Low-Calorie Diet and Intensive Lifestyle Program Using Integrated Personalized Diabetes Management to Achieve Diabetes Remission in Adults with Type 2 Diabetes

What This Trial Is About

Researchers are evaluating whether a low-calorie diet combined with an intensive lifestyle program using Integrated Personalized Diabetes Management iPDM can achieve diabetes remission more effectively than standard care in adults with overweight and type 2 diabetes mellitus. The study also aims to assess improvements in metabolic health, quality of life, and cost-effectiveness associated with the intervention. Participants will be randomly assigned to either an intervention group or a standard care group. The intervention group follows a low-calorie diet with two meal replacements per day up to 1,200 kcalday during a 3-month intensive phase, alongside personalized exercise programs, continuous glucose monitoring CGM, and telemedicine lifestyle counseling every two weeks. This is followed by a 3-month maintenance phase with behavioral reinforcement every four weeks and a meal plan of up to 1,500 kcalday. The standard care group receives routine diabetes care and education visits at baseline, 3 months, and 6 months. During the 6-month study, participants attend regular assessments including physical exams, body composition analysis, laboratory tests such as HbA1c, fasting glucose, lipid profile, and questionnaires on quality of life and mental health. The intervention group uses CGM devices with data reviewed biweekly. Researchers measure diabetes remission based on HbA1c levels without medication, metabolic changes, and patient-reported outcomes. Monthly telehealth visits monitor progress during the maintenance phase, and the study concludes with a final comprehensive assessment at 6 months.

Effectiveness of a Low-Calorie Diet Combined With Intensive Lifestyle Intervention Using Integrated Personalized Diabetes Management for Achieving Diabetes Remission in Patients With Type 2 Diabetes Mellitus