Effect of Education With Mobile App on Metabolic Control in Patients With Type 2 Diabetes
NCT ID: NCT06278571
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
480 participants
INTERVENTIONAL
2023-01-30
2025-09-03
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention with mobile application and website
Group with educational site and mobile App
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.
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.
Group with educational site
Group with educational site
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.
Control group with nutritional therapy
This group will receive only the usual medical care by your treating physician.
Control Group
Group with the usual care
No interventions assigned to this group
Interventions
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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.
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.
Control group with nutritional therapy
This group will receive only the usual medical care by your treating physician.
Eligibility Criteria
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Inclusion Criteria
* 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
* blindness
* lower limb amputation
* cancer
20 Years
60 Years
ALL
Yes
Sponsors
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Coordinación de Investigación en Salud, Mexico
OTHER_GOV
Responsible Party
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Principal Investigators
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Lubia Velazquez, PhD
Role: PRINCIPAL_INVESTIGATOR
UIEC. HGR 1. IMSS
Locations
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Instituto Mexicano Del Seguro Social
Mexico City, Mexico City, Mexico
Countries
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References
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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.
Other Identifiers
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R-2018-785-100
Identifier Type: -
Identifier Source: org_study_id
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