Pharmacotherpy 1 Unit 2 DM Lifestyle Counseling & Guidelines

2 Key organizations that have developed EBM guidelines for the diagnosis and management of DM

-American Diabetes Association (ADA) (2022 ADA Standards of Medical Care) -American Association of Clinical Endocrinologists (AACE) (2020 AACE Comprehensive Type 2 DM Management Algorithm)

Reasons to not initiate metformin (3)

-Contraindications exist -A1C level indicates the need for insulin (at which time both insulin and metformin could be started) -A1C level is very close to goal (within 0.5%) at the time of diagnosis and patient is motivated to make lifestyle modifications

Guideline criteria for the diagnosis of diabetes (DM)

-FGP concentration (8 hours or more of no caloric intake) ≥ 126 mg/dL or -Plasma glucose concentration > 200 mg/dL, 2 hours after ingesting a 75-g oral glucose load in the morning after an 8 hour fast or -Symptoms of hyperglycemia and a random plasma glucose concentration of ≥ 200 mg/dL or -A1C level ≥ 6.5%

Hypoglycemia Treatment

-Glucose (15-20 g) is the preferred treatment for the conscious individual with blood glucose 70 mg/dL [3.9 mmol/L]), although any form of carbohydrate that contains glucose may be used. -15 - 20 g of glucose for conscious individuals with hypoglycemia, usually three or four glucose tablets or 4 ounces of juice or sugar-sweetened soda or eight ounces of low-fat milk. -Fifteen minutes after treatment, if SMBG shows continued hypoglycemia, the treatment should be repeated. -Once SMBG returns to normal, the individual should consume a meal or snack to prevent recurrence of hypoglycemia. -Glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose, 54 mg/dL

Factors to consider when choosing A1C goals: (7)

-Hypoglycemic risk -Disease Duration -Life expectancy -Important co-morbidities -Established vascular complications -Patient preference -Resources and support

Hypoglycemia Risk factors (3)

-Missed or irregular meals -Physical activity -Alcohol consumption

If Hypoglycemia symptoms occur:

-Patients should promptly check the blood glucose. -If the blood glucose has not increased to an acceptable level after 15 minutes, the treatment regimen should be repeated. -Once blood glucose has normalized, the patient can then eat a small meal or snack containing protein and carbohydrate to prevent any recurrence. -Unconsciousness is an indication for glucagon injection -For the patient at risk for severe hypoglycemia, a glucagon kit should be prescribed and administration instructions taught to family members and caregivers.

Hypoglycemia Symptoms

-Shakiness -Nervousness/anxiety -sweating/chills/clamminess -irritability/impatience -confusion -rapid heartbeat -lightheaded/dizzy -hunger/nausea -sleepiness -blurred/impaired vision -tingling/ numbness in lips or tongue -headaches -weakness/ fatigue - anger/stubbornness/sadness -lack of coordination -nightmare -seizers -unconsciousness

Key components of the diabetic food exam (inspection): Musculoskeletal

-deformity (ie claw/hammer toe, prominent metatarsal head, chart joint, bunion/ overlapping toes) -muscle wasting (guttering between metatarsals)

Key components of the diabetic food exam (inspection): Vascular assessment

-foot pulses -ABI

The frequency of hypoglycemia increases with: (9)

-intensive insulin targets -use of sulfonylureas -decreased caloric intake -delayed meals -exercise -alcohol consumption -CKD -T2D duration -cognitive impairment

Risk Factor for foot ulcers

-previous amputation -past foot ulcer history -peripheral neuropathy -foot deformity -peripheral vascular disease -visual impairment -Diabetic nephropathy -poor glycemic control -cigarettes smoking

Key components of the diabetic food exam (inspection): Dermatologic

-skin status: color, thickness, dryness, crackling -sweating -infection (check between toes for fungal infection) -ulceration -calluses/blistering (hemorrhage into callus)

Key components of the diabetic food exam (inspection): Neurological assessment

-vibration -pinprick sensation -ankle reflexes -VPT

Helpful Hints for Metformin Guidelines: (5)

1. All patients start with Lifestyle therapy and consider metformin as 1st medication 2. Patients with ASCVD or CKD or Heart Failure 3. Obese patients 4. When to advance to additional medications (3-6 months) (check at 3 months) 5. Insulin in Type 2 DM

Glucose Status and Classification: Fasting plasma glucose-Impaired fasting glucose (prediabetes)

100-125 mg/dL

Glucose Status and Classification: 2-Hour Post load glucose (OGTT)-Impaired glucose tolerance (prediabetes)

140-199 mg/dL

Typical carb per meal: Snack

15g

Typical carb per meal: Breakfast

45g

Typical carb per meal: Lunch

45g

Glucose Status and Classification: HbA1c-Increased risk of DM (prediabetes)

5.7% to 6.4%

Typical carb per meal: Dinner

60g

What would be an appropriate A1C goal for this population?

