More than 86 million people, including 22 million people 65 years or older, have pre-diabetes, which increases their risk of heart disease, strokes, or diabetes.  As we've watched that number grow, it's sometimes felt that despite billions of dollars of research and intervention, there's little we can do.  That feeling shifted a little over a month ago when Sylvia Matthews Burwell, the secretary of Health and Human Services, announced that Medicare was planning to pay for lifestyle interventions focusing on diet and physical activity to prevent type 2 diabetes.  It's an example of small scale research efforts in health services that have worked and that have expanded to reach more people.  That's the topic of this week's Healthcare Triage.

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Articles appear every day on major breakthroughs, which 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.  When most people think of diabetes research, they're thinking about a cure or a new medication.  Those grand slams are exciting, but they rarely happen.  Nevertheless, people want to see those.  Donors want to support 'em, organizations hire people to go after them.

Health services research is more about hitting singles day after day.  There's no billion dollar payoff, no fame, no Nobel Prize, but it gets the job done and it's often more likely to change the health of most Americans.  The Diabetes Prevention Program is based on work in an Indianapolis YMCA by a social ecologist named Dave Morrero who works with me at the Indiana University School of Medicine.  The other collaborator, a physician named Ron Ackerman, once shared a cubicle with me when we were both fellows, and also did much of the work here at Indiana University.

The Diabetes Prevention Program grew out of extensive research of weight management and behavioral learning.  Years ago, more than 3,200 patients ages 25-75 with pre-diabetes were randomized to one of three groups.  

The first was given an intensive lifestyle intervention.  By focusing on a low fat, low calorie diet with the addition of exercise through brisk walking or a similar intensity activity, it encouraged people to lose at least 7% of their body weight and maintain that over the course of the trial.  The backbone of the intervention involved 16 one-hour face-to-face meetings that helped each individual participant set and achieve goals to improve health habits.  

The second group was treated with metformin, a medication that can lower blood glucose, and the third was a control group and they were provided with a placebo medication.

The trial was ended early 'cause the results were so compelling.  Those in the medication arm had a 31% reduction in the risk of developing diabetes.  More important, those in the lifestyle intervention saw a 58% reduction in their risk.  Moreover, if you were 60 years or older at the beginning of the study, your reduction in risk was 71%. 

A later meta-analysis confirmed that these results for lifestyle interventions were replicable across numerous different studies.  Unfortunately, this is a perfect example of where efficacy does not necessarily translate into effectiveness.  Identifying patients with pre-diabetes was sometimes difficult.  Physicians weren't reimbursed for doing it, so many didn't do it, and as those barriers were overcome, a larger one remained.  There was no real world, widespread mechanism to start the intensive intervention the prevention program required.  

At more than $1,400 a patient, it was just too expensive and impractical to run in doctors' offices.  It was at this point that Dr. (?~3:35) thought of reaching out to the YMCA, or "The Y" as it is now known.  As a large, nationwide community organization, they figured the Y just might be able to bring the lifestyle intervention to scale.

There are more than 2,700 Ys in the United States and more than 46 million people live within three miles of one of them.  They engaged the Y of Greater Indianapolis in 2003 just as the organization was looking for innovative strategies to expand the Y's reputation beyond a "gym and swim" place primarily for health seekers.

As the behavioral expert, Dave Morrero worked with the Y to reshape all 16 core intervention lessons and several maintenance lessons into a group-based format led by instructors who were Y employees.   The new intervention was only $205 per person, a fraction of the original cost.  In 2004, Dr. Ackerman with Dr. Morrero as his key collaborator, received funding from the National Institutes of Health for the deploy study, which was designed to test the new Y model for delivery of the intervention.

Those in the intervention group had a 6% decrease in weight, compared to 2% in the control group.  Their cholesterol also dropped 22 miligrams per deciliter, while cholesterol levels in the control group rose 6 miligrams per deciliter.  More important, these differences were sustained after 28 months.  

The study showed that the Y might be a promising channel for wide scale dissemination of the intervention program.  Further studies found that primary care clinics could put in pre-diabetes screening using easy to perform hemoglobin A1c testing in the office.  Patients who were found to be at high risk were referred to a Y coordinator who offered them the opportunity to take part in the Y program at no charge.

Over the 29 months of the next study, about 18,000 primary care patients were screened for diabetes and about 29% of them were determined to be at high risk.  More than 500 of them participated in the program.  Those who were offered it achieved about 5lbs more in weight loss over a year.  Those who attended at least half the classes achieved almost 12 more lbs of weight loss than those were managed in the clinic only.

Despite the strong research findings, the Y's program still remained hidden to most Americans, but in 2009, Drs Ackerman and Morrero presented their research as well as the research of other investigators at a national meeting of the Centers for Disease Control and the NIH.  This meeting, attended by a host of government health organizations and several private health system purchasers and payers, catalyzed a new partnership between the Y and United Health Group, a major health insurance company.  

The CDC and others later joined in this effort, which involved scaling the Y's program to over 43 states and the DIstrict of Columbia.

Thier research was the Diabetes Prevention Act of 2009.  This act, later passed as a component of the Affordable Care Act, appropriated money to CDC for the National Diabetes Prevention Program, which provides training and recognition for organizations like the Y that seek third party payment for the program.

In 2012, the Center for Medicare and Medicaid Innovation granted the Y about $12 million to start a pilot program to evaluate whether Medicaid payment for its program might be cost effective.  Among several other sources of data, the actuaries at the Centers for Medicare and Medicaid Services used findings from Dr. Ackerman's study of United Healthcare clients that were offered the Y's program to discover that the intervention offered cost savings.

They estimate that if the Y program were expanded to all Medicare beneficiaries, the government might save about $2,650 per participant over 15 months, much more than the program cost.  I spend too much time here at Healthcare Triage complaining that our health policy fails to be based on research or that things we do don't work.  It's nice once in a while to have the opposite be true.

Healthcare Triage is supported in part by viewers like you through patreon.com, a service that allows you to support the show through a monthly donation.  We'd especially like to thank our research associates Joe Sevits and M.T, and our surgeon admiral Sam.  Thanks, Joe, M.T., and Sam!  More information can be found at patreon.com/healthcaretriage.