Glycemic Control and the Ask Me 3® Educational Program
Difference in Glycemic Control Among Patients With Type 2 Diabetes Mellitus Receiving the Ask Me 3® Educational Program: A 3-Month Follow-Up Study
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2025
CompletedFirst Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
July 1, 2026
June 1, 2026
1.4 years
June 10, 2026
June 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Proportion of participants with HbA1c <7.0% at 3 months
at baseline and 3 months after the intervention
Study Arms (2)
Control
NO INTERVENTIONEducational program
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinica Nova de Monterrey
San Nicolás de los Garza, Nuevo León, 66450, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Investigation & Teaching Manager
Study Record Dates
First Submitted
June 10, 2026
First Posted
July 1, 2026
Study Start
June 5, 2025
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
July 1, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
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.