UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060090 |
|---|---|
| Receipt number | R000068724 |
| Scientific Title | An Observational Study on Blood Glucose Variation Patterns in Healthy Individuals under Free-Living Conditions |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/15 17:13:41 |
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Basic information
Public title
Analysis of Blood Glucose Variation Patterns in Healthy Individuals under Free-Living Conditions
Acronym
Free-Living Glucose Variability Study
Scientific Title
An Observational Study on Blood Glucose Variation Patterns in Healthy Individuals under Free-Living Conditions
Scientific Title:Acronym
Free-Living Glucose Variability Study
Region
| Japan |
Condition
Condition
None (Healthy Individuals)
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to record and analyze temporal changes in blood glucose levels during daily living by having Japanese healthy individuals wear an intermittently scanned continuous glucose monitoring device (isCGM) for a specified period. In particular, the study aims to calculate CGM metrics, including Time in Range (TIR), and to clarify characteristic glucose variability patterns in individuals with normal glucose tolerance. Additionally, the study will examine associations between glucose variability and physical characteristics such as body composition (visceral fat and muscle mass), obesity indices, age, sex, and height. By establishing reference ranges for healthy glucose profiles specific to the Japanese population, this study seeks to contribute to the development of diagnostic, preventive, and interventional indicators for diabetes.
Basic objectives2
Others
Basic objectives -Others
An observational study aimed at analyzing glucose variability patterns and their determinants in healthy individuals.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the percentage of time spent in each CGM-derived metric: Time in Range (TIR), Time in Tight Range (TITR), Time Above Range (TAR), and Time Below Range (TBR) in individuals with normal glucose tolerance, and to determine their reference values and distribution.
Key secondary outcomes
To calculate CGM metrics including TBR, TIR, TAR, MARD, GMI, SD, %CV, and MAGE. If necessary, participants will be classified into normal glucose tolerance, impaired glucose tolerance, and diabetes groups based on blood test results, and the percentage of time spent in TIR, TITR, TAR, and TBR will be calculated and compared among these groups.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers aged 18 years or older who respond to recruitment advertisements, are able to undergo blood sampling, questionnaires, isCGM placement, and body composition analysis, and who provide written informed consent after adequate explanation.
Key exclusion criteria
Individuals with diagnosed diabetes or impaired glucose tolerance, those receiving oral steroid therapy, those with significant internal medical disorders, those who are pregnant or breastfeeding, and those deemed inappropriate by the investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Haraguchi |
Organization
Nagasaki university hospital
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197262
a-haraguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | HIDEYUKI |
| Middle name | |
| Last name | TSUCHIYAMA |
Organization
Nagasaki university hospital
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197262
Homepage URL
tsuchiyama-h@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7464
a-haraguchi@nagasaki-u.ac.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
| 2025 | Year | 12 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a non interventional prospective observational study in which participants wear an isCGM device for a specified period to obtain glucose data under free living conditions. The study aims to establish reference values for CGM metrics in healthy individuals and contribute to the development of future diagnostic and preventive indicators for diabetes.
Management information
Registered date
| 2025 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068724
