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A Study Examining Pre-Breakfast Blood Glucose Variability in Patients Using Continuous Glucose Monitors

A Study on Early Morning Fasting Blood Glucose Variability in Patients Using isCGM - A Study on Blood Glucose Fluctuations

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061722
Enrollment
20
Registered
2026-05-28
Start date
2025-10-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

We ask participants to maintain a consistent daily routine for four weeks, as much as possible.

Sponsors

JCHO Tokuyama Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Is there an inverse correlation between early morning fasting blood glucose levels and the fasting C-peptide index?

Secondary

MeasureTime frame
Does fasting blood glucose fluctuate periodically in the early morning?

Countries

Japan

Contacts

Public ContactShunsuke Hayashi

JCHO Tokuyama Central Hospital Department of Hematology and Diabetes/Endocrinology

hayashi-shunsuke@tokuyama.jcho.go.jp0834-28-4411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026