Tokyo, Oct. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063395) titled 'Daily physical activity, glucose control, and insulin requirements in children and adolescents with type 1 diabetes' on Oct. 24.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Osaka Metropolitan University

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

Objective: Narrative objectives1 - To investigate associations between daily physical activity measured with the Fitbit Inspire 3 and glycemic outcomes, including hypoglycemic events, time in range, and total daily insulin dose, in children and adolescents with type 1 diabetes. We will also examine changes in glycemic outcomes and insulin delivery during 0 to 4 and 4 to 12 hours after physical activity. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Activity measurement by wearing the Fitbit Inspire 3 for approximately 30 days. No changes to insulin therapy or exercise prescriptions.

Eligibility: Age-lower limit - 2 years-old = Gender - Male and Female Key inclusion criteria - 1 Patients with type 1 diabetes aged 2 to 18 years at enrollment. 2 Patients receiving outpatient care at Osaka Metropolitan University Hospital or Abeno Medical Clinic. 3 Regular users of continuous glucose monitoring. 4 Ability to wear Fitbit Inspire 3 and provide data for approximately one month. 5 Appropriate informed consent and assent, when applicable. Key exclusion criteria - 1. Patients judged by their attending physician to have safety concerns related to participation. 2. Patients unable to wear Fitbit Inspire 3 due to skin problems or other reasons. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 22 Day Date of IRB - 2026 Year 10 Month 22 Day Anticipated trial start date - 2026 Year 10 Month 26 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072560

Disclaimer: Curated by HT Syndication.