Hypoglycemia Prevention and Awareness Program (NCT06775288) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Hypoglycemia Prevention and Awareness Program
Turkey (Türkiye)62 participantsStarted 2024-11-01
Plain-language summary
The aim of this project is to examine the effects of the Hypoglycemia Prevention and Awareness Program (HypoPAP) on patient outcomes, including metabolic, psychological, social, and economic parameters, in individuals with type 2 diabetes and impaired hypoglycemia awareness.
Through the interventions provided to participants, the study aims to achieve the following improvements:
* Physiological parameters: Enhanced glycemic control, reduced hypoglycemia frequency, improved hypoglycemia awareness, and optimized HbA1c levels.
* Psychological parameters: Reduced fear of hypoglycemia, increased hypoglycemic confidence, and improved attitudes toward hypoglycemia management.
* Social parameters: Decreased social withdrawal due to fear of hypoglycemia, as assessed through relevant items in validated scales.
* Economic parameters: Reduced frequency of hospitalizations and emergency department visits.
Overall, the program seeks to enhance participants' ability to prevent and manage hypoglycemia, thereby improving their overall well-being.
Who can participate
Age range
18 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:
* Being 18 years of age and older
* Being able to communicate in Turkish
* Being diagnosed with type 2 diabetes
* Having used insulin for at least one year
* Having reduced hypoglycemia awareness
* Being willing to participate in the study
* Having and being able to use information technology products (telephone, computer).
Exclusion Criteria:
* Having visual, auditory, cognitive impairment
* Having a condition that prevents communication
* Not being able to use information technology products
* Having chronic renal failure, chronic vascular disease, chronic liver disease, cancer
* Pregnancy
* Endocrine and eating disorders
* Individuals who do not agree to participate in the study
* Do not meet the inclusion criteria will not be included.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.