Glycemic Control and the Ask Me 3® Educational Program (NCT07678671) | Clinical Trial Compass
By InvitationNot Applicable
Glycemic Control and the Ask Me 3® Educational Program
Mexico250 participantsStarted 2025-06-05
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses something called the Ask Me 3® educational program to help manage Type 2 diabetes — can you explain what that program actually involves day-to-day, and whether that kind of approach makes sense given where I am in managing my condition?
2The trial measures changes in HbA1c over 3 months, which is a relatively short window — does that timeframe give us enough meaningful information about whether this approach could help my long-term blood sugar control?
3Since this study is 'enrolling by invitation,' how would I even be considered for it, and is there a reason you would or wouldn't think I'm a good candidate based on my current HbA1c levels and treatment history?
4This trial is listed as Phase NA, which typically means it's testing an educational or behavioral intervention rather than a drug — does that change the risk profile compared to other studies, and are there any downsides to participating I should still be aware of?
5Before considering this trial, should I first explore whether changes to my current medication or a standard diabetes education program might achieve similar improvements in my HbA1c without the added commitments of a research study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in glycated hemoglobin (HbA1c) level from baseline to 3 months
Timeframe: From enrollment to the end of follow-up at 3 months