Type 1 and 2 diabetes
Conditions
Interventions
Use BD Microfine plus 32G x 4mm for insulin injection during the first 4 weeks and use Novo Pen needle 32G x 6mm during next 4 weeks.
Use Novo Pen needle 32G x 6mm for insulin injection during the fir
Sponsors
Tokyo Medical University The 3rd Department of Internal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Type 1 and 2 diabetic patients at the age of 20 years or older 2)Insulin-requiring diabetics who have used a pen device for at least one year prior to Study Visit 0 3)Patients who need two or more injections per day. 4)Patients who measure blood glucose level themselves at home. 5)Patients who have maintained a stable Hemoglobin A1C level from 5.5% to 8.5%. 6)Body Mass Index is under 35. 7)Patients who have a will to complete all the procedures of this investigation. 8)Patients who can fill in results on the CRFs. 9)Patients who can understand informed consent and have a will to enroll in this investigation.
Exclusion criteria
Exclusion criteria: 1)Pregnancy or possibility of pregnancy. 2)Lactating women 3)Serious neurological diseases 4)Physical conditions which unable subjects to carry out the study procedures (e.g., Incapability to inject by themselves). 5)Thyroid deficiencies and/or nephrotic syndrome. 6)Patients who are currently enrolled in another clinical study 7)Patients who have already discussed details with employees of BD Japan or enrolled study subjects regarding the Investigation. 8)Patients for whom Principle Investigator or Investigators consider that their enrollment could expose them to any risk. 9)Patients who can confuse the interpretation of investigation results or who have done. 10)Employees of pharmaceutical or medical device companies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average variation rates between glycated albumin level after one-month use of BD Microfine plus 32G x 4mm and that after one-month use of Novo Pen needle 32G x 6mm. | — |
Countries
Japan
Contacts
Public ContactTakashi Miwa
Tokyo Medical University The 3rd Department of Internal Medicine
Outcome results
None listed