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Findings Point Toward Customized Diabetes Prevention

Mary Caffrey
The findings generated data on 19 specific clinical variables that could help physicians and patients made personalized decisions about diabetes prevention.
Fifteen years ago, the landmark finding that a lifestyle intervention program could do a better job at preventing diabetes than taking metformin set in motion the creation of the National Diabetes Prevention Program (DPP), which will be funded by Medicare starting next spring.

The risk of developing type 2 diabetes can depend on a host of factors—from age, to activity level, to underlying clinical measures. So, there was an obvious question: while the DPP's success in a broad population was well-documented, what factors could predict its success for the individual patient?

Now, the Diabetes Prevention Program Research Group has tackled that topic in a study just published in Diabetes Care, the journal of the American Diabetes Association.

What they found is encouraging for those who see lifestyle intervention, and especially the DPP, as a solution to America’s $245 billion annual tab for diabetes. In patients who stuck with the program, meaning those who had lost least 5% of body weight at 6 months, the lifestyle intervention worked well “regardless of baseline risk,” the authors wrote, and was “substantially more effective than metformin intervention in those at highest risk.”

More importantly, the study produced data across 19 specific clinical variables that can guide physicians and patients. In short, diabetes prevention could become customized.

“That is our hope,” William Herman, MD, of the University of Michigan, the study’s lead author, wrote in an email to The American Journal of Managed Care®. “Our goal was to facilitate personalized decision-making.”

Among patients who adhered to their regimen, the study found:
  • The lowest-risk patients who took part in the lifestyle intervention had an 8% absolute risk reduction (ARR) of developing diabetes and a 35% absolute likelihood of reverting to normal glucose regulation (NGR), compared with placebo.
  • The highest-risk patients in the lifestyle group had a 39% ARR of developing diabetes and a 24% greater likelihood of reverting to NGR, compared with placebo.
  • The lowest-risk patients taking metformin had no reduction risk for developing diabetes, and a 17% greater likelihood of reverting to NGR. High-risk patients who took metformin had a 25% ARR of developing diabetes and an 11% greater likelihood of reverting to NGR.
Diabetes consumes $1 of every $3 in Medicare—a share that helped convince CMS to invest in DPP to turn the tide. The yearlong program has a CDC-approved curriculum of 16 weekly core sessions, followed by a maintenance period of monthly sessions. A 2002 study funded by the National Institutes of Health (NIH) found a 58% reduction in participants progressing to diabetes.

However, this new study confirms the biggest problem in prevention: adherence is really hard, whether the person is taking a pill or trying to follow a healthier lifestyle. In recent years, multiple programs have emerged to offer the DPP—both through in-person and in online formats. Several digital health companies are embracing principles of behavioral science to simultaneously tackle the adherence and the behavioral change hurdles.

“The study reinforces even more clearly what the original DPP study by the NIH demonstrated: that behavioral interventions are more effective for those at risk for diabetes than is metformin; this is true across the baseline risk spectrum,” said Carolyn Jasik, MD, director of Medical Affairs at Omada Health. “For too long, the barrier to behavioral interventions being the actual standard of care was scalability, access, and personalization—that’s what Omada has come to the market to solve.”

How the Study Worked
The study tracked 19 clinical variables in 3234 patients who met the clinical criteria for prediabetes to enroll in the DPP. They were randomized into 3 groups: 1079 to do the lifestyle intervention, 1073 to take metformin, and 1082 to take placebo. Besides weight, body mass index, blood pressure, fasting plasma glucose, and triglycerides, variables included age, gender, race/ethnicity, education and income status, smoking status, physical activity levels, family history of diabetes, and polycystic ovary disease (among women).



 
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