Development of an Information Board and Mobile Application for the Care of Type 2 Diabetes
SANENT
1 other identifier
interventional
1,512
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Oct 2021
Typical duration for not_applicable diabetes-mellitus-type-2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
July 23, 2021
CompletedStudy Start
First participant enrolled
October 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedMarch 31, 2022
March 1, 2022
1.9 years
June 30, 2021
March 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1C
Change in HbA1C
12 months
Secondary Outcomes (9)
Blood lipids changes
12 months
Blood pressure changes
12 months
Body mass index
12 months
Treatment compliance change
12 months
Mental health improvement
12 months
- +4 more secondary outcomes
Study Arms (2)
Mobile health application
EXPERIMENTALParticipants 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).
Standard care
NO INTERVENTIONParticipants assigned to the control arm will continue their regular standard diabetes care without mobile health technology assistance.
Interventions
Patients will use a mobile app on their smart phones
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Coordinacion Clinica de Educacion e Investigacion en Salud Medicina Familiar
Mexico City, Mexico City, 010710, Mexico
Unidad de Medicina Familiar 33
Chihuahua City, 31204, Mexico
Establecimiento salud: Centro de Salud Urbano Zona Oriente "La Vurgencita"
Colima, 28047, Mexico
Related Publications (1)
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.
PMID: 35379298DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nelly Cisneros Gonzalez, MD
Consejo General de Salud
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2021
First Posted
July 23, 2021
Study Start
October 4, 2021
Primary Completion
August 31, 2023
Study Completion
February 28, 2024
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share