Care Guide for Diabetes

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Healthways Medical Integrity

SUGGESTED GUIDELINES

PROCESS IMPORTANT FINDINGS, MEASUREMENTS AND

VALUES

INTERVENTIONS FOLLOW-UP

Screening for Diabetes (DM) in non-pregnant adults (1,2,4,6,15,19)

 Fasting plasma glucose (FPG) and Hemoglobin A1C level are practical screening tests

 All adults 45 years or older

 Consider screening all adults who are overweight (Body Mass Index [BMI] ≥25 kg/m² or ≥23 kg/m² in Asian

Americans ⁽¹⁾ and have one or more additional risk factors for diabetes including: ⁽¹⁾

 Physical inactivity

 History of gestational diabetes or delivering a baby weighing >9 lbs

 Polycystic Ovarian Syndrome (PCOS)

 Family history of diabetes in a first degree relative

 Member of a high risk racial/ethnic group:

(African American, Latino, Native American, Asian American, Pacific Islander)

 Hypertension (HTN) (≥

140/90 mmHg or on therapy for hypertension).

 Diabetes

 Clinical Diagnosis: Classic symptoms of DM and a random glucose ≥ 200 mg/dL

 Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (Fasting is defined as no caloric intake for at least 8 hours)

 2-h Plasma Glucose (PG) ≥ 200 mg/dL during a 75 gm Oral Glucose Tolerance Test (OGTT)

 Hemoglobin A1C (A1C) >6.5%

The test should be performed in a laboratory using a method that is National Glycohemoglobin Standardization Program (NGSP) certified and standardized to the Diabetes Control and

Complications Trial (DCCT) assay

 Confirmation of Diagnosis by Laboratory Test

 In the absence of unequivocal hyperglycemia result should be confirmed by repeat testing

 If abnormal, follow diabetes guidelines

 If normal, repeat at least every three years

 For high-risk patients, repeat more frequently, but at least annually

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 High-density lipoprotein (HDL)cholesterol level

<35 mg/dL (0.90 mmol/L) and/or a triglyceride level

>250 mg/dL (2.82 mmol/L)

 A1C ≥5.7-6.4, IGT, or FPG 100 – 125 mg/dL (IFG) on previous test

 Other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans, Metabolic Syndrome)

 History of Cardiovascular Disease (CVD)

 In individuals with none of the above criteria, testing for diabetes should begin at age 45 years

 If results are normal, testing for diabetes should be repeated at least every 3 years. Consider more frequent testing, at least annually if high risk ⁽¹⁹⁾ (e.g., those with prediabetesshould be tested yearly)

 Categories of increased risk for diabetes (prediabetes):

 FPG 100 – 125 mg/dL = Impaired Fasting Glucose (IFG)

 2-h PG 140 – 199 mg/dL = Impaired Glucose Tolerance (IGT)

 A1C 5.7-6.4%

 Re-test on a separate occasion to confirm diagnosis

 If re-test is negative, repeat testing on negative test ⁽¹⁹⁾

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Healthways Medical Integrity Monitoring for

Glucose Control

(1,4,6,15,19)

A1C:

 If at goal: test twice a year

 If not at goal, or if change made in therapy: test every three months ⁽¹⁾

Goal:

 A1C < 7.0 % in non-pregnant adults

 A1C goal may be more stringent (≤6.5%) for select patients if this can be achieved without leading to excessive hypoglycemia or other adverse effects of treatment.

Appropriate patients may include those with:

 short duration of diabetes

 long life expectancy

 no significant CVD

 Less stringent treatment goals (< 8%) may be appropriate for patients with:

 a history of severe hypoglycemia

 limited life expectancy

 advanced microvascular or macrovascular complications

 extensive comorbid conditions

 long-standing diabetes in whom the general goal is difficult to attain despite Diabetes Self- Management Education (DSME), appropriate glucose monitoring, and effective doses of multiple glucose-lowering agents including insulin

 If above goal of < 7.0 %, follow guidelines for pharmacologic and non-pharmacologic treatment – Medical Nutrition Therapy (MNT) and exercise

 Self-management education as indicated

 Repeat every three months until goal is reached

 Repeat twice a year if meeting treatment goal

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Healthways Medical Integrity Self-Monitoring of

Blood Glucose (SMBG) ^(1,15,19)

