Skip to content

After hypodermic injection of needleless syringe and special filling pen A controlled study of blood glucose variation

After hypodermic injection of needleless syringe and special filling pen A controlled study of blood glucose variation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034674
Enrollment
Unknown
Registered
2020-07-14
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood glucose variability

Interventions

Two groups:Needleless syringe versus special flling pen

Sponsors

Department of Endocrinology, Tangdu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. For men or women aged 18-70 years, women of childbearing age should take adequate contraceptive measures to minimize the risk of pregnancy; 2. Patients who meet the diagnostic criteria of type 2 diabetes and have a course of more than half a year; 3. BMI 18 Kg/m2 to 30Kg/m2; 4. Patients who received once daily injection of insulin glargine and one or three oral drugs (excluding secretagogue agents) had a daily total dose of insulin glargine 12 IU to 50 IU, and used insulin glargine for more than 1 month; 5. Patients with fasting venous blood glucose between 5.0 and 9.0 mmol/L; 6. Patients who have read and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have conflict of interest with this study; 2. Patients with poor glycemic control and unable to participate in this study, such as repeated hypoglycemia, diabetic ketoacidosis or hyperosmolar coma history, and other adverse events of blood glucose control; 3. Patients with severe diabetic complications, such as diabetic foot, diabetic nephropathy, etc; 4. Patients with severe cardiovascular events in recent 6 months; 5. Patients with deficiency or low immunity due to hormone or immunosuppressive therapy; 6. Patients with NSAIDs; 7. Patients with sulfonylureas and insulin secretagogues; 8. Patients with a history of tumor; 9. Patients with a history of unstable or rapidly progressive kidney disease; 10. Patients with unstable major mental history; 11. Patients with a history of hemoglobinopathy (such as sickle cell anemia, thalassemia, sideroblastic anemia); 12. Pregnant or lactating women; 13. Patients with definite infection recently, such as urinary tract infection and pneumonia; 14. Patients with recent active bleeding of important organs, such as gastric hemorrhage, cerebral hemorrhage, etc; 15. Patients with exfoliative dermatitis, impetigo, pyogenic infection and other skin diseases; 16. Patients with a history of acute pancreatitis or pancreatectomy; 17. Any situation that the researcher considers may cause the subject unable to complete the study or may cause significant risk to the subject. 18. Patients with the following laboratory results: (1) Obvious abnormal liver function or active liver disease (AST > 3.0 times of upper normal limit or ALT > 3.0 times of normal upper limit); (2) Creatinine clearance rate was less than 60 ml / min; (3) Anemia caused by any cause; (4) The pregnancy test results of women of childbearing age were positive.

Design outcomes

Primary

MeasureTime frame
Blood glucose variability;

Secondary

MeasureTime frame
Insulin consumption and health economics assessment;

Countries

China

Contacts

Public ContactGao Bin

Department of Endocrinology, Tangdu Hospital

8823317@qq.com+86 13772100470

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026