The National Institutes of Health has provided $3.5 million for a large-scale clinical trial testing a radical new approach to managing Type 2 diabetes that in a previous study put nearly 70% of participants in remission without weight loss or medication.
UVA Health’s Daniel J. Cox developed the approach, built on the notion that educating people on making wise dietary and exercise choices can allow them to control their blood sugar and possibly alter the course of the disease.
“Instead of focusing on reducing weight with diets or medication, we focus on reducing how much blood glucose goes up and stays up after eating and drinking,” said Cox, professor of psychiatry and internal medicine at the University of Virginia School of Medicine. “These blood glucose elevations are what leads to high A1C and cardiovascular risks among adults with Type 2 diabetes.”
More than 30 million people worldwide have Type 2 diabetes, a condition in which the body becomes unable to regulate blood sugar. This can lead to heart disease, kidney disease, blindness and other serious medical conditions. Type 2 diabetes typically affects people over age 45, but is increasingly striking children, teenagers and young adults. Many people must use medication or insulin injections to manage the condition.
Cox’s approach, called Glucose Everyday Matters, or GEM, aims to prevent blood sugar spikes via educated food and drink selection. This is coupled with physical activity to hasten recovery when blood-sugar spikes do occur. So someone might indulge in a piece of fruit or a small, sweet treat, knowing how it will affect them, and then go for an evening stroll to help even out their blood sugar.
The approach showed promise in a small initial trial. Seventeen adults recently diagnosed with Type 2 diabetes tested the program in combination with continuous glucose monitoring. They also received text messages to help them stay on track. After three months, 67% were in remission and only one participant needed to begin medication.
Previous studies had evaluated the program delivered face-to-face by medical providers, but the pilot clinical trial was the first time it had been tested when self-administered. Participants did not have to come in for the intervention; instead, they just received a couple of calls from the researchers and followed a treatment manual.
Cox’s latest study will build on the prior research to determine at a larger and longer scale if it offers a safe and effective new tool for managing Type 2 diabetes among those recently diagnosed. The randomized clinical trial will enroll 200 people in Virginia and Colorado and assess, over five years, whether the GEM program helps them better control their blood sugar and reduces their need for medication. The trial will also compare the cost of GEM with other options and evaluate whether the program has additional benefits, such as weight loss and decreased depression symptoms.
“It’s an exciting time for people with Type 2 diabetes, with both new medications and new lifestyle interventions to improve the control of diabetes, giving patients many new options. Lifestyle interventions have the advantage of being able to put diabetes in remission,” Cox said. “GEM is a one-time, brief, six-week intervention that impacts a lifelong lifestyle.”
Cox himself went from an A1C of 10.3 at the time of diagnosis to reading consistently under 6.0 for the past 13 years on no medication and using his approach.
The results of the pilot study have been published in the scientific journal JMIR Diabetes. The research team consisted of Tamara K. Oser, Mark Cucuzzella, Marilyn Stasinopoulos, Matt Moncrief, Anthony L. McCall and Cox.
For information on the trial, IRB-HSR #220259, contact Cox at firstname.lastname@example.org or call 434-566-2099.
Cox has no financial interest in the work; Oser has served on a physician advisory board for Cecilia Health and Dexcom.
Abbott provided continuous glucose monitoring supplies for the pilot trial, but UVA handled all data management, monitoring and analysis independently.
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