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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Female
• Intervention / Treatment: Behavioral: Educational intervention with App and web site education; Behavioral: Educational interventión with web site education; Other: Control group with nutritional therapy

Detailed Description

Groups with educational website Participants will be invited to review the site at least once a week. There will be access to social networks and experts' blog for interaction with the patient, as well as an email for doubts with the researchers. The educational site has different educational modules that the patient can review dynamically, reinforcement messages and didactic activities at the end of each module to reinforce the learning acquired. The user will have free access to the educational platform. The educational site will automatically record the number of visits, modules and date of review and will be stored in a database. The above in order to measure adherence to the educational platform.

Groups with educational site and App for reinforcement This group will have access to the App-DM2, which will be installed on the cell phones of patients with diabetes, will have a record for a family member who will serve as a support network for the review of the APP-DM2. It will be compatible with the Android platform. At the beginning of the study the researchers will register each patient and they will receive via SMS message and/or email. The software will be compatible with both Android Smartphone. The investigator will ask the patient to download the application for their initial visit and review it on subsequent visits.

The control group will receive personalized counseling at the beginning of the study, both medical and nutritional, and will continue with their usual medical treatment provided in their family medicine units.

All patients will be scheduled at 3, 6 and 12 months of follow-up for capillary glucose, blood pressure, anthropometry and body composition measurements as follow-up and monitoring measures. In all patients at baseline, 6 and 12 months, venous blood biochemical, clinical, anthropometric and dietary variables will be measured and used for statistical analysis.

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Ciudad de mexico, Mexico, 03100
    • Instituto Mexicano del Seguro Social

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

• 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.

Exclusion criteria

• chronic kidney disease with renal replacement therapy
• blindness
• lower limb amputation
• cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention with mobile application and website; Group with educational site and mobile App	Behavioral: Educational intervention with App and web site education; 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.; Behavioral: Educational interventión with web site education; 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.
Active Comparator: Group with educational site	Behavioral: Educational interventión with web site education; 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.; Other: Control group with nutritional therapy; This group will receive only the usual medical care by your treating physician.
No Intervention: Control Group; Group with the usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with changes to a healthy lifestyle	Lifestyle will be measured at baseline and 12 months through a validated questionnaire.	The baseline and 12 months after the intervention will be evaluated.
The proportion of patients with adequate knowledge of diabetes	The proportion of patients with adequate knowledge of diabetes will be measured at baseline and 12 months.	The baseline and 12 months after the intervention will be evaluated.

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico
• Investigators: Principal Investigator: Lubia Velazquez, PhD, UIEC. HGR 1. IMSS

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): September 3, 2025

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: R-2018-785-100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No