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Enrolling by Invitation

NCT Number: NCT07678671

Glycemic Control and the Ask Me 3® Educational Program

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinica Nova de Monterrey

San Nicolás de los Garza, Nuevo León, 66450, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

educational program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of participants with HbA1c <7.0% at 3 months

    Time frame: at baseline and 3 months after the intervention

    Percentage of participants whose HbA1c is below 7.0% at the 3-month follow-up assessment.

Sponsors and collaborators

Lead sponsor

Maria Elena Romero Ibarguengoitia

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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