Effect of Insulin Administered by Needle-free Jet Injection on Blood Glucose Control and Injection Feelings in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Continuous Glucose Monitoring(CGM)
研究概览
简要总结
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.
详细描述
This is a single-center, prospective, 1:1 parallel-group, randomized controlled trial. The intervention will last for 12 weeks. The laboratory staff who tests the HbA1c level, the outcome assessor who collects the blood glucose data and injection experience include the measurement of perceived pain, skin condition at the injection site, and device preference in participants, and the statisticians will be blinded to the treatment allocation.
After informed consent is obtained, the participants can attend an initial study visit to determine eligibility for the trial. We propose to enroll 60 patients with type 1 diabetes (T1DM), participants are randomized into two groups, 30 in the needle-free jet injection group and 30 in the pen injection group. Sample size estimation is based on hypothesized changes in the primary outcome pre-prandial glucose in the morning. Participants are randomized using a computer-generated list.
In order to ensure high quality data, two staff are responsible for the input of original data into the database to check and confirm the accuracy. When the data entered by two people are inconsistent, the auxiliary staff decides which data to use.
Data analysis will be conducted under the intention-to-treat principle by including all the randomized patients in the data analysis. Missing data will be filled in with multiple imputation method. Any substantial difference in baseline characteristics will be adjusted with mixed-model regression analysis. Sensitivity analysis will be conducted by using per-protocol data by excluding those patients who drop out of the RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Needle-free Jet Injector
Subjects will be instructed to use a needle-free syringe to inject insulin during the study period. The dosage and frequency of insulin are determined by the responsible physician according to the patient's condition.
干预措施: Jet Injector without A Needle (Device)
Conventional Insulin Pen
Patients allocated to the control group will be instructed to use conventional insulin pens to inject insulin. Except for the syringe, all of them are the same as the experimental group.
Routine Care
Subjects can receive the education provided by health-care professionals and training in the outpatient department and inpatient departments.
结局指标
主要结局
Continuous Glucose Monitoring(CGM)
时间窗: from baseline to week 4, 12
CGM reflects the blood glucose fluctuations in the past 2-3 days.
changes in serum hemoglobin A1c level
时间窗: from baseline to week 12
A1c reflects the average blood glucose level in the past 2-3 months.
次要结局
- Adjusted Diabetes Quality of Life Measure (A-DQOL)(from baseline to week 2，4，12)
- Visual Analog Scale(From baseline to every 2 weeks)
- Insulin Treatment Satisfaction Questionnaire(from baseline to week 2，4，12)
- Fasting blood glucose(From baseline to every 2 weeks)
- Weight in kilograms(from baseline to week 4，12)
- Diastolic blood pressure(from baseline to week 4，12)
- Adverse events(every 2 weeks from baseline to week 12)
- Total daily dose of insulin(every 2 weeks from baseline to week 12)
- Insulin Treatment Attitude Scale(from baseline to week 2，4，12)
- Insulin Treatment Adherence Questionnaire(from baseline to week 2，4，12)
- Height in meters(from baseline to week 4，12)
- Skin condition at the injection site(every 2 weeks from baseline to week 12)
- Systolic blood pressure(from baseline to week 4，12)
研究者
Xia Li
Professor, Department of Endocrinology, Institute of of Metabolism and Endocrinology, Nationa Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital of Central South University
Second Xiangya Hospital of Central South University