 SMBG at least 3-4 times a day

(19) if using multiple insulin injections or insulin pump:

 prior to meals and snacks

 occasionally 2-hours post- prandially ⁽¹⁹⁾

 at bedtime

 prior to exercise

 when low blood glucose is suspected

 after treating low blood glucose until they are normoglycemic

 prior to critical tasks such as driving

 SMBG pre-and post-

prandially, may be needed, for non-insulin treated patients, to guide treatment decisions and/

or patient self-management

Goal:

Test Plasma Glucose (PG) Preprandial 80 - 130 mg/dL ⁽¹⁾ Older (≥ 65 years of age) ⁽¹⁾ or CVD 90-130 ⁽¹⁾ mg/dL⁽¹⁹⁾

Hx of hypoglycemia 90-140 mg/dL ⁽¹⁹⁾

Postprandial < 180 mg/dL

 Glucose (15-20 g) is the preferred treatment for a conscious individual with hypoglycemia, although any form of carbohydrate that contains glucose may be used ⁽¹⁾Retest after 15 minutes, if continued hypoglycemia, repeat treatment

 Once SMBG returns to normal, encourage a snack or meal with protein

 When used properly, continuous glucose monitoring (CGM) in conjunction with intensive insulin regimens is a useful tool to lower A1C in selected adults (aged ≥25 years) with Type 1 diabetes CGM use requires as assessment of individual readiness for the technology as well as initial and ongoing education and support.⁽¹⁾

 Educate patient and/or caregivers on how to adjust therapies based on results of SMBG and/or A1C results

 Prescribe an appropriate rapid carbohydrate source for all who are at risk for hypoglycemia

 Instruct patient and/or caregivers in identifying and managing episodes of hypoglycemia

 Glucagon should be prescribed for those at high risk for severe hypoglycemia. Those in close contact with or having custodial care of, people with

hypoglycemia-prone diabetes should be instructed on glucagon administration ⁽¹⁾

 Assess SMBG technique

 Consider use of sensor-

augmented low glucose suspend threshold pump for patients with frequent nocturnal hypoglycemia and/or hypoglycemia

unawareness

 Evaluate need for and frequency of SBGM at each visit

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Healthways Medical Integrity Foot Care and

Neuropathy Screening ^(1,3,15)

 Screen for distal

polyneuropathy (DPN) starting at the time of diagnosis of type 2 DM and 5 years after the diagnosis of type 1 DM and at least annually thereafter

 Screening test should include the use of a 10-g

monofilament, assessment of pin prick, vibration using a 128-Hz tuning fork, and temperature perception, at the distal plantar aspect of both great toes, and assessment of ankle reflexes

 The foot exam should include a visual inspection and palpation

 Initial screening should include a claudication history and assessment of pedal pulses

 Screen for cardiovascular autonomic neuropathy with orthostatic BP and pulse at time of diagnosis of type 2 DM and 5 years after the diagnosis of type 1 DM

 Document full foot exam each year – foot structure, vascular status, and skin integrity

 Consider obtaining an Ankle Brachial Index (ABI)

 Identify those at high risk for foot ulcers and amputations, which include those with:

 Vision impairment

 Diabetic nephropathy (especially those on dialysis)

 Poor glycemic control

 Cigarette smoking

 Peripheral vascular disease (PVD)

 Previous amputation

 Past foot ulcer history

 Foot deformity

 Peripheral neuropathy

 Document full (comprehensive) foot exam each year – foot structure, vascular status, protective sensory status, and skin integrity

 All patients with insensate feet, foot deformities, or a history of foot ulcers should have their feet examined at every encounter ⁽¹⁾

 Screen for peripheral arterial disease (PAD)

 History of claudication

 Peripheral pulses

 Consider obtaining an Ankle Brachial Index (ABI)

 Refer for further vascular assessment if with significant claudication or a positive ABI, and consider exercise,

medications, and surgical options

 Provide foot self-care education annually

 Refer patients who smoke, have loss of protective sensation (LOPS), altered biomechanics and structural abnormalities, or have a history of prior lower- extremity complications to foot care specialist

 Screen annually

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 Evaluate for appropriate footwear prescription or referral if abnormal

 Repeat basic foot-care education

 Medications for the relief of specific symptoms related to painful DPN and autonomic neuropathy are recommended to improve the quality of life

 Provide a tailored and step- wise pharmacological approach

 Follow-up and document:

o symptom improvement o medication adherence o education side effects

Retinopathy Screening and Treatment (1,6,15,19)

 For adults with type 1 diabetes:

