Volunteers Sought for Large Home-based Study on Diabetes, Obesity
Scripps Research and Tempus are launching a study that uses genetic and other information to better understand what drives the development of obesity and type 2 diabetes.
By understanding how and why individual blood sugar levels change in response to food, researchers hope to improve the treatment of obesity and diabetes.
“There is growing evidence that glycemic responses to the same foods differ significantly from person to person,” Edward Ramos, PhD, director of Digital Clinical Trials at the Scripps Research Translational Institute and principal investigator of the study, said in a press release.
The “PRediction Of Glycemic RESponse Study,” or PROGRESS, is recruiting approximately 1,000 participants over age 18. The investigators are seeking equal proportions of volunteers with and without a diagnosis of type 2 diabetes.
Diabetes is a complex condition, of which obesity is a major risk factor. On a large-scale level, overeating and/or poor nutrition are known to contribute to both obesity and diabetes but how this happens at the individual level remains poorly understood.
Through the use of at-home sample collection and digital health kits, participants will monitor their own diets, activity, and continuous glucose (sugar) levels over 10 days. An additional three years of monitoring will follow this initial study period.
The “site-less” model, which includes a mobile app for communication, allows people to take part remotely, removing many traditional barriers to clinical trial participation, such as scheduling constraints, travel and transportation challenges, and clinic access.
“Advances in individualized data collection through personal health tracking devices enable us to better quantify a wide range of personal traits that will assist in refining more personalized approaches for glycemic control,” Ramos added.
Algorithms predicting blood sugar changes at the individual level will include data on variables such as diet, chewing, and saliva composition, as well as digestion, genetics, body mass index, gut microorganisms, electronic health records, and lifestyle.
These algorithms will rely on artificial intelligence methods, due to the complexity of the above factors, the many ways in which they connect with each other, and the huge amounts of data this generates.
“Despite recent advances in understanding the many genetic and environmental factors underlying diabetes, there have been few large-scale studies that fully address the complex, multi-modal nature of this disease,” said Joel Dudley, PhD, Tempus’ chief scientific officer.
“This study aims to build a foundation of data and understanding that will enable development of intelligent precision medicine technologies to address unmet clinical needs in diabetes at scale,” he added. “We’re delighted to collaborate with Scripps Research to advance our understanding of diabetes and the pursuit of next-generation clinical trial design.”