Standards of Medical Care in Diabetes—2011

American Diabetes Association

doi:10.2337/dc11-S011

Position Statement

Standards of Medical Care in Diabetes—2011

American Diabetes Association

Diabetes Care 2011 Jan; 34(Supplement 1): S11-S61. https://doi.org/10.2337/dc11-S011

Article Figures & Tables

Tables

Table 1

ADA evidence grading system for clinical practice recommendations

Level of evidence	Description
A	Clear evidence from well-conducted, generalizable, randomized controlled trials that are adequately powered, including: Evidence from a well-conducted multicenter trial Evidence from a meta-analysis that incorporated quality ratings in the analysis
	Compelling nonexperimental evidence, i.e., “all or none” rule developed by Center for Evidence Based Medicine at Oxford
	Supportive evidence from well-conducted randomized controlled trials that are adequately powered, including: Evidence from a well-conducted trial at one or more institutions Evidence from a meta-analysis that incorporated quality ratings in the analysis
B	Supportive evidence from well-conducted cohort studies Evidence from a well-conducted prospective cohort study or registry Evidence from a well-conducted meta-analysis of cohort studies
	Supportive evidence from a well-conducted case-control study
C	Supportive evidence from poorly controlled or uncontrolled studies Evidence from randomized clinical trials with one or more major or three or more minor methodological flaws that could invalidate the results Evidence from observational studies with high potential for bias (such as case series with comparison to historical controls) Evidence from case series or case reports
	Conflicting evidence with the weight of evidence supporting the recommendation
E	Expert consensus or clinical experience

Table 2

Criteria for the diagnosis of diabetes

A1C ≥6.5%. The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.^*

FPG ≥126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h.^*

2-h plasma glucose ≥200 mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.^*

In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dl (11.1 mmol/l)

↵*In the absence of unequivocal hyperglycemia, result should be confirmed by repeat testing.

Table 3
Categories of increased risk for diabetes (prediabetes)*
FPG 100–125 mg/dl (5.6–6.9 mmol/l): IFG
or
2-h plasma glucose in the 75-g OGTT 140–199 mg/dl (7.8–11.0 mmol/l): IGT
or
A1C 5.7–6.4%

↵*For all three tests, risk is continuous, extending below the lower limit of the range and becoming disproportionately greater at higher ends of the range.

Table 4

Criteria for testing for diabetes in asymptomatic adult individuals

Testing should be considered in all adults who are overweight (BMI ≥25 kg/m²^*) and have additional risk factors:
- physical inactivity
- first-degree relative with diabetes
- high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander)
- women who delivered a baby weighing >9 lb or were diagnosed with GDM
- hypertension (≥140/90 mmHg or on therapy for hypertension)
- HDL cholesterol level <35 mg/dl (0.90 mmol/l) and/or a triglyceride level >250 mg/dl (2.82 mmol/l)
- women with polycystic ovarian syndrome (PCOS)
- A1C ≥5.7%, IGT, or IFG on previous testing
- other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans)
- history of CVD
In the absence of the above criteria, testing for diabetes should begin at age 45 years.
If results are normal, testing should be repeated at least at 3-year intervals, with consideration of more frequent testing depending on initial results and risk status.

↵*At-risk BMI may be lower in some ethnic groups.

Table 5

Testing for type 2 diabetes in asymptomatic children

Criteria

Overweight (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, PCOS, or small-for-gestational-age 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

Table 6

Screening for and diagnosis of GDM

Perform a 75-g OGTT, with plasma glucose measurement fasting and at 1 and 2 h, at 24–28 weeks of gestation in women not previously diagnosed with overt diabetes.

The OGTT should be performed in the morning after an overnight fast of at least 8 h.

The diagnosis of GDM is made when any of the following plasma glucose values are exceeded:

Fasting ≥92 mg/dl (5.1 mmol/l)
1 h ≥180 mg/dl (10.0 mmol/l)
2 h ≥153 mg/dl (8.5 mmol/l)

Table 7

Therapies proven effective in diabetes prevention trials

Study (ref.)	n	Population	Mean age (years)	Duration (years)	Intervention (daily dose)	Incidence in control subjects (%/year)	Relative risk reduction (%) (95% CI)	3-Year number needed to treat^δ
Lifestyle
Finnish DPS (14)	522	IGT, BMI ≥25 kg/m²	55	3.2	I-D&E	6	58 (30–70)	8.5
DPP (13)	2,161^*	IGT, BMI ≥24 kg/m², FPG >5.3 mmol/l	51	3	I-D&E	10.4	58 (48–66)	6.9
Da Qing (15)	259^*	IGT (randomized groups)	45	6	G-D&E	14.5	38 (14–56)	7.9
Toranomon Study (35)	458	IGT (men), BMI = 24 kg/m²	∼55	4	I-D&E	2.4	67 (P < 0.043)^†	20.6
Indian DPP (19)	269^*	IGT	46	2.5	I-D&E	23	29 (21–37)	6.4
Medications
DPP (13)	2,155^*	IGT, BMI >24 kg/m², FPG >5.3 mmol/l	51	2.8	Metformin (1,700 mg)	10.4	31 (17–43)	13.9
Indian DPP (19)	269^*	IGT	46	2.5	Metformin (500 mg)	23	26 (19–35)	6.9
STOP-NIDDM (17)	1,419	IGT, FPG >5.6 mmol/l	54	3.2	Acarbose (300 mg)	12.4	25 (10–37)	9.6
XENDOS (36)	3,277	BMI >30 kg/m²	43	4	Orlistat (360 mg)	2.4	37 (14–54)	45.5
DREAM (18)	5,269	IGT or IFG	55	3.0	Rosiglitazone (8 mg)	9.1	60 (54–65)	6.9
Voglibose Ph-3 (37)	1,780	IGT	56	3.0 (1-year Rx)	Vogliobose (0.2 mg)	12.0	40 (18–57)	21 (1-year Rx)

Modified and reprinted with permission (38).
↵Percentage points: δNumber needed to treat to prevent 1 case of diabetes, standardized for a 3-year period to improve comparisons across studies.
↵*Number of participants in the indicated comparisons, not necessarily in entire study.
↵†Calculated from information in the article. DPP, Diabetes Prevention Program; DPS, Diabetes Prevention Study; DREAM, Diabetes Reduction Assessment with Ramipril and Rosiglitazone Medication; STOP-NIDDM, Study to Prevent Non-Insulin Dependent Diabetes; XENDOS, Xenical in the prevention of Diabetes in Obese Subjects. I, individual; G, group; D&E, diet and exercise.

Table 8

Components of the comprehensive diabetes evaluation

Medical history

Age and characteristics of onset of diabetes (e.g., DKA, asymptomatic laboratory finding)
Eating patterns, physical activity habits, nutritional status, and weight history; growth and development in children and adolescents
Diabetes education history
Review of previous treatment regimens and response to therapy (A1C records)
Current treatment of diabetes, including medications, meal plan, physical activity patterns, and results of glucose monitoring and patient's use of data
DKA frequency, severity, and cause
Hypoglycemic episodes
- Hypoglycemia awareness
- Any severe hypoglycemia: frequency and cause
History of diabetes-related complications
- Microvascular: retinopathy, nephropathy, neuropathy (sensory, including history of foot lesions; autonomic, including sexual dysfunction and gastroparesis)
- Macrovascular: CHD, cerebrovascular disease, PAD
- Other: psychosocial problems^*, dental disease^*

Physical examination

Height, weight, BMI
Blood pressure determination, including orthostatic measurements when indicated
Fundoscopic examination^*
Thyroid palpation
Skin examination (for acanthosis nigricans and insulin injection sites)
Comprehensive foot examination:
- Inspection
- Palpation of dorsalis pedis and posterior tibial pulses
- Presence/absence of patellar and Achilles reflexes
- Determination of proprioception, vibration, and monofilament sensation

