Effect of Education With Mobile App on Metabolic Control in Patients With Type 2 Diabetes
Efecto de la educación a través de Una aplicación móvil Con Reforzamiento médico y Nutricional Para Incidir en el Control metabólico, Conocimientos y Estilo de Vida de Los Pacientes Con Diabetes Tipo 2
1 other identifier
interventional
480
1 country
1
Brief Summary
The objective of this study is to compare the effect of education through a mobile application with medical and nutritional reinforcement on the metabolic control of Mexican patients with type 2 diabetes attending primary care clinics in Mexico. The research question is: What is the effect of education through a mobile application with medical and nutritional reinforcement vs. nutritional and medical reinforcement, versus an educational platform to influence the metabolic control of patients with type 2 diabetes? Multicenter clinical trial in six family medicine units of the Mexican Institute of Social Security. These selected units are: UMF 9, UMF 28, UMF 7, UMF 1, UMF 9 and UMF 10. Patients with type 2 diabetes will be randomly assigned to the educational intervention through the educational site, (n=160 patients), two clinics will be assigned for the use of the mobile App and the educational site (n=160 patients), and two clinics will be part of the control group (n=160 patients).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2023
CompletedFirst Submitted
Initial submission to the registry
February 16, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2025
CompletedApril 24, 2025
January 1, 2025
2.2 years
February 16, 2024
April 22, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Number of participants with glycosylated hemoglobin at control goals
Glycosylated hemoglobin
12 months
Number of participants with iipid profile in control targets
Assessment of the effect of the intervention on lipid profile
The baseline and 12 months after the intervention will be evaluated.
Number of participants with body mass index profile in control target
Weight and height will be measured at baseline and at 12 months to obtain the body mass index.
The baseline and 12 months after the intervention will be evaluated.
Secondary Outcomes (2)
Number of patients with changes to a healthy lifestyle
The baseline and 12 months after the intervention will be evaluated.
The proportion of patients with adequate knowledge of diabetes
The baseline and 12 months after the intervention will be evaluated.
Study Arms (3)
Intervention with mobile application and website
EXPERIMENTALGroup with educational site and mobile App
Group with educational site
ACTIVE COMPARATORGroup with educational site
Control Group
NO INTERVENTIONGroup with the usual care
Interventions
This group will only receive intervention with access to the educational website from home, where they will review the different modules focused on diabetes care, nutrition and exercise. in addition to the usual medical care by your treating physician.
This group will receive, in addition to nutritional therapy, diabetes education through an educational site, to learn more about the most important aspects of diabetes care. In addition to the usual medical care by your treating physician.
This group will receive only the usual medical care by your treating physician.
Eligibility Criteria
You may qualify if:
- Patients with type 2 diabetes.
- Enrolled as beneficiaries of the Mexican Social Security Institute.
- With HbA1 greater than 7% and less than 13%.
- With and without pharmacological treatment for diabetes (hypoglycemic agents or insulin).
- Who can read and write.
- With ≤ 60 years of age7.
- With ≤10 years of diabetes diagnosis.
You may not qualify if:
- chronic kidney disease with renal replacement therapy
- blindness
- lower limb amputation
- cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Mexicano Del Seguro Social
Mexico City, Mexico City, 03100, Mexico
Related Publications (1)
Torres San Miguel GP, Sevilla Gonzalez ML, Lopez Ramirez E, Flores Lopez MF, Velazquez Lopez L. Effect of a Mediterranean Diet Adapted to the Mexican Population on Indicators of Metabolic Risk in Patients With Obstructive Sleep Apnea: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 21;14:e72513. doi: 10.2196/72513.
PMID: 40839868DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lubia Velazquez, PhD
UIEC. HGR 1. IMSS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants are unaware of other intervention arms
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2024
First Posted
February 26, 2024
Study Start
January 30, 2023
Primary Completion
April 30, 2025
Study Completion
September 3, 2025
Last Updated
April 24, 2025
Record last verified: 2025-01