2016 Diabetes Practice Guidelines
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1 2016 Diabetes Practice Guidelines SOURCE(S): 1. American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care January 2016 Volume 39, Supplement 1. Diagnosis Diabetes can be classified into the following general categories: 1. Type 1 diabetes (due to b-cell destruction, usually leading to absolute insulin deficiency) 2. Type 2 diabetes (due to a progressive insulin secretory defect on the background of insulin resistance) 3. Gestational diabetes mellitus (GDM) (diabetes diagnosed in the second or third trimester of pregnancy that is not clearly overt diabetes) 4. Specific types of diabetes due to other causes, e.g., monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young [MODY]), diseases of the exocrine pancreas (such as cystic fibrosis), and drug- or chemical-induced diabetes (such as in the treatment of HIV/AIDS or after organ transplantation) Diagnosis is determined by: Fasting Blood Glucose - A fasting blood glucose level of 126 mg/dl or higher ( Fasting is defined as no caloric intake for at least 8 hours.) Random Blood Glucose - A blood glucose level of 200 mg/dl or higher (on 1 or more retests) taken at any time of the day, along with symptoms of diabetes o Blood glucose rather than A1C should be used to diagnose acute onset of type 1 diabetes in individuals with symptoms of hyperglycemia Hemoglobin A1C levels greater than or equal to 6.5% indicate diabetes. Levels between % indicate pre-diabetes. In a patient with classic symptoms of diabetes including polyuria, polydipsia, and unexplained weight loss, a random plasma glucose greater than or equal to 200. Complete history and physical exam o A complete medical evaluation should be performed at the initial visit to: i. Classify diabetes ii. Detect diabetes complications iii. Review previous treatment and risk factor control in patients with established diabetes iv. Assist in formulating a management plan v. Provide a basis for continuing care Testing to detect type 2 diabetes and prediabetes in asymptomatic people should be considered in adults of any age who are overweight or obese (BMI 25 kg/m 2 ) and who have one or more additional risk factors for diabetes. In those without these risk factors, testing should begin at age 45. Approved at 3/20/15 HIQIC 1
2 Testing should be considered in all adults who are overweight (BMI 25 kg/m2*) and have additional risk factors: o Physical inactivity o First-degree relative with diabetes o High-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander) o Women who delivered a baby weighing >9 lb or were diagnosed with GDM o Hypertension ( 140/90 mmhg or on therapy for hypertension) o HDL cholesterol level <35 mg/dl (0.90 mmol/l) and/or a triglyceride level >250 mg/dl (2.82 mmol/l) o Women with polycystic ovary syndrome o A1C 5.7%, IGT, or IFG on previous testing o Other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans) o History of CVD In the absence of the above criteria, testing for diabetes should begin at age 45 years. Criteria for Testing for Type 2 diabetes in asymptomatic children and adolescents (age 18 and younger): o Overweight or obese (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal for height), plus any two of the following risk factors: Family history of type 2 diabetes in first- or second-degree relative Race/ethnicity (Native American, African American, Latino, Asian American, Pacific Islander) Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestationalage birth weight) Maternal history of diabetes or GDM during the child s gestation Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a younger age Frequency: every 3 years Maturity-onset diabetes of the young should be considered in individuals who have mild stable fasting hyperglycemia and multiple family members with diabetes not characteristic of type 1 or type 2 diabetes. o Consider referring individuals with diabetes not typical of type 1 or type 2 diabetes and occurring in successive generations (suggestive of an autosomal dominant pattern of inheritance) to a specialist for further evaluation. Labs: bun/creatinine, thyroid function tests, urine for microalbuminuria, ekg, cholesterol/ triglycerides/ldl Consider screening those with type 1 diabetes for autoimmune disorders (ie/ thyroid dysfunction, celiac disease) as appropriate. Consider assessing for and addressing common comorbid conditions (e.g., depression, obstructive sleep apnea) that may complicate diabetes management. 2
3 Gestational Diabetes: All pregnant women who are between 24 and 28 weeks of gestation should undergo a 75-gram 2-hour oral glucose tolerance test (OGTT). Blood should be drawn for glucose levels at baseline, at 1 hour, and at 2 hours. A woman only needs to have a single abnormal value to be diagnosed with gestational diabetes. o Perform OGTT in the morning after an overnight fast of at least 8 hours o Gestational Diabetes diagnosis: when any one of the following plasma glucose levels are exceeded: o Fasting >92mg/dL o 1 hour >180mg/dL o 2 hours >153mg/dL Screen women with gestational diabetes mellitus for persistent diabetes at 6 12 weeks postpartum, using the oral glucose tolerance test and clinically appropriate nonpregnancy diagnostic criteria. Women with a history of gestational diabetes should have lifelong screening for the development of diabetes or prediabetes at least every three years Women with a history of gestational diabetes who are found to have prediabetes should receive lifestyle interventions or Metformin to prevent diabetes. Screening for Cystic Fibrosis- Related Diabetes (CFRD) Annual screening for CFRD should begin at age 10 in all patients with cystic fibrosis, using glucose tolerance test (not A1C). Patients with CFRD should be treated with insulin to attain individualized glycemic goals. Beginning 5 years after the diagnosis of cystic fibrosis related diabetes, annual monitoring for complications of diabetes is recommended. Prevention or Delay of Type 2 Diabetes Patients with prediabetes should be referred to an intensive diet and physical activity behavioral counseling program targeting loss of 7% of body weight and increasing moderate intensity physical activity (such as brisk walking) to at least 150 minutes / week. Metformin therapy for prevention of Type 2 Diabetes may be considered in those with impaired glucose tolerance (IGT), especially for those with BMI greater than or equal to 35 kg/m, under 60 years of age, and women with prior gestational diabetes mellitus. Screening for and treatment of modifiable risk factors for cardiovascular disease is suggested. Diabetes and self-management education and support programs are appropriate venues for people with prediabetes to receive education and support to develop and maintain behaviors that can prevent or delay the onset of diabetes. 3
4 Treatment Medication Common drugs for treating type II diabetes o Metformin Metformin, if not contraindicated and if tolerated, is the preferred initial pharmacological agent for type 2 diabetes. It is more effective than other type 2 diabetes drugs in reducing blood sugar levels when used alone or in combination with other drugs. In addition, Metformin reduces body weight and improves cholesterol profiles. Metformin is associated with fewer side effects than Sulfonylureas. Some patients with kidney problems should not receive Metformin. If noninsulin monotherapy at maximum tolerated dose does not achieve or maintain the A1C target over 3 months, then add a second oral agent, a glucagon-like peptide 1 receptor agonist, or basal insulin. o Sulfonylurea(glimepiride, glyburide, and tolazamide o Glitazones(rosiglitazone or pioglitazone) o Exenatide (Byetta), pramlintide (Symlin), and liraglutide (Victoza), injectable o Repaglinide (Prandin) and nateglinide (Starlix) o Alpha-glucosidase inhibitors (such as acarbose) o Januvia and saxagliptin (Onglyza). (DPP-4 inhibitor blocker) - works in the pancreas and liver Insulin o Multiple types short acting vs long acting vs mixed o Treatment of choice for type I diabetes and also used for type II diabetes that cannot be well controlled with other medicines o Most individuals with type 1 diabetes should use insulin analogs to reduce hypoglycemia risk o Individuals who have been successfully using continuous subcutaneous insulin infusion should have continued access after they turn 65 years of age. Surgery Bariatric surgery may be considered for adults with BMI 35 kg/m 2 and type 2 diabetes, especially if the diabetes or associated comorbidities are difficult to control with lifestyle and pharmacological therapy. Medications for other risks and complications ACE inhibitors are recommended as: o First choice medicine for treating high blood pressure o Patients who have signs of kidney disease (e.g. microalbuminuria Angiotensin receptor blockers (ARB s) are used when ace inhibitors do not work or are not tolerated Antiplatelets agents o Daily low-dose aspirin is recommended for a majority of adults with diabetes o Clopidogrel (Plavix) may be used when aspirin cannot be given, or after certain cardiac 4
5 procedures or events Statins are generally the preferred lipid lowering drug o For persons with a high cardiovascular risk, the cardiovascular benefits of statin therapy outweigh the risk of side effects Other When choosing glucose-lowering medications for overweight or obese patients with type 2 diabetes, consider their effect on weight. Whenever possible, minimize the medications for comorbid conditions that are associated with weight gain. Chronic Care Model The Chronic Care Model has been shown to be an effective framework for improving the quality of diabetes care. This model includes six core elements for the provision of optimal care of patients with chronic disease. Care should be aligned with components of the Chronic Care Model to ensure productive interactions between a prepared proactive practice team and an informed activated patient. The six core elements include: 1. A delivery system that is more proactive and not reactive where planned visits are coordinated through a team based approach) 2. Self-management support 3. Decision support (basing care on evidence-based, effective care guidelines) 4. Clinical information systems (using registries that can provide patient specific and population-based support to the care team) 5. Community resources and policies (identifying or developing resources to support healthy lifestyles) 6. Health systems (to create a quality oriented culture) Food Insecurity Evaluate hyperglycemia and hypoglycemia in the context of food insecurity, evaluate and propose solutions Homelessness, poor literacy, and poor numeracy often occur with food insecurity, and appropriate resources should be researched and proposed Regular Tests/Exams for Management of Complications Patients should see the physician managing their diabetes every three months. At these visits, the following should occur: o Blood pressure check o Inspection of skin and bones on the feet and legs o Evaluation of sensation on the feet with a Semmes Weinstein filaments Hemoglobin A1C at least twice a year if under control, 4 times a year if not well controlled o Point-of-care testing for A1C provides the opportunity for more timely treatment changes 5
6 Cholesterol risk profile and annually o Lifestyle modification focusing on the reduction of saturated fat, trans fat, and cholesterol intake; increase of n-3 fatty acids, viscous fiber, and plant stanols/sterols; weight loss (if indicated); and increased physical activity should be recommended to improve the lipid profile in patients with diabetes. Retinopathy - annual dilated retinal exam needed Laser photocoagulation therapy is indicated to reduce the risk of vision loss in patients with high risk proliferative diabetic retinopathy (PDR), clinically significant macular edema, and some cases of severe non-proliferative diabetic retinopathy (NPDR). o The presence of retinopathy is not a contraindication to aspirin therapy for cardio-protection, as this therapy does not increase the risk of retinal hemorrhage Blood Pressure To reduce the risk or slow the progress of nephropathy and/or retinopathy, treat hypertension. Target readings for people with diabetes are: 140/90 for many with diabetes 130/80 for those who are younger, have kidney damage, or have heart, cerebrovascular or peripheral vascular disease Microalbuminuria annually to watch for progression to CKD and ESRD o Perform an annual test to assess urine albumin excretion in type 1 diabetic patients with diabetes duration of 5 years or more and in all type 2 diabetics starting at the time of diagnosis. o In the treatment of the non-pregnant patient with micro or macroalbuminuria, either ACE inhibitors or ARBs should be used. o Limited protein diet may improve renal function and is recommended for those with CKD Dental exam and cleaning every six months Foot care o All patients with diabetes should have an annual comprehensive foot examination to identify risk factors predictive of ulcers and amputations. The foot examination should include inspection, assessment of foot pulses, and testing for loss of protective sensation (LOPS) (10-g monofilament plus testing any one of the following: vibration using 128-Hz tuning fork, pinprick sensation, ankle reflexes, or vibration perception threshold). o o Foot ulcers and wound care may require care by a podiatrist, orthopedic or vascular surgeon, or rehabilitation specialist experienced in the management of individuals with diabetes. The risk of ulcers or amputations is increased in people who have the following risk factors: Previous amputation Past foot ulcer history Peripheral neuropathy Foot deformity Peripheral vascular disease Visual impairment Diabetic nephropathy (especially patients on dialysis) Poor glycemic control Cigarette smoking 6
7 Education People with diabetes should receive diabetes self-management education (DSME) and diabetes selfmanagement support (DSMS) when their diabetes is diagnosed and as needed thereafter. Effective selfmanagement and quality of life are the key outcomes of DSME and DSMS and should be measured and monitored as part of care. Diabetes education to help patients acquire the following self-management skills and understanding: Diet and exercise are key components of diabetes management. Potential risks and complications of diabetes. How to test and record blood glucose levels of home How to follow a diabetic diet: o Nutrition therapy is recommended for all people with type 1 and type 2 diabetes as an effective component of the overall treatment plan. o Individuals who have pre-diabetes or diabetes should receive individualized medical nutrition therapy (MNT) as needed to achieve treatment goals, preferably by a registered dietician familiar with the components of diabetes MNT. o Goals of Nutrition Therapy for Adults With Diabetes: 1) To promote and support healthful eating patterns, emphasizing a variety of nutrient-dense foods in appropriate portion sizes, in order to improve overall health and specifically to: Attain individualized glycemic, blood pressure, and lipid goals Achieve and maintain body weight goals Delay or prevent complications of diabetes 2) To address individual nutrition needs based on personal and cultural preferences, health literacy and numeracy, access to healthful food choices, willingness and ability to make behavioral changes, and barriers to change. 