Type 2 diabetes
Conditions
Interventions
Group A: the Pt-led group Subjects adjust insulin dosage by themselves during the 24 weeks * U300 as one unit per day is increased if there is no hypoglycemic signs in last 3 days (3 measurements),
/investigators'
instruction, aiming for FPG below 110 mg/dl * After patients feel to have hypoglycemia, they make a contact (by telephone, etc.) to their physicians/investigators, then the dosage (unit) adjustment
Sponsors
Japan society for Patient Reported Outcome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. Type 2 diabetic patients who newly start to use insulin, and are able to inject by themselves 2. Men and women at 20 years of age or older when providing their written consent 3. Patients who are diagnosed as type 2 diabetes for 6 months or longer 4. Use OHA for at least 3 months or longer 5. HbA1c is 7% or higher, and lower than 10% 6. BMI is 30.0 kg/m2 or lower 7. Can appropriately use SMBG (Self-Monitoring of Blood Glucose) 8. Can provide a written consent
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients with dementia or possibly with dementia, or with psychological illness 2. Unable to make judgement for themselves, or incapable of reading and writing 3. Need a proxy's consent to join the study 4. With visual impairment which interferes with self-injection 5. Have an experience of using GLP-1 or insulin in the past 6. Currently on systemic steroid, beta-blocker, monoamine oxidase, etc., that may have an influence on glycemic control 7. If insulin is contradicted to use, or needs to be carefully used 8. Have an experience of myocardial infarction, angina, stroke, or cerebral infarction within 6 months before the baseline 9. With liver failure (ALT is doubled or higher than that of the upper limit in healthy individuals) 10. With renal impairment (SCr is 125 mumol/L or higher (1.4 mg/dL or higher) among men, and is 110 mumol/L or higher (1.3 mg/dL or higher) among women 11. Possibly pregnant or pregnant, or plant to be pregnant during the study period 12. Currently have malignancy, or had it in the past 13. Any condition that physicians think to be inappropriate to join the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of changes in scores of PAID (The Problem Areas In Diabetes Scale) from baseline to the 24th week | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed