Education with mobile App and educational website in the metabolic control of patients with type 2 diabetes. Protocol study of a Multicenter Clinical Trial

Background: Diabetes education is a fundamental pillar for accomplishing metabolic control, improving knowledge about the disease and the lifestyle in the patient with diabetes. The benefit of mHealth has been shown to be an important tool for monitoring, disease care and lifestyle improvement in patients 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 the metabolic control of the patient with T2D with mHealth intervention and educational website called "I understand my diabetes". Methods. T he study is designed as a randomized controlled trial with a parallel-group design. The total study duration is 12 months with data collection at baseline, 3, 6, 9 and 12 months. We plan to include 480 Mexican adult patients with T2D. Participants will be randomized to one of three interventions: (1) Group with Web education program (2) Group web education program+ mobile App for diet and exercise plan (1) Usual care intervention. The primary outcome is changes in glycated hemoglobin A1c. Other outcome measures include changes in Lipid profile, body composition and anthropometric measurements, quality of life, lifestyle and physical activity. Discussion: The study has a 12-month follow-up of intervention and will provide knowledge and results of the effect of the use of a mobile app and educational website on the metabolic control of patients with diabetes. The results may be relevant for implementation in public institutions with high demand of patients with type 2 diabetes without severe complications of the disease. Interventions with diabetes education and reinforcement with the healthcare professional with the use of mHealth may be strategies to achieve and maintain metabolic control and disease care in patients with diabetes. 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.