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New Approaches to Type 1 Diabetes: Some Promises, Some Failures

Early antibody treatment showed promise against recently diagnosed disease, but prophylaxis with low-dose insulin conferred no benefit.

We have long sought to prevent diabetes in high-risk children and reduce the burden of disease in newly diagnosed patients. In one recent trial, over 84,000 relatives of diabetes patients underwent genetic, immunologic, and metabolic screening. Of 372 children identified as having a 50% or greater risk for developing diabetes within 5 years, 339 were randomly assigned to close observation or to low-dose, subcutaneous ultralente insulin (total 0.25 U/kg/day administered in 2 daily doses). Over 3.7 years, diabetes was diagnosed in 69 children in the treatment group and 70 children in the observation group. Separate analyses of all subjects, adherent subjects, and subjects with normal and abnormal glucose tolerance at baseline produced similar results.

In another trial, 24 subjects with newly diagnosed diabetes (age, 7-30 years; median age, 13 in treated subjects, 16 in controls) were randomly assigned to receive 14-day treatment with monoclonal antibody against CD3 or no antibody. One year later, insulin production as measured by C-peptide response was maintained or improved in 9 treatment subjects and 2 controls. Levels of glycosylated hemoglobin were also lower in treated patients (6.98) than in controls (7.53). The most serious adverse effects were fever (9 patients) and mild or moderate anemia (9 patients); rash developed in 7 patients.

Comment: The lifelong daily injections and medical complications of diabetes are burdensome. Although the results of prevention with low-dose insulin were discouraging, an editorialist notes the extraordinary accomplishment of screening over 84,000 people. Treating recently diagnosed children is far more practical, and the study of antibody therapy is probably the first of many immunologic trials. How long the benefits of immune treatment will last and whether the cost and adverse effects of this treatment are justified remain to be seen.

— Howard Bauchner, MD

Published in Journal Watch Pediatrics and Adolescent Medicine June 28, 2002

Citation(s):

Diabetes Prevention Trial–Type 1 Diabetes Study Group. Effects of insulin in relatives of patients with type I diabetes mellitus. N Engl J Med 2002 May 30; 346:1685-91.

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• Medline abstract (Free)

Herold KC et al. Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus. N Engl J Med 2002 May 30; 346:1692-8.

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• Medline abstract (Free)

Gale EAM. Can we change the course of beta-cell destruction in type 1 diabetes? N Engl J Med 2002 May 30; 346:1740-2.

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• Medline abstract (Free)