 An initial dilated and comprehensive eye examination by an ophthalmologist or optometrist within 5 years after the onset of diabetes

 For patients with type 2 diabetes:

 Presence/absence of retinopathy

 The presence of retinopathy is not a contraindication to aspirin therapy for cardioprotection, as this therapy does not increase the risk of retinal hemorrhage

 Glaucoma, cataracts, and other disorders of the eye occur earlier and more frequently in people with diabetes

 If abnormal exam by optometrist, refer for further evaluation and treatment by ophthalmologist

 Promptly refer patients with any level of macular edema, severe non-proliferative diabetic retinopathy (NPDR), or any proliferative diabetic retinopathy (PDR) to an ophthalmologist who is knowledgeable and experienced in the management

 Yearly routine examination and more frequently if retinopathy is progressing

 If there is no evidence of retinopathy for one or more eye examinations, then examinations every 2 years may be considered Close follow-up during pregnancy and for 1 year postpartum

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 An initial dilated and comprehensive eye examination by an ophthalmologist or optometrist shortly after the diagnosis of diabetes

 An initial dilated and comprehensive eye

examination is recommended for children at the start of puberty or at age ≥10 years, whichever is earlier, once the child has had diabetes for 3-5 years

 Women with preexisting diabetes who are planning pregnancy or who are pregnant should have a comprehensive eye examination in the first trimester of pregnancy with continued close follow-up throughout pregnancy

 Factors that increase the risk of, or are associated with retinopathy:

 Chronic hypoglycemia and hyperglycemia ⁽¹⁹⁾

 nephropathy

 hypertension

 Intensive diabetes management with goal of achieving near-normal glycemic levels has been shown to prevent and/or delay onset of diabetic retinopathy

 Lowering blood pressure has been shown to decrease the progression of retinopathy

and treatment of diabetic retinopathy

 Treatment:

 Laser photocoagulation therapy

 Anti-vascular endothelial growth factor (VEGF) therapy

Nephropathy Screening and Treatment (1,3,15,19)

 At least annually,

quantitatively assess urinary albumin (e.g., urine albumin- to-creatinine ratio (UACR) and estimated glomerular

 Serum Creatinine (Cr)

 Serum potassium (K+) if patient is on Angiotensin Converting Enzyme Inhibitor (ACE-I), Angiotensin Receptor Blocker (ARB) or diuretic

 Confirm with repeat test and rule out other causes (e.g., infection)

 ACE-I or ARB is not

recommended for the primary prevention of diabetic kidney

 Repeat urine albumin excretion test at least annually

 Monitor K⁺and Cr if on ACE-I or ARB or diuretic

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filtration rate (eGFR) in patients with type 1 diabetes of

≥ 5 years duration and in all patients with type 2 diabetes starting at diagnosis or shortly thereafter*

 Measure serum creatinine at least annuallyin all adults with diabetes, regardless of the degree of urine albumin excretion, to estimate glomerular filtration rate (eGFR) and stage the level of chronic kidney disease (CKD)

 Optimize glucose control to reduce the risk or slow the progression of diabetic kidney disease ⁽¹⁾

 Optimize blood pressure control to reduce the risk or slow the progression of diabetic kidney disease ⁽¹⁾

* Due to variability in urinary albumin excretion, at least two out of three tests within a six-month period should be abnormal before considering a patient to have developed increased urinary albumin excretion or had a progression in albuminuria

 Spot urine albumin-to-creatinine ratio:

 Normal: < 30mg/g creatinine

 Increased urinary albumin excretion ≥ 30mg/g creatinine**

Stages of Chronic Kidney Disease:

 Stage 1: Kidney damage^§ with normal or increased eGFR (eGFR ≥90)

 Stage 2: Kidney damage with mildly decreased eGFR (eGFR 60-89)

 Stage 3: Moderately decreased eGFR (eGFR 30-59)

 Stage 4: Severely decreased eGFR (eGFR 15-29)

 Stage 5: Kidney failure (eGFR <15 or dialysis)

§ Kidney damage defined as abnormalities on pathologic, urine, blood, or imaging test

** The terms "microalbuminuria" (30-299 mg/24 h) and "macroalbuminuria" (>300 mg/24 h) will no longer be used, since albuminuria occurs on a continuum.

