Type 1 DiabetesNCT04094740
Effect of Needle-free Jet Injection of Insulin on Glucose Control and Injection Feelings in Type 1 Diabetic Patients
A study testing Jet Injector without A Needle in people with Type 1 Diabetes, run by Second Xiangya Hospital of Central South University.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Jet Injector without A Needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Insulin Administered by Needle-free Jet Injection on Blood Glucose Control and Injection Feelings in Patients With Type 1 Diabetes
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.
Read the detailed 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Jet Injector without A Needle
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jet Injector without A NeedleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Needle-free Jet Injector | Experimental | 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. Receives: Device: Jet Injector without A Needle |
| Conventional Insulin Pen | No intervention | 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 | No intervention | Subjects can receive the education provided by health-care professionals and training in the outpatient department and inpatient departments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Glucose Monitoring(CGM)
CGM reflects the blood glucose fluctuations in the past 2-3 days.
Measured: from baseline to week 4, 12
changes in serum hemoglobin A1c level
A1c reflects the average blood glucose level in the past 2-3 months.
Measured: from baseline to week 12
Secondary outcomes (13)
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).
Measured: From baseline to every 2 weeks
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.
Measured: from baseline to week 2，4，12
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.
Measured: from baseline to week 2，4，12
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.
Measured: from baseline to week 2，4，12
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 degreeⅠand worry degreeⅡ.
Measured: from baseline to week 2，4，12
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.
Measured: every 2 weeks from baseline to week 12
Fasting blood glucose
the blood sugar level after fasting for eight hours
Measured: From baseline to every 2 weeks
Systolic blood pressure
Systolic blood pressure
Measured: from baseline to week 4，12
Diastolic blood pressure
Diastolic blood pressure
Measured: from baseline to week 4，12
Height in meters
Height in meters will be measured
Measured: from baseline to week 4，12
Weight in kilograms
Weight in kilograms will be measured.
Measured: from baseline to week 4，12
Total daily dose of insulin
Contains all insulin doses for the day
Measured: every 2 weeks from baseline to week 12
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.
Measured: every 2 weeks from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Li, Second Xiangya Hospital of Central South University
- Investigators
- Xia Li, MD/PHD, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094740
- Sponsor's protocol ID
- JI-EC T1D 2019
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Insulin Administered by Needle-free Jet Injection on Blood Glucose Control and Injection Feelings in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04094740
- Acronym / sponsor ID
- JI-EC T1D 2019
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Needle-free Jet Injector | Experimental | Device: Jet Injector without A NeedleSubjects 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. |
| Conventional Insulin Pen | No intervention | –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 | No intervention | –Subjects can receive the education provided by health-care professionals and training in the outpatient department and inpatient departments. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jet Injector without A NeedlePatients 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. | Device | Needle-free Jet Injector |
Primary outcome
Continuous Glucose Monitoring(CGM)
Time frame: from baseline to week 4, 12
CGM reflects the blood glucose fluctuations in the past 2-3 days.
changes in serum hemoglobin A1c level
Time frame: from baseline to week 12
A1c reflects the average blood glucose level in the past 2-3 months.
13 secondary outcomes
Visual Analog Scale
Time frame: From baseline to every 2 weeks
Insulin Treatment Satisfaction Questionnaire
Time frame: from baseline to week 2，4，12
Insulin Treatment Attitude Scale
Time frame: from baseline to week 2，4，12
Insulin Treatment Adherence Questionnaire
Time frame: from baseline to week 2，4，12
Adjusted Diabetes Quality of Life Measure (A-DQOL)
Time frame: from baseline to week 2，4，12
Skin condition at the injection site
Time frame: every 2 weeks from baseline to week 12
Fasting blood glucose
Time frame: From baseline to every 2 weeks
Systolic blood pressure
Time frame: from baseline to week 4，12
Diastolic blood pressure
Time frame: from baseline to week 4，12
Height in meters
Time frame: from baseline to week 4，12
Weight in kilograms
Time frame: from baseline to week 4，12
Total daily dose of insulin
Time frame: every 2 weeks from baseline to week 12
Adverse events
Time frame: every 2 weeks from baseline to week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xia Li, MD/PHD principal investigator
Central South University
Questions about this trial
What is this clinical trial studying?
A study testing Jet Injector without A Needle in people with Type 1 Diabetes, run by Second Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xia Li, MD/PHD (+86 17373199692, lixia2014@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Glucose Monitoring(CGM) (time frame: from baseline to week 4, 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.