Effect of Needle-free Jet Injection of Insulin on Glucose Control and Injection Feelings in Type … (NCT04094740) | Clinical Trial Compass
UnknownNot Applicable
Effect of Needle-free Jet Injection of Insulin on Glucose Control and Injection Feelings in Type 1 Diabetic Patients
60 participantsStarted 2019-10-01
Plain-language summary
People with type 1 diabetes need long-term insulin injections. However, needles may cause discomfort or provoke anxiety if the patient has needle phobia, factors that contribute to poor compliance with insulin, especially in younger patients. Use of needle-free technology has been proposed as a strategy to mitigate these problems. There have been few studies on the efficacy of needle-free syringes for patients with type 1 diabetes. To determine the efficacy of needle-free injection of insulin in its patient population, people with type 1 diabetes, we conduct a pilot study to assess glycemic control and injection experience of patients. For the comparator device, we used an insulin pen. The primary objective is to explore whether needle-free syringes are more beneficial to control blood glucose than insulin pens of type 1 diabetes, which the blood sugar fluctuates significantly. The secondary objective is to evaluate the experience and safety of insulin administration by the needle-free injection.
Who can participate
Age range
12 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:
* Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report
* Insulin dependence from disease onset
* Older than 12
* The patient's blood glucose is stable after the washout period (insulin dose is less than 30% compared with the last adjustment).
Exclusion Criteria:
* Recent unstable angina, myocardial infarction, or severe cardiac failure, blood pressure ≥180/100mm Hg, activities of hepatic transaminases \>2.5 times the upper limit of normal and estimated glomerular filtration rate \<30mL/min/1.73m2
* Being pregnant
* Serious mental problems
* Abuse of alcohol or narcotics
* Use of systemic glucocorticoids
* Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial
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
Continuous Glucose Monitoring(CGM)
Timeframe: from baseline to week 4, 12
2
changes in serum hemoglobin A1c level
Timeframe: from baseline to week 12
Trial details
NCT IDNCT04094740
SponsorSecond Xiangya Hospital of Central South University