Diabetes Mellitus, Type 2NCT04093284
Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
A study testing The needle-free jet injector in people with Diabetes Mellitus, Type 2, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
Using CGMS to compare the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- The needle-free jet injector
- Type of treatment
- 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
- 12 Sep 2019to 30 Oct 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- volunteer to participate and be able to sign informed consent prior to the trial.
- patients with type 2 diabetes, aged 18-65 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (12-18 units) combined with oral medicationis, stable for more than 2 months.
- No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
- Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.
Who cannot join
- Patients with insulin allergy.
- Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
- Drug abuse and alcohol dependence in the past 5 years.
- Systemic hormone therapy was used in the last three months.
- Patients with poor compliance and irregular diet and exercise.
- Patients with pregnancy, lactation or pregnancy intention.
- Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Using CGMS to compare the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen
Read the detailed description
Compared with conventional pen, needle-free jet injection of insulin has faster flow rate and larger area of local subcutaneous absorption. The aim of this study was to investigate the effects of subcutaneous insulin glargine injection with needle-free jet injection and conventional pen on blood glucose profile of CGMS and safety in type 2 diabetic patients.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- The needle-free jet injector
- Keywords
- Needle-free jet injection, Insulin glargine, Flash Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The needle-free jet injectorDevice
Continuous insulin therapy for 9 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The needle-free jet injector Continuous insulin therapy for 9 days, then changed to conventional insulin pen therapy for 9 days Receives: Device: The needle-free jet injector |
| Group B | Experimental | The conventional insulin pen therapy for 9 days, then changed to needle-free jet injector Continuous insulin therapy for 9 days Receives: Device: The needle-free jet injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose profile
changes of blood glucose profile
Measured: 9 days
Secondary outcomes (1)
Sensitivity Questionnaire of Patients
changes of Sensitivity Questionnaire of Patients
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start12 Sep 2019 (estimated)
- Primary completion20 Oct 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093284
- Sponsor's protocol ID
- KY20190823-01
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kong X, Luo M, Cai L, Zhang P, Yan R, Hu Y, Li H, Ma J. Needle-free jet injection of insulin glargine improves glycemic control in patients with type 2 diabetes mellitus: a study based on the flash glucose monitoring system. Expert Opin Drug Deliv. 2021 May;18(5):635-641. doi: 10.1080/17425247.2021.1863945. Epub 2021 Feb 19.
PubMed 33317342
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
- ClinicalTrials.gov ID
- NCT04093284
- Acronym / sponsor ID
- KY20190823-01
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Needle-free jet injection, Insulin glargine, Flash Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 12 Sep 2019 (estimated)
- Primary completion
- 20 Oct 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 18 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.
Using CGMS to compare the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen
Detailed description
Compared with conventional pen, needle-free jet injection of insulin has faster flow rate and larger area of local subcutaneous absorption. The aim of this study was to investigate the effects of subcutaneous insulin glargine injection with needle-free jet injection and conventional pen on blood glucose profile of CGMS and safety in type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: The needle-free jet injectorThe needle-free jet injector Continuous insulin therapy for 9 days, then changed to conventional insulin pen therapy for 9 days |
| Group B | Experimental | Device: The needle-free jet injectorThe conventional insulin pen therapy for 9 days, then changed to needle-free jet injector Continuous insulin therapy for 9 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- volunteer to participate and be able to sign informed consent prior to the trial.
- patients with type 2 diabetes, aged 18-65 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (12-18 units) combined with oral medicationis, stable for more than 2 months.
- No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
- Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.
Key exclusion criteria (7 listed)
- Patients with insulin allergy.
- Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
- Drug abuse and alcohol dependence in the past 5 years.
- Systemic hormone therapy was used in the last three months.
- Patients with poor compliance and irregular diet and exercise.
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 |
|---|---|---|
| The needle-free jet injectorContinuous insulin therapy for 9 days | Device | Group A, Group B |
Primary outcome
Blood glucose profile
Time frame: 9 days
changes of blood glucose profile
1 secondary outcome
Sensitivity Questionnaire of Patients
Time frame: 9 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Derived from this study: PubMed 33317342Kong X, Luo M, Cai L, Zhang P, Yan R, Hu Y, Li H, Ma J. Needle-free jet injection of insulin glargine improves glycemic control in patients with type 2 diabetes mellitus: a study based on the flash glucose monitoring system. Expert Opin Drug Deliv. 2021 May;18(5):635-641. doi: 10.1080/17425247.2021.1863945. Epub 2021 Feb 19.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing The needle-free jet injector in people with Diabetes Mellitus, Type 2, run by Nanjing First Hospital, Nanjing Medical 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 7 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 18 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 Jianhua Ma (+8618951670116 ext. +8618951670116, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose profile (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093284, which also lists 1 linked publication.
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 18 Sep 2019.