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A Study on the Effects of Bolus Increment Setting Adjustment on Glycemic Control in Advanced Hybrid Closed Loop (AHCL) Systems

A Study of the Association Between Bolus Increment Settings and Glycemic Metrics in Pediatric Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System - Bolus Increment Adjustment and Changes in Glycemic Metrics in an Advanced Hybrid Closed-Loop System

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060852
Enrollment
50
Registered
2026-03-09
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Type 1 diabetes

Interventions

Change bolus inclement

Sponsors

Tokyo Metropolitan Children Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Changes in TIR from one month before to two months after bolus increment reduction during AHCL therapy.

Countries

Japan

Contacts

Public ContactTomohiro Nagata

Tokyo Metropolitan Children Medical Center Department of Endocrinology and Metabolism

g19056moana@yahoo.co.jp042-300-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026