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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Educational program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of follow-up at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline and 3 months after the intervention |
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Inclusion Criteria:
Adults aged 18 years or older. Beneficiaries of Hospital ClÃnica 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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinica Nova de Monterrey | San Nicolás de los Garza | Nuevo León | 66450 | Mexico |
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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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |