Diabetes Mellitus Type 2NCT07678671
Glycemic Control and the Ask Me 3® Educational Program
A study testing Educational program in people with Diabetes Mellitus Type 2, run by Maria Elena Romero Ibarguengoitia at 1 site in Mexico.
Trial summary
The goal of this clinical trial is to determine whether the Ask Me 3® educational program improves glycemic control in adults with type 2 diabetes mellitus receiving care at a metabolic clinic. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteMexico
- Study dates
- 5 Jun 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Beneficiaries of Hospital Clínica Nova.
- Male and female participants.
- Confirmed diagnosis of type 2 diabetes mellitus according to the institution's established clinical practice guidelines.
- Patients receiving care at the Metabolic Clinic.
Who cannot join
- Pregnant women.
- Patients with autoimmune, immunological, or oncological comorbidities.
- Patients receiving palliative care.
- Patients with cognitive or psychiatric conditions that impair their ability to provide informed consent independently (e.g., delirium, schizophrenia, or similar conditions).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Hospital Clinica Nova de Monterrey
San Nicolás de los Garza, Nuevo León, 66450
About this study
Official title: Difference in Glycemic Control Among Patients With Type 2 Diabetes Mellitus Receiving the Ask Me 3® Educational Program: A 3-Month Follow-Up Study
The goal of this clinical trial is to determine whether the Ask Me 3® educational program improves glycemic control in adults with type 2 diabetes mellitus receiving care at a metabolic clinic. The main questions it aims to answer are:
Does participation in the Ask Me 3® educational program improve glycated hemoglobin (HbA1c) and fasting plasma glucose levels after a 3-month follow-up?
Read more
Researchers will compare participants who receive the Ask Me 3® educational program with those who receive standard medical care alone to determine whether the educational intervention improves glycemic control.
Participants will:
Provide written informed consent and undergo eligibility assessment. Be randomly assigned to either the intervention group or the control group. Complete baseline assessments, including demographic information, anthropometric measurements, medical history, dietary habits, physical activity, diabetes education, and nutritional counseling history.
Have baseline HbA1c and fasting plasma glucose values collected from their medical records.
Receive either the Ask Me 3® educational program (intervention group) or standard care (control group).
Attend routine follow-up visits over a 3-month period. Complete a final evaluation, including repeat clinical measurements and collection of HbA1c and fasting plasma glucose values to assess changes in glycemic control.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Educational program
- Keywords
- Type 2 Diabetes Mellitus, Glycemic Control, Patient Education, Patient Safety
- 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.
Educational programBehavioural
The intervention consists of implementing the Ask Me 3® educational program as an adjunct to standard medical care for adults with type 2 diabetes mellitus. Participants assigned to the intervention group will receive structured education based on the three core Ask Me 3® questions, designed to enhance communication with healthcare providers, improve understanding of their health condition and treatment plan, and promote active participation in self-care and decision-making.
The educational intervention will be delivered at baseline by trained healthcare personnel. Participants will continue receiving routine clinical follow-up at the Metabolic Clinic for 3 months.
Glycemic control will be assessed using glycated hemoglobin (HbA1c) and fasting plasma glucose measurements obtained at baseline and at the end of the follow-up period.
The control group will receive standard medical care and routine follow-up without the Ask Me 3® educational program.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Educational program | Experimental | Not described Receives: Behavioral: Educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated hemoglobin (HbA1c) level from baseline to 3 months
Difference in the change in HbA1c (%) from baseline to 3 months between participants receiving the Ask Me 3® educational program and those receiving usual care.
Measured: From enrollment to the end of follow-up at 3 months
Secondary outcomes (1)
Proportion of participants with HbA1c <7.0% at 3 months
Percentage of participants whose HbA1c is below 7.0% at the 3-month follow-up assessment.
