Ireland
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Enrolling by invitation Not applicable

Glycemic Control and the Ask Me 3® Educational Program

NCT07678671 · tracked via the Priya Life Science Mexico tracker
Sponsor
Maria Elena Romero Ibarguengoitia
Phase
Not applicable
Started
2025-06-05
Last updated
2026-09-17

Condition(s) studied

Diabetes Mellitus Type 2

Investigational drug(s) / intervention(s)

Educational program

Educational program: 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 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Primary outcome measure(s)

  • Change in glycated hemoglobin (HbA1c) level from baseline to 3 months — 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.

Trial sites (1)

FacilityCityRegionStatus
Hospital Clinica Nova de Monterrey San Nicolás de los Garza Nuevo León
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07678671 on ClinicalTrials.gov ↗ ← All trials in Mexico