufficiency (serum creatinine >1.5 mg/dl)– ARBs shown to delay progression of nephropathy (A)
Recommendations: Nephropathy Treatment
ADA. VI. Prevention, Management of Complications. Diabetes Care 2011;34(suppl 1):S33.
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DIABETES CARE IN SPECIFIC SETTINGS
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• All patients with diabetes admitted to the hospital should have:– Their diabetes clearly identified in the medical record (E)
• An order for blood glucose monitoring, with results available to the health care team (E)
• Goals for blood glucose levels:– Critically ill patients: 140-180 mg/dl (A)– More stringent goals, such as 110-140 mg/dl may be
appropriate for selected patients, if achievable without significant hypoglycemia (C)
– Non-critically ill patients: base goals on glycemic control, severe comorbidities (E)
Recommendations:Diabetes Care in the Hospital
ADA. VIII. Diabetes Care in Specific Settings. Diabetes Care. 2011;34(suppl 1):S43.
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• A hypoglycemia management protocol should be adopted and implemented by each hospital or hospital system– Establish a plan for treating hypoglycemia for each
patient; document episodes of hypoglycemia in medical record and track
• Obtain A1C for all patients if results within previous 2-3 months unavailable (E)
• Patients with hyperglycemia who do not have a diagnosis of diabetes should have appropriate plans for follow-up testing and care documented at discharge (E)
Recommendations:Diabetes Care in the Hospital
ADA. VIII. Diabetes Care in Specific Settings. Diabetes Care. 2011;34(suppl 1):S43.
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STRATEGIES FOR IMPROVINGDIABETES CARE
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• Facilitate timely and appropriate intensification of lifestyle and/or pharmaceutical therapy of patients who have not achieved beneficial levels of blood pressure, lipid, or glucose control
• Research on the comprehensive chronic care (CCM) model suggests additional strategies to improve diabetes care including: – Consistent, evidence-based care guidelines– Collaborative, multidisciplinary teams– Audit and feedback of process and outcome data to
providers– Alterations in reimbursement
Provider and Team Behavior Change
ADA. IX. Strategies for Improving Diabetes Care. Diabetes Care. 2010;33(suppl 1):S47.
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Diabetes Treatment Algorithms
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At diagnosis:Lifestyle
+metformin
Lifestyle + metformin+
Basal insulin
Step 2Step 1 Step 3
Lifestyle + metformin+
sulfonylurea
Lifestyle + metformin+ pioglitazone
No hypoglycemiaEdema/CHFBone loss
Lifestyle + metformin+ GLP-1 agonistNo hypoglycemia
Weight lossNausea/vomiting
Lifestyle + metformin
+ pioglitazone+
sulfonylurea
Lifestyle + metformin
+ basal
insulin
TIER 1: WELL-VALIDATED THERAPIES
TIER 2: LESS WELL-VALIDATED THERAPIES
Lifestyle + metformin
+ Intensive
insulin
Diabetes Care, Vol. 32, 2009, 193-203.
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A1C 6.5 – 7.5%**
Monotherapy
MET +
GLP-1 or DPP4 1
TZD 2
Glinide or SU 5
TZD + GLP-1 or DPP4 1
MET +Colesevelam
AGI 3
2 - 3 Mos.***
2 - 3 Mos.***
2 - 3 Mos.***
Dual Therapy
MET +GLP-1 or DPP4 1
+
TZD 2
Glinide or SU 4,7
A1C > 9.0%
No Symptoms
Drug Naive Under Treatment
INSULIN± Other
Agent(s) 6
Symptoms
INSULIN± Other
Agent(s) 6
INSULIN± Other
Agent(s) 6
Triple Therapy
AACE/ACE Algorithm for Glycemic Control Committee
Cochairpersons:Helena W. Rodbard, MD, FACP, MACEPaul S. Jellinger, MD, MACE
Zachary T. Bloomgarden, MD, FACEJaime A. Davidson, MD, FACP, MACEDaniel Einhorn, MD, FACP, FACEAlan J. Garber, MD, PhD, FACEJames R. Gavin III, MD, PhDGeorge Grunberger, MD, FACP, FACEYehuda Handelsman, MD, FACP, FACEEdward S. Horton, MD, FACEHarold Lebovitz, MD, FACEPhilip Levy, MD, MACEEtie S. Moghissi, MD, FACP, FACEStanley S. Schwartz, MD, FACE
* May not be appropriate for all patients** For patients with diabetes and A1C < 6.5%,
pharmacologic Rx may be considered*** If A1C goal not achieved safely
† Preferred initial agent
1 DPP4 if PPG and FPG or GLP-1 if PPG
2 TZD if metabolic syndrome and/or nonalcoholic fatty liver disease (NAFLD)
3 AGI if PPG
4 Glinide if PPG or SU if FPG
5 Low-dose secretagogue recommended
6 a) Discontinue insulin secretagogue
with multidose insulin b) Can use pramlintide with prandial insulin
7 Decrease secretagogue by 50% when added to GLP-1 or DPP-4
8 If A1C < 8.5%, combination Rx with agents that cause hypoglycemia should be used with caution
9 If A1C > 8.5%, in patients on Dual Therapy,insulin should be considered
MET +
GLP-1
or DPP4 1 ± SU 7
TZD 2
GLP-1
or DPP4 1 ± TZD 2
A1C 7.6 – 9.0%
Dual Therapy 8
2 - 3 Mos.***
2 - 3 Mos.***
Triple Therapy 9
INSULIN± Other
Agent(s) 6
MET +
GLP-1 or DPP4 1
or TZD 2
SU or Glinide 4,5
MET +
GLP-1
or DPP4 1+ TZD 2
GLP-1
or DPP4 1 + SU 7
TZD 2
MET † DPP4 1 GLP-1 TZD 2 AGI 3
Available at www.aace.com/pub© AACE December 2009 Update.
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SUMMARY
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Diabetes Management Guidelines: 2011USPHS Scientific and Training Symposium – Pharmacy Category
June 21st, 2011
CDR Ryan Schupbach, Pharm.D., BCPS, CACP, NCPSClinical Pharmacy Director, PHS Claremore Indian Hospital
Clinical Assistant Professor, University of Oklahoma College of [email protected]