Type 1 and Type 2 Diabetes
Conditions
Interventions
None listed
Sponsors
Toho University Omori Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: About Type 1 Diabetes 1. Patients with type 1 diabetes 2. Patients aged 18 years or older but under 75 years at the start of the study (at the time of ethics committee approval) 3. Patients undergoing treatment with frequent insulin injections 4. Patients with HbA1c <8.0% at the start of the study (at the time of ethics committee approval) 5. Patients capable of consenting to participate in this study and able to understand the consent form and other explanatory documents About Type 2 Diabetes 1. Patients with Type 2 Diabetes 2. Patients aged 18 years or older at the start of the study (at the time of ethics committee approval) 3. Patients undergoing treatment with frequent insulin injections 4. Patients with HbA1c <10.0% at the start of the study (at the time of ethics committee approval) 5. Patients capable of consenting to participate in this study and able to understand the consent form and other explanatory documents
Exclusion criteria
Exclusion criteria: About Type 1 Diabetes Patients meeting any of the following criteria are excluded from this study. 1. Type 2 diabetes 2. Heavy alcohol drinkers (pure alcohol intake of 60g/day or more for men, 30g/day or more for women) 3. Patients with dementia 4. Pregnant women, women who may be pregnant, women who wish to become pregnant, and breastfeeding women 5. Patients whose primary physician determines they have poor adherence 6. Other patients deemed unsuitable for participation in this study by the responsible physician About Type 2 Diabetes Patients meeting any of the following criteria are excluded from this study. 1. Type 1 diabetes 2. Heavy alcohol drinkers (pure alcohol intake of 60g/day or more for men, 30g/day or more for women) 3. Patients with dementia 4. Pregnant women, women who may be pregnant, women who wish to become pregnant, and breastfeeding women 5. Patients deemed to have poor adherence by their primary physician 6. Other patients deemed unsuitable for participation in this study by the responsible physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in DTSQ and DTR-QOL scores before switching and 6 months after switching | — |
Secondary
| Measure | Time frame |
|---|---|
| Before switching and 1 month, 3 months, and 6 months after switching, confirm the following: HbA1c, TIR (Time In Range: percentage of time within the target range (70-180 mg/dL)), TAR (Time Above Range: percentage of time above the TIR in the hyperglycemic range), TBR (Time Below Range: percentage of time below the TIR in the hypoglycemic range), fasting blood glucose, insulin dosage, weight Safety evaluation items: Hypoglycemic episodes (number/duration, etc. of: self-reported hypoglycemia; Level 1 hypoglycemia (blood glucose <70 mg/dL persisting for 15 minutes or more without blood glucose <54 mg/dL, or occurring within 15 minutes); Level 2 hypoglycemia (blood glucose <54 mg/dL persisting for 15 minutes or more)) | — |
Countries
Japan
Contacts
Public ContactYoko Iwata
Toho University Omori Medical Center Diabetes, Metabolism and Endocrinology Center
Outcome results
None listed