ADA Journal: Diabetes Care: July, 2023
Diabetes can be diagnosed by demonstrating increased
concentrations of glucose in venous plasma or increased hemoglobin A1c (HbA1c)
in the blood. Glycemic control is monitored by the people with diabetes
measuring their own blood glucose with meters and/or with continuous
interstitial glucose monitoring (CGM) devices and also by laboratory analysis
of HbA1c.
The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of ketones, autoantibodies, urine albumin, insulin, proinsulin, and C-peptide are addressed.
TAKE-HOME MESSAGE
This expert committee–based guideline provides evidence-based
recommendations for laboratory analysis in diabetes screening, diagnosis, and
monitoring.
The key recommendations include diabetes screening for people
at high risk of diabetes (fasting blood glucose testing, 2-hour OGTT, or HbA1c
testing), and random plasma glucose level measurement in people with classic
symptoms of hyperglycemia.
The guideline also outlines specific recommendations for
analytic consideration in the measurement of glucose levels, provides guidance
regarding self-monitoring of blood glucose levels (with glucose meters or CGM),
and outlines recommendations for the diagnosis of diabetes in specific
populations, including pregnant women.
This document was approved by the American Diabetes
Association (ADA).
This guideline provides the most up-to-date evidence-based
recommendations on diabetes screening, diagnosis, and monitoring.
DOES GLUCOSE NEED TO BE MEASURED IN PLASMA FOR THE DIAGNOSIS
OF DIABETES MELLITUS?
Fasting glucose should be measured in venous plasma when used
to establish the diagnosis of diabetes, with a value >7.0 mmol/L (> 126
mg/dL) diagnostic of diabetes.
WHEN AND HOW DIABETES MELLITUS SHOULD BE SCREENED IN HIGH-RISK INDIVIDUALS?
Screening by HbA1c, FPG or 2-h OGTT is recommended for individuals
who are at high risk of diabetes. If HbA1c is <5.7% (<39 mmol/mol), FPG
is <5.6 mmol/L (<100 mg/dL), and/or 2-h plasma glucose is <7.8 mmol/L
(<140 mg/dL) testing should be repeated at 3-year intervals. Glucose should
be measured in venous plasma when used for screening of high-risk individuals.
DOES PLASMA GLUCOSE NEED TO BE MEASURED FOR THE MONITORING OF
DIABETES MELLITUS?
Routine measurement of plasma glucose concentrations is not
recommended as the primary means of monitoring or evaluating therapy in
individuals with diabetes.
WHAT ARE THE PRE-ANALYTICAL CONSIDERATIONS IN GLUCOSE
TESTING?
Blood for fasting plasma glucose analysis should be drawn in
the morning after the subject has fasted overnight (at least 8 h).
SHOULD HbA1c BE USED FOR SCREENING AND DIAGNOSIS OF DIABETES
MELLITUS?
Laboratory-based HbA1c testing can be used to diagnose a)
diabetes, with a value ≥ 6.5% (>48 mmol/mol) diagnostic of diabetes, and)
prediabetes (or high risk for diabetes) with aHbA1c level of 5.7% to 6.4%
(39-46 mmol/mol)
SHOULD HbA1c BE USED IN MONITORING DIABETES MELLITUS?
HbA1c should be measured routinely (usually every 3 months
until acceptable, individualized targets are achieved and then no less than
every 6 months) in most individuals with diabetes mellitus to document their
degree of glycemic control.
WHAT ARE THE HbA1c TREATMENT GOALS IN DIABETES MELLITUS?
Treatment goals should be based on ADA recommendations which
include maintaining HbA1c concentrations <7% (<53 mmol/mol) for many
nonpregnant patients with diabetes and more stringent goals in selected
individual patients if this can be achieved without significant hypoglycemia or
other adverse effects of treatment.
Higher target ranges are recommended for children and
adolescents and are appropriate for individuals with limited life expectancy, extensive
co-morbid illnesses, a history of severe hypoglycemia and advanced
complications.
WHAT ARE THE HbA1c TREATMENT GOALS IN DIABETES MELLITUS
DURING PREGNANCY?
During pregnancy and in preparation for pregnancy, women with
diabetes should try to achieve HbA1c goals that are more stringent than in the
non-pregnant state, aiming ideally for <6.0% (<42 mmol/mol) during
pregnancy to protect the fetus from congenital malformations and the baby and
mother from perinatal trauma and morbidity owing to large-for-date babies.
SHOULD ISLET AUTOANTIBODIES BE USED FOR THE DIAGNOSIS,
SCREENING, MONITORING OF TYPE 1 AND TYPE 2 DIABETES?
Standardized islet autoantibody tests are recommended for the classification of diabetes in adults in whom there is phenotypic overlap between type 1 and type 2
diabetes and uncertainty as to the type of diabetes.
WHEN IS TESTING FOR URINE ALBUMIN INDICATED?
Annual testing for albuminuria should begin in pubertal or
post-pubertal individuals 5 years after diagnosis of type 1 diabetes and at the
time of diagnosis of type 2 diabetes, regardless of treatment.
Urine albumin should be measured annually in adults with diabetes, using morning spot urine albumin to creatinine ratio (uACR).
If eGFR is <60 ml/min/1.73m2 and/or albuminuria is > 30
mg/g creatinine in a spot urine sample, the uACR should be repeated every 6
months to assess change among people with diabetes and hypertension.
First-morning void urine sample should be used to measure albumin: creatinine ratio.
IS THERE A ROLE FOR THE MEASUREMENT OF INSULIN AND C-PEPTIDE
CONCENTRATIONS TO DISTINGUISH TYPE 1 FROM TYPE 2 DIABETES MELLITUS?
In most people with diabetes or risk for diabetes or
cardiovascular disease, routine testing for insulin or proinsulin is not
recommended. These assays are useful primarily for research purposes.
Comments
You must login to write comment