UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061130 |
|---|---|
| Receipt number | R000069419 |
| Scientific Title | Structural analysis of diabetes-related stigma: Integrated analysis of data from Tokushima University and the Kansai Electric Power Medical Research Institute |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/04/01 15:45:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Structural Analysis of Diabetes-Related Stigma
Acronym
TODS Integrated Study (TODS-I Study)
Scientific Title
Structural analysis of diabetes-related stigma: Integrated analysis of data from Tokushima University and the Kansai Electric Power Medical Research Institute
Scientific Title:Acronym
Integrated Structural Analysis of Diabetes Stigma
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to integrate KISS data and clinical information obtained from the (TODS Study) conducted at Tokushima University (Approval No. 4570-3) and the study (Development of a stigma scale for patients with chronic diseases related to lifestyle) conducted at Kansai Electric Power Hospital (Approval No. 19-008). By combining these datasets, the study seeks to perform a structural analysis of diabetes-related stigma among individuals with type 1 and type 2 diabetes and to identify stigma patterns and their associated clinical backgrounds.
Basic objectives2
Others
Basic objectives -Others
This study is an exploratory analysis aimed at identifying the structural characteristics of diabetes-related stigma.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of structural patterns (clusters) of diabetes-related stigma using clustering analysis of integrated KISS data and clinical information.
Key secondary outcomes
Comparison of clinical characteristics (age, sex, diabetes type, HbA1c, etc.) across the identified clusters.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with diabetes (type 1 or type 2).
Patients aged 20 years or older.
Patients who have provided informed consent.
Patients who are capable of answering the self-reported interview sheet.
Key exclusion criteria
Patients who did not provide informed consent.
Patients who have difficulty completing the self-reported interview sheet.
Patients deemed unsuitable for participation by the attending physician.
Patients with suspected cognitive impairment or psychological/psychiatric disorders.
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Munehide |
| Middle name | |
| Last name | Matsuhisa |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center Institute of Advanced Medical Sciences
Zip code
7700042
Address
3-18-15 Kuramoto-cho, Tokushima-city
TEL
088-633-7587
matuhisa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Sugimura |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center Institute of Advanced Medical Sciences
Zip code
7700042
Address
3-18-15 Kuramoto-cho, Tokushima-city
TEL
088-633-7587
Homepage URL
c202556006@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Munehide Matsuhisa
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kansai Electric Power Medical Research Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima-city
Tel
088-633-9294
awachiken@tokushima-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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
747
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study uses a diabetes stigma questionnaire to identify score profiles and conduct a cross-sectional analysis of the clinical characteristics associated with those profiles.
Management information
Registered date
| 2026 | Year | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069419