Albuminuria is defined as UACR ≥30 mg/g

disease in individuals with diabetes who have normal blood pressure and normal UACR (,30 mg/g) ⁽¹⁾

 Therapy with ACE-I or ARBs is recommended to treat modestly elevated (30-299 mg/24h) or higher levels (≥ 300 mg/24h) of urinary albumin excretion if not contraindicated ***/‡

 Non-dihydropyridine calcium channel blocker (CCB) may be beneficial if ACE-I and ARB are contraindicated or if ACE-I and ARB are not tolerated

 Reduction of dietary protein below the recommended daily allowance of 0.8 g/kg/day (based on ideal bodyweight) is not recommended for people with diabetes and diabetic kidney disease (albuminuria ≥30mg/24h). It does not

alter glycemic measures, cardiovascular risk measures,

or, course of eGFR decline

 Dietary protein restriction might be considered in patients whose nephropathy seems to be progressing despite optimal

 Consider referral to nephrologist for evaluation for kidney transplantation, hemodialysis (in-center or home) or peritoneal dialysis

(19). Continue surveillance to monitor response to therapy and progression of disease after diagnosis of albuminuria

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*Consider other causes for protein in the urine: Exercise, meat consumption, prolonged standing.

Repeat in AM after positive test ⁽¹⁹⁾

glucose and blood pressure control and use ACE-I and/or ARBs

 Refer to nephrologist for eGFR < 30 ml/min

 Consider referral to nephrologist when there is uncertainty about the etiology of kidney disease:

 heavy proteinuria

 active urine sediment

 absence of retinopathy

 rapid decline in eGFR

 resistant hypertension

 Additional reasons for referral may include:

 difficult management of anemia

 secondary

hyperparathyroidism ⁽¹⁹⁾

 metabolic bone disease

 electrolyte disturbance, or

 resistant hypertension

*** ACE-I and ARBs are contraindicated in pregnancy.

Antihypertensive drugs known to be effective and safe in pregnancy include methyldopa, labetalol, diltiazem, clonidine, and prazosin

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‡ There are some reports of angioedema with ACE-I and with ARBs. Combination of ACE-I + ARB usually not recommended.

ACE-I better than ARB for CV outcomes ⁽¹⁹⁾

Blood Pressure Management

(1,6, 15,16,18,19,22,23,24)

 Measure blood pressure (BP) at every encounter

 Use Therapeutic Lifestyle Changes (TLC)/Lifestyle Modification (LM)

 Use diet, exercise, tobacco cessation, weight loss and medications to achieve target BP

 Encourage tobacco cessation (5-As) and weight loss

 Adjust treatment as necessary at each visit until target values achieved

Goal:

 The American Diabetes Association Patients with diabetes and

hypertension should be treated to a blood pressure goal of <140/90 mmHg ⁽¹⁾

 Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) recommends a blood pressure goal of

<140/90 for persons of all ages with diabetes

 Lower systolic targets, such as <130 mmHg, may be appropriate for certain individuals, such as younger patients, if it can be achieved without undue treatment burden

 Patients with diabetes should be treated to a diastolic blood pressure

<90 mm Hg ⁽¹⁾

 Inform patient of BP goals

 Encourage home BP monitoring

 Treat all patients with diabetes and Hypertension (HTN) with a regimen that includes an ACE-I or ARB, unless contraindicated.

If one class is not tolerated, use the other ***/‡

 Patients with diabetes and hypertension generally require multidrug therapy to reach treatment goals

 If BP >120/80 mm Hg, initiate TLC that includes:

 Weight loss if overweight

 Exercise

 DASH-style diet (including reduced 2-gram ⁽¹⁸⁾ sodium and increased potassium intake)

 Measure blood pressure and evaluate management at each visit

 Review home blood pressure record

 Monitor K+ and Cr in patients on

pharmacotherapy

 Assess for medication side effects

 Assess compliance with lifestyle modification

 Assess compliance with medication(s)

 Encourage and assist, providing compliance tools and suggestions

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 110-129/65-79 mm Hg is a reasonable target for pregnant diabetic women with chronic hypertension***

*** ACE-I and ARBs are contraindicated in pregnancy. Antihypertensive drugs known to be effective and safe in pregnancy include methyldopa, labetalol, diltiazem, clonidine, and prazosin

o Be careful with

increasing K⁺in patients on ACE-I/ARB⁽¹⁹⁾

 Moderation of alcohol use (no more than 1 alcohol- containing drink a day for women, no more than 2 alcohol-containing drinks a day for men)

If targets not achieved with TLC, and BP is ≥140/80 mm Hg, add

pharmacologic therapy (multiple drug therapy is generally required)