Measured: at baseline and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start5 Jun 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Elena Romero Ibarguengoitia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria Elena Romero Ibarguengoitia, Hospital Clinica Nova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678671
- Sponsor's protocol ID
- Ask me 3 and Diabetes
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to institutional data management and confidentiality policies. However, de-identified (anonymized) data may be made available upon reasonable request to the corresponding author, subject to institutional review and approval, as well as applicable ethical and legal requirements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in Glycemic Control Among Patients With Type 2 Diabetes Mellitus Receiving the Ask Me 3® Educational Program: A 3-Month Follow-Up Study
- ClinicalTrials.gov ID
- NCT07678671
- Acronym / sponsor ID
- Ask me 3 and Diabetes
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Type 2 Diabetes Mellitus, Glycemic Control, Patient Education, Patient Safety
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Maria Elena Romero IbarguengoitiaUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 1 Jul 2026 (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 goal of this clinical trial is to determine whether the Ask Me 3® educational program improves glycemic control in adults with type 2 diabetes mellitus receiving care at a metabolic clinic. The main questions it aims to answer are:
Does participation in the Ask Me 3® educational program improve glycated hemoglobin (HbA1c) and fasting plasma glucose levels after a 3-month follow-up?
Researchers will compare participants who receive the Ask Me 3® educational program with those who receive standard medical care alone to determine whether the educational intervention improves glycemic control.
Participants will:
Provide written informed consent and undergo eligibility assessment. Be randomly assigned to either the intervention group or the control group. Complete baseline assessments, including demographic information, anthropometric measurements, medical history, dietary habits, physical activity, diabetes education, and nutritional counseling history.
Have baseline HbA1c and fasting plasma glucose values collected from their medical records.
Receive either the Ask Me 3® educational program (intervention group) or standard care (control group).
Attend routine follow-up visits over a 3-month period. Complete a final evaluation, including repeat clinical measurements and collection of HbA1c and fasting plasma glucose values to assess changes in glycemic control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Educational program | Experimental | Behavioral: Educational program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Beneficiaries of Hospital Clínica Nova.
- Male and female participants.
- Confirmed diagnosis of type 2 diabetes mellitus according to the institution's established clinical practice guidelines.
- Patients receiving care at the Metabolic Clinic.
Key exclusion criteria (4 listed)
- Pregnant women.
- Patients with autoimmune, immunological, or oncological comorbidities.
- Patients receiving palliative care.
- Patients with cognitive or psychiatric conditions that impair their ability to provide informed consent independently (e.g., delirium, schizophrenia, or similar conditions).
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 |
|---|---|---|
| Educational programThe intervention consists of implementing the Ask Me 3® educational program as an adjunct to standard medical care for adults with type 2 diabetes mellitus. Participants assigned to the intervention group will receive structured education based on the three core Ask Me 3® questions, designed to enhance communication with healthcare providers, improve understanding of their health condition and treatment plan, and promote active participation in self-care and decision-making. The educational intervention will be delivered at baseline by trained healthcare personnel. Participants will continue receiving routine clinical follow-up at the Metabolic Clinic for 3 months. Glycemic control will be assessed using glycated hemoglobin (HbA1c) and fasting plasma glucose measurements obtained at baseline and at the end of the follow-up period. The control group will receive standard medical care and routine follow-up without the Ask Me 3® educational program. | Behavioural | Educational program |
Primary outcome
Change in glycated hemoglobin (HbA1c) level from baseline to 3 months
Time frame: From enrollment to the end of follow-up at 3 months
Difference in the change in HbA1c (%) from baseline to 3 months between participants receiving the Ask Me 3® educational program and those receiving usual care.
1 secondary outcome
Proportion of participants with HbA1c <7.0% at 3 months
Time frame: at baseline and 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to institutional data management and confidentiality policies. However, de-identified (anonymized) data may be made available upon reasonable request to the corresponding author, subject to institutional review and approval, as well as applicable ethical and legal requirements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program in people with Diabetes Mellitus Type 2, run by Maria Elena Romero Ibarguengoitia at 1 site 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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated hemoglobin (HbA1c) level from baseline to 3 months (time frame: From enrollment to the end of follow-up at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.