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2018 Clinical practice guidelines for Diabetes Care by DAROC

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Diabetes Association of Republic of China (DAROC) has released its clinical practice guidelines for diabetes care- 2018.It incorporates diagnostic criteria for diabetes, pre-diabetes and gestational diabetes, and the screening methods for diabetes in asymptomatic subjects. There are recommendations for  Treatment goals for adults with diabetes, older adults with diabetes, children and adolescents with type 1 diabetes, women with gestational diabetes and inpatients also. The new Guidelines have been published in the Journal of the Formosan Medical Association.

Major Recommendations-

Treatment algorithm for people with type 2 diabetes-

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The treatment algorithm for patients with type 2 diabetes mellitus. The algorithm has been revised in response to the consensus by the American Diabetes Association and the European Association for the Study of Diabetes and the results from cardiovascular outcome trials published in 2018.

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While applying this treatment algorithm in clinical situations, the following points should be considered.

  • A healthy lifestyle is a foundation for the treatment of diabetes.
  • Weight control is essential in patients with diabetes and obesity.
  • The general target of HbA1c is <7%, with individual considerations.
  • The selection of anti-diabetic medications should be individualized according to patient’s age and comorbidities, the efficacy and adverse effects of the drugs, and the risk of hypoglycemia.
  • Combination of two anti-diabetic agents is recommended if HbA1c is higher than 8.5%.
  • Insulin injection is preferred if typical symptoms of hyperglycemia are present. After blood glucose is stabilized, insulin therapy can be continued or discontinued.
  • Biguanide (metformin) is the preferred initial pharmacological agent for type 2 diabetes if it is not contraindicated and is tolerated.
  • If the glycemic goal is not achieved three months after monotherapy, consider another anti-diabetic medication with different mechanisms.
  • In patients with cardiovascular diseases, consider medications which have shown beneficial effects on cardiovascular diseases and/or mortality, such as GLP-1 receptor agonists, SGLT2 inhibitors and thiazolidinediones.
  • If the glycemic goal is not achieved three months after dual anti-diabetic medications, consider a third anti-diabetic agent with different mechanisms.
  • If the glycemic target is not achieved three months after triple anti-diabetic medications, consider intensified insulin therapy, including basal insulin plus 1–3 doses of pre-prandial insulin or 2–3 doses of premixed insulin.
  • Combination therapy of thiazolidinedione and insulin can increase the risk of fluid retention and heart failure. Close monitoring of cardiac function is suggested.
  • If the glycemic target is not achieved within 3–12 months, consider referral to endocrinologists.
  • Bariatric surgery can be considered for adults with moderate or severe obesity (body mass index ≥32.5 kg/m2) and type 2 diabetes.
Figure 2

Courtesy Journal of the Formosan Medical Association.

Criteria for the diagnosis of diabetes.

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1. Hemoglobin A1c ≥ 6.5% or

2. Fasting plasma glucose ≥126 mg/dL (7.0 mmol/L) or
3. 2-h plasma glucose ≥200 mg/dL (11.1 mmol/L) during an OGTT or
4. Classic symptoms of hyperglycemia or hyperglycemic crisis, and a random plasma glucose ≥200 mg/dL (11.1 mmol/L)

Diabetes is diagnosed if one of the above criteria is met. Results should be confirmed by repeat testing in the presence of equivocal hyperglycemia.

a. The test should be performed in a laboratory using a method that is certified by the National Glycohemoglobin Standarization Program (NGSP) and is standardized to the Diabetes Control and Complications Trial (DCCT) assay.
b. Fasting is defined as no caloric intake for at least 8 h.
c. Oral glucose tolerance test (OGTT). The test should be performed as described by the World Health Organization (WHO), using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water.

Categories of increased risk for diabetes (prediabetes).

1. Impaired glucose tolerance (IGT): 2-h plasma glucose in the 75-g OGTT 140–199 mg/dL (7.8–11.0 mmol/L)

2. Impaired fasting glucose (IFG): FPG 100–125 mg/dL (5.6–6.9 mmol/L)

3. Hemoglobin A1c 5.7–6.4%

FPG, fasting plasma glucose.

The differential diagnosis between type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM).

Age at onset Usually younger than 30 years old Usually older than 40 years old
Onset Acute – usually symptomatic Insidious – usually asymptomatic
Clinical manifestation Thin or normal weight
Body weight loss Polyuria Polydipsia
Obese, Family history of T2DM May accompany with acanthosis nigricans or polycystic ovary syndrome
Ketoacidosis Common Rare
Fasting C-peptide Low or undetectable Normal, decreased or increased
C-peptide after glucagon stimulation test Low or undetectable Normal, decreased or increased
Autoantibody (such as ICA, GADA, IA-2A, IAA and ZnT8Ab) Usually present Usually absent
Treatment Insulin required Lifestyle modification and/or anti-diabetic drugs including insulin
Presence of other autoimmune diseases Usually present Rare
a. ICA, islet cell cytoplasmic autoantibodies; GADA, glutamic acid decarboxylase autoantibodies; IA-2A, insulinoma-associated-2 autoantibodies; IAA, insulin autoantibodies; ZnT8Ab, zinc transporter 8 autoantibodies.

