Comparing the Effects of Insulin Glargine on Blood Glucose Between Needle-free Jet Injection and Insulin Pen

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: The needle-free jet injector; Device: Conventional insulin pen

• Registration Number: NCT04074603
• Lead Sponsor: Jian-hua Ma

Brief Summary

To comparing 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 and safety in type 2 diabetic patients.

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-29
• Study First Posted: 2019-08-30
• Study Start: 2019-09-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• volunteer to participate and be able to sign informed consent prior to the trial.
• patients with type 2 diabetes, aged 18-80 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. The dosage of insulin glargine (4-35 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	The needle-free jet injector	needle-free before needle
Group B	Conventional insulin pen	needlebefore needle-free

Primary Outcome Measures

Name	Time	Method
The glucose fluctuation	2 weeks	The effect of Needle-free Jet Injection and Insulin Pen injection Insulin Glargine on glucose profile (MAGE, 24h-MG, CV%, SDBG, TAR, TIR, TBR) changes in type 2 diabetes mellitus by FGM.
Blood glucose changes	2 weeks	The effect of Needle-free Jet Injection and Insulin Pen injection Insulin Glargine on blood glucose changes in T2Dm

Secondary Outcome Measures

Name	Time	Method
Assessment of safety and tolerance	2 weeks	The effect of Needle-free Jet Injection and Insulin Pen injection Insulin Glargine on safety and tolerance changes in type 2 diabetes mellitus by Questionnaire.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China