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NURSE PROTOCOL FOR DIABETES MELLITUS IN ADULTS THIS PAGE INTENTIONALLY LEFT BLANK Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 TABLE OF CONTENTS DIABETES Diabetes Mellitus in Adults Appendix A: Continuum of Care Visits Appendix B: Summary of Recommendations Appendix C: Oral Hypoglycemic Agent and Oral Agent Adjustment Guidelines Appendix D: Oral Agents for Treatment of Type 2 Diabetes Appendix E: FDA Approved Indications for Combination Therapy Appendix F: Insulin Products Available in the United States Appendix G: Insulin Adjustment Guidelines Appendix H: Treatment Algorithm of Type 2 Diabetes 7 7.1 7.13 7.15 7.17 7.18 7.23 7.24 7.26 7.28 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THIS PAGE INTENTIONALLY LEFT BLANK Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 NURSE PROTOCOL FOR DIABETES MELLITUS IN ADULTS DEFINITION Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action or both. Diabetes is characterized by fasting plasma glucose (FPG) >126 mg/dL or random plasma glucose > 200 mg/dL (with testing on two separate days) accompanied by symptoms. Symptoms of diabetes mellitus are frequently due to the osmotic diuresis associated with hyperglycemia. Complications of diabetes may be acute and/or chronic. Acute complications include: hyperglycemia, hypoglycemia, diabetic ketoacidosis and hyperosmolar hyperglycemic nonketotic syndrome. The chronic complications of diabetes are most often the result of sustained hyperglycemia and include damage, dysfunction and failure of various organs, such as eyes, kidneys, nerves, heart and vascular system. ETIOLOGY Type 1 Diabetes Mellitus 1. Cause: inadequate or absolute lack of insulin production secondary to destruction of the pancreatic Beta cells. Individuals are dependent on exogenous insulin for survival. Type 1 comprises less than 10% of all cases of diabetes. 2. Contributing factors: a. b. Autoimmune mediated response. Idiopathic (No evidence of autoimmunity is present). Type 2 Diabetes Mellitus 1. Cause: combination of insulin resistance and/or inadequate insulin production. Individuals may produce excessive amounts of insulin but they are unable to use it effectively. Insulin resistance places increasing demands on the pancreas, which eventually cannot compensate, resulting in a relative, and later an absolute, hypoinsulinemic state. 2. Risk factors: a. b. c. d. Overweight - BMI >25 kg/m2 (see BMI chart in Nutrition Manual). BMI >22 for Asian Americans. Waist circumference >102cm (40 inches) for men and >88cm (35 inches) for women. Sedentary lifestyle. Age >45 years old. Diabetes 7.1 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 e. f. g. h. i. j. First degree relative with diabetes. Race – African-American, Latino, Native American, Asian and Pacific Islander at greater risk. History of large birth-weight babies - >9 pounds or history of diagnosed with gestational diabetes. History of impaired glucose tolerance or fasting glucose >100 mg/dL (>100 is impaired fasting glucose with 33% chance to develop diabetes in 6 years). Hypertensive (blood pressure >140/90 mmHg). Have HDL cholesterol level <35mg/dL and/or triglyceride level > 250mg/dL. Pre-diabetes 1. 2. 3. 4. SUBJECTIVE Impaired glucose tolerance Patients are asymptomatic but at high risk for developing cardiovascular disease and diabetes. Impaired fasting glucose is 100-125 mg/dL. Plasma glucose at 2 hour oral glucose tolerance test (75gram) between 140-199 mg/dL. 1. The client may be asymptomatic. Elevated glucose levels are often found in routine lab work, during evaluations for surgery or work-up for other conditions. 2. There may or may not be a family history or obvious risk factors. 3. Client history may or may not reveal the following: a. b. c. d. 4. Symptoms of hyperglycemia. Unexplained weight loss or gain. Previously diagnosed with “borderline diabetes,” gestational diabetes or impaired glucose tolerance. Past or current symptoms of coronary heart disease, heart failure, cerebrovascular disease, peripheral vascular disease, renal disease, gout or sexual dysfunction. The following should be investigated and documented in chart: a. Current diabetes self-management routine, if previously diagnosed, to include: 1) Medications. 2) Diet and eating pattern. 3) Self-management training. 4) Self-monitoring of blood glucose (SMBG) pattern and results. Diabetes 7.2 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 5) 6) b. c. d. e. f. g. h. i. j. k. l. m. 5. Exercise history. Acute complications, emergency room visits and hospitalizations related to diabetes. History of infections. Family history of diabetes. CHD risk factors. History of target organ damage. Psychosocial/economic factors. Tobacco, alcohol and recreational drug use. Female reproductive history: menstrual history, method of contraception, pregnancies and outcomes. Special test results related to the diagnosis of diabetes. Prior HbA1c records. Immunization history. Clients may report sudden, or insidious, onset of one or more of the following symptoms related to diabetes: a. b. c. d. e. f. g. h. i. j. k. 6. Duration of diabetes. Frequency of usage and indications for OTC medications, prescriptions, and alternative medications, home remedies, nutritional supplements. Frequent urination, bladder dysfunction, impotence. Extreme thirst. Extreme hunger. Weight loss despite normal or increased appetite. Blurred vision. Fatigue, weakness, lethargy. Nausea/vomiting. Slow-healing wounds. Recurrent infections. Burning, tingling