Effects of a Health Intervention on Hypoglycemic Coping : a Pilot Study (NCT06384118) | Clinical Trial Compass
CompletedNot Applicable
Effects of a Health Intervention on Hypoglycemic Coping : a Pilot Study
China100 participantsStarted 2023-08-01
Plain-language summary
From August 2023 to January 2024, 100 patients with type 2 diabetes who met the inclusion and exclusion criteria were selected from the endocrinology department of The purpose of this study was to construct a hypoglycemia coping intervention program for type 2 diabetic patients based on the IMB theory and to investigate the feasibility, acceptability, and initial effects of the program.
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:
* Patients who meet the 2018 ADA medical standards for Diabetes diagnosis and treatment, are diagnosed with T2DM and use insulin or sulfonylurea drugs;
* Duration of diabetes mellitus ≥1 year
* Age ≥18 years old;
* A history of hypoglycemia in the past 6 months;
* Type 2 diabetes patients with hypoglycemia coping style questionnaire inclination, avoidance, compromise;
* Good communication and language skills;
* Have a smartphone and can use it;
* Voluntary participation in this study.
Exclusion Criteria:
* Patients with type 1 diabetes;
* Patients with type 2 diabetes combined with serious complications;
* Patients who have recently or are participating in other similar studies.
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.
What they're measuring
1
The hypoglycemic coping style
Timeframe: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention