Diabetes Mellitus Type 2
Conditions
Keywords
Type 2 Diabetes Mellitus, Glycemic Control, Patient Education, Patient Safety
Brief 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.
Interventions
BEHAVIORALEducational 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.
Sponsors
Maria Elena Romero Ibarguengoitia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with HbA1c <7.0% at 3 months | at baseline and 3 months after the intervention | Percentage of participants whose HbA1c is below 7.0% at the 3-month follow-up assessment. |
Countries
Mexico
Outcome results
None listed