or numbness in extremities. Sleep apnea. The following are signs and symptoms of complications or target organ damage: a. b. c. d. e. f. g. Visual disturbances. Chest pain. Shortness of breath. Edema. Dizziness. Headache. Confusion or other neurologic symptoms (e.g., difficulty with speech or movement, facial or one-sided numbness). Diabetes 7.3 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 h. OBJECTIVE 1. Nausea and vomiting. Physical examination a. b. c. d. e. f. g. h. i. j. k. l. Appearance 1) Type 1 = Thin, ill appearance, dehydrated, may have had significant weight loss. 2) Type 2 = Frequently overweight or obese. Height, weight and BMI. Routine assessment of blood pressure (standing and sitting or sitting and lying) to assess for dehydration and autonomic neuropathy. Blood pressure may be greater than 140/90 mmHg. Extremities - assess client extremities for changes in color, deformity, injury, sensation, temperature changes, muscle strength and deep tendon reflexes (use a 128-Hz tuning fork and a monofilament). Shiny spots over tibial bones, loss of hair over lower legs and toes, ulcerations of feet/legs, carbuncles and ulcers, lipohypertrophy or lipoatrophy at insulin injection sites. Mouth - assess for gum problems, tooth decay and oral candidiasis. Optic Fundi – Assess for retinopathy including: microaneurysm, retinal detachment, glaucoma, vitreous hemorrhage, neovascularization, decreased extraocular movement, narrowing, copper-wiring, or AV nicking. Arterial Pulses – Palpate and auscultate pulses. Neurologic - Perform a complete neurologic exam. Decreased or absent deep tendon reflexes, numbness or burning sensation or sensory loss may be present. Gastrointestinal neurologic manifestation presents a gastroparesis with nausea, vomiting and weight loss. Neck - Palpate the thyroid for an enlarged thyroid. Assess for hoarseness and difficulty swallowing. Skin - Inspect for sites of previous insulin injections, shiny spots over tibial bones, loss of hair over lower legs and toes, ulcerations of feet/legs, carbuncles and ulcers, lipohypertrophy or lipoatrophy at insulin injection sites. Early on in type 2 diabetes hyperinsulinemia may be evidenced by Acanthosis Nigricans around the neck, waist, inguinal and axillary skin folds (dark velvety hyperpigmentation). Cardiovascular – Perform a cardiac exam. Orthostatic hypotension, hypertension, decreased capillary refill, absent pedal pulses, impaired circulation. Abdomen - Perform abdominal exam. Palpate for an enlarged liver. Inspect the hands for mobility and deformities. Diabetes 7.4 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 2. Diagnostic laboratory findings (Non-Pregnant Adults) a. b. c. Confirmed fasting plasma glucose level of >126 mg/dL on at least two different occasions (on subsequent days). OR Confirmed random plasma glucose level of >200 mg/dL (with classic symptoms of diabetes), on two different occasions. OR Two-hour oral glucose tolerance test (OGTT) of >200 mg/dL. NOTE: The OGTT is done only if diagnostic testing is indicated and client has a normal fasting plasma glucose level. This test is useful only if strict adherence is given to proper OGTT procedure using 75 grams of glucose, and is not recommended for routine clinical use. ASSESSMENT Diabetes Mellitus (Type 1 or Type 2) PLAN DIAGNOSTIC AND FOLLOW-UP STUDIES Inform the client of the importance of abnormal results and follow-up and referrals. If a service is not available in the clinic, the client should be given resource/referral information that must be appropriately documented in the client’s record. The client’s follow-through on the recommendations should be documented at the next visit. 1. 2. 3. 4. 5. 6. 7. 8. Glycosylated hemoglobin or HbA1c – Every six months for well controlled patients on diet therapy or oral medication. Every three months for patients on insulin, poorly controlled or when medications have been changed. Treatment goal is <7%. Total cholesterol and lipid profile annually (every 3-6 months if abnormal or if client is taking lipid-lowering agents). Serum creatinine, potassium, and sodium annually. ECG annually (or as indicated). Referral for dilated eye exam annually. Annual microalbuminuria test. 24-hour urine collection for creatinine clearance annually (if indicated by positive urine protein). TSH in all type 1 diabetic patients and as indicated in type 2. Liver function studies (LFTs) if clients are on lipid-lowering drugs and/or metformin. If on plioglitazone or rosiglitazone, LFTs monthly for 8 months then periodically thereafter. Diabetes 7.5 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 9. 10. 11. 12. 13. 14. Complete foot exam (vascular, neurologic) initially and annually to identify high-risk feet (peripheral neuropathy with loss of protective sensation, evidence of increased pressure, bony deformity, peripheral vascular disease, history of ulceration or amputation, severe nail pathology). Foot inspection for dryness, corns, calluses and ulcers and inquire about pain, burning, tingling, and/or numbness at each visit. Referral for dental exam annually. Weight and calculation of BMI on each visit; height annually. Referral to other specialties and services as needed. Urine cultures as indicated. Urinalysis for ketones, protein and sediment. Refer to Family Planning for women of reproductive age. THERAPEUTIC NON-PHARMACOLOGIC For clients with newly-diagnosed Type 2 Diabetes, a random blood glucose <250 mg/dL OR a fasting blood glucose (FBG) <200 mg/dL, initiate/instruct in diet modification and increased physical activity for 4-8 weeks, and then evaluate client status. A recent position statement from the American Diabetes Association and European Diabetes Association recommends starting pharmacologic agents if the HbA1c is greater than 7%. In addition, if the client presents with three or more symptoms of hyperglycemia, or has signs of an infection, proceed directly to pharmacologic intervention. 1. Medical Nutrition Therapy goals are to: (See Client Education/Counseling Section) a. b. c. d. e. 2. Maintain near-normal glucose levels. Attain and maintain desirable body weight. Decrease fat/cholesterol intake, if needed to achieve optimal lipid levels. Fat percentage recommendation is dependent on desired lipid outcomes. Promote meal pattern consistency. Prevent and treat acute and chronic complications of diabetes. Recommend increased physical activity as indicated to: a. b. Promote weight and lipid control. Individualize with consideration for existing medical conditions such as cardiovascular disease, Diabetes 7.6 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 c. d. 3. peripheral neuropathy, arthritis, age and diabetes medications, if any. Reduce cardiovascular risk factors. Decrease insulin resistance and increase metabolism. Self-Monitoring of Blood Glucose (SMBG): a. b. c. d. e. f. g. h. i. Assess effectiveness of meal plan, exercise and medication. Determine frequency of SMBG. Consider type of diabetes and hypoglycemic agent. Assess client’s willingness, financial resources and level of diabetes control Patients with Type 1 diabetes check 3 or more times a day. Pregnant women taking insulin for gestational diabetes should check 3 or more times a day. Patients with Type 2 diabetes who are being treated with insulin should check 2 or more times per day. However, it is recommended that they check as often as needed until they reach blood glucose targets. Once 50% of blood glucose values are within target blood glucose range, SMBG frequency can be modified to treatment (e.g., diet only, 2-3 times per week; oral medications, daily; insulin therapy 3-4 times per day). Frequent monitoring is essential for those on intensive insulin therapy or pump therapy. Individualized target blood glucose range based on treatment regimen and age. Recommended target: pre-meal glucose between 90-130 mg/dL, random glucose less than 180mg/dL. Occasionally a 2-hour post-prandial blood glucose may be useful in evaluating control (target <180mg/dL). When medication, diet or medical treatment changes, increase frequency of SMBG until 50% or more of BG values are within target range. Additional testing is needed during times of stress, especially infection/illness. Diabetes 7.7 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 PHARMACOLOGIC NOTE: Before initiating oral agents, assess alcohol intake, baseline liver functions and renal function. 1. Type 2 clients with persistently elevated blood glucose level (>200 mg/dL random or >140 mg/dL fasting), or if HbA1c >7% after 8 weeks: a. Initiate oral agents at the lowest starting dose to prevent or minimize side effects. Instruct on SMBG and the need of maintaining a glycemic record (see Appendix A). NOTE: Consider initial insulin therapy for patients who are not adequately controlled by diet, who are symptomatic, or have ketonuria, ketonemia, or present with severe hyperglycemia (glucose greater than 350 mg/dL). Be aware that insulins lispro (Humalog), aspart (Novolog) and glulisine (Apidra) are fast-acting insulins and should be taken 5-10 minutes before meals. Regular insulin should be taken 30 minutes before meals. Insulin glargine (Lantus) should never be mixed with other insulins. b. c. d. Oral agents for the treatment of type 2 diabetes dosing may be increased every 1-2 weeks until maximum dose is reached or a second agent from a different class may be added as combination therapy. (See Appendix D.) If blood glucose is controlled except for morning hyperglycemia, consider combination therapy of an oral agent with insulin. Add insulin at bedtime (0.10.2 U/kg NPH or glargine) subcutaneously. Dose may be adjusted, up or down 2-4 units, every week based on fasting morning blood glucose levels and client’s target blood glucose range. (See Appendix E.) If unable to achieve target blood glucose range on oral agent therapy or combination therapy, begin insulin therapy with two or more injections/day: NOTE: See Appendix F for types of insulin by category. Intermediate-acting + short-acting insulin before breakfast AND Diabetes 7.8 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Intermediate-acting + short-acting insulin before evening meal. For initiation of therapy, the total daily dose of insulin units is calculated by multiplying 0.3U x kg (current weight). a.m. p.m. Distribution of total units 2/3 1/3 Short/Intermediate ratio 1:2 1:1 e. f. 2. Insulin doses may be titrated weekly until blood glucose control is achieved (see Appendix G, Insulin Dose Adjustment Guidelines). Consider using 70/30 or 50/50 insulin for individuals unable to mix insulins. Clients taking short-acting insulin must be instructed to take it prior to meals. Instruct on signs, symptoms and treatment of hypoglycemia, SBGM and frequency, recordkeeping, target blood glucose range and emergency contact in case of questions or problems. Type 1 clients will likely already be taking insulin injections. Evaluate their existing insulin regimen and level of blood glucose control with target blood glucose range and, if indicated, consider insulin dose adjustment using Insulin Dose Adjustment Guidelines in Appendix G. If newly diagnosed, initiate insulin therapy with two injections/day with: Short-acting + intermediate-acting before breakfast AND Short-acting + intermediate-acting before dinner To calculate total daily dose of insulin units, multiply 0.3 unit x kg (current weight). Morning Evening Distribution of total units 2/3 1/3 Short-acting/ intermediate-acting ratio 1:2 1:1 Insulin dose may be titrated weekly until blood glucose control is achieved (see Appendix G, Insulin Dose Adjustment Guidelines.) Consider using 70/30 or 50/50 insulin for individuals unable to mix insulins. Diabetes 7.9 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 CLIENT EDUCATION/COUNSELING The client and/or family participation is key to successful management of diabetes and should be involved in decisions and goal-setting. Prioritize information to prevent overwhelming the client. Important factors in achieving blood glucose control are client education, behavior change, and consistent follow-up. If goals are not being met, the management plan needs to be revised and/or goals need to be reassessed. The overall goals of education are: effective self-management skills, enhanced clinical outcomes, and optimal quality of life. Assessment should include the client’s educational needs, readiness to learn, and preferred learning style. While some aspects of diabetes selfmanagement should be on an individual basis (one-on-one), group classes can address topics appropriate for most clients (e.g., dining out, reading labels, and physical activity) and allow clients to share and learn from others’ experiences and recognize that others face similar challenges. 1. Determine mutually agreed upon blood glucose, HbA1c and lipid goals. 2. Address lifestyle changes: a. b. c. d. e. Nutrition Use an individualized approach appropriate for the person’s lifestyle and diabetes management goals. No single approach has proven to be most effective. Refer all clients to the nutritionist for assessment and selection of an appropriate meal-planning approach. May use one of the following basic instruction tools: 1) “The First Step on Diabetes Meal Planning,” a basic pamphlet based on the Food Guide Pyramid. 2) “Healthy Food Choices,” a pamphlet with guidelines for healthy food choices, what to eat and timing of meals and snacks. 3) “Idaho Plate Method,” a poster focusing on portion control and appropriate food choices for meals and snacks. Physical activity. If smoker or tobacco user, refer to local cessation program and/or the Georgia Tobacco Quit Line, 1-877-270-STOP (7867). Reduce/control weight - focus on reaching reasonable weight. Control blood pressure <130/80 mmHg. Diabetes 7.10 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 f. g. 3. Reduce/control hyperlipidemia (LDL <100mg/dl). Less than 2 alcohol containing beverages/day if male; 1 alcoholic beverage/day if female. (One alcoholic beverage/day is defined as 12 oz beer, 5 oz wine, 1.5 oz distilled spirits. Each contains approximately 15 grams alcohol). Patients should be counseled that most mixers contain large amounts of sugar and/or fats and should be avoided. Instruct on survival skills: a. b. c. d. e. Insulin injection technique (if appropriate), proper preparation, insulin storage, timing of injections and site rotation. Self-monitoring of blood glucose. Causes, signs, symptoms, and appropriate corrective actions for hypoglycemia and hyperglycemia. When to call health care provider and who to call in case of emergency. Sick-day management. 4. Teach preventive care of feet, eyes and mouth/teeth. 5. Address long-term neurological, kidney, retinal and cardiac complications. 6. For women of childbearing age, discuss family planning in relation to blood glucose control. 7. Assist client to establish three short-term behavior changes. 8. Assess and administer vaccines indicated according to the current Advisory Committee on Immunization Practices (ACIP) childhood or adult immunization schedule (i.e. vaccines recommended for persons with diabetes). See the Georgia Immunization Program Manual, Recommended Schedule and Guidelines, for current ACIP schedules and administration guidelines for each vaccine. The Georgia Immunization Manual may be accessed on line at http://health.state.ga.us/publications/manuals.asp. 9. Counsel client about alternative therapy. 10. Emphasize prevention and risk reduction strategies for cardiovascular disease. Diabetes 7.11 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 FOLLOW-UP (See Appendix A for Continuum of Care.) The frequency of visits depends upon: 1. The type of diabetes. 2. Blood glucose goals and degree to which the goals are being achieved. 3. Changes in the treatment regimen. 4. Presence of complications or other medical conditions. CONSULTATION/REFERRAL 1. Unless other instructions have been given by medical director, refer to a physician for: a. b. c. d. e. Blood glucose levels >240 mg/dL. Recurring episodes of hypoglycemia (glucose level <70 mg/dL or after one episode of severe hypoglycemia [loss of consciousness or glucose <40 mg/dL]). Ketones in urine. Pregnancy (always refer). New-onset angina, intermittent claudication, proteinuria, acute vision loss, acute illness, influenza, kidney infection, nausea and vomiting, urinary tract infection, fever of unknown origin, or acute foot injury or ulceration. 2. Refer to support groups and other community resources (e.g., American Diabetes Association, smoking cessation, recreation departments). 3. Annual referral to an eye specialist. 4. Other specialty consultations/referrals as needed. Diabetes 7.12 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 APPENDIX A Continuum of Care Visits Client Name ________________________ MR# ___________________Phone __________ Continuum of Care Activities/Frequency Dates Contact Frequency Daily for initiation of insulin or regimen change. Weekly for initiation of oral glucose-lowering agent(s) or change in regimen. Routine diabetes visits 1. Every 2-3 months for clients who are not meeting goals. 2. Every 3-4 months for all other clients. Medical History A. Assess treatment regimen (every regular diabetes visit). 1. Frequency/severity of hypo- or hyperglycemia. 2. SMBG results. 3. Patient regimen adjustments. 4. Adherence problem. 5. Lifestyle changes. 6. Symptoms of complications. 7. Other medical illnesses. 8. Medications (OTC, Rx, home remedies, alternative medications). 9. Psychosocial issues. 10. Tobacco, alcohol, and recreational drug use, and alternative therapies. 11. Immunization history. Laboratory Evaluation A. HbA1c - Goal <7.0%: 1. Quarterly if treatment changes or client is not meeting goals. 2. Twice per year if stable. B. Fasting plasma glucose. C. Fasting lipid profile annually: LDL Goal <100 mg/dl HDL Goal >45 mg/dl, men; >55 mg/dl, women. D. Microalbumin measurement annually. Diabetes 7.13 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Physical Examination A. Physical examination annually. B. Dilated eye examination annually. C. Every regular diabetes visit: 1. Weight 2. Blood pressure- Goal <130/80 mmHg 3. Previous abnormalities on the physical exam D. Each visit, foot inspection for trauma. E. Dryness, corns, calluses, ulcers. Inquire about pain, burning, tingling, numbness. F. Foot examination annually or more often in clients with high-risk foot condition, peripheral neuropathy with loss of protective sensation, evidence of deformity, peripheral vascular disease, history ulceration, amputation. Evaluation of Management Plan A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P. Q. R. Short and long-term goals. Medications. Blood glucose level. Frequency/severity of hypo- or hyperglycemia. SMBG results. Complications. Control of dyslipidemia. Blood pressure. Weight. Mineral and nutritional therapy. Exercise regimen. Adherence to self-management training: 1. Knowledge of diabetes 2. Self-management skills Follow-up of referrals. Psychosocial adjustment. Smoking cessation if indicated. Annual influenza vaccine. Assessment for need for pneumococcal vaccine. Assessment for the need of all other adult immunization(s) (i.e., tetanus, hepatitis B and more); refer to Immunization manual. Diabetes 7.14 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Appendix B Summary of recommendations for adults with diabetes Glycemic control HbA1c <7.0%* Preprandial capillary plasma glucose 90–130 mg/dL (5.0–7.2 mmol/L) Peak postprandial capillary plasma glucose <180 mg/dL (<10.0 mmol/L) Blood pressure <130/80 mmHg Lipids LDL <100 mg/dL (<2.6 mmol/L) ** Triglycerides <150 mg/dL (<1.7 mmol/L) HDL >40 mg/dL (>1.1 mmol/L) Key concepts in setting glycemic goals: • HbA1c is the primary target for glycemic control • Goals should be individualized • Certain populations (children, pregnant women, and elderly) require special considerations • Less intensive glycemic goals may be indicated in patients with severe or frequent hypoglycemia • More stringent glycemic goals (i.e. a normal HbA1c, <6%) may further reduce complications at the cost of increased risk of hypoglycemia (particularly in those with type 1 diabetes) • Postprandial glucose may be targeted if HbA1c goals are not met despite reaching preprandial glucose goals * Referenced to a non-diabetic range of 4.0–6.0% using a Diabetes Control and Complications Trial-based assay. Postprandial glucose measurements should be made 1–2 hours after the beginning of the meal, generally peak levels in patients with diabetes. Current National Cholesterol Education Program/Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) guidelines suggest that in patients with triglycerides 200 mg/dL, the "non-HDL cholesterol" (total cholesterol minus HDL) be used. The goal is 130 mg/dL (31). For women, it has been suggested that the HDL goal be increased by 10 mg/dL. ** For patients with known coronary heart disease and other cardiovascular disorders an LDL level <70 has recently been recommended. Diabetes 7.15 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Correlation between HbA1c level and mean plasma glucose levels on multiple testing over 2–3 months Mean plasma glucose HbA1c (%) mg/dL mmol/L 6 135 7.5 7 170 9.5 8 205 11.5 9 240 13.5 10 275 15.5 11 310 17.5 12 345 19.5 Diabetes 7.16 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 APPENDIX C Nurse Protocol for Management of Diabetes Mellitus in Adults Oral Hypoglycemic Agent and Oral Agent Adjustment Guidelines 1. Consider oral hypoglycemic agent or oral agent therapy for clients with Type 2 DM if: a. At diagnosis, if HbA1c is greater than 7%, a random plasma glucose is 250350 mg/dL, or fasting plasma glucose is 200 mg/dL with mild or no symptoms of diabetes. b. If after 8-12 weeks FBG is >140 mg/dL or HbA1c >7%. NOTE: Metformin therapy should be considered as the preferred oral agent for most patients (in the absence of contraindications). Educate patient on potential side effects. 