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Distinct Diagnostic Criteria of Fulminant Type 1 Diabetes Based on Serum C-Peptide Response and HbA_1c Levels at Onset

¹ Third Department of Internal Medicine, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi, Yamanashi, Japan
² Department of Pediatrics, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi, Yamanashi, Japan
³ Department of Endocrinology and Metabolism, Toranomon Hospital, Tokyo, Japan
⁴ Okinaka Memorial Institute for Medical Research, Tokyo, Japan

Address correspondence and reprint requests to T. Kobayashi, MD, PhD, Professor and Chairman, Third Department of Internal Medicine, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi, 1110 Tamaho, Yamanashi 409-3898, Japan. E-mail: tetsurou{at}yamanashi.ac.jp

OBJECTIVE—Diagnostic criteria in fulminant type 1 diabetes, a novel subtype of type 1 diabetes, remain unclear.

RESEARCH DESIGN AND METHODS—We analyzed basal and longitudinal changes of serum C-peptide levels during a 75-g oral glucose tolerance test (OGTT) in 125 consecutively recruited patients with type 1 diabetes including fulminant type 1 diabetes (n = 25) and acute-onset type 1 diabetes (n = 100). Discriminating criteria of fulminant type 1 diabetes were examined using receiver-operating characteristic curve analysis and multiple logistic regression analysis.

RESULTS—The integrated values of serum C-peptide response during OGTT (C-peptide) in fulminant type 1 diabetes at onset, 1 year, and 2 years after onset were markedly lower than those in acute-onset type 1 diabetes. None of the patients with fulminant type 1 diabetes had improvement of C-peptide response to OGTT. Fasting C-peptide values at onset in fulminant type 1 diabetes were significantly lower than those in acute-onset type 1 diabetes. We established diagnostic criteria of serum C-peptide and HbA_1c levels at onset that discriminate fulminant type 1 diabetes from acute-onset type 1 diabetes with high sensitivity and specificity: a criterion in which the levels of both the fasting C-peptide is 0.033 nmol/l and HbA_1c is 8.0% or a criterion in which the levels of both the C-peptide is 0.540 nmol/l and HbA_1c is 8.0%.

CONCLUSIONS—Fulminant type 1 diabetes has extremely low ß-cell function at onset that rarely recovers after onset. Sensitive and specific diagnostic criteria were established for detection of fulminant type 1 diabetes based on serum C-peptide and HbA_1c levels at onset.

Abbreviations: AUC, area under receiver-operating characteristic curve • GADAb, GAD autoantibody • IAA, insulin autoantibody • IA-2Ab, insulinoma-associated protein 2/islet cell antigen 512 autoantibody • ICA, islet cell antibody • OGTT, oral glucose tolerance test • ROC, receiver-operating characteristic

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