Laboratory evaluation

A1C, if results not available within past 2–3 months
If not performed/available within past year:
- Fasting lipid profile, including total, LDL and HDL cholesterol and triglycerides
- Liver function tests
- Test for urine albumin excretion with spot urine albumin-to-creatinine ratio
- Serum creatinine and calculated GFR
- Thyroid-stimulating hormone in type 1 diabetes, dyslipidemia, or women over age 50 years

Referrals

Annual dilated eye exam
Family planning for women of reproductive age
Registered dietitian for MNT
DSME
Dental examination
Mental health professional, if needed

↵*See appropriate referrals for these categories.

Table 9
Correlation of A1C with average glucose
A1C (%) Mean plasma glucose
mg/dl mmol/l
6 126 7.0
7 154 8.6
8 183 10.2
9 212 11.8
10 240 13.4
11 269 14.9
12 298 16.5

These estimates are based on ADAG data of ∼2,700 glucose measurements over 3 months per A1C measurement in 507 adults with type 1, type 2, and no diabetes. The correlation between A1C and average glucose was 0.92 (51). A calculator for converting A1C results into estimated average glucose (eAG), in either mg/dl or mmol/l, is available at http://professional.diabetes.org/eAG.

Table 10

Summary of glycemic recommendations for many nonpregnant adults with diabetes

A1C	<7.0%*
Preprandial capillary plasma glucose	70–130 mg/dl* (3.9–7.2 mmol/l)
Peak postprandial capillary plasma glucose† Goals should be individualized based on*: duration of diabetes age/life expectancy comorbid conditions known CVD or advanced microvascular complications hypoglycemia unawareness individual patient considerations More or less stringent glycemic goals may be appropriate for individual patients. Postprandial glucose may be targeted if A1C goals are not met despite reaching preprandial glucose goals.	<180 mg/dl* (<10.0 mmol/l)

Postprandial glucose measurements should be made 1–2 h after the beginning of the meal, generally peak levels in patients with diabetes.

Table 11

Reduction in 10-year risk of major CVD endpoints (CHD death/non-fatal MI) in major statin trials, or substudies of major trials, in diabetic subjects (n = 16,032)

Study (ref.)	CVD	Statin dose and comparator	Risk reduction (%)	Relative risk reduction (%)	Absolute risk reduction (%)	LDL cholesterol reduction (mg/dl)	LDL cholesterol reduction (%)
4S-DM (215)	2°	Simvastatin 20–40 mg vs. placebo	85.7 to 43.2	50	42.5	186 to 119	36
ASPEN 2° (220)	2°	Atorvastatin 10 mg vs. placebo	39.5 to 24.5	34	15	112 to 79	29
HPS-DM (216)	2°	Simvastatin 40 mg vs. placebo	43.8 to 36.3	17	7.5	123 to 84	31
CARE-DM (217)	2°	Pravastatin 40 mg vs. placebo	40.8 to 35.4	13	5.4	136 to 99	27
TNT-DM (218)	2°	Atorvastatin 80 mg vs. 10 mg	26.3 to 21.6	18	4.7	99 to 77	22
HPS-DM (216)	1°	Simvastatin 40 mg vs. placebo	17.5 to 11.5	34	6.0	124 to 86	31
CARDS (221)	1°	Atorvastatin 10 mg vs. placebo	11.5 to 7.5	35	4	118 to 71	40
ASPEN 1° (220)	1°	Atorvastatin 10 mg vs. placebo	9.8 to 7.9	19	1.9	114 to 80	30
ASCOT-DM (219)	1°	Atorvastatin 10 mg vs. placebo	11.1 to 10.2	8	0.9	125 to 82	34

Studies were of differing lengths (3.3–5.4 years) and used somewhat different outcomes, but all reported rates of CVD death and nonfatal MI. In this tabulation, results of the statin on 10-year risk of major CVD endpoints (CHD death/nonfatal MI) are listed for comparison between studies. Correlation between 10-year CVD risk of the control group and the absolute risk reduction with statin therapy is highly significant (P = 0.0007). Analyses provided by Craig Williams, PharmD, Oregon Health & Science University, 2007.

