The Effect of the New ADA and WHO Guidelines on the Number of Diagnosed Cases of Diabetes Mellitus
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Lone G. M. Jørgensen
Abstract
In the new lowered diagnostic discriminator for diabetes mellitus (DM) from the American Diabetes Association (ADA), fasting peripheral venous plasma glucose (f-vPG) of 7.0 mmol/l is identical to the 99.9 centile of f-vPG (7.05 mmol/l, 95%CI: 6.91–7.20 mmol/l) in a low-risk reference population. We investigated its diagnostic concordance with other diagnostic discriminators. As no index test is available for DM we used the ADA discriminator as gold standard.
We isolated a low-risk reference population (n = 424) from a randomised general population (n = 726) by ruling out of all cases with clinical and biochemical risk indicators for DM. We based our analysis on measurements traceable to primary standard concentration, a bias of <1.5% and CV% < 2.5.
The distribution of the fasting capillary whole blood glucose (f-CBG; mmol/l) in the reference population was ln Gaussian with the 99.9 centile of 6.62 mmol/l (95% CI 6.47–6.77 mmol/l) and the 97.5 centile of 5.92 mmol/l (5.82–6.02 mmol/l). The 6.1 mmol/l f-CBG WHO limit corresponds approximately to the 97.6 centile, and this limit is thus not traceable to the ADA discriminator, which corresponds to f-CBG of 6.4 mmol/l. This is the case in groups only, as recalculation will introduce unpredictable errors.
Thus, in our general population a varying number of subjects will be at risk of DM as a mere consequence of different limits. The f-CBG limit of 6.1 mmol/l will thus lead to 2.4% false-positive diagnoses or, in EU, to around 44 × 106 adults being diagnosed. The number of cases at risk of DM vary from 5.4 × 106 to 44 × 106 in EU.
We conclude that application of different diagnostic limits results in highly variable number of diagnosed DM cases, and therefore one diagnostic discriminator is needed to provide reproducible diagnoses.
Copyright © 2003 by Walter de Gruyter GmbH & Co. KG
Artikel in diesem Heft
- Editors' Introduction: Welcome to the Special Issue on Diabetes Mellitus
- Linking Research and Innovative Clinical Practice: The Story of Diabetes Mellitus
- Insulin Resistant States and Insulin Signaling
- Diabesity: An Inflammatory Metabolic Condition
- Plasma Adiponectin and Hyperglycaemia in Diabetic Patients
- Platelet Function and Acetyl-Coenzyme A Metabolism in Type 1 Diabetes Mellitus
- Oxidative Stress in Diabetes
- Carbonyl Stress and Diabetic Complications
- Chemical Modification of Proteins by Lipids in Diabetes
- Glyoxal and Methylglyoxal Levels in Diabetic Patients: Quantitative Determination by a New GC/MS Method
- Dyslipidemia in Patients with Type 2 Diabetes. Relationships between Lipids, Kidney Disease and Cardiovascular Disease
- Haemoglobin A1c – A Marker for Complications of Type 2 Diabetes: The Experience from the UK Prospective Diabetes Study (UKPDS)
- Glycated Hemoglobin Standardization – National Glycohemoglobin Standardization Program (NGSP) Perspective
- Haemoglobin A1c: Analysis and Standardisation
- Point-of-Care Testing in Diabetes Mellitus
- Evaluation of Portable Blood Glucose Meters. Problems and Recommendations
- Measurements of Glucose on the Skin Surface, in Stratum Corneum and in Transcutaneous Extracts: Implications for Physiological Sampling
- Biological Variability of Albumin Excretion Rate and Albumin-to-Creatinine Ratio in Hypertensive Type 2 Diabetic Patients
- Clinical and Laboratory Evaluation of Specific Chemiluminescence Assays for Intact and Total Proinsulin
- Clinical Impact of the New Criteria for the Diagnosis of Diabetes Mellitus
- The Effect of the New ADA and WHO Guidelines on the Number of Diagnosed Cases of Diabetes Mellitus
- Detecting Type 2 Diabetes by a Single Post-Challenge Blood Sample
- Laboratory Tests in Diagnosis and Management of Diabetes Mellitus. Practical Considerations
- Obesity, Glucose Intolerance and Diabetes and Their Links to Cardiovascular Disease. Implications for Laboratory Medicine
- Meetings and Awards
Artikel in diesem Heft
- Editors' Introduction: Welcome to the Special Issue on Diabetes Mellitus
- Linking Research and Innovative Clinical Practice: The Story of Diabetes Mellitus
- Insulin Resistant States and Insulin Signaling
- Diabesity: An Inflammatory Metabolic Condition
- Plasma Adiponectin and Hyperglycaemia in Diabetic Patients
- Platelet Function and Acetyl-Coenzyme A Metabolism in Type 1 Diabetes Mellitus
- Oxidative Stress in Diabetes
- Carbonyl Stress and Diabetic Complications
- Chemical Modification of Proteins by Lipids in Diabetes
- Glyoxal and Methylglyoxal Levels in Diabetic Patients: Quantitative Determination by a New GC/MS Method
- Dyslipidemia in Patients with Type 2 Diabetes. Relationships between Lipids, Kidney Disease and Cardiovascular Disease
- Haemoglobin A1c – A Marker for Complications of Type 2 Diabetes: The Experience from the UK Prospective Diabetes Study (UKPDS)
- Glycated Hemoglobin Standardization – National Glycohemoglobin Standardization Program (NGSP) Perspective
- Haemoglobin A1c: Analysis and Standardisation
- Point-of-Care Testing in Diabetes Mellitus
- Evaluation of Portable Blood Glucose Meters. Problems and Recommendations
- Measurements of Glucose on the Skin Surface, in Stratum Corneum and in Transcutaneous Extracts: Implications for Physiological Sampling
- Biological Variability of Albumin Excretion Rate and Albumin-to-Creatinine Ratio in Hypertensive Type 2 Diabetic Patients
- Clinical and Laboratory Evaluation of Specific Chemiluminescence Assays for Intact and Total Proinsulin
- Clinical Impact of the New Criteria for the Diagnosis of Diabetes Mellitus
- The Effect of the New ADA and WHO Guidelines on the Number of Diagnosed Cases of Diabetes Mellitus
- Detecting Type 2 Diabetes by a Single Post-Challenge Blood Sample
- Laboratory Tests in Diagnosis and Management of Diabetes Mellitus. Practical Considerations
- Obesity, Glucose Intolerance and Diabetes and Their Links to Cardiovascular Disease. Implications for Laboratory Medicine
- Meetings and Awards
