UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063047 |
|---|---|
| Receipt number | R000071088 |
| Scientific Title | Verification of the Efficacy of a Diabetes Self-Management Support App for Patients with Diabetes Receiving Home-Based Care: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/24 17:55:55 |
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Basic information
Public title
Effectiveness of a Diabetes Self-Management Support App for home-based patients with diabetes
Acronym
Effectiveness of Diabetes Self-Management Support Apps
Scientific Title
Verification of the Efficacy of a Diabetes Self-Management Support App for Patients with Diabetes Receiving Home-Based Care: A Randomized Controlled Trial
Scientific Title:Acronym
Verification of the Efficacy of a Diabetes Self-Management Support App for Patients with Diabetes Receiving Home-Based Care
Region
| Japan |
Condition
Condition
Type 2 diabetic patient
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine, through a randomized controlled trial, whether the use of a diabetes self-management support app developed by the applicants influences the self-management behaviors and awareness of patients with diabetes receiving home-based care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese translated the Summary of Diabetes Self-Care Activities Measure
The exercise self-efficacy scale for diabetes self-care
The self-efficacy scale for diabetes self-care
Diabetes Mellitus Dietary. Self Efficacy Scale
Japanese version of the Treatment Self-Adjustment Questionnaire for Diabetics
Key secondary outcomes
Changes in weight, blood pressure, blood glucose levels, HbA1c, and eGFR
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Conventional health guidance and the use of Diabetes Self-Management Support Apps
Interventions/Control_2
Conventional health counseling only
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study is intended for patients who meet all of the following criteria:
1. Patients aged 20 to 80 years
2. Patients with type 2 diabetes attending the University Hospital, Hamamatsu University School of Medicine
3. Patients who have provided informed consent to participate in this study by signing a consent form
4. Patients who use a smartphone on a daily basis
5. Patients who can speak and read Japanese
Key exclusion criteria
Patients who meet any of the following criteria shall be excluded from this study.
1. Patients with an infectious disease
2. Patients with type 1 diabetes
3. Patients with diabetic nephropathy at stage 3 or higher
4. Patients currently undergoing treatment for a malignant tumor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keigo |
| Middle name | |
| Last name | Inagaki |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Nursing
Zip code
431-3192
Address
1-20-1 Handayama,Chuo-ku,Hamamatsu, Shizuoka, Japan
TEL
053-435-2511
kinagaki@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Keigo |
| Middle name | |
| Last name | Inagaki |
Organization
Hamamatsu University School of Medicine
Division name
Faculty of Nursing
Zip code
431-3192
Address
1-20-1 Handayama,Chuo-ku,Hamamatsu, Shizuoka, Japan
TEL
053-435-2511
Homepage URL
kinagaki@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama,Chuo-ku,Hamamatsu, Shizuoka, Japan
Tel
053-435-2511
kinagaki@hama-med.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
| 2026 | Year | 09 | Month | 30 | 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 | 09 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 28 | 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 | 09 | Month | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071088