Table 12
Summary of recommendations for glycemic blood pressure and lipid control for most adults with diabetes
A1C <7.0%^*
Blood pressure <130/80 mmHg^†
Lipids
LDL cholesterol <100 mg/dl (<2.6 mmol/l)^‡

↵*More or less stringent glycemic goals may be appropriate for individual patients. Goals should be individualized based on: duration of diabetes, age/life expectancy, comorbid conditions, known CVD or advanced microvascular complications, hypoglycemia unawareness, and individual patient considerations.

↵†Based on patient characteristics and response to therapy, higher or lower systolic blood pressure targets may be appropriate.

↵‡In individuals with overt CVD, a lower LDL cholesterol goal of <70 mg/dl (1.8 mmol/l), using a high dose of a statin, is an option.
Table 13
Definitions of abnormalities in albumin excretion
Category Spot collection (μg/mg creatinine)
Normal <30
Microalbuminuria 30–299
Macro (clinical)-albuminuria ≥300

Table 14

Stages of CKD

Stage	Description	GFR (ml/min per 1.73 m² body surface area)
1	Kidney damage^* with normal or increased GFR	≥90
2	Kidney damage^* with mildly decreased GFR	60–89
3	Moderately decreased GFR	30–59
4	Severely decreased GFR	15–29
5	Kidney failure	<15 or dialysis

↵*Kidney damage defined as abnormalities on pathologic, urine, blood, or imaging tests. Adapted from ref. 284.

Table 15

Management of CKD in diabetes

GFR (ml/min/1.73 m²)	Recommended
All patients	Yearly measurement of creatinine, urinary albumin excretion, potassium
45–60	Referral to nephrology if possibility for nondiabetic kidney disease exists (duration type 1 diabetes <10 years, heavy proteinuria, abnormal findings on renal ultrasound, resistant hypertension, rapid fall in GFR, or active urinary sediment)
	Consider need for dose adjustment of medications
	Monitor eGFR every 6 months
	Monitor electrolytes, bicarbonate, hemoglobin, calcium, phosphorus, parathyroid hormone at least yearly
	Assure vitamin D sufficiency
	Consider bone density testing
	Referral for dietary counselling
30–44	Monitor eGFR every 3 months
	Monitor electrolytes, bicarbonate, calcium, phosphorus, parathyroid hormone, hemoglobin, albumin, weight every 3–6 months
	Consider need for dose adjustment of medications
<30	Referral to nephrologist

Adapted from http://www.kidney.org/professionals/KDOQI/guideline_diabetes/.

Table 16

Plasma blood glucose and A1C goals for type 1 diabetes by age-group

	Plasma blood glucose goal range (mg/dl)		A1C (%)	Rationale
	Before meals	Bedtime/overnight	A1C (%)	Rationale
Toddlers and preschoolers (0–6 years)	100–180	110–200	<8.5	Vulnerability to hypoglycemia Insulin sensitivity Unpredictability in dietary intake and physical activity A lower goal (<8.0%) is reasonable if it can be achieved without excessive hypoglycemia
School age (6–12 years)	90–180	100–180	<8	Vulnerability to hypoglycemia A lower goal (<7.5%) is reasonable if it can be achieved without excessive hypoglycemia
Adolescents and young adults (13–19 years)	90–130	90–150	<7.5	A lower goal (<7.0%) is reasonable if it can be achieved without excessive hypoglycemia
Key concepts in setting glycemic goals Goals should be individualized and lower goals may be reasonable based on benefit-risk assessment. Blood glucose goals should be modified in children with frequent hypoglycemia or hypoglycemia unawareness. Postprandial blood glucose values should be measured when there is a discrepancy between pre-prandial blood glucose values and A1C levels and to help assess glycemia in those on basal/bolus regimens.