Tokyo, May 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061722) titled 'A Study Examining Pre-Breakfast Blood Glucose Variability in Patients Using Continuous Glucose Monitors' on May 28.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - JCHO Tokuyama Central Hospital

Condition: Condition - Diabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - We will examine whether early morning fasting blood glucose levels are inversely correlated with the fasting C-peptide index in data collected during isCGM use. Furthermore, we will investigate whether early morning fasting blood glucose levels fluctuate cyclically. Basic objectives2 - Others

Intervention: Interventions/Control_1 - We ask participants to maintain a consistent daily routine for four weeks, as much as possible.

Eligibility: Age-lower limit - 19 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 20

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 10 Month 02 Day Date of IRB - 2025 Year 10 Month 02 Day Anticipated trial start date - 2025 Year 10 Month 02 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070641

Disclaimer: Curated by HT Syndication.