Clinical trial NCT04974333: Development of an Information Board and Mobile Application for the Care of Type 2 Diabetes
Official title: Development of an Information Board and Mobile Application for the Care of Type 2 Diabetes at the First Level of Medical Care for the Health Sector in Mexico
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes type 2
mobile health technology
diabetes control
intervention
lifestyle habits
Lead sponsor: General Health Council, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
name: Eli Lilly and Company
First posted: 2021-07-23
Enrollment: 1512
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1C
timeFrame: 12 months
Secondary outcomes:
measure: Blood lipids changes
timeFrame: 12 months
measure: Blood pressure changes
timeFrame: 12 months
measure: Body mass index
timeFrame: 12 months
measure: Treatment compliance change
timeFrame: 12 months
measure: Mental health improvement
timeFrame: 12 months
measure: Physical activity changes
timeFrame: 12 months
measure: Changes in albumin to creatine ratio
timeFrame: 12 months
measure: Quality of life changes
timeFrame: 12 months
measure: Waist circumference
timeFrame: 12 months
Other outcomes:
Locations:
city: Ciudad de mexico
country: Mexico
facility: Coordinacion Clinica de Educacion e Investigacion en Salud Medicina Familiar
state: DF
city: Chihuahua
country: Mexico
facility: Unidad de Medicina Familiar 33
city: Colima
country: Mexico
facility: Establecimiento salud: Centro de Salud Urbano Zona Oriente "La Vurgencita"
Study officials:
affiliation: Consejo General de Salud
name: Nelly Cisneros Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barengo NC, Apolinar LM, Estrada Cruz NA, Fernandez Garate JE, Correa Gonzalez RA, Diaz Valencia PA, Gonzalez CAC, Rodriguez JAG, Gonzalez NC; SANENT Study Group. Development of an information system and mobile application for the care of type 2 diabetes patients at the primary care level for the health sector in Mexico: study protocol for a randomized controlled, open-label trial. Trials. 2022 Apr 4;23(1):253. doi: 10.1186/s13063-022-06177-0.