Abstract
BACKGROUND: Diabetes education is key to achieving metabolic control and promoting healthy behaviors in people with type 2 diabetes. Mobile health (mHealth) tools have been shown to be an important tool for monitoring, disease care and lifestyle improvement in people with type 2 diabetes (T2D). In less developed countries, the effect of educational intervention through mHealth is still inconclusive. The objective of this study is to evaluate the effect of an intervention on metabolic control in people with T2D with mHealth intervention and educational website called "I understand my diabetes". METHODS: The study is designed as a 12-month randomized controlled trial with three parallel arms: (1) Web-based education, (2) Web-based education + mobile app (diet and exercise plan), (3) Usual care. The total study duration is 12 months with data collection at baseline, 3, 6, 9 and 12 months. We will enroll 408 Mexican adults with T2D, randomized equally across arms. Measurements at baseline, 3, 6, 9, and 12 months include A1c (primary outcome), lipid profile, anthropometry, body composition, quality of life, lifestyle, and physical activity. DISCUSSION: The trial will evaluate whether reinforcing diabetes education with an app and educational website improves metabolic outcomes in people with type 2 diabetes. Findings may be relevant for implementation in public institutions with high demand of people with type 2 diabetes who have not presented severe complications of the disease. Integration of mHealth into routine care could enhance self-management and disease control in people with type 2 diabetes.Clinical Trial Registration: Trial registration number: Clinical Trials.gov. Registry (NCT0627857I). The protocol number: Effect of Education with Mobile App on metabolic control in Patients With type 2 Diabetes. The registration number R-2018-785-100. Instituto Mexicano del Seguro Social. Mexico. Registration date: February 22, 2024.