Elsevier

The Lancet

Volume 354, Issue 9179, 21 August 1999, Pages 617-621
The Lancet

Articles
Glucose tolerance and mortality: comparison of WHO and American Diabetic Association diagnostic criteria

https://doi.org/10.1016/S0140-6736(98)12131-1Get rights and content

Summary

Background

The American Diabetes Association (ADA) recommend that fasting glucose alone with the oral glucose tolerance test should be used to diagnose diabetes mellitus. We assessed mortality associated with the ADA fasting-glucose criteria compared with the WHO 2 h post-challenge glucose criteria.

Methods

We assessed baseline data on glucose concentrations at fasting and 2 h after the 75 g oral glucose tolerance test from 13 prospective European cohort studies, which included 18 048 men and 7316 women aged 30 years or older. Mean follow-up was 7–3 years. We assessed the risk of death according to the different diagnostic glucose categories.

Findings

Compared with men who had normal fasting glucose (<6.1 mmol/L), men with newly diagnosed diabetes mellitus by the ADA fasting criteria (≤7.0 mmol/L) had a hazard ratio for death of 1.81 (95% CI1.49–2.20); for women the hazaid ratio was 1.79 (1.18–2.69). For impaired fasting glucose (6.1–6.9 mmol/L), the hazard ratios were 1.21 (1.05–1.41) and 1.08 (0.70–1.66). Fbrthe WHO criteria (≤11.1 mmol/L), the ratios for newly diagnosed diabetes were 2.02 (1.66–2.46) in men and 2.77 (1.96–3.92) in women, and for impaired glucose tolerance (7.8–11.1 mmol/L) were 1.51 (1.32–1.72) and 1.60 (1.22–2.10). Within each fasting-glucose classification, mortality increased with increasing 2 h glucose. However, for 2 h glucose classifications of impaired glucose tolerance, and diabetes, there was no trend for increasing fasting glucose concentrations.

Interpretation

Fasting-glucose concentrations alone do not identify individuals at increased risk of death associated with hyperglycaemia. The oral glucose tolerance test provides additional prognostic information and enables detection of individuals with impaired glucose tolerance, who have the greatest attributable risk of death

Introduction

The diagnostic criteria for diabetes mellitus and glucose intolerance have been reviewed by the American Diabetes Association (ADA) and WHO.1, 2 The ADA proposed that diabetes be defined by a fasting plasma glucose concentration of 7.0 mmol/L alone and did not recommend the use of the oral glucose tolerance test. WHO recommended that the oral glucose tolerance test should be used only if the blood glucose concentration is in the uncertain range of 5.5–11.1 mmol/L. For the diagnosis of diabetes mellitus, WHO recommended the same fasting concentration as the ADA, as well as a 2 h glucose concentration of at least 11.1 mmol/L. A high degree of disagreement in the fasting and 2 h classifications has been seen between the two recommendations in European populations.3 Among individuals with diabetes according to the ADA fasting glucose criteria, only 46% had 2 h glucose concentrations higher than 11.1 mmol/L, which fulfilled the previous WHO 2 h glucose criteria for the diagnosis of diabetes.4

The purpose of the diagnostic criteria that are based on blood glucose concentration is to identify individuals who have no symptoms of diabetes but who have hyperglycaemia1, 2, 3, 4, 5, 6 and are, therefore, at increased risk of subsequent complications and mortality. Previous studies7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 have shown conflicting results on the relation between blood glucose and mortality in the general population.

Unfortunately, the proposed changes in the diagnostic criteria that use fasting glucose concentrations alone have been prepared without a thorough analysis of their implications on mortality and cardiovascular complications. In the DECODE (Diabetes Epidemiology: Collaborative analysis Of Diagnostic criteria in Europe) study, we aimed to analyse the existing data to assess the prognostic impact of the new criteria.3 We assessed all-cause mortality during the follow-up of respondents to surveys in which glucose-tolerance status was established at baseline.

Section snippets

Participants and design

We invited researchers in Europe who had done population-based studies or large studies in occupational groups of the standard 2 h oral glucose tolerance test to participate. Details of included study populations have been published.3 We also included populations from Malta28 and Northern Sweden2 that entered the study later than those listed elsewhere. Individual data on fasting glucose and concentrations 2 h after load, as well as other variables, were sent to the Diabetes and Genetic

Results

The hazard ratio for all-cause mortality in men with newly diagnosed diabetes was 1.85 (95% CI 1.52–2.26) and for men previously known to have diabetes 1.92 (1.63–2.26) compared with individuals without diabetes defined by the WHO 2 h glucose criteria. For women, the corresponding ratios were 2.43 (1.73–3.40) and 2.41 (1.86–3.12). When the diagnosis of diabetes was based on the ADA fasting glucose criteria, hazards ratios were 1.75 (1.45–2.12) in men and 1.77 (1.18–2.65) in women.

Hazard ratio

Discussion

The main reason to test for high blood glucose concentration in people who have no symptoms of diabetes is to prevent late complications of hyperglycaemia, the most important of which is death. Diagnostic categories used should, therefore, be agreed and properly characterised by future risk of complications to form diagnostic criteria of diabetes and glucose intolerance. Over the years, various diagnostic criteria for diabetes have been proposed, and the introduction of the WHO criteria in 1980,

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