Evaluation of Efficacy and Safety of Insulin Glargine Injected by Needle-free Jet Syringe
1 other identifier
interventional
60
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Sep 2019
Shorter than P25 for not_applicable diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2019
CompletedFirst Submitted
Initial submission to the registry
September 16, 2019
CompletedFirst Posted
Study publicly available on registry
September 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedSeptember 18, 2019
September 1, 2019
1 month
September 16, 2019
September 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood glucose profile
changes of blood glucose profile
9 days
Secondary Outcomes (1)
Sensitivity Questionnaire of Patients
9 days
Study Arms (2)
Group A
EXPERIMENTALThe needle-free jet injector Continuous insulin therapy for 9 days, then changed to conventional insulin pen therapy for 9 days
Group B
EXPERIMENTALThe conventional insulin pen therapy for 9 days, then changed to needle-free jet injector Continuous insulin therapy for 9 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33317342DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2019
First Posted
September 18, 2019
Study Start
September 12, 2019
Primary Completion
October 20, 2019
Study Completion
October 30, 2019
Last Updated
September 18, 2019
Record last verified: 2019-09