Clinical trial NCT06278571: Effect of Education With Mobile App on Metabolic Control in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Female
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2024-02-26
Enrollment: 480
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter clinical trial
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with glycosylated hemoglobin at control goals
timeFrame: 12 months
measure: Number of participants with iipid profile in control targets
timeFrame: The baseline and 12 months after the intervention will be evaluated.
measure: Number of participants with body mass index profile in control target
timeFrame: The baseline and 12 months after the intervention will be evaluated.
Secondary outcomes:
measure: Number of patients with changes to a healthy lifestyle
timeFrame: The baseline and 12 months after the intervention will be evaluated.
measure: The proportion of patients with adequate knowledge of diabetes
timeFrame: The baseline and 12 months after the intervention will be evaluated.
Other outcomes:
Locations:
city: Ciudad de mexico
country: Mexico
facility: Instituto Mexicano Del Seguro Social
Study officials:
affiliation: UIEC. HGR 1. IMSS
name: Lubia Velazquez, PhD
role: PRINCIPAL_INVESTIGATOR
References: