UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060665 |
|---|---|
| Receipt number | R000069385 |
| Scientific Title | Cross-Sectional Study of Evaluating the Burden on Japanese Children with Type 1 Diabetes and Their Primary Caregivers |
| Date of disclosure of the study information | 2026/02/13 |
| Last modified on | 2026/02/13 09:59:45 |
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Basic information
Public title
Cross-Sectional Study of Evaluating the Burden on Japanese Children with Type 1 Diabetes and Their Primary Caregivers
Acronym
VOICE-T1D
Scientific Title
Cross-Sectional Study of Evaluating the Burden on Japanese Children with Type 1 Diabetes and Their Primary Caregivers
Scientific Title:Acronym
VOICE-T1D
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the health and diabetes-related quality of life (QOL) of children with type 1 diabetes and their primary caregivers. In addition, to evaluate the level of diabetes-related burden among primary caregivers and their perceived level of social support, including accessibility to support in daily life and treatment, as well as satisfaction with that support.
Basic objectives2
Others
Basic objectives -Others
The following questionnaires will be used for evaluation.
PedsQL Generic Core Scales
PedsQL 3.2 Diabetes Module
SF-8
PDQOL
F-Burden
SSQ6
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Using the following questionnaires, assess the health and diabetes-related quality of life (QOL) of children with type 1 diabetes and their primary caregivers.
PedsQL Generic Core Scales
PedsQL 3.2 Diabetes Module
SF-8
PDQOL
In addition, using the following questionnaires, evaluate the level of diabetes-related burden among primary caregivers and their perceived level of social support.
F-Burden
SSQ6
Key secondary outcomes
To evaluate the associations between scores on the PedsQL Generic Core Scales and the PedsQL 3.2 Diabetes Module in children with type 1 diabetes and scores on the SF-8 and PDQOL in their primary caregivers.
To summarize the demographic characteristics of children with type 1 diabetes and their primary caregivers, as well as baseline diabetes-related characteristics of the children with type 1 diabetes.
To assess the associations between demographic characteristics and diabetes-related characteristics of children with type 1 diabetes and scores on the PedsQL Generic Core Scales, PedsQL 3.2 Diabetes Module, SF-8, PDQOL, F-Burden, and SSQ6.
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
| 2 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with Type 1 Diabetes who meet all of the following criteria:
Patients diagnosed with type 1 diabetes before the age of 18
Patients aged 2 to 22 years at the time of obtaining informed consent
Patients for whom informed consent has been obtained from the patient themselves (if aged 18 years or older) or from a parent/legal guardian (if under 18 years of age)
Patients currently receiving insulin therapy
Primary Caregivers who meet all of the following criteria:
A primary caregiver who lives with a child with type 1 diabetes who is enrolled in this study and who meets all inclusion criteria and does not meet any exclusion criteria
A primary caregiver who has provided informed consent
Key exclusion criteria
Children with Type 1 Diabetes who meet any of the following criteria:
Patients who are participating in another interventional clinical trial (Participation in other observational studies does not preclude enrollment in this study.)
Patients who do not live with their primary caregiver
Patients for whom informed consent cannot be obtained from their primary caregiver
Patients who are not receiving insulin therapy
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuri |
| Middle name | |
| Last name | Shiraki |
Organization
Sanofi K. K.
Division name
General Medicine Medical
Zip code
163-1488
Address
Tokyo Opera City Tower, 20-2 Nishi-Shinjuku 3-chome, Shinjuku-ku, Tokyo
TEL
080-8007-0077
yuri.shiraki@sanofi.com
Public contact
Name of contact person
| 1st name | Haruhisa |
| Middle name | |
| Last name | Okawa |
Organization
Sanofi K. K.
Division name
General Medicine Medical
Zip code
163-1488
Address
Tokyo Opera City Tower, 20-2 Nishi-Shinjuku 3-chome, Shinjuku-ku, Tokyo
TEL
080-8017-2157
Homepage URL
haruhisa.okawa@sanofi.com
Sponsor or person
Institute
Sanofi K. K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K. K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS
Address
5-20-9-401 Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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 | 02 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Target sample size is 500 pairs. (500 children with type 1 diabetes and their 500 primary caregivers)
Management information
Registered date
| 2026 | Year | 02 | Month | 13 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069385