8%

Glucose Status and Classification: Fasting plasma glucose-Normal

<100 mg/dL

Glucose Status and Classification: 2-Hour Post load glucose (OGTT)-Normal

<140 mg/dL

Glucose Status and Classification: HbA1c-Normal

<5.7%

When should a patient recieve a statin?

> 40yrs old and has diabetes or < 40yr old diabetic with additional risk factors

2022 ADA Recommendations Secondary Prevention of ASCVD (statin therapy): E 10.26 In adults with diabetes aged >75 years already on statin therapy

continue statin treatment.

A1C Goals for American Association of Clinical Endocrinologists (AACE)

A1C <6.5%

A1C Goals for American Diabetes Association (ADA)

A1C <7%

2022 ADA Recommendations Secondary Prevention of ASCVD (statin therapy): 10.28 Statin therapy is ________ in pregnancy

contraindicated

Using oral agents to control DM

Based upon current guidelines, ADA and AACE suggest that metformin should be initiated for treatment of type 2 diabetes along with lifestyle interventions at the time of diagnosis.

Hypoglycemia Management

Check, treat, check, eat

Which population is generally at a higher risk for developing hypoglycemia?

Elderly

Glucose Status and Classification: Fasting plasma glucose-DM

FPG 126 mg/dL

Adjusting Insulin Doses: Out-of-Range Result- Early morning

Insulin Component to Adjust- Long-acting insulin Evening NPH

Adjusting Insulin Doses: Out-of-Range Result- Mid-afternoon

Insulin Component to Adjust- Long-acting insulin Morning NPH

Adjusting Insulin Doses: Out-of-Range Result- Post-breakfast/pre-lunch

Insulin Component to Adjust- Pre-breakfast rapid-acting/short-acting insulin

Adjusting Insulin Doses: Out-of-Range Result- Post-dinner/bedtime

Insulin Component to Adjust- Pre-dinner rapid-acting/short-acting insulin

Adjusting Insulin Doses: Out-of-Range Result- Post-lunch/pre-dinner

Insulin Component to Adjust- Pre-lunch rapid-acting/short-acting insulin Morning NPH

Adding/ adjusting insulins: Types- Basal insulins

Longer acting - glargine, detemir

Hypoglycemia prevention

Patients should understand situations that increase their risk of hypoglycemia, such as fasting for tests or procedures, delayed meals, during or after intense exercise, and during sleep.

Adding/ adjusting insulins: Types- Bolus insulin

Rapid or short acting -- aspart, glulisine, lispro, regular insulin

2022 ADA Recommendations Primary Prevention (statin therapy): 10.22 In adults with diabetes and 10- year atherosclerotic cardiovascular disease risk of 20% or higher

add ezetimibe to maximally tolerated statin therapy to reduce LDL cholesterol levels by 50% or more.

2022 ADA Recommendations Secondary Prevention of ASCVD (statin therapy): 10.24 For patients with diabetes and atherosclerotic cardiovascular disease considered very high risk using specific criteria, if LDL cholesterol is 70 mg/dL on maximally tolerated statin dose

consider adding additional LDLlowering therapy (such as ezetimibe or PCSK9 inhibitor)

2022 ADA Recommendations Secondary Prevention of ASCVD (statin therapy): 10.23 For patients of all ages with diabetes and atherosclerotic cardiovascular disease

high-intensity statin therapy should be added to lifestyle therapy.

A1C goals should be

individualized. Hypoglycemia has been associated with an increased risk of death, and thus HCP must be aware of the potential for hypoglycemia in certain populations.

2022 ADA Recommendations Secondary Prevention of ASCVD (statin therapy): 10.27 In adults with diabetes aged >75 years

initiate statin therapy after discussion of potential benefits and risks

2022 ADA Recommendations Primary Prevention (statin therapy): 10.20 For patients with diabetes aged 20-39 years with additional atherosclerotic cardiovascular disease risk factors

initiate statin therapy in addition to lifestyle therapy.

When mealtime glucose control is needed or when glycemic goals are not met on a basal insulin regimen plus oral agents or a GLP-1 receptor agonist... additional

insulin therapy intensification to a basal-bolus regimen (using a rapid-acting insulin analog or inhaled insulin)

2022 ADA Recommendations Secondary Prevention of ASCVD (statin therapy): 10.25 For patients who do not tolerate the intended intensity

the maximally tolerated statin dose should be used.

2022 ADA Recommendations Primary Prevention (statin therapy): 10.21 In patients with diabetes at higher risk, especially those with multiple atherosclerotic cardiovascular disease risk factors or aged 50-70 years

use high intensity statin therapy

2022 ADA Recommendations Primary Prevention (statin therapy): 10.19 For patients with diabetes aged 40-75 years without atherosclerotic cardiovascular disease

use moderate-intensity statin therapy in addition to lifestyle therapy.

Glucose Status and Classification: 2-Hour Post load glucose (OGTT)-DM

≥200 mg/dL

Glucose Status and Classification: HbA1c-DM

≥6.5%