Diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with type 1 diabetes, patients with reduced insulin secretion following pancreatic surgery, or patients with type 2 diabetes who are considered insulin-dependent. 2. Patients receiving intensive insulin therapy (long-acting insulin plus (ultra) rapid-acting insulin); patients receiving premixed insulin plus (ultra) rapid-acting insulin; patients receiving three daily injections of (ultra) rapid-acting insulin alone; or patients receiving continuous subcutaneous insulin infusion (CSII) via an insulin pump. 3. Patients whose daily routines are generally consistent and who do not stay up late excessively or experience significant fluctuations in their daily schedules (unstable blood glucose levels are not an exclusion criterion). 4. Since obesity affects insulin secretion, this study is limited to patients with a BMI < 25.
Exclusion criteria
Exclusion criteria: 1. Exclude jobs involving three-shift work and shift workers. Exclude dialysis patients. 2. Patients who menstruate are excluded because blood glucose fluctuations associated with menstruation are known to occur. 3. Patients under the age of 18 or those suspected of having impaired cognitive function will be excluded. 4. Patients using intermediate-acting insulin are excluded. Patients receiving only once-weekly long-acting insulin injections are excluded. 5. Patients with cancer, patients undergoing chemotherapy, and patients receiving steroid therapy (patients with cancer whose condition is stable and who are not undergoing chemotherapy are excluded from the exclusion criteria). 6. Patients taking SU agents or glinides (insulin secretagogues). 7. Patients with an eGFR <45 are excluded because impaired renal function results in elevated serum C-peptide levels. 8. Patients who cannot understand the overview of the clinical trial, or who have impaired comprehension or cognitive function. 9. Patients who are unable to decide on their own whether to participate in the trial. 10. Any other patients deemed unsuitable by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Is there an inverse correlation between early morning fasting blood glucose levels and the fasting C-peptide index? | — |
Secondary
| Measure | Time frame |
|---|---|
| Does fasting blood glucose fluctuate periodically in the early morning? | — |
Countries
Japan
Contacts
JCHO Tokuyama Central Hospital Department of Hematology and Diabetes/Endocrinology