D2d enrolls 1st participant

A patient at the University of Kansas site is the 1st participant enrolled in D2d. The participant is still in D2d.

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Press release on D2d

Tufts Medical Center (where the D2d Coordinating Center is based) and NIDDK coordinate a press release to announce the official start of D2d activities.

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Participant recruitment begins

D2d begins screening people at high risk for diabetes to join D2d. Screening takes place in many medical centers throughout the United States. The first participant is screened on October 16, 2013 at the Florida Hospital Translational Research Institute...

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U.S. government shutdown delays the start of recruitment

The U.S. federal government enters a shutdown because neither legislation appropriating funds for fiscal year 2014 nor a continuing resolution for the interim authorization of appropriations are enacted before the new fiscal year begins. Participant recruitment in D2d is...

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D2d becomes the first NIDDK supported trial to use IRBShare

Obtaining IRB approval from each separate collaborating clinical site has long been considered a major reason for delaying the start of activities in multi-center trials. D2d becomes the first NIDDK-supported trial and only the fifth NIH-supported study to join...

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Investigators’ Kick-off meeting

The first meeting of the D2d Research Group is held in Bethesda, MD. Investigators and coordinators from all sites and all supporting units (e.g., central laboratory, central pharmacy) plan a successful study launch.

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U01 grant to conduct D2d is formally awarded

Tufts Medical Center receives the U01 cooperative agreement grant to fund and conduct D2d. The grant is awarded by NIDDK and the NIH Office of Dietary Supplements. Project Manager Patty Sheehan and Principal Investigator Anastassios Pittas (shown in the...

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The D2d DSMB inaugural meeting takes place

The inaugural meeting of the D2d Data Safety Monitoring Board (DSMB) takes place in Bethesda, MD. The core D2d team – composed of Dr. Pittas (principal investigator), Dr. Staten (NIH project scientist), Dr. Ware (lead statistician) and Ms. Sheehan...

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U01 cooperative agreement grant application undergoes scientific review

The U01 grant application seeking funding for D2d undergoes a highly favorable scientific peer review by a NIH Special Emphasis Study Section, specifically convened to review the application. The review panel considers the application “outstanding” and gives a priority...

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U01 cooperative agreement grant is submitted

The D2d team submits a U01 grant application to NIH for funding to conduct D2d. Assembling a 1,140-page grant application was a Herculean effort by the D2d planning team. Many scientific, logistical, financial and administrative components came together to...

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