Diagnosis of gestational diabetes mellitus (GDM).

Plasma glucose, mg/dL (mmol/L) 75-g OGTT “one-step strategy” 100-g OGTT “two-step strategy”
Fasting ≥92 (5.1) ≥95 (5.3)
1-h plasma glucose during an OGTT ≥180 (10.0) ≥180 (10.0)
2-h plasma glucose during an OGTT ≥153 (8.5) ≥155 (8.6)
3-h plasma glucose during an OGTT ≥140 (7.8)
OGTT, oral glucose tolerance test.
a. At first prenatal visit, check fasting plasma glucose or hemoglobin A1c to exclude preexisting diabetes (if fasting plasma glucose ≥ 126 mg/dl or hemoglobin A1c ≥ 6.5%). At a 24th-28th gestational week, perform a 75-g OGTT and measure plasma glucose at fasting, 1h and 2h during the OGTT. The OGTT should be performed in the morning after an overnight fast of at least 8 h. The diagnosis of GDM is made when one of the plasma glucose values meets or exceeds the cutoffs. This method is called “one-step strategy” by the American Diabetes Association.
b. At a 24th-28th gestational week, perform a nonfasting 50-g glucose challenge test in women not previously diagnosed with overt diabetes. If the plasma glucose level measured 1 h after the glucose challenge test is ≥ 130 mg/dL (sensitivity is 90%) or ≥140 mg/dL (sensitivity is 80%), proceed to a 100-g OGTT. The 100-g OGTT should be performed when the patient is fasting. The diagnosis of GDM is made if at least two of the four plasma glucose levels (measured at fasting, 1 h, 2 h and 3 h during the OGTT) meet or exceed the cutoffs. This method is called “two-step strategy” by the American Diabetes Association.

 Criteria for the screening for diabetes in asymptomatic adults.

1. In adults aged 40–64 years, screening for diabetes every 3 years should be considered. For adults aged 65 or over, annual screening for diabetes is recommended.

2. Using a risk assessment calculator, the Taiwan Diabetes Risk Score, to estimate the risk for undiagnosed diabetes. For subjects with very high risk of undiagnosed diabetes, annual screening is recommended. For subjects with high or moderate risk of undiagnosed diabetes, screening every 3 years is recommended.

3. Screening should be considered if condition A or condition B is met.

A. Screening is recommended if the subject has two or more of the following risk factors. If the screening result excludes the presence of diabetes, repeated screening at least every 3 years is recommended.

– body mass index (BMI) ≥24 kg/m2 or waist circumference ≥90 cm in men or waist circumference ≥80 cm in women
– first-degree relative with diabetes
– history of cardiovascular disease
– hypertension (BP ≥ 140/90 mmHg or receiving therapy for hypertension)
‐ plasma HDL cholesterol <35 mg/dL or plasma triglyceride ≥250 mg/dL
‐ women with polycystic ovary syndrome
‐ women with a history of gestational diabetes mellitus
‐ physical inactivity
‐ clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans)
B. Subjects who have impaired fasting glucose, impaired glucose tolerance, or hemoglobin A1c 5.7–6.4% are suggested to be tested annually.

Treatment goals for non-pregnant adults with diabetes.

Plasma HbA1c <7.0 %
glucose Fasting or pre-prandial glucose 80–130 mg/dL
2-h postprandial glucose 80–160 mg/dL
Blood General target <140/90 mmHg
pressure Diabetic nephropathy <130/80 mmHg
Lipid (primary goal) LDL cholesterol <100 mg/dL
<70 mg/dL (in individuals with cardiovascular disease)
Lipid (secondary goal) Total cholesterol <160 mg/dL
Non-HDL cholesterol <130 mg/dL
<100 mg/dL (in individuals with cardiovascular disease)
HDL cholesterol Men: >40 mg/dL
Women: >50 mg/dL
Triglyceride <150 mg/dL
Lifestyle modification Smoking cessation Strongly recommended
Physical activity At least 150 min/week of moderate-intensity exercise, or at least 3 days/week, 20 min/day of moderate-to-vigorous-intensity exercise
BMI 18.5–24 kg/m
Waist circumference Men: <90 cm
Women: <80 cm
BMI, body mass index; HbA1c, hemoglobin A1c; HDL, high density lipoprotein; LDL, low-density lipoprotein.
a. Goals should be individualized. Please refer to Table 8 for the considerations for individualized goals.

