Long-Term Outcome of Individuals Treated With Oral Insulin

作者：Kendra Vehik, David Cuthbertson, Holly Ruhlig, Desmond Schatz, Mark Peakman, Jeffrey P. Krischer, for the DPT-1 and TrialNet Study Groups · 发表于：Diabetes Care · 年份：2011 · DOI：10.2337/dc11-0523 · 被引用次数：118 · 研究领域：Diabetes and associated disorders、Diabetes Management and Research、Salivary Gland Disorders and Functions

OBJECTIVE: To evaluate the long-term intervention effects of oral insulin on the development of type 1 diabetes and to assess the rate of progression to type 1 diabetes before and after oral insulin treatment was stopped in the Diabetes Prevention Trial-Type 1 (DPT-1). RESEARCH DESIGN AND METHODS: The follow-up included subjects who participated in the early intervention of oral insulin (1994-2003) to prevent or delay type 1 diabetes. A telephone survey was conducted in 2009 to determine whether diabetes had been diagnosed and, if not, an oral glucose tolerance test (OGTT), hemoglobin A1c (HbA1c), and autoantibody levels were obtained on all subjects who agreed to participate. RESULTS: Of 372 subjects randomized, 97 developed type 1 diabetes before follow-up; 75% of the remaining 275 subjects were contacted. In the interim, 77 subjects had been diagnosed with type 1 diabetes and 54 of the remainder have had an OGTT; 10 of these were diagnosed with type 1 diabetes, subsequently. Among individuals meeting the original criteria for insulin autoantibodies (IAAs) (≥80 nU/mL), the overall benefit of oral insulin remained significant (P=0.05). However, the hazard rate in this group increased (from 6.4% [95% CI 4.5-9.1] to 10.0% [7.1-14.1]) after cessation of therapy, which approximated the rate of individuals treated with placebo (10.2% [7.1-14.6]). CONCLUSIONS: Overall, the oral insulin treatment effect in individuals with confirmed IAA≥80 nU/mL appeared to be maintained with addit...