Tokyo, March 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060852) titled 'A Study on the Effects of Bolus Increment Setting Adjustment on Glycemic Control in Advanced Hybrid Closed Loop (AHCL) Systems' on March 9.

Study Type: Interventional

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

Primary Sponsor: Institute - Tokyo Metropolitan Children Medical Center

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

Objective: Narrative objectives1 - The bolus increment is the minimum unit of bolus insulin that can be delivered during meals or for correction in an insulin pump. In the MiniMed 780G system, three settings are available: 0.025 units, 0.05 units, and 0.1 units, with the default setting being 0.1 units. Reducing the bolus increment may allow more precise adjustment of correction insulin dosing, and theoretically may enable earlier and more appropriate automated correction insulin delivery. However, no previous studies have evaluated the impact of bolus increment setting adjustment in Advanced Hybrid Closed Loop (AHCL) systems on glycemic control metrics. The purpose of this study is to clarify the effect of bolus increment setting adjustment during AHCL therapy on glycemic control metrics in children with type 1 diabetes. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Change bolus inclement

Eligibility: Age-lower limit - 2 years-old

Gender - Male and Female Key inclusion criteria - Patients who visited the Department of Endocrinology and Metabolism at Tokyo Metropolitan Children Medical Center between January 2023 and March 2028 will be eligible for inclusion. Differences in the type of rapid-acting insulin used in the insulin pump and variations in insulin pump settings will not be considered as exclusion criteria.

Inclusion Criteria: Patients diagnosed with type 1 diabetes mellitus; Patients younger than 20 years of age; Patients using the AHCL (Advanced Hybrid Closed Loop) function; Patients with both sensor usage and SmartGuard usage 70% or more; Patients or their legally authorized representatives who have received sufficient explanation of the study and provided written informed consent based on their free will and full understanding. Key exclusion criteria - Patients whose carbohydrate ratio, active insulin time, or SmartGuard target glucose settings were changed during the study period. Patients whose insulin preparation was changed during the study period. Patients who developed thyroid dysfunction during the study period. Patients who are considered inappropriate for participation in the study by the principal investigator for any other reason. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 06 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069627

Disclaimer: Curated by HT Syndication.