UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060852 |
|---|---|
| Receipt number | R000069627 |
| Scientific Title | A Study of the Association Between Bolus Increment Settings and Glycemic Metrics in Pediatric Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System |
| Date of disclosure of the study information | 2026/03/09 |
| Last modified on | 2026/03/06 17:26:49 |
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Basic information
Public title
A Study on the Effects of Bolus Increment Setting Adjustment on Glycemic Control in Advanced Hybrid Closed Loop (AHCL) Systems
Acronym
Pediatric T1D AHCL Bolus Increment Study
Scientific Title
A Study of the Association Between Bolus Increment Settings and Glycemic Metrics in Pediatric Type 1 Diabetes Using an Advanced Hybrid Closed-Loop System
Scientific Title:Acronym
Bolus Increment Adjustment and Changes in Glycemic Metrics in an Advanced Hybrid Closed-Loop System
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in TIR from one month before to two months after bolus increment reduction during AHCL therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Change bolus inclement
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 2 | years-old | <= |
Age-upper limit
| 18 | 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 sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nagata |
Organization
Tokyo Metropolitan Children Medical Center
Division name
Department of Endocrinology and Metabolism
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
042-300-5111
g19056moana@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Nagata |
Organization
Tokyo Metropolitan Children Medical Center
Division name
Department of Endocrinology and Metabolism
Zip code
183-8561
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
TEL
042-300-5111
Homepage URL
g19056moana@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Children Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Children Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Children Medical Center
Address
2-8-29 Musashidai, Fuchu, Tokyo, Japan
Tel
042-300-5111
g19056moana@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069627
