Difference in Glycemic Control Among Patients With Type 2 Diabetes Mellitus Receiving the Ask Me 3® Educational Program: A 3-Month Follow-Up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Change in glycated hemoglobin (HbA1c) level from baseline to 3 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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).
Arms & Interventions
Control
Educational program
Intervention: Educational program (Behavioral)
Outcomes
Primary Outcomes
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
- Proportion of participants with HbA1c <7.0% at 3 months(at baseline and 3 months after the intervention)
Investigators
Maria Elena Romero Ibarguengoitia
Investigation & Teaching Manager
Hospital Clinica Nova