Effect of Real-Time Versus Blinded Continuous Glucose Monitoring on Behavior, Glucose Changes, and Weight Loss in Adults with Prediabetes and Obesity

What this Trial Is About

Researchers are evaluating how continuous glucose monitoring CGM affects blood sugar fluctuations, lifestyle habits, and metabolic health in adults with prediabetes who are overweight or obese BMI of 27 kgm or higher. The study aims to find out if having real-time access to glucose data encourages behavior changes and improves metabolic outcomes compared to using CGM without seeing the glucose data. This randomized, open-label crossover study involves 30 adults aged 18 to 70 years with confirmed prediabetes and stable weight. Participants will undergo two 12-week phases using a CGM device one with real-time glucose data visible open CGM and one with glucose data hidden blinded CGM. The order of these phases is randomized and separated by a 30-day washout period. During the open CGM phase, participants can view their glucose levels continuously, while in the blinded phase, the data is masked. The study evaluates how access to glucose information influences diet, physical activity, and metabolic markers. Throughout the study, participants will attend baseline and follow-up visits where their weight, blood tests, physical activity, dietary intake, and health status are assessed. The primary outcomes include changes in glycemic variability and daily energy intake measured at the end of each 12-week CGM phase. Secondary measures include changes in body weight, blood glucose levels, HbA1c, physical activity, and participant adherence to CGM use. The total study duration for each participant includes the two 12-week CGM phases plus the washout period.

The Impact of Continuous Glucose Monitoring on Glucose Variability and Weight Loss in Individuals With Prediabetes and Obesity