© American Diabetes Association ®, Inc., 2002
In Pursuit of Type 1 Diabetes Prevention
Diabetes Prevention TrialType 1 Diabetes Study Group: Effects of insulin in relatives of patients with type 1 diabetes mellitus. N Engl J Med 346:1685 1691, 2002.
Objective. To determine whether insulin can prevent or delay the onset of overt type 1 diabetes in relatives of patients with type 1 diabetes who are at increased risk of the disease.
Design and methods. The Diabetes Prevention TrialType 1 (DPT-1) was a randomized, controlled, open comparison trial of prophylactic intervention with parenteral insulin versus no treatment in prediabetic subjects. First- and second-degree relatives of type 1 diabetic patients were recruited and screened with a test for islet cell antibodies (ICAs). Those who tested positive for ICAs were then staged to define their risk for diabetes by measuring insulin autoantibodies (IAAs), assessing oral glucose tolerance, and measuring first-phase insulin response to intravenous glucose. Researchers also screened for the presence of the haplotype known to be protective against diabetes (HLA-DQA1* 0102, DQB1*0602). Its presence excluded individuals from further participation. ICA-positive relatives were eligible for the parenteral trial if their first-phase insulin response was below a set threshold, if their oral glucose tolerance test (OGTT) results were not completely normal, or both. Such individuals have a 5-year projected risk of diabetes of more than 50%. Relatives who tested positive for ICAs and IAAs with normal glucose tolerance and a first-phase insulin response above the set threshold have intermediate risk for diabetes (5-year projected risk of 2550%). These individuals were offered enrollment in the oral insulin trial, which is ongoing.
The high-risk subjects were randomly assigned to either the
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