UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053732 |
|---|---|
| Receipt number | R000061168 |
| Scientific Title | Validation of the Utility of Personal Health Record for Prevention of Diabetes Onset and Progression: A Randomized Controlled Trial of Urban and Rural Residents in Kyoto, Japan |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2026/03/10 11:35:59 |
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Basic information
Public title
Validation of the Utility of Personal Health Record for Prevention of Diabetes Onset and Progression: A Randomized Controlled Trial of Urban and Rural Residents in Kyoto, Japan
Acronym
Validation of the Utility of PHR for Prevention of Diabetes Onset and Progression in Kyoto City, Japan
Scientific Title
Validation of the Utility of Personal Health Record for Prevention of Diabetes Onset and Progression: A Randomized Controlled Trial of Urban and Rural Residents in Kyoto, Japan
Scientific Title:Acronym
Validation of the Utility of Personal Health Record for Prevention of Diabetes Onset and Progression: A Randomized Controlled Trial of Urban and Rural Residents in Kyoto, Japan
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of PHR usage for diabetes on enhancing lifestyle and related indicators among urban and rural residents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in average number of step
Key secondary outcomes
Change in Time in range, Change in weight and blood pressure etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Advice on using PHR
Interventions/Control_2
Non
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents of designated areas in Kyoto City
Individuals aged 40 and above
Those whose recent blood tests, such as health examination results, show an HbA1c level of 5.6% or higher
Individuals who possess a smartphone and are capable of installing required applications
Key exclusion criteria
Patients with mental illnesses
Individuals with difficulty walking
Those deemed inappropriate by a physician (including type 1 diabetes)
Individuals who cannot understand Japanese (those who cannot communicate in Japanese)
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshida-konoecho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
0757534400
kyotophryobou@gmail.com
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Tateyama |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshida-konoecho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
0757534400
Homepage URL
kyotophryobou@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university Graduate school and faculty of medicine, ethics committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 28 | 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
101
Results
Ninety-six participants (49 intervention, 47 control; mean age 63.1 years; 31.3% rural) were analyzed. The between-group difference in the change in average daily steps (intervention - control) was 1,195 steps (95% CI: 153.5 to 2,237.2; p = 0.025). For glycemic control, the between-group differences in the change in time in range and glucose management indicator were 1.6% (95% CI: -6.50 to 3.29) and -0.01% (95% CI: -0.24 to 0.21), respectively.
Results date posted
| 2026 | Year | 03 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Personal Health Records (PHRs) integrate health checkups, medical, and lifestyle data, and are expected to support health promotion and disease prevention. However, evidence on linking PHR use with lifestyle modification and behavioral change remains limited. This study evaluated the effectiveness of a PHR-based intervention for diabetes prevention.
Participant flow
A randomized controlled trial was conducted from March 2024 to March 2025 among residents aged >=40 years in Kyoto City and surrounding areas with HbA1c >=5.6%. Participants were randomized with stratification by sex and residential area.
Adverse events
None
Outcome measures
All participants collected PHR data via a smartphone application, a wrist-worn activity tracker, and continuous glucose monitoring. The intervention group additionally received monthly lifestyle counseling by health promoters, based on PHR data visualized on a web dashboard. The primary outcome was the change in average daily steps at 3 months. Secondary outcomes included glycemic control, blood pressure, BMI, and related measures. Between-group differences in changes over time were analyzed using ANCOVA adjusted by baseline, age, and sex, residential area.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061168
