Development of an Information Board and Mobile Application for the Care of Type 2 Diabetes (SANENT)

General Health Council, Mexico

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Mobile health application on phone

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT04974333

CEI-001-20181109

Details and patient eligibility

About

The SANENT trial is a primary care-based, prospective, two-arm, randomized controlled, open-label, blinded-endpoint study with the aim to compare a diabetes management strategy using an information board and a mobile application versus standard care in patients with uncontrolled type 2 diabetes. This trial aims to recruit 1440 type 2 diabetes patients during a period of six months until the requested number of participants have been achieved. The total length of the intervention will be one year. The SANENT trial protocol is presented according to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) recommendations

Full description

Trial setting

This trial will be conducted within primary health care practices in three states (Colima, Tlaxcala y Guanajuato) of Mexico. These states were selected because they have a high prevalence of diabetes and have implemented an Electronic Health Record System.

Patient and Public involvement

During the planning phase of the study, a pilot project was carried out evaluating the design and applicability of the information board and mobile application in 31 type 2 diabetes patients. The final intervention was then modified according to the qualitative data received from the patients. the investigators also involved primary healthcare clinicians in the development and evaluation of the information. The results of the study will be made available to all trial participants and participating general practices. Finally, the General Health Council of Mexico who manages the countries public health system is included as collaboration partner in this trial and has been involved in all phases of the design of this study.

Sample size calculations

Considering a difference in HbA1C of 0.5% between the intervention and the control group, a standard deviation of 1.5%, a power of 90% and an alpha of 0.05 (two-sided tests) with a drop-out rate of 25% during the study, a minimum of 504 will be needed in total in each of the three states. Thus, the total number of patients will be 1512.

Screening and recruitment

The participating healthcare centers were selected because they have the most recent version of the Electronic Health Record System that allows linking clinical information to the mobile app and the information board used in this study. In addition, these centers count with the necessary health information system infrastructure. Finally, each of these centers take care of the clinical control of diabetes patients. The primary healthcare workers of the participating centers will screen their type 2 diabetes patient lists and will invite eligible patients. Patients will receive an invitation letter and a leaflet with general information about the study. Eligible patients may also be contacted by phone, emails, or text by the healthcare professionals. Patients will be enrolled for screening and random allocation over a six-month period. During the first visit of the screening phase, the eligibility criteria and medical record will be revised by the healthcare professionals. In case the patient is potentially eligible, the patient will be invited to the study upon obtaining informed consent. Before the next screening visit, the HbA1C of the patient will be measured to complete the eligibility assessment. Once the diagnosis of uncontrolled type 2 diabetes has been made, all other baseline measurements and laboratory tests will be conducted.

Random allocation

This trial will use a parallel group design, randomizing patients to either the intervention or the control arm by a computer-generated sequence with an allocation ratio of 1:1. The randomization of the study participants will be done after having provided consent and when all baseline assessments have been completed to minimize reporting and selection bias.

Random allocation will be done using a validated secure web-based randomization operated by a data manager, not involved in the patient recruitment, located at the Autonomic University of Mexico. This will ensure concealment of the treatment sequence up to the allocation. The treatment sequence will be generated by a computer-generated sequence of random numbers. Allocation will be carried out with an algorithm to ensure groups are balanced for important baseline prognostic and other factors: study site, age (<65/≥65 years), sex (male/female), duration of diabetes (<5 years/≥5 years) and number of medications (<5/≥5) which are considered as a key prognostic variable for the primary outcome of this trial. The treatment allocation codes will be concealed in sequentially numbered envelopes that will be opened each time a patient will be enrolled.

Enrollment: 1,512 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women treated for type 2 diabetes with an HbA1C>8.5%;
• ≥20 years-of-age;
• Signed up for diabetes treatment and control in one of the participating primary healthcare practices.
• Having access to a mobile phone (or having a family member who will help them in sending, understanding, and retrieving messages and information provided in Spanish language through the mobile application)

Exclusion criteria

• Participants who are pregnant, within 3 months postpartum or planning pregnancy during the trial;
• Breastfeeding;
• Serious medical condition (i.e. dialysis treatment);
• Having been admitted to hospital within the last 3 months for hyperglycemia or hypoglycemia;
• Not permanent residents of the states where the study is conducted.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,512 participants in 2 patient groups

Mobile health application

Experimental group

Description:

Participants assigned to the intervention group will use a mobile application on their smart phones that will assist the patients with their diabetes control, provide and update information on their clinical history, offer a monitoring their nutritional and physical activity habits as well as anthropometric measurements, provide recommendations how to improve on nutritional habits and physical activity behavior, assist in planning and reminding on clinical appointments. The duration of the intervention will be 12 months. Each patient will be invited to follow-up visits and measurements each three months (month 3, month 6, month 9 and month 12).

Treatment:

Device: Mobile health application on phone

Standard care

No Intervention group

Description:

Participants assigned to the control arm will continue their regular standard diabetes care without mobile health technology assistance.