Tokyo, Feb. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060665) titled 'Cross-Sectional Study of Evaluating the Burden on Japanese Children with Type 1 Diabetes and Their Primary Caregivers' on Feb. 13.

Study Type: Observational

Primary Sponsor: Institute - Sanofi K. K.

Condition: Condition - Type 1 diabetes Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 2 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 Size - 500

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069385

Disclaimer: Curated by HT Syndication.