2. Clients on sulfonylurea agents (glyburide, glipizide and chlorpropamide) must be instructed on symptoms, causes and treatment of hypoglycemia. A sulfonylureainduced facial flushing reaction may occur when some sulfonylureas are administered with alcohol. This syndrome is characterized by facial flushing and occasional breathlessness but without the nausea, vomiting, and hypotension seen with a true alcohol-disulfiram reaction 3. Self blood glucose monitoring by the client or client’s family should be done 2-4 times/day (if possible), or as previously described under non-pharmacologic therapy, and a record maintained. SBGM record should be reviewed with the client at each visit. 4. Dose adjustment should be made if (See Appendix G): a. b. c. 5. HbA1c greater than 7%. More than 50% of fasting or random BG values are outside of the target BG range. More than 2 (unexplained) episodes of hypoglycemia (BG less than 70 mg/dL) occur in one week or one episode of severe hypoglycemia (loss of consciousness or glucose <40 mg/dL). Liver function monitoring for pioglitazone (Actos) and rosiglitazone (Avandia): a. b. c. d. Serum transaminase levels at the initiation of therapy and periodically thereafter. Patients with ALT levels between 2 and 3 times the upper limits of normal at baseline or during therapy should be evaluated to determine the cause of the elevation and the levels should be monitored frequently. Rosiglitazone and pioglitazone should not be used in patients with clinical evidence of active liver disease or if ALT concentrations are >3 times normal. If ALT >3X upper normal limits during therapy, retest promptly and discontinue if ALT remains >3X upper normal limits. Diabetes 7.17 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 APPENDIX D Oral Agents for Treatment of Type 2 Diabetes Generic Name Trade Name Starting Dose Next Increase Next Increase Next Increase Maximum Dose Glyburide (2n generation sulfonylurea) Diabeta, Micronase 1.25 mg (renal and/or hepatic impaired) 2.55mg every morning with food 1 week: Increase increment of 2.5 mg daily 1 week: Increase increment of 2.5 mg daily (divide dose to twice a day if > 10 mg per day) 1 week: Increase increment of 2.5 mg daily (divide dose to twice a day if > 10 mg per day) 10 mg morning 10 mg evening Glyburide (2n generation sulfonylurea) Glyburide/ Metformin Glynase, PresTab, Pfizer, Glycron, Zoetica, Diabeta and Micronase Glucovance (2nd generation sulfonylurea/biguanides) Glipizide (2nd generation Glucotrol 20 mg total 0.75 (renal and/hepatic or geriatric) 1.5 – 3 daily 2-10 days Increase by 1.5-3.0 mg daily 2-10 days Increase by 1.5—3.0 mg daily (divide the dose to twice a day) 2-10 days Increase by 1.5-3.0 mg daily 12mg (Most patients not benefit from >15mg/ day) . (Initial therapy) 1.25/250 mg every day with a meal OR 1.25/250 mg twice a day with meals, if FBG > 200 mg/dl or HbA1c > 9% 2 weeks: Increase increment of 1.25/250 mg daily OR (From initial) 2.5/500 mg every morning 1.25/250mg every evening 2 weeks: Increase increment of 1.25/250 mg daily OR 2.5/500 mg every morning 2.5/500 mg every evening 2 weeks: Increase increment of 1.25/250mg daily OR 3.75/750 mg every morning 2.5/500 mg every evening (From initial) 10/2000 mg total daily OR (2nd line therapy) 2.5/500 mg twice a day with meals NOTE: The initial dosage of combination product should not exceed the daily dosage the patient received of the products given separately. 2.5 mg (geriatric or hepatic (From 2nd line) 3.75/750 mg every morning 2.5/500 mg every evening (From 2nd line) 3.75 mg/750mg every morning 3.75/750 mg every evening (From 2nd line) 5.0 mg/1000mg every morning 3.75/750 mg every evening 3 – 7 days: Increase increment of 3 – 7 days: Increase increment of 3 - 7 days: Increase increment of Diabetes From 2nd line) 20/2000 mg 40 mg total in divided doses 7.18 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Generic Name Trade Name sulfonylurea) Starting Dose Next Increase Next Increase Next Increase Maximum Dose disease) - 5 mg (30 min. before breakfast) 2.5 – 5 mg daily 2.5 – 5 mg daily 2.5 – 5 mg daily (divide dose to twice a day if greater than 15 – 20 3 months: 15-20 mg every morning maximum 15 mg/ dose. 2 weeks: Increase increment of 2.5/250 mg or 2.5/500 mg Use same tablet as initiated for increment, twice a day dosing with stronger dose in the morning, with meals. (Initial therapy) 10/2000 mg total daily Glipizide extendedrelease Glucotrol XL 2.5-5 mg every morning 3 months: 5-10 mg every morning 3 months: 10-15 mg every morning Glipizide/ Metformin (2nd generation sulfonylurea/big uanides) Metaglip (Initial therapy) 2.5/250 mg daily with meal 2 weeks: Increase increment of 2.5/250 mg or 2.5/500 mg Use same tablet as initiated for increment, twice a day dosing with stronger dose in the morning, with meals. 2 weeks: Increase increment of 2.5/250 mg or 2.5/500 mg Use same tablet as initiated for increment, twice a day dosing with stronger dose in the morning, with meals. 