Diabetes Mellitus, Type 2SANENTNCT04974333
Development of an Information Board and Mobile Application for the Care of Type 2 Diabetes
A study testing Mobile health application on phone in people with Diabetes Mellitus, Type 2, run by General Health Council, Mexico at 3 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Mobile health application on phone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,512 participants
- Where
- 3 sitesMexico
- Study dates
- 4 Oct 2021to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Mexico3 sites, 3 recruiting
- Recruiting
Unidad de Medicina Familiar 33
Chihuahua City, 31204
Ulises Parra Giron, MD, ulises.parragi@ims.gob.mx
- Recruiting
Establecimiento salud: Centro de Salud Urbano Zona Oriente "La Vurgencita"
Colima, 28047
Gerson J Villanueva Ruiz, MD, cs_zona.oriente@hormail.com
- Recruiting
Coordinacion Clinica de Educacion e Investigacion en Salud Medicina Familiar
Mexico City, Mexico City, 010710
Cecilia V Lucio De La Rosa, MD, +525555682022, cecilia.lucio@imss.gob.mx
About this study
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
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
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Mobile health application on phone
- Keywords
- diabetes type 2, mobile health technology, diabetes control, intervention, lifestyle habits
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health application on phoneDevice
Patients will use a mobile app on their smart phones
| Study group | Role | What they receive |
|---|---|---|
| Mobile health application | Experimental | 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). Receives: Device: Mobile health application on phone |
| Standard care | No intervention | Participants assigned to the control arm will continue their regular standard diabetes care without mobile health technology assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Change in HbA1C
Measured: 12 months
Secondary outcomes (9)
Blood lipids changes
Changes in serum cholesterol, LDL, HDL cholesterol, triglycerides
Measured: 12 months
Blood pressure changes
Changes in systolic and diastolic blood pressure
Measured: 12 months
Body mass index
Changes in body mass index (kg/m2)
Measured: 12 months
Treatment compliance change
Treatment compliance using Morisky scale. The Morisky scale is a validated scale designed to estimate the risk of medication non-adherence. The scale consists of eight questions, first seven items having a dichotomous answer (yes/no) that indicates adherent or non-adherent behaviour. For item 8, a patient can choose an answer on a 5-point Likert scale, expressing how often happens that a patient does not take his medications. The Morisky scores can range from 0 to 8 points.
Measured: 12 months
Mental health improvement
Depression will be measured using the Beck questionnaire. The Beck questionnaire adda up the score reported for each of the 21 questions ranging from zero to three. Each answer is scored on a scale value of 0-3. Measures of 0-9 indicates that a person is not depressed, 10-18 indicates mild-moderate depression, 19-29 indicates moderate-severe depression and 30-63 indicates severe depression.
Measured: 12 months
Physical activity changes
Changes in physical activity will be assessed using the International Physical Activity Questionnaire. The International Physical Activity Questionnaire allows to estimate the overall total physical activity metabolic equivalents-minutes/week score. All activities are converted into minutes before calculating metabolic equivalent minutes. To calculate metabolic equivalents minutes a week the metabolic equivalents value given is multiplied (remember walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days that that activity was undertaken. The higher the metabolic equivalent-minutes/week score, the more activity the participant is.
Measured: 12 months
Changes in albumin to creatine ratio
Changes in kidney function will be measured using the albumin to creatine ratio. A ratio of albumin (mcg/L) to creatinine (mg/L) of less than 30 is normal; a ratio of 30-300 signifies microalbuminuria and values above 300 are considered as macroalbuminuria.
Measured: 12 months
Quality of life changes
Short Form 36 questionnaire assessing changes in quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 12 months
Waist circumference
Change in waist circumference (measured in cm)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start4 Oct 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion28 Feb 2024 (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 Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Health Council, Mexico
- Sponsor type
- Other government
- Collaborators
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Nelly Cisneros Gonzalez, MD, Principal investigator, Consejo General de Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974333
- Sponsor's protocol ID
- CEI-001-20181109
- Acronym
- SANENT
- Status last verified
- Mar 2022
- First submitted
- 30 Jun 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35379298
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04974333
- Acronym / sponsor ID
- SANENT / CEI-001-20181109
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes type 2, mobile health technology, diabetes control, intervention, lifestyle habits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,512 participants (estimated)
- Lead sponsor
- General Health Council, MexicoOther government
- Collaborators
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Eli Lilly and Company
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 23 Jul 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile health application | Experimental | Device: Mobile health application on phoneParticipants 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 intervention | –Participants assigned to the control arm will continue their regular standard diabetes care without mobile health technology assistance. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Mobile health application on phonePatients will use a mobile app on their smart phones | Device | Mobile health application |
Primary outcome
HbA1C
Time frame: 12 months
Change in HbA1C
9 secondary outcomes
Blood lipids changes
Time frame: 12 months
Blood pressure changes
Time frame: 12 months
Body mass index
Time frame: 12 months
Treatment compliance change
Time frame: 12 months
Mental health improvement
Time frame: 12 months
Physical activity changes
Time frame: 12 months
Changes in albumin to creatine ratio
Time frame: 12 months
Quality of life changes
Time frame: 12 months
Waist circumference
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 35379298Barengo 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.
- Individual participant dataSharing planned: No
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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.
Nelly Cisneros Gonzalez, MD principal investigator
Consejo General de Salud
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health application on phone in people with Diabetes Mellitus, Type 2, run by General Health Council, Mexico at 3 sites 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leticia Manuel Apolinar, PhD (+525556276900 ext. 21479, letymanu@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: 12 months). 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 NCT04974333, 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 31 Mar 2022.