Treatment goals for older adults with diabetes.

Health status HbA1c FPG Bedtime glucose Blood pressure
Healthy (few coexisting chronic illness, intact cognitive and functional status) <7.5% 90–130 mg/dL 90–150 mg/dL <140/90 mmHg
Complex/intermediate (multiple coexisting chronic illnesses or more than 2 instrumental ADL impairments or mild-to-moderate cognitive impairment) <8.0% 90–150 mg/dL 100–180 mg/dL <140/90 mmHg
Very complex/poor health (long-term care or end-stage chronic illnesses or moderate-to-severe cognitive impairment or 2 + ADL dependencies) <8.5% 100–180 mg/dL 110–200 mg/dL <150/90 mmHg
ADL, activities of daily living; FPG, fasting plasma glucose; HbA1c, hemoglobin A1c.
a. Coexisting chronic illnesses are conditions serious enough to require medications or lifestyle management and may include arthritis, cancer, congestive heart failure, depression, emphysema, falls, hypertension, incontinence, stage 3 or worse chronic kidney disease, myocardial infarction and stroke.
b. The presence of a single end-stage chronic illness, such as stage 3–4 congestive heart failure or oxygen-dependent lung disease, chronic kidney disease requiring dialysis, or uncontrolled metastatic cancer, may cause significant symptoms or impairment of functional status and significantly reduce life expectancy.

Individualized goals for glycemic control.

Glycemic goals for women with gestational diabetes mellitus.

Pre-prandial plasma glucose <95 mg/dL
One-hour post-meal plasma glucose <140 mg/dL
Two-hour post-meal plasma glucose <120 mg/dL
Glycated albumin <15.8%

Recommendations of laboratory tests for metabolic monitoring and examinations for the screening of diabetic complications.

Laboratory tests or examinations Suggested testing intervals
Plasma glucose and HbA1c Every 3 months
Diabetes self-management education Every 3 months
Lipid profile, including LDL-cholesterol, HDL-cholesterol, total cholesterol and triglyceride Every 1 year
In people with dyslipidemia or under therapy for dyslipidemia, tests can be repeated every 3–6 months
Tests for nephropathy, including serum creatinine, estimated glomerular filtration rate (eGFR), urinalysis and/or urinary albumin excretion Every 1 year
In the presence of abnormal results, tests can be repeated every 3–6 months.
Examinations for retinopathy, including visual acuity and fundoscopic examination Every 1 year
Examinations for diabetic foot, including palpation of pedal pulses and measurement of ankle-brachial index Every 1 year
Examinations for neuropathy: 10-g monofilament test, vibration tests with 128-Hz tuning fork and tests for ankle reflexes Every 1 year
Periodontal and dental examinations Every 1 year
Screening for certain cancers According to the recommendations and services provided by the Health Promotion Administration, Ministry of Health and Welfare in Taiwan
Diabetes self-management, including measuring body weight, blood pressure, self-monitoring of blood glucose and foot care. Frequently
Evaluation of anxiety and depression For high-risk patients or in the presence of clinical symptoms and/or signs
a. In patients with anaemia, haemoglobin variants, chronic kidney disease or pregnancy, it is possible that there are discrepancies between HbA1c values and mean plasma glucose concentrations. In these conditions, consider glycated albumin and/or self-monitoring of blood glucose to evaluate glycemic control.
b. Proteinuria can be detected with urine dipstick testing. If the result by dipstick testing is negative, consider urinary albumin-to-creatinine ratio (UACR) if it is available. Proteinuria or albuminuria is diagnosed if two out of three tests within a 3- to 6-month period are abnormal.
c. Assessment frequency is based on the result of a fundoscopic examination. If there is no evidence of retinopathy, annual follow-up is recommended. If retinopathy is progressing, examinations can be repeated every 3–6 months. During pregnancy, a more frequent follow-up plan is suggested. Referral to an ophthalmologist is suggested in the following conditions: 1. If the patient experiences sudden visual loss and/or symptoms/signs of retinal detachment, referral within 24 hours is suggested. 2. If the patient has pre-retinal and/or vitreous hemorrhage, neovascularization, or iritis, referral within a week is suggested. 3. If the patient has severe diabetic retinopathy, unexplained vision loss, macular edema, unexplained or equivocal findings from fundoscopy, cataract, or the fundus cannot be assessed, referral within 1–2 months is suggested.
d. If the patient has foot ulcer or infection, referral to specialized team for foot care is suggested.

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