3) To maintain the pleasure of eating by providing positive messages about food choices while limiting food choices only when indicated by scientific evidence. 4) To provide the individual with diabetes with practical tools for day-to-day meal planning rather than focusing on individual macronutrients, micronutrients, or single foods. Importance of medication adherence and how to take medications, including insulin How to recognize and treat low and high blood sugar levels: o Treatment of hypoglycemia (plasma glucose <70 mg/dl) requires ingestion of glucose- or carbohydrate-containing foods. o Severe hypoglycemia (where the individual requires the assistance of another person and cannot be treated with oral carbohydrate due to confusion or unconsciousness) should be treated using emergency glucagon kits, which require a prescription. Those in close contact with, or having custodial care of, people with hypoglycemia-prone diabetes (family members, roommates, school personnel, child care providers, correctional institution staff, or coworkers) should be instructed in use of such kits. o Patients should understand situations that increase their risk of hypoglycemia, such as when 7
8 fasting for tests or procedures, during or after intense exercise, and during sleep and that increase the risk of harm to self or others from hypoglycemia, such as with driving. How to adjust insulin for exercise, illness, change in eating, or traveling o Hypoglycemia unawareness or one or more episodes of severe hypoglycemia should trigger reevaluation of the treatment regimen. o In individuals taking insulin and/or insulin secretagogues, physical activity can cause hypoglycemia if medication dose or carbohydrate consumption is not altered. For individuals on these therapies, added carbohydrate should be ingested if pre-exercise glucose levels are <100 mg/dl (5.6 mmol/l). o In the presence of proliferative diabetic retinopathy (PDR) or severe non-pdr (NPDR), vigorous aerobic or resistance exercise may be contraindicated because of the risk of triggering vitreous hemorrhage or retinal detachment How to inspect feet and choose proper footwear o Patients at risk should understand the implications of the loss of protective sensation, the importance of foot monitoring on a daily basis, the proper care of the foot, including nail and skin care, and the selection of appropriate footwear. Patients with visual difficulties, physical constraints preventing movement, or cognitive problems that impair their ability to assess the condition of the foot and to institute appropriate responses will need other people, such as family members, to assist in their o care. All individuals with peripheral neuropathy should wear proper footwear and examine their feet daily to detect lesions early. Anyone with a foot injury or open sore should be restricted to non weight-bearing activities. Importance of annual dilated retinal examination A patient-centered communication style that incorporates patient preferences, assesses literacy and numeracy, and addresses cultural barriers to care should be used. o Include assessment of the patient s psychological and social situation as an ongoing part of the medical management of diabetes Psychosocial screening and follow up may include, but are not limited to, attitudes about the illness, expectations for medical management and outcomes, affect/mood, general and diabetes-related quality of life, resources (financial, social, emotional) and psychiatric history. Routinely screen for psychosocial problems such as depression and diabetes-related distress, anxiety, eating disorders, and cognitive impairment. Older adults (ages 65 or older) with diabetes should be considered a high priority population for depression screening and treatment. Patients with comorbid diabetes and depression should receive a stepwise collaborative care approach for the management of depression. 8
9 Life Style Modifications Weight Reduction Maintain normal body weight (BMI x kg/m 2 ) For weight loss, either low-carbohydrate, low-fat calorie-restricted, or Mediterranean diets may be effective. Diet, physical activity, and behavioral therapy designed to achieve 5% weight loss should be prescribed for overweight and obese patients with type 2 diabetes ready to achieve weight loss Nutrition/Diet Saturated fat less than 7% of total calories trans fats intake should be minimized. Reduction of saturated fat, trans fat, and cholesterol intake, as well as increase of n-3 fatty acids, viscous fiber, and plant stanols/sterols is recommended to improve the lipid profile of patients with diabetes. Carbohydrate monitoring and counting skills Monitoring carbohydrate intake, whether by carbohydrate counting, choices, or experience-based estimation, remains a key strategy in achieving glycemic control. Minimize or eliminate alcohol People with type 1 diabetes should eat at about the same times each day and try to be consistent with the types of food they choose. Exercise Perform at least 150 minutes/week of moderate aerobic physical activity (50-70% of maximum heart rate), spread over at least 3 days per week with no more than 2 consecutive days without exercise. All individuals should be encouraged to limit the amount of time they spend being sedentary by breaking up extended amounts of time (.90 min) spent sitting. In the absence of contraindications, people with type 2 diabetes should be encouraged to perform resistance training at least twice per week. All people with diabetes should check with regular physician and eye doctor before starting an exercise program, as well as make sure they are using proper footwear. Children with diabetes or pre-diabetes should be encouraged to engage in at least 60 minutes of physical activity each day. Decrease other cardiovascular risk factors Stop smoking Note: E-cigarettes are not supported as an alternative to smoking or to facilitate smoking cessation. 9
10 Monitor for symptoms Self-monitoring of blood glucose (SMBG) levels daily Patients who are on insulin pump therapy or multiple insulin injections daily, should perform self-monitoring of blood glucose at least three times a day. Continuous glucose monitoring in conjunction with intensive insulin regimens can be a useful tool to lower A1C in adults at least 25 years of age with type 1 diabetes Insulin-treated patients with hypoglycemia unawareness or an episode of severe hypoglycemia should be advised to raise their glycemic targets to strictly avoid further hypoglycemia for at least several weeks, to partially reverse hypoglycemia unawareness, and to reduce risk of future episodes. When prescribing SMBG, ensure that patients receive ongoing instruction and regular evaluation of SMBG technique, SMBG results, and their ability to use SMBG data to adjust therapy. Check feet every day for sores/ulcers Take blood pressure on a regular basis Immunizations Annually provide an influenza vaccine to all patients with diabetes >6 months of age, if no contraindications are present. 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 PPSV months after initial vaccination. Adults >65 years of age, if previously vaccinated with PPSV23, should receive a follow-up after 12 months with PCV13. Administer hepatitis B vaccination to unvaccinated adults with diabetes who are aged years. Consider administering hepatitis B vaccination to unvaccinated adults with diabetes who are aged 60 years or older. Treatment Goals Effective self-management. Blood sugar should be between 80 and 130 mg per deciliter before meals for adult diabetics, and between 100 and 180 mg per deciliter at bed time for adult diabetics Blood pressure less than 140/90 LDL cholesterol target levels are now driven primarily by risk status rather than specific LDL cholesterol levels 10
11 Triglycerides less than 150 Hemoglobin A1C less than 7% Absence of diabetic foot ulcers Prevention of cardiovascular events Prevention or slowing of diabetic nephropathy, neuropathy, and retinopathy This guideline summary is not intended to replace a clinician s judgment or to establish a protocol for all patients with a particular condition. Some patients will not fit the conditions contemplated by a guideline; moreover, a guideline will rarely establish the only appropriate approach to a problem. The guideline is intended to assist clinicians by providing a framework, based on evidence-based research, for evaluation and treatment of certain medical conditions. 11
12 Previous Updates/References: 1. Standards of Medical Care in Diabetes Diabetes Care January Vol 38 no. supplement 1 S1-S Buse JB, Polonsky KS, Burant CF. Type 2 diabetes mellitus. In: Kronenberg HM, Melmed S, Polonsky KS, Larsen PR. Williams Textbook of Endocrinology. 12th ed. Philadelphia, PA: Saunders Elsevier; 2011:chap Eisenbarth GS, Buse JB. Type 1 diabetes mellitus. In: Kronenberg HM, Melmed S, Polonsky KS, Larsen PR. Williams Textbook of Endocrinology. 12th ed. Philadelphia, PA: Saunders Elsevier; 2011:chap American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care Jan;33 Suppl 1:S American Diabetes Association. Executive Summary: Standards of Medical Care in Diabetes Diabetes Care. January 2012 vol. 35 Suppl.I S4-S10. Accessed on September 28, 2012 from 6. American Diabetes Association. Standards of medical care in diabetes Diabetes Care Jan;33 Suppl 1:S American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care. January 2012 vol. 35:S11-S63. Accessed on September 28, 2012 from 8. American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care January 2013 vol. 36 no. Supplement 1 S11-S66 9. ADA. IX. Strategies for Improving Diabetes Care. Diabetes Care. 2011;34(suppl 1):S12, Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and metaanalysis. Am J Med Mar;122(3): e In the clinic. Type 2 diabetes. Ann Intern Med. 2007;146:ITC
13 12. Lipsky BA, Berendt AR, Cornia PB, et al.; Infectious Diseases Society of America Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis 2012;54:e132 e Oral Drug Treatment of Type 2 Diabetes Mellitus: A Clinical Practice Guideline from the American College of Physicians. Annals of Internal Medicine Feb;156(3):I-36. Accessed on September 28, 2012 from Oral Drug Treatment of Type 2 Diabetes Mellitus: A Clinical Practice Guideline from the American College of Physicians. Annals of Internal Medicine Feb;156(3):I-36. Accessed on September 28, 2012 from 13
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