Cross-Sectional Study of Evaluating the Burden on Japanese Children with Type 1 Diabetes and Their Primary Caregivers

Cross-Sectional Study of Evaluating the Burden on Japanese Children with Type 1 Diabetes and Their Primary Caregivers - VOICE-T1D

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060665

Enrollment

500

Registered

2026-02-13

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Type 1 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactHaruhisa Okawa

Sanofi K. K. General Medicine Medical

haruhisa.okawa@sanofi.com080-8017-2157

Outcome results