Supported by a grant (U01DK098246) from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH); a U34 planning grant (U34-DK-088043) for the planning of the trial from the NIDDK; funding for the initial planning meeting regarding the U34 proposal from the American Diabetes Association; the National Heart, Lung, and Blood Institute; the Centers for Disease Control and Prevention; resources and facilities from the Department of Veterans Affairs; grants (P30 DK017047, P30 DK020541-44, P30 DK020572, P30 DK072476, P30 DK079626, P30 DK092926, U54 GM104940, UL1 TR000170, UL1 TR000439, UL1 TR000445, UL1 TR001102, UL1 TR001108, UL1 TR001409, 2UL1TR001425, UL1 TR001449, UL1 TR002243, UL1 TR002345, UL1 TR002378, UL1 TR002489, UL1 TR002529, UL1 TR002535, UL1 TR002537, UL1 TR002541, and UL1 TR002548) from the NIH; educational materials from the National Diabetes Education Program; and donated medications and supplies from Becton Dickinson, Bristol Myers Squibb, Merck , Novo Nordisk, Roche Diagnostics, and Sanofi.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

The members of the writing committee (David M. Nathan, M.D., John M. Lachin, Sc.D., Ashok Balasubramanyam, M.D., Henry B. Burch, M.D., John B. Buse, M.D., Nicole M. Butera, Ph.D., Robert M. Cohen, M.D., Jill P. Crandall, M.D., Steven E. Kahn, M.B., Ch.B., Heidi Krause-Steinrauf, M.S., Mary E. Larkin, R.N., Neda Rasouli, M.D., Margaret Tiktin, D.N.P., Deborah J. Wexler, M.D., and Naji Younes, Ph.D.) assume responsibility for the overall content and integrity of this article.

The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank the participants, whose loyal dedication made this trial possible.