UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061488 |
|---|---|
| Receipt number | R000070350 |
| Scientific Title | Self-care behaviors and healthcare app utilization for diabetes prevention and management: a mixed-methods study using questionnaires and log data |
| Date of disclosure of the study information | 2026/05/08 |
| Last modified on | 2026/05/08 11:00:15 |
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Basic information
Public title
Self-care behaviors and healthcare app utilization for diabetes prevention and management: a mixed-methods study using questionnaires and log data
Acronym
Self-care behaviors and healthcare app utilization for diabetes prevention and management: a mixed-methods study using questionnaires and log data
Scientific Title
Self-care behaviors and healthcare app utilization for diabetes prevention and management: a mixed-methods study using questionnaires and log data
Scientific Title:Acronym
Self-care behaviors and healthcare app utilization for diabetes prevention and management: a mixed-methods study using questionnaires and log data
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current status of self-care behaviors and healthcare app utilization for diabetes prevention and management in Japan.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Self-care behaviors aimed at diabetes prevention and management (health maintenance)
2.Smartphone healthcare apps utilization aimed at diabetes prevention and management (health maintenance)
Key secondary outcomes
1.Reasons for not using / discontinuing use / using smartphone healthcare apps aimed at diabetes prevention and management (health maintenance)
2.Participation rate in specific health guidance and diabetes prevention programs
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Healthy individuals]
1.Aged 30-74 years
2.Underwent health checkup in the past year
3.Able to confirm health checkup results
4.Fasting blood glucose < 110 mg/dl and HbA1c < 6.5%
5.Consented to participate in the study
[Pre-diabetes]
1.Aged 30-74 years
2.Underwent health checkup in the past year
3.Able to confirm health checkup results
4.Fasting blood glucose 110 to <126 mg/dl and HbA1c < 6.5%
5.Consented to participate in the study
[Diabetic patients]
1.Aged 30-74 years
2.Currently receiving treatment for diabetes
3.Consented to participate in the study
Key exclusion criteria
[Healthy individuals and Pre-diabetes]
1.History of diabetes or dementia
2.Currently taking blood glucose lowering medication, or unknown medication status
3.Hospitalized in the past year
4.Missing outdoor activity log info for the past year or smartphone healthcare app info
[Diabetic patients]
1.History of dementia
2.Hospitalized in the past year
3.Missing outdoor activity log info for the past year or smartphone healthcare app info
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Nishi |
Organization
INTAGE Healthcare Inc.
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL
03-5294-8393
nishi-r@intage.com
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Nishi |
Organization
INTAGE Healthcare Inc.
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL
03-5294-8393
Homepage URL
nishi-r@intage.com
Sponsor or person
Institute
INTAGE Healthcare Inc.
Institute
Department
Personal name
Ryosuke Nishi
Funding Source
Organization
INTAGE Healthcare Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
PLAMED Inc.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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 | 05 | Month | 08 | 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 | 04 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070350
