FemaleNCT06278571
Effect of Education With Mobile App on Metabolic Control in Patients With Type 2 Diabetes
A study testing Educational intervention with App and web site education and Educational interventión with web site education in people with Female, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Female
- What is being tested?
- Educational intervention with App and web site education and Educational interventión with web site education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteMexico
- Study dates
- 30 Jan 2023to 3 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- chronic kidney disease with renal replacement therapy
- blindness
- lower limb amputation
- cancer
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Mexicano Del Seguro Social
Mexico City, Mexico City, 03100
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Female
- Being tested
- Educational intervention with App and web site education, Educational interventión with web site education, Control group with nutritional therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention with App and web site educationBehavioural
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 educationBehavioural
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 therapyOther
This group will receive only the usual medical care by your treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with mobile application and website | Experimental | Group with educational site and mobile App Receives: Behavioral: Educational intervention with App and web site education; Behavioral: Educational interventión with web site education |
| Group with educational site | Active comparator | Group with educational site Receives: Behavioral: Educational interventión with web site education; Other: Control group with nutritional therapy |
| Control Group | No intervention | Group with the usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with glycosylated hemoglobin at control goals
Glycosylated hemoglobin
Measured: 12 months
Number of participants with iipid profile in control targets
Assessment of the effect of the intervention on lipid profile
Measured: 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.
Measured: The baseline and 12 months after the intervention will be evaluated.
Secondary outcomes (2)
Number of patients with changes to a healthy lifestyle
Lifestyle will be measured at baseline and 12 months through a validated questionnaire.
Measured: 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.
Measured: The baseline and 12 months after the intervention will be evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start30 Jan 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion3 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lubia Velazquez, PhD, Principal investigator, UIEC. HGR 1. IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278571
- Sponsor's protocol ID
- R-2018-785-100
- Status last verified
- Jan 2025
- First submitted
- 16 Feb 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40839868
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06278571
- Acronym / sponsor ID
- R-2018-785-100
- Conditions
- Female
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 3 Sep 2025 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Multicenter clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention with mobile application and website | Experimental | Behavioral: Educational intervention with App and web site education, Behavioral: Educational interventión with web site educationGroup with educational site and mobile App |
| Group with educational site | Active comparator | Behavioral: Educational interventión with web site education, Other: Control group with nutritional therapyGroup with educational site |
| Control Group | No intervention | –Group with the usual care |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- chronic kidney disease with renal replacement therapy
- blindness
- lower limb amputation
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention with App and web site educationThis 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. | Behavioural | Intervention with mobile application and website |
| Educational interventión with web site educationThis 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. | Behavioural | Group with educational site, Intervention with mobile application and website |
| Control group with nutritional therapyThis group will receive only the usual medical care by your treating physician. | Other | Group with educational site |
Primary outcome
Number of participants with glycosylated hemoglobin at control goals
Time frame: 12 months
Glycosylated hemoglobin
Number of participants with iipid profile in control targets
Time frame: The baseline and 12 months after the intervention will be evaluated.
Assessment of the effect of the intervention on lipid profile
Number of participants with body mass index profile in control target
Time frame: The baseline and 12 months after the intervention will be evaluated.
Weight and height will be measured at baseline and at 12 months to obtain the body mass index.
2 secondary outcomes
Number of patients with changes to a healthy lifestyle
Time frame: The baseline and 12 months after the intervention will be evaluated.
The proportion of patients with adequate knowledge of diabetes
Time frame: The baseline and 12 months after the intervention will be evaluated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Derived from this study: PubMed 40839868Torres 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lubia Velazquez, PhD principal investigator
UIEC. HGR 1. IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention with App and web site education and Educational interventión with web site education in people with Female, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with glycosylated hemoglobin at control goals (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06278571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.