UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061722 |
|---|---|
| Receipt number | R000070641 |
| Scientific Title | A Study on Early Morning Fasting Blood Glucose Variability in Patients Using isCGM |
| Date of disclosure of the study information | 2026/05/28 |
| Last modified on | 2026/05/28 17:28:59 |
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Basic information
Public title
A Study Examining Pre-Breakfast Blood Glucose Variability in Patients Using Continuous Glucose Monitors
Acronym
Blood glucose fluctuations in continuous glucose monitoring
Scientific Title
A Study on Early Morning Fasting Blood Glucose Variability in Patients Using isCGM
Scientific Title:Acronym
A Study on Blood Glucose Fluctuations
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
The purpose of this study is to test the hypothesis that early morning fasting blood glucose levels are inversely correlated with the fasting C-peptide index, and that early morning fasting blood glucose levels fluctuate cyclically.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Is there an inverse correlation between early morning fasting blood glucose levels and the fasting C-peptide index?
Key secondary outcomes
Does fasting blood glucose fluctuate periodically in the early morning?
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We ask participants to maintain a consistent daily routine for four weeks, as much as possible.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Hayashi |
Organization
JCHO Tokuyama Central Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
7450822
Address
1-1 Kodacho, Shunan, Yamaguchi 745-0822, Japan
TEL
0834-28-4411
hayashi-shunsuke@tokuyama.jcho.go.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Hayashi |
Organization
JCHO Tokuyama Central Hospital
Division name
Department of Hematology and Diabetes/Endocrinology
Zip code
7450822
Address
1-1 Kodacho, Shunan, Yamaguchi 745-0822, Japan
TEL
0834-28-4411
Homepage URL
hayashi-shunsuke@tokuyama.jcho.go.jp
Sponsor or person
Institute
JCHO Tokuyama Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tokuyama Central Hospital
Address
1-1 Kodacho, Shunan, Yamaguchi 745-0822, Japan
Tel
0834-28-4411
irb-cr@tokuyama.jcho.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070641
