The Diabetes Prevention Program: An Einstein Success Legend

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Source:   —  April 07, 2016, at 0:43 AM

Allen M. Spiegel Reading a March thirty, two thousand sixteen article in the NY Times, "The Noiseless Research That Led to a Resounding Success in Diabetes Prevention," transported me back in time and space to an interview I did at the Fox News TV studio in NY City in August two thousand one.

The Diabetes Prevention Program: An Einstein Success Legend

By Dr. Allen M. Spiegel

Reading a March thirty, two thousand sixteen article in the NY Times, "The Noiseless Research That Led to a Resounding Success in Diabetes Prevention," transported me back in time and space to an interview I did at the Fox News TV studio in NY City in August two thousand one. At the time, I served as the director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH). The Diabetes Prevention Program (DPP), a randomized, multi-center clinical trial, was launched by NIDDK in one thousand nine hundred ninety-fifth to define whether an intensive life-style intervention involving changes in diet and exercise or a drug, metformin, compared to a control group, could delay or prevent the onset of type two diabetes (T2D; previously adult-onset diabetes). Between one thousand nine hundred ninety-six and one thousand nine hundred ninety-nine, a diverse grouping of 3.234 adults, all with impaired glucose tolerance and at high risk for development of T2D, was randomized among three arms of the trial. In July two thousand one, the Data Safety and Monitoring Board (DSMB) for the trial informed me that both the lifestyle and metformin arms of the trial had reached predetermined targets for diabetes prevention, and recommended early termination of the trial. Following a meeting with the principal investigators from the twenty-seven participating centers, I accepted the DSMB'south recommendation. The full DPP results were eventually published in a New England Journal of Medicine paper, but since this was large news given the prevalence of T2D and the presently proven skill to prevent or at minimum delay its onset in subjects with what came to be termed prediabetes, the results were announced at a press conference at NIH with the then Health and Human Services (HHS) secretary, Tommy Thompson. The press conference was followed by a publicity campaign that included the aforementioned Fox News interview.

As NIDDK director, I was alert that Einstein, below the leadership of its principal investigator (PI) Harry Shamoon (who currently heads the Harold and Muriel Obstruct Institute for Clinical and Translational Research) and program coordinator Janet Brown, was one of the DPP'south top performing sites, critical in recruiting subjects from minority groups, African-Americans and Hispanic-Americans, disproportionately affected by T2D. I also had gotten to know another key Einstein faculty member, Elizabeth Walker, who led the DPP'south medication adherence group. The Einstein site research team included Nir Barzilai, who'd experience with the drug metformin before its approval in the U. S., and Judith Wylie-Rosett who co-developed the lifestyle intervention with the overall lifestyle core PI, Rena Wing, then at the Univ of Pittsburgh. In two thousand-third, leadership of the Einstein site team passed to Jill Crandall, who'd been recruited to Einstein by Norman Fleischer, chief of the diabetes/endocrine div and a former director of Einstein'south Diabetes Research Center. Jill became one of the national leaders of the DPP Outcomes Study (DPPOS), which has followed the trial participants since the finish of the DPP in two thousand-first. DPPOS has shown that prevention or delay of T2D with lifestyle intervention or metformin can persist for at least ten years, and that the lifestyle intervention, after a 10-year follow-up, achieved an improvement in cardiovascular sickness risk factors comparable to that seen in metformin and control groups, but with less medication.

The conundrum faced by NIDDK and the DPP investigators following the demonstration of the powerful diabetes prevention effect of the intensive lifestyle intervention was how to translate this finding cost-effectively in a "genuine world' setting. Among ourselves we quipped that the lifestyle intervention as delivered in the DPP was the equivalent of providing each subject with Oprah'south personal trainer. An investigator at the IN DPP site, David Marrero, came up with the idea of using local YMCAs as a venue to deliver a more cost-effective version of the DPP lifestyle intervention. Research by Marrero and others led to passage of the Diabetes Prevention Act of two thousand nine, which later was enacted into law as portion of the Affordable Care Act. The Centers for Medicare and Medicaid Services determined that implementing the YMCA-based program for all eligible beneficiaries would rescue the government money. That's culminated in the recent announcement by the current HHS secretary, Sylvia Burwell, that Medicare will cover the lifestyle intervention to prevent T2D.

As Aaron Carroll writes in the NY Times piece: "Articles show up every day on 'major breakthroughs,' which later never pan out, while this one, full of successes, seldom made the news. This is the curse of health services research, which seeks to make better pop health through improvements in access or delivery of care." And that brings me to the Montefiore Health System, a national boss in pop health improvement. Indeed, the photos used adorn Carroll'south article arrive from a Bronx YMCA on Castle Hill Ave where Lourdes Ventura, a "lifestyle educator," is shown teaching a class that's portion of Montefiore'south implementation of the lifestyle intervention below the leadership of Amanda Parsons and Nicole Hollingsworth, vice president and helper vice president, respectively, of community and pop health at Montefiore. The synergism Einstein can attain as portion of the Montefiore Health System, rigorous research translated into improved pop health, is truly exemplified by the Diabetes Prevention Program success story.

Quick forwarding to the present day, Drs. Crandall and Diane McKee in the dept of family and social medicine (DFSM) presently co-direct the NIH-funded Glycemia Reduction Approaches in Diabetes (GRADE) which is a long-term study to optimize different treatments for early-stage T2D. Using the leading-edge Montefiore electronic medical record system for participant identification and recruitment within the DFSM'south practice-based research network (the NY City Research Improvement Networking Group), the Bronx GRADE team has become the highest patient-recruiting site in the nation for this real-world effectiveness study.  Our challenge presently is to construct on such successes and prolong them to the many other health challenges, from cancer to neuropsychiatric diseases, faced by the Bronx, NYC and the U. S.

(My thanks to Harry Shamoon for his assistance in writing this post.)

Dr. Spiegel is The Marilyn and Stanley M. Katz Dean of The Albert Einstein College of Medicine.

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This post was originally featured on The Doctor'south Tablet, the blog of Albert Einstein College of Medicine.

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