Effect of Needle-free Jet Injection of Insulin on Glucose Control and Injection Feelings in Type 1 Diabetic Patients

Type 1 Diabetes Clinical Trial

Official title:

Effect of Insulin Administered by Needle-free Jet Injection on Blood Glucose Control and Injection Feelings in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04094740
• Other study ID #: JI-EC T1D 2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2019
• Source: Second Xiangya Hospital of Central South University
• Contact: Xia Li, MD/PHD
• Phone: +86 17373199692
• Email: lixia2014[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Jet Injector without A Needle
Patients in the experimental group will use a needle - free jet injector to inject insulin, which delivers insulin at a high velocity into subcutaneous tissue and dispenses insulin over a larger area than a syringe.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Glucose Monitoring(CGM)	CGM reflects the blood glucose fluctuations in the past 2-3 days.	from baseline to week 4, 12
Primary	changes in serum hemoglobin A1c level	A1c reflects the average blood glucose level in the past 2-3 months.	from baseline to week 12
Secondary	Visual Analog Scale	Visual Analog Scale is used to assess perceived pain in each injection. Participants will complete a visual analog scale in which perceived pain is scored from 0 (no pain) to 10 (worst pain ever).	From baseline to every 2 weeks
Secondary	Insulin Treatment Satisfaction Questionnaire	Insulin Treatment Satisfaction Questionnaire (ITSQ) is used to assess the diabetes insulin treatment satisfaction. This scale contains 5-factor, 22-item instrument assessing regimen inconvenience, lifestyle flexibility, glycemic control, hypoglycemic control, and satisfaction with the insulin delivery device. Participants evaluate it based on their treatment experience over the past 4 weeks. Each item is divided into seven grades (1-7 points), and the total score of the scale is the mean score of the five dimensions. Higher score reflects better the satisfaction.	from baseline to week 2,4,12
Secondary	Insulin Treatment Attitude Scale	Insulin Treatment Attitude Scale (ITAS) is to assess the attitude of diabetes towards insulin treatment. This scale contains 3 aspects with a total of 20 items, Using the Liket5 scoring method, from strongly disagree (1 point) to strongly agree (5 points), the total score of more than 60 points is considered as the presence of psychological insulin resistance.	from baseline to week 2,4,12
Secondary	Insulin Treatment Adherence Questionnaire	Insulin treatment adherence questionnaire (ITAQ) is to assess the diabetes insulin treatment compliance. This scale contains five aspects with a total of 22 items: Medications, diet, exercise, self-monitoring of blood sugar, regular review. Items are graded on a regular basis (1 point), occasionally (2 points), and never (3 points), the total score of more than 44 points is considered as better the compliance.	from baseline to week 2,4,12
Secondary	Adjusted Diabetes Quality of Life Measure (A-DQOL)	Adjusted-Diabetes Quality of Life Measure (DQOL) is to assess the quality of life of diabetic patients. This scale contains four aspects with a total of 46 items: satisfaction degree, influence degree, worry degree?and worry degree?.	from baseline to week 2,4,12
Secondary	Skin condition at the injection site	The staff detects the skin condition by the B-mode ultrasound machine to assess whether there is fatty hyperplasia, skin depression, etc.	every 2 weeks from baseline to week 12
Secondary	Fasting blood glucose	the blood sugar level after fasting for eight hours	From baseline to every 2 weeks
Secondary	Systolic blood pressure	Systolic blood pressure	from baseline to week 4,12
Secondary	Diastolic blood pressure	Diastolic blood pressure	from baseline to week 4,12
Secondary	Height in meters	Height in meters will be measured	from baseline to week 4,12
Secondary	Weight in kilograms	Weight in kilograms will be measured.	from baseline to week 4,12
Secondary	Total daily dose of insulin	Contains all insulin doses for the day	every 2 weeks from baseline to week 12
Secondary	Adverse events	Safety-related outcomes including hypoglycemic events, hospitalization, and emergency room visits will be collected at each follow-up time point including the weekly telephone interview.	every 2 weeks from baseline to week 12