AHA/ACC/CDC Recommendations Pharmacology:

 Stage I (140-159/90-99):

 LM only trial

 Consider thiazide

 Angiotensin-converting enzyme inhibitor (ACE-I) and/or Beta Blocker (BB) for patients with Coronary Heart Disease/Post MI

 ACE-I or ARB. If one class is not tolerated, use the other (cough or angioedema with ACE-1 are not

contraindications to use ARB) ⁽¹⁸⁾

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 Use 1 or more agents at bedtime

 Recheck in 3 months or based on risk of adverse outcome

 Stage II (≥160/100):

 Two-drug combination preferred

 ACE-I or ARB, BB, CCB.

(Can use loop diuretic in combination with thiazide to correct volume overload) ⁽¹⁸⁾

 LM and

o Thiazide + ACE-I, or o Thiazide + ARB, or o Thiazide + calcium

channel blocker (CCB) o Or consider ACE-I +

CCB

 Recheck in 2-4 weeks or based on risk of adverse outcome

 BP not at goal on 1^st recheck

 Thiazide for most patients or ACE-I, ARB, CCB, or combination

 If currently on BP med(s), titrate and/or add drug from a different class

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 Recheck in 2-4 weeks or based on risk of adverse outcome

 BP not at goal on 2^nd recheck

 Optimize dose or add medication

 Assess adherence, advise on self-monitoring, request readings from home and/or other setting

 Consider secondary cause

 Consider referral to HTN specialist

 BP at goal

 Encourage self-monitoring and adherence to meds

 Pt. to alert provider if BP elevates or if side effects occur

 Follow-up visits as clinically appropriate

Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) Pharmacology:

 All ages (BP >140/90)

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 Non-black: thiazide-type diuretic, or ACE-I, or ARB or CCB, alone or in combo

 Black: thiazide-type diuretic or CCB, alone or in

combination

 All races: ACE-I or ARB, alone or + other drug class

 If blood pressure is refractory to optimal doses of at least three antihypertensive agents of different classifications, one of which is a diuretic, or if with hypokalemia, early age (<40 y/o) and no family history of

hypertension ⁽¹⁹⁾, consider an evaluation for secondary forms of hypertension

‡ There are some reports of angioedema with ACE-I and ARBs

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Healthways Medical Integrity Lipid Management

(1,5,6,16,19)

Preventive / Surveillance

 Screening lipid profile is reasonable at diabetes

diagnosis, at an initial medical evaluation and/or at age 40, and periodically thereafter

(1)Testing every 3-5 years is acceptable for adults with low risk lipid levels⁽¹⁹⁾:

 (Low Density Lipids (LDL) <100 mg/dL,

 High Density Lipids (HDL) >50 mg/dL, and

 Triglycerides (TG) < 150 mg/dL

 Use diet, regular exercise, avoidance of tobacco, healthy weight management and medications to achieve recommended lipid levels

 Discuss potential overall risks and benefits before starting statin therapy

 Perform baseline liver enzyme, creatinine kinase (if indicated), hemoglobin A1C (if diabetes status not known) and urinalysis tests before starting statin therapy

ADA: “Treatment initiation and initial statin dose is driven primarily by risk status rather than LDL cholesterol level”

(1)

Goal: ATP III Guidelines

 LDL Cholesterol (LDL-C): Primary goal is < 100 mg/dL

 LDL < 70 mg/dL for patients with established cardiovascular disease (CVD) or at very high risk

 Reducing LDL 30-40%, regardless of initial LDL level is an alternative goal in

individuals on maximum tolerated statin therapy who are not meeting target LDL

 HDL Cholesterol >40 mg/dL in men and >50 mg/dL in women

 Triglycerides (TGs): < 150 mg/dL

 If TGs > 200, non-HDL cholesterol should be < 130 mg/dL

G Goal: ACC/AHA Guidelines*

 The focus of therapy is reduction of atherosclerotic cardiovascular disease (ASCVD) risk in those most likely to benefit

 Initiate TLC/LM for all patients

 Reduce intake of saturated fats and cholesterol

 Reduce/eliminate trans fats

 Increase fiber intake and plant stanols/sterols

 Increase omega-3 fatty acids

 Increase daily physical activity

 Initiate weight management if indicated

 Avoid tobacco

 ADA Treatment

Recommendations and Goals:

(1)

 In addition to the TLC/LM listed above, intensify TLC/LM and optimize glycemic control for individuals with elevated triglyceride levels (≥150 mg/dL) and or low HDL (<40 mg/dL for men, <50 mg/dL

 For individuals with fasting triglyceride levels ≥ 500 mg/dL, evaluate for secondary causes

 Perform fasting liver enzyme tests before initiating statin therapy.

