UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063395 |
|---|---|
| Receipt number | R000072560 |
| Scientific Title | Analysis of Associations Between Smartwatch-Measured Daily Physical Activity, Glycemic Variability, and Insulin Requirements: A Prospective Observational Study in Children and Adolescents With Type 1 Diabetes |
| Date of disclosure of the study information | 2026/10/24 |
| Last modified on | 2026/10/23 18:43:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Daily physical activity, glucose control, and insulin requirements in children and adolescents with type 1 diabetes
Acronym
Fitbit-CGM Pediatric with Type1 Diabetes Activity Study
Scientific Title
Analysis of Associations Between Smartwatch-Measured Daily Physical Activity, Glycemic Variability, and Insulin Requirements: A Prospective Observational Study in Children and Adolescents With Type 1 Diabetes
Scientific Title:Acronym
Fitbit-CGM Pediatric Activity Study
Region
| Japan |
Condition
Condition
Type 1 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Others (Evaluation of the relationship between physical activity levels, glycemic variability, and insulin demand)
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of hypoglycemic events per day during the approximately 30-day observation period, defined as CGM glucose values below 70 mg/dL for at least 15 consecutive minutes.
Key secondary outcomes
Time in range, time below range, which includes glucose below 54 mg/dL, time above range, mean glucose, glycemic variability SD and CV, total daily insulin dose U/kg/day, post-activity glycemic and insulin dose changes during 0 to 4 and 4 to 12 hours, and age-stratified device wear time, data availability, synchronization success, missing data, and availability of steps, heart rate, and moderate-to-vigorous physical activity data.
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
Activity measurement by wearing the Fitbit Inspire 3 for approximately 30 days. No changes to insulin therapy or exercise prescriptions.
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
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 sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Yuyama |
Organization
Osaka Metropolitan University
Division name
Department of Pediatrics, Graduate School of Medicine
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3816
y-yuyama44@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Yuyama |
Organization
Osaka Metropolitan University
Division name
Department of Pediatrics, Graduate School of Medicine
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3816
Homepage URL
y-yuyama44@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Japan Association for Diabetes Education and Care
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Otemae University, Abeno Medical Clinic
Name of secondary funder(s)
JAPAN IDDM NETWORK
IRB Contact (For public release)
Organization
Osaka Metropolitan University Graduate School of Medicine Ethics Committee
Address
Asahi-cho 1-2-7, Osaka, Osaka
Tel
06-6645-3456
gr-a-knky-crb@omu.ac.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
大阪公立大学医学部附属病院小児科、あべのメディカルクリニック外来。
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 24 | 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 | 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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective observational study will enroll children and adolescents with type 1 diabetes. Participants will wear Fitbit Inspire 3 for approximately 30 days to collect daily physical activity data, including steps, moderate to vigorous physical activity, heart rate, and sleep indices. These data will be integrated with CGM and insulin delivery records to examine associations with hypoglycemic events, time in range, and total daily insulin dose. Exploratory event-based analyses will assess glycemic outcomes during 0 to 4 and 4 to 12 hours after physical activity. Data availability, synchronization success, missingness, and device wear time will also be evaluated across age groups. The study will not mandate changes to insulin therapy or physical activity.
Management information
Registered date
| 2026 | Year | 10 | Month | 23 | Day |
Last modified on
| 2026 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072560