2.5/500 mg twice a day with meals (for FBS 280 – 320 mg/dL) (2nd line therapy) Increase increment of 5/500 mg (2nd line therapy) 2.5 – 5/500 mg twice a day with meals Chlorpropamide (1st generation sulfonylurea) Diabinese Metformin (Monitor SCr & liver function) (biguanide) Glucophage 100 – 125 mg am (geriatric) (2nd (2nd line therapy) Increase increment of 5/500 mg line therapy) Increase increment of 5/500 mg 20 mg every morning. (2nd line therapy) 20/2000 mg total daily 3 – 5 days: Increase increment of 50 – 125 mg daily in the morning 3 – 5 days: Increase increment of 50 – 125 mg daily in the morning 3 – 5 days: Increase increment of 50 – 125 mg daily in the morning 750 mg every morning (there is usually no improvemen t at greater than 500 mg) 500 mg every morning with meal and 500mg every evening with meal. 1-2 weeks: 1000 mg every morning 500 mg every evening with meals 2 weeks: 850 mg every morning 850 mg every evening with meals 1700 mg total daily in divided doses 850 mg in the morning with meals 850 mg in the morning with meal 500 mg in the evening with 1-2 weeks: 1000 mg every morning 500 mg every evening with meals 850 mg three times a day with meals OR 1000 mg in 250 mg every morning (others) Diabetes 2550 mg total daily in divided doses 7.19 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Generic Name Metformin extendedrelease (Monitor SCr & liver function) Trade Name Glucophage XR Acarbose (AlphaGlucosidase Inhibitor) Do not use in pts with SCr > 2 mg/dL Precose Glimepiride (2nd generation sulfonylurea) Amaryl Starting Dose 500 mg with evening meal Next Increase Next Increase meal OR 850 my in the morning with meal 850 mg in the evening with meal 1 week: 1000 mg with evening meal the morning 1000 mg in the evening with meals 1 week: 1500 mg with evening meal Next Increase Maximum Dose 1 week: 2000 mg with evening meal OR 1000 mg twice daily with meals 2000 mg total daily in divided doses 25 mg daily with first bite of main meal, increasing over few days to three times a day with meals Gradually increase dose every 4 – 8 weeks 50 mg three times a day Gradually increase dose every 4 – 8 weeks 100 mg twice a day 1 mg with breakfast or first main meal (geriatric) 2 weeks: Increase increment of 1 mg daily 2 weeks: Increase increment of 1 mg daily 2 weeks: Increase increment of 1 mg daily 1 week: Double the daily dose and give in up to 4 divided doses in response to changes in patient’s meal pattern 1 week: Double the daily dose and give in up to 4 divided doses in response to changes in patient’s meal pattern 1 week: Double the daily dose and give in up to 4 divided doses in response to changes in patient’s meal pattern May convert to conventional metformin dosing 50 mg three times a day if wt < 60 kg (132 lbs) 100 mg three times a day if wt > 60 kg (132 lbs) 8 mg daily 1 - 2 mg with breakfast or first main meal (others) Repaglinide (meglitinide analogue) Prandin 0.5 mg for patients not previously treated with a blood glucose lowering agent at 15 min. before meal 1-2 mg 15 to 30 minutes before each meal for patients Diabetes 16 mg total daily in response to changes in patient’s meal pattern 7.20 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Generic Name Trade Name Starting Dose Next Increase Next Increase Next Increase Maximum Dose previously treated with blood glucose lowering agents Nateglinide (insulin secretagogue) Starlix Miglitol (alphaglucosidase inhibitor) Glyset Pioglitazone Actos 15 - 30 mg daily The dose may be increased in increments up to 45 mg daily 45 mg daily Avandia 4 mg daily OR 2 mg twice a day 8 - 12 weeks: 8 mg daily OR 4 mg twice a day 8 mg daily (Thiazolidinedione) 120 mg three times a day 1 to 30 minutes prior to meals OR 60 mg three times a day before meals (If near goal HbA1c) 25 mg with first bite of main meal, increasing over few days to three times a day with meals (Monitor liver function) Rosiglitazone (Thiazolidinedione) (Monitor liver function) Special Note: Rosiglitazone has been associated with the new onset or worsening of macular edema in diabetic patients (Lexicomp 1/5/2006 Update) 120 mg three times a day 4 – 8 weeks: 50 mg three times a day with meals Diabetes 3 months: 100 mg three times a day with meals 300 mg total daily in divided doses 7.21 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Generic Name Trade Name Starting Dose Next Increase Rosiglitazone/ Metformin (Thiazolidinedione/biguanide) Avandamet Therapy should be The dosage of a fixed combination may be titrated upward, not exceeding 500 mg of metformin and/or 4 mg rosiglitazone or a maximum daily dosage of 2 gm of metformin and 8 mg of rosiglitazone is reached 8 mg/2 Gm total daily Sitagliptin DPP IV Inhibitors Januvia none 100 mg/day individualized in patients already receiving metformin 100 mg/once daily (Lower doses for GFR<60ml/ minute Diabetes Next Increase Next Increase Maximum Dose 7.22 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 APPENDIX E FDA Approved Indications for Combination Therapy Sulfonylurea Sulfonylurea Metformin 50-60 mg/dL decrease in FBG 1.7%-2.2% decrease in HbA1c Insulin 40-50 mg/dL decrease in FBG 0.8-1.1% decrease in HbA1c Metformin Acarbose Miglitol 50-60 mg/dL decrease in FBG 1.7%2.2% decrease in HbA1c 40-50 mg/dL decrease in FBG 0.9-1.3% decrease in HbA1c 30-60 mg/dL decrease in PPG 0.6-0.8% decrease in HbA1c 0.8% decrease in HbA1c 91.5 mg/dL below baseline treatment with insulin 1.9% below baseline treatment with insulin 1.8 mg/dL increase from insulin monother apy Repaglinide Rosiglitazone Pioglitazone 50 mg/dL decrease in FBG 1.2% decrease in HbA1c 40 mg/dL decrease in FBG 1.4-1.7% decrease in HbA1c 30-50 mg/dL decrease in FBG 0.6-0.8% decrease in HbA1c 40 mg/dL decrease in FBG 1.4% decrease in HbA1c 30-50 mg/dL decrease in FBG 0.7-1.0% decrease in HbA1c FBG = Fasting blood glucose PPG = Post-prandial glucose HbA1c = Hemoglobin A1c Diabetes 7.23 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 APPENDIX F Insulin Products Available in the United States Insulin Rapid acting (onset <15 minutes, peak 30-90 minutes, duration 3-5 hours). Humalog Humalog Cartridges Novolog Apidra Exubera (nasal) Short-Acting (onset 30-60 minutes, peak 50-120 minutes, duration 5-8 hours). Humulin R Regular Humulin R Cartridges Novolin R Novolin R Penfill Novolin R Intermediate-Acting (onset 1-3 hours, peak unpredictable 7-15 hours, duration 20 hours). Humulin L (Lente) Humulin N (NPH) Humulin N Cartridges Novolin L Novolin N Novolin N Penfill Novolin N prefilled Long-Acting (onset 4-6 hours, peak unpredictable, duration 16-20 hours). Long Acting (24Hrs) (onset 1.1 hours, no peak, duration 24 hours) Glargine (Lantus) Detemir (Levemir) SMBG reflecting insulin action Dose 10-20 minutes before meals Dose 30 minutes before meals Dose - before dinner Every evening/bedtime – breakfast Before breakfast Lantus: Dose once daily at the same time of day. Detemir: Dose once or twice daily Diabetes 7.24 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Insulin Mixtures Humulin 50/50 Humulin 70/30 Humulin 70/30 (cartridge) Novolin 70/30 Novolin 70/30 Penfill Novolin 70/30 Prefilled Humalog 75/25 Humalog 50/50 Novolog 70/30 The onset, peak, and duration of action of these mixtures would reflect a composite of the intermediate and short or rapid acting components with one peak of action. SMBG reflecting insulin action Before meals/ bedtime Diabetes 7.25 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 APPENDIX G Insulin Adjustment Guidelines 1. Decisions regarding insulin adjustments are dependent upon: a. b. c. d. Knowledge of the action time and duration of action of the various insulin preparations available. (Refer to Appendix F.) The client’s blood glucose monitoring records to identify patterns of glucose levels. Assessment of client’s follow through with nutritional recommendations and activity. The degree of acceptable glycemic control for each individual client. 2. An increase or decrease of 1-2 units in the appropriate insulin may cause a difference of 40-50 mg/dL in the glucose level. Adjustments should be made in one dose at a time increments and the response/result evaluated carefully before making additional changes. 3. Suggested adjustments: Before breakfast Before Lunch Before Evening Meal Bedtime short-acting intermediate-acting 1. Intermediate-acting + short acting 2. Intermediate-acting + short acting short-acting short-acting intermediate-acting 3. short-acting short-acting short-acting long-acting Diabetes 7.26 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 Glucose Outside Range Possible Adjustment High increase every evening or bedtime intermediate-acting or long-acting insulin Low decrease every evening or bedtime intermediate- acting or long-acting insulin High add or increase morning shortacting insulin Low decrease morning short-acting insulin High increase morning intermediateacting or long-acting insulin OR lunchtime short-acting insulin Low decrease AM intermediate-acting or long-acting insulin OR lunchtime short-acting insulin High add or increase dinner short-acting insulin Low Low decrease dinner short-acting insulin decrease intermediate-acting or long- acting insulin, OR change predinner NPH/Lente to bedtime FBG Before Lunch Before Dinner Before Bedtime (HS) During Night Diabetes 7.27 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 APPENDIX H T TREATMENT ALGORITHM OF TYPE 2 DIABETES Nutrition and Physical Activity Inadequate? FPG > 120 mg/dL HbA1c > 7% First-Line Therapies Sulfonylureas or Metformin or Acarbose or Rosiglitazone or Pioglitazone Lean Overweight Postprandial Renal Impairment Renal Impairment Dyslipidemic Hyperglycemic Insulin Resistant Insulin Resistant Insulin Resistant MONOTHERAPY INADEQUATE? FPG > 130 mg/dL HbA1c > 7% MONOTHERAPY ADEQUATE? FPG < 130 mg/dL HbA1c < 7% INITIATE ORAL COMBINATION THERAPY CONTINUE COMBINATION THERAPY ADEQUATE? FPG < 130 mg/dL HbA1c < 7% CONTINUE COMBINATION THERAPY INADEQUATE? FPG > 130 mg/dL HbA1c > 7% Diabetes Consider: Referral to a specialist Adding Bedtime insulin or third oral agent Switching to insulin If uncontrolled on insulin, Add Rosiglitazone, or Pioglitazone or Metformin 7.28 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 REFERENCES 1. 2. 3. 4. 5. 6. 7. 8. 9. American Diabetes Association, Standards of Medical Care for Patients with Diabetes Mellitus. Diabetes Care, Vol. 30, Supplement 1, 2007, pp. S4-S41. M.J. Franz, Diabetes Education and Program Management, A Core Curriculum for Diabetes Education, Fifth Edition, American Association of Diabetes Educators, Chicago, 2003, pp. 25-99. (Current) Constance R. Uphold and Mary Virginia Grant, Clinical Guidelines in Family Practice, Fourth Edition, Barmarrae Books Inc., Gainesville, FL, 2003. pp.164-180. (Current) Joint National Committee on Detection, Evaluation and Treatment of High Blood Pressure, The Seventh Report-JNC7 Express, NIH Publication No. 03-5233, May 2003, pp. 14-19. (Current) Lexi-Drugs OnlineTM, Lexi-Comp DatabaseTM, Lexi-Comp, Inc., Hudson, Ohio, March 29, 2007. American Society of Health-Systems Pharmacists, American Hospital Formulary Service, Bethesda, MD, 2007, pp. 3126-3138, 3140-3211. Facts and Comparisons, Facts and Comparisons 4.0 Online, Wolters Kluwer Health, Inc., 2007 <http://online.factsandcomparisons.com>. Georgia Dietetic Association Diet Manual and Nutrition Practice Guidelines, Georgia Dietetic Association, 2004. (Current) American Diabetes Association, Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy, Diabetes Care, Vol.29, 2006, pp. 1963-1972. Diabetes 7.29 Division of Public Health Nurse Protocols for Registered Professional Nurses for 2008 THIS PAGE INTENTIONALLY LEFT BLANK Diabetes 7.30