 Monitor Creatinine phosphokinase (CPK) in patients with muscle discomfort

 Measure fasting lipid panel at 4-12 weeks following the start or the adjustment of current statin therapy to moderate- or high-intensity therapy, to determine adherence.

 Repeat fasting lipid panel every 3-12 months thereafter, as clinically indicated

 Monitor for adverse effects and determine cause. Once resolved, start lower dose of same statin or other

appropriate statin

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 Guidelines do not apply to persons with NYHA class II- IV heart failure and persons on hemodialysis

 Statin therapy reduces ASCVD risk in persons with baseline LDL-C levels >

70 mg/dL

 Emphasize lifestyle and statin therapy before considering non-statin drugs

 Non-statin therapies do not provide acceptable ASCVD risk reduction benefits compared to their potential for adverse effects

 ASCVD risk reduction outweighs the risk of adverse events in adults age

>21y/o with:

 Clinical ASCVD

 Primary elevations of

 LDL-C >190 mg/dL

 Diabetes aged 40 to 75 years with LDL-C 70 to189 mg/dL and without clinical ASCVD, or

 No clinical ASCVD or diabetes with LDL-C 70 to189 mg/dL and estimated 10-year ASCVD risk

>7.5%

 Clinical ASCVD means: history of acute coronary syndromes, or a history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin

and consider medical therapy to risk of pancreatitis ADA Drug Therapy Recommendations:⁽¹⁾

 For individuals of all ages with diabetes and overt CVD, high-intensity therapy should be added to TLC/LM

 For individuals with

diabetes aged <40 years with additional CVD risk factors, consider using moderate-or high-intensity statin therapy and TLC/LM

 For individuals with diabetes aged 40-75 years without additional CVD risk factors, consider using moderate-intensity statin therapy and TLC/LM

 For individuals with diabetes aged 40-75 years with additional CVD risk factors, consider using high- intensity therapy and TLC/LM

 For individuals with diabetes aged >75 years without additional CVD risk factors, consider use of moderate-intensity statin therapy and TLC/LM

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 Use the “Pooled Cohort Equations” of the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic

Cardiovascular Risk in Adults to estimate 10-year ASCVD risk (e10yASCVDr) in both white and black men and women to identify those most likely to benefit.

Available at

http://my.americanheart.org/professio nal/StatementsGuidelines/Prevention Guidelines/Prevention-

Guidelines_UCM_457698_SubHome Page.jsp

 Do not use the “Pooled Cohort Equations” to estimate 10-year ASCVD risk for persons with clinical ASCVD or with LDL–C ≥190 mg/dL since they are already in a group that would benefit from statin

 There are no specific value treatment targets for LDL-C

 LDL-C values are used to assess treatment effectiveness and adherence

 Adults >21 y/o with LDL-C > 190 mg/dL or triglycerides > 500 mg/dL should be evaluated for secondary causes of hyperlipidemia

 Secondary elevation of LDL-C

 For individuals with

diabetes aged >75 years with additional CVD risk factors, consider use of moderate- or high-intensity therapy and TLC

 Providers may need to adjust intensity of statin therapy based on individual patient response to medication (e.g., side effects, tolerability, LDL cholesterol levels)

 Cholesterol laboratory testing may be done annually or as needed to monitor adherence

 Combination therapy (statin/fibrate and

statin/niacin) has not been shown to provide additional cardiovascular benefit above statin therapy alone and is not generally recommended

 Use aspirin therapy (75-162 mg/day as a secondary prevention strategy in individuals with diabetes and a history of CVD

 For individuals with CVD and documented aspirin

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 Diet

o Saturated trans fats, weight gain, anorexia

 Drugs

o Diuretics, cyclosporine, glucocorticoids, amiodarone

 Diseases

o Biliary obstruction, nephrotic syndrome

 Disorders/Altered Metabolism o Hypothyroidism, obesity,

pregnancy

 Secondary elevation of triglycerides

 Diet

o Weight gain, very low-fat diets, high intake of refined carbohydrates, excessive alcohol intake

 Drugs

o Oral estrogens,

glucocorticoids, bile acid sequestrants, protease inhibitors, retinoic acid, anabolic steroids, sirolimus, raloxifene, tamoxifen, beta blockers (not carvedilol), thiazides

 Diseases

o Nephrotic syndrome, chronic renal failure, lipodystrophies

allergy, clopidogrel (75mg/day) should be used

 Statin therapy is

contraindicated in pregnancy

 ATP III: Drug therapy if LDL- C ≥ 100 mg/dL

 If triglycerides > 500 mg/dL, treat with fibrate or niacin first

 If HDL is < 40 mg/dL and LDL cholesterol is between 100 and 129 mg/dL, a fibrate or niacin might be used, especially if a patient is intolerant to statins

 Diabetic patients without CVD, who are over age 40, and have at least one additional risk factor, should be treated with a statin

 Treat all diabetic patients of any age who have CVD with a statin, regardless of baseline lipid levels

 Statin therapy is

contraindicated in pregnancy

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 Disorders/Altered Metabolism o Diabetes (poorly controlled),

hypothyroidism, obesity, pregnancy

Statin Therapy (response may vary)

 High-Intensity Statin Therapy.

Daily dose lowers LDL-C on average, by approx. ≥50%

o Atorvastatin 80 mg o Rosuvastatin 20 (40) mg

 Moderate-Intensity Statin Therapy. Daily dose lowers LDL–C on average, by approximately 30% to <50%

o Atorvastatin 10 (20) mg o Rosuvastatin (5) 10 mg o Simvastatin 20–40 mg‡

o Pravastatin 40 (80) mg o Lovastatin 40 mg o Fluvastatin XL 80 mg o Fluvastatin 40 mg bid o Pitavastatin 2-4 mg

 Low-Intensity Statin Therapy.

Daily dose lowers LDL–C on average, by <30%

o Simvastatin 10 mg o Pravastatin 10–20 mg o Lovastatin 20 mg o Fluvastatin 20–40 mg o Pitavastatin 1 mg

 Discuss potential overall risks and benefits before starting statin therapy

 Perform baseline liver enzyme, creatinine kinase (if indicated) and urinalysis tests before starting statin therapy

 ACC/AHA High-intensity statin therapy* if*:

 Clinical ASCVD < 75 y/o

 LDL-C ≥ 190 mg/d L

 Diabetes Type 1 or 2 with age 40-75 and e10yASCVDr

>7.5%

 ACC/AHA Moderate-intensity statin therapy* if

 Clinical ASCVD > 75 y/o or

< 75 y/o if not candidate for high-intensity statin

 LDL-C 70-190 mg/dL with Diabetes Type 1 or 2, age 40-75 y/o and e10yASCVDr

< 7.5%

(20)

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 ACC/AHA Moderate- to High- Intensity Statin therapy* if

 Estimated 10yr ASCVD

>7.5% with LDL-C 70-190 mg/dL, age 40-75 y/o

 If individual does not meet above criteria, consider additional factors influencing ASCVD risk, potential impact of statin treatment on ASCVD risk, risks vs. benefits of statin and individual preferences when considering the initiation of statin therapy

* The ACC/AHA guidelines are not widely accepted.

Neither the AACE or ADA have accepted these guidelines

(21)

21

Healthways Medical Integrity Women’s

Health ^(1,7,16)

 Pre-conception counseling for women with diabetes ⁽¹⁾

 Address the importance of tight glycemic control to reduce the risk of congenital anomalies⁽¹⁾

 A1C <7%, if this can be achieved without hypoglycemia ⁽¹⁾

 Documentation of counseling in all potentially fertile women

 Discuss and prescribe appropriate birth control. If pregnancy desired, achieve A1C as close to normal as possible without leading to excessive hypoglycemia

 Counsel sexually active women of child bearing age on

medications contraindicated during pregnancy (ACE-I, ARBS, statins) ⁽¹⁾

 Oral agents for diabetes, ACE-I, statins and ARBs should be discontinued before pregnancy***

 Women with pre-gestational diabetes should have a baseline ophthalmology exam in the first trimester and then be monitored every trimester as indicated by degree of retinopathy ⁽¹⁾

 Gestational diabetes should be managed initially with diet and exercise, and medications should be added if needed ⁽¹⁾

 Target A1C in pregnancy is <6%

if this can be achieved without significant hypoglycemia ⁽¹⁾

 Evaluate plans for pregnancy as appropriate

(22)

22

Tobacco Use ^(1,8,9)  Smoking cessation  Tobacco use patterns

 Prior quit attempts

 Readiness assessment

 e-cigarettes are not supported as an alternative to smoking or to facilitate smoking cessation ⁽¹⁾

5 A’s

 Ask about smoking

 Advise user to quit

 Assess willingness to quit

 Assist user to quit (i.e. refer to smoking cessation program and consider pharmacotherapy)

 Arrange follow-up Pharmacologic adjuvants:

 Nicotine replacement

 Bupropion (Zyban, Wellbutrin)

 Varenicline (Chantix)

 Call on quit date or within 72 hrs to boost self-efficacy

 Assess each visit: smoking status, weight gain, nicotine withdrawal symptoms

(23)

23

Healthways Medical Integrity Selected

Preventive Health Measures (1,6,14,15,17)

 Substance abuse

 Pneumococcal vaccination

 Influenza vaccination

 Document patient’s use pattern

 Document each patient has had a vaccination and document if adverse event occurs

 Recommend appropriate lifestyle changes and/or referral to appropriate

 Administer pneumococcal polysaccharide vaccine 23 (PPSV23) to all patients with diabetes ≥ 2 years of age. Adults

≥ 65 years of age, if not previously vaccinated, should receive pneumococcal conjugate vaccine 13 (PCV13), followed by PPSV23 6-12 months after initial vaccination. Adults ≥ 65 years of age, if previously vaccinated with PPSV23, should receive a follow-up ≥ 12 months with PCV13” ⁽¹⁾

 Administer vaccination to all patients with diabetes age ≥ 6 months beginning each September

 Re-evaluation each visit and document for each patient

 As indicated

 Yearly

(24)

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 Hepatitis B

 Aspirin therapy

 Document patient has had a

vaccination and document if adverse event occurs

 Document appropriate patients are on aspirin

 The National Heart, Lung and Blood Institute (NHLBI) recommends, as does FDA, the use of aspirin for “secondary prevention.” Specifically, the use of “aspirin for preventing another heart attack or stroke in patients who have already had a heart attack or stroke, or have other evidence of coronary artery disease, such as angina or a history of a coronary bypass operation or coronary angioplasty.”

 Current ADA Guidelines state

“consider aspirin therapy (75-

 Administer hepatitis B vaccination to unvaccinated diabetic patients who are aged 19 through 59 years

 Consider administering hepatitis B vaccination to unvaccinated adults with diabetes who are aged ≥60 years

 Ask patients if they are on aspirin or other antiplatelet agent.

 Encourage patients to talk to their prescribing healthcare provider about the best treatment for their individual situation.

 Administer aspirin in doses of 75-162 mg a day

 Alternative is clopidogrel 75 mg daily for those who cannot tolerate aspirin

 It is reasonable to use dual antiplatelet therapy for up to year after an acute coronary event, and after angioplasty

 As indicated

 Evaluate and document at each visit

(25)

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162mg/day) as a primary prevention strategy for

individuals with type 1 or type 2 diabetes at increased

cardiovascular risk (10-year risk

>10%): ⁽¹⁾

o Most men > 50 yrs and women aged >60 yrs who have at least one additional major risk factor (family history of CVD, HTN, smoking, dyslipidemia, or albuminuria)

 “Aspirin should not be recommended for CVD prevention for adults with diabetes at low CVD risk (10- year CVD risk <5%:”

o “Men aged <50 years and women aged <60 years with no major additional CVD risk factors, since the potential adverse effects from bleeding likely offset the potential benefits” ⁽¹⁾

(26)

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 Physical activity

 Calculate Body Mass Index (BMI) and measure waist:

 BMI Target: 18.5-24.9 kg/m2

 Waist Target: ≤ 35 inches for females ≤40 inches for males.

(criteria varies for different ethnic groups)

 Goal is at least 150 minutes per week

 Moderate-intensity aerobic activity (50-70% of maximum heart rate)⁽¹⁾

 Spread over at least 3 days a week

 No more than 2 consecutive days without exercise

 Limit sedentary time by breaking up extended amounts of time (>90 minutes) spent sitting ⁽¹⁾

 If not contradicted, adults with type 2 diabetes should be encouraged to perform resistance training at least twice per week ⁽¹⁾

adults with BMI > 35 kg/m²and Type 2, especially if diabetes or co-morbidities are uncontrolled with lifestyle/drug therapy

 Encourage an appropriate level of exercise based on functional

 limitations

 Consider referring to a formal exercise training program where available

 Annually if indicated