Reading a March 30, 2016 article in the New York Times, "The Quiet Research That Led to a Resounding Success in Diabetes Prevention," transported me back in time and place to an interview I did at the Fox News TV studio in New York City in August 2001. 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 1995 to determine 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 2 diabetes (T2D; formerly adult-onset diabetes). Between 1996 and 1999, a diverse group 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 2001, 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 27 participating centers, I accepted the DSMB's recommendation. The full DPP results were eventually published in a New England Journal of Medicine paper, but since this was big news given the prevalence of T2D and the now proven ability to prevent or at least 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 aware that Einstein, under the leadership of its principal investigator (PI) Harry Shamoon (who currently heads the Harold and Muriel Block Institute for Clinical and Translational Research) and program coordinator Janet Brown, was one of the DPP's 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's medication adherence group. The Einstein site research team included Nir Barzilai, who had 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 University of Pittsburgh. In 2003, leadership of the Einstein site team passed to Jill Crandall, who had been recruited to Einstein by Norman Fleischer, chief of the diabetes/endocrine division and a former director of Einstein's Diabetes Research Center. Jill became one of the national leaders of the DPP Outcomes Study (DPPOS), which has followed the trial participants since the end of the DPP in 2001. DPPOS has shown that prevention or delay of T2D with lifestyle intervention or metformin can persist for at least 10 years, and that the lifestyle intervention, after a 10-year follow-up, achieved an improvement in cardiovascular disease 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 "real world' setting. Among ourselves we quipped that the lifestyle intervention as delivered in the DPP was the equivalent of providing each subject with Oprah's personal trainer. An investigator at the Indiana 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 2009, which later was enacted into law as part of the Affordable Care Act. The Centers for Medicare and Medicaid Services determined that implementing the YMCA-based program for all eligible beneficiaries would save the government money. That has 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 New York Times piece: "Articles appear every day on 'major breakthroughs,' which later never pan out, while this one, full of successes, rarely made the news. This is the curse of health services research, which seeks to improve population health through improvements in access or delivery of care." And that brings me to the Montefiore Health System, a national leader in population health improvement. Indeed, the photos used to illustrate Carroll's article come from a Bronx YMCA on Castle Hill Avenue where Lourdes Ventura, a "lifestyle educator," is shown teaching a class that is part of Montefiore's implementation of the lifestyle intervention under the leadership of Amanda Parsons and Nicole Hollingsworth, vice president and assistant vice president, respectively, of community and population health at Montefiore. The synergism Einstein can achieve as part of the Montefiore Health System, rigorous research translated into improved population health, is truly exemplified by the Diabetes Prevention Program success story.
Fast forwarding to the present day, Drs. Crandall and Diane McKee in the department of family and social medicine (DFSM) now 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's practice-based research network (the New York 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 now is to build on such successes and extend 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.)
This post was originally featured on The Doctor's Tablet, the blog of Albert Einstein College of Medicine.