diabetes management guidelines: 2011 diabetes management guidelines: 2011 usphs scientific and...

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

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

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

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.

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


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”


“Overall, the risk for death among people with diabetes is about twice that of people of similar age but without diabetes. “

• 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

• 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

STANDARDS OF MEDICAL CAREIN DIABETES—2011

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.

CLASSIFICATION AND DIAGNOSIS OF DIABETES

• 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.

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.

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.


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


TESTING FOR DIABETES IN ASYMPTOMATIC PATIENTS

• 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

DETECTION AND DIAGNOSIS OF GESTATIONAL DIABETES MELLITUS

• 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.

PREVENTION AND/OR DELAY OF TYPE 2 DIABETES

• 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.

DIABETES CARE

• Initial Medical Evaluation

• Medical History

• Review of current treatment plan (if any)

• Physical Examination

• Laboratory Examination

• Referrals

Components of the Comprehensive Diabetes Evaluation

• 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.

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)


ADA. V. Diabetes Care. Diabetes Care 2011;34(suppl 1):S17. Table 8.

*See appropriate referrals for these categories.

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



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



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



• 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


• 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


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)


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.

Recommendations:Glycemic Goals in Adults


• 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)

Recommendations:Glycemic Goals in Adults


• 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)

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)

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.


• 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


• 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


PREVENTION AND MANAGEMENT OFDIABETES COMPLICATIONS

• 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.

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


• 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


• 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


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.

• 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


• 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


Recommendations: Smoking Cessation


*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)

• 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


DIABETES CARE IN SPECIFIC SETTINGS

• 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.

• 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.

STRATEGIES FOR IMPROVINGDIABETES CARE

• 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.

Diabetes Treatment Algorithms

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


+ basal

insulin

TIER 1: WELL-VALIDATED THERAPIES

TIER 2: LESS WELL-VALIDATED THERAPIES


+ Intensive

insulin

Diabetes Care, Vol. 32, 2009, 193-203.

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.

SUMMARY

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]

diabetes management guidelines: 2011 diabetes management guidelines: 2011 usphs scientific and...

Documents

diabetes center

diabetes epidemiology

diabetes mellitus slide

treatment of diabetes

diabetes management

financial impact of

diabetes outcome